en Living With HIV SHE: Celebrating Wom ncy Resource APP: NAM’s New Pregna r Sheena McCormack PrEP: Talk with Professo
Autumn 2013: issue 17
www.baseline-hiv.co.uk
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This autumn National AIDS Trust (NAT) has launched a terrific new resource called My Care, My Voice for people living with HIV in England www.mycaremyvoice.org.uk. It’s a great, easy-to-navigate website which not only explains what you can expect from a range of clinical and other services but outlines your rights, making it easier for you to make a case to get exactly what you are entitled to from your care. NAM has recently launched smartphone apps about contraception and conception. Chris O’Connor interviews NAM Editor Roger Pebody in this issue. We’re running features on the SHE Programme, an empowerment programme for women living with HIV, which is being rolled out across Europe and we spoke with the Medical Research Council’s Professor Sheena McCormack about the PROUD Study, currently enrolling at risk HIV negative people to see if taking a daily Truvada pill plus condom use can provide protection against acquiring HIV. It’s halfway enrolled so if you know any suitable trial participants, please show them the interview. With all the recent changes to the NHS structure and changes to the foundations of HIV services underway we spoke with a number of experts to ask them what opportunities the new NHS offers to ensure we get equitable care regardless of living in London, Luton or Lowestoft. It looks like many HIV clinics will close or evolve the ways they deliver care so its really important we feed into any consultations to ensure commissioners hear what kind of care is important to us and we can play our part to ensure the great outcomes that have been achieved in HIV are not compromised. Follow us on Twitter @BASELINETWEET and please join the BASELINE Group on Facebook. If you can’t find the group please drop me an email at robert@baseline-hiv.co.uk
In this issue 4 bylines 6 letters 8 headline: UK news 14 headline: global news 16 PROUD study interview 20 nam pregnancy app 24 equity in healthcare 30 testing times 32 chris morgan 34 hotline 36 headline:HIV treatment news 40 SHE programme 44 hepatitis section 60 myline: Thandi Haruperi 62 i-base Q and A 64 home HIV testing 66 myline: a London lass
Contact the team: Editor: Robert Fieldhouse robert@baseline-hiv.co.uk Associate Editor: Jane Phillips editor@baseline-hiv.co.uk News Editor: Chris O’Connor chris@baseline-hiv.co.uk
Autumn 2013
Editorial Administrator: Tom Matthews Proof reader / Social Networking Michael Duggan / Rebecca Gibson Designer: Gareth Williams Intern: Daniel Jon
For magazine and web advertising please contact robert@baseline-hiv.co.uk Copyright of all articles remains with the publisher. All other rights recognised. Views expressed by individual contributors are not necessarily those of the publisher. The mention, appearance or likeness of any person or organisation in articles or advertising in BASELINE is not to be taken as any indication of health, HIV status or lifestyle.
www.baseline-hiv.co.uk
Deadlines for the next issue Copy 15/11/2013 Advertising 22/11/2013
Robert Fieldhouse has been working and volunteering in the HIV sector since 1997.
Rebecca McDowall is a Treatments Officer and Distribution Manager at HIV i-base.
Jane
Gemma Peppé is Events and Campaigns
Phillips spends her time Tweeting, Facebooking and fiddling about with words. Looking forward to another exciting year growing with BASELINE. CHECK us out on Twitter @ baselinetweet and on Facebook by joining our group BASELINE.
Manager at The Hepatitis C Trust. Before working at the charity she worked as a music agent and studied film and documentary research at London College of Printing. She is currently making her second documentary Catching The Virus which chronicles her experience on a clinical trial.
Chris O’Connor covers issues from the wine trade to the trade in counterfeit medicine. Busily attending medical conferences and scouting for the latest stories.
Thandi Haruperi is the Director of RestorEgo, an accomplished advocate, trainer, public speaker and motivator.
Chris Morgan is the man behind Compass, the
Lisa Power is Policy Director at Terrence Higgins
gay financial advisers and Unusual Risks, the HIV financial advisers. He has been at the forefont of HIV financial issues for over a decade and co-wrote the HIV and insurance guidelines that the life assurance industry uses today.
Trust.
Joel Korn qualified as a counsellor in 2008 and is a member of the BACP. He offers confidential counselling and group therapy; his specialisms being intercultural relationships, sexuality and HIV. Currently Joel works at River House Trust as a member of the Support and Development Team. Autumn 2013
Roy Kilpatrick has worked in HIV policy, prevention and addictions since 1989 and writes in his own blog, scotfreehiv, and forpositivelite. com. He has contributed on behalf of people living with HIV to national health promotion campaigns, HIV standards and strategic planning with NHS and Government bodies, and was a founding member of Gay Men’s Health.
www.baseline-hiv.co.uk
iStayHealthy the free mobile health app Launched in early 2011 with more than 3,000 downloads to date • Record and review essential blood results (CD4/Viral Load) • Manage and record current medications (anti-retroviral as well as non-HIV meds) • Provide reminders to take medications regularly and on time
A tool for people living with HIV available for Apple and Android mobile users. blogs.poz.com/iStayHealthy
Email your letter to: editor@baseline-hiv.co.uk
Dear Robert Just writing to say how much I enjoyed the last issue. Glad to see some coverage about PrEP. It’s an issue that many find confusing. Any chance of a more detailed piece? Name and address withheld Editor responds: Sure. BASELINE’s news editor Chris O’Connor did a longer interview with Professor Sheena McCormack who is one of the lead investigators for the PROUD study. Hope that helps to shed some more light on the issue.
Hi Robert Any chance of something on living with HIV, hep C and haemophilia? Editor responds: This is something that we are working on publishing in a future issue.
Autumn 2013
Hi there Do you accept articles written by people living with HIV? I was diagnosed in 2011 and have just started treatment (and am feeling much better). Is this the kind of thing you’d want? Editor responds: Thanks for contacting us. We always welcome personal, or opinion pieces from people living with HIV. We have a small group of columnists who write regularly but if you fancy submitting a 500-600 word piece about your personal experience we’ll consider publishing in a future issue. You can send the copy to editor@baseline-hiv.co.uk
Hello BASELINE I really enjoyed the up-front, honest and inspiring articles on taking hepatitis C treatment by Jim and Martin. I too have done pegylated interferon and ribavirin – and cleared- it was challenging, to say the least but I got through it with support from my family and friends. Please can we have more personal pieces like this? Editor responds: We are running a fascinating piece in this issue from Gemma Peppé of the Hepatitis C Trust. She has recently taken part in the AbbVie interferon free trial and I’m sure many of you will find her experience, inspiring, heartfelt and uplifting. Enjoy.
www.baseline-hiv.co.uk
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Chris O’Connor
news: UK MRC Recruiting to Two Vaccine Studies
Late diagnosis improving in Europe
The Medical Research Council is looking for HIV negative people to take part in two HIV vaccine trials The first will give participants three different vaccines; DNA, MVA and gp140. MVA has been widely used as a vaccine against smallpox. It is not possible to catch HIV from the vaccines. Researchers will test two different courses of vaccination. The main aim of the study is to shorten the course of vaccination. You will need to be 18-45, HIV negative and at low risk of acquiring HIV, willing to have asexual health screen, not pregnant and using contraception. People qualify to receive £1300 or £1700 depending which arm of the study you are assigned to. The second study will test three HIV DNA vaccinations administered through intramuscular, intradermal (through the top layer of skin on upper arm and transcutaneously (a needle free method to deliver the vaccine through the skin). The trial will last 6 months with at least 11 clinic visits. There is no risk of acquiring HIV from this vaccine. For your time you will receive £100 per clinic visit- up to £1100 over the course of the study. For more information contact Dr C Bryn Jones or Kristen Kuldanek on 020 3312 6047.
The late diagnosis of HIV and its consequences have been looked at in the European-wide COHERE study of 85,000 HIV positive individuals in 35 countries. Late diagnoses fell overall from 57% to 52% from 2000 to 2010/11 – but it increased over time for people who inject drugs (PWID) – men and women - from Southern and Eastern Europe. Of the group, 54% of the COHERE participants were late presenters; defined as having a CD4 below 350 or receiving an AIDS diagnosis 6 months after an HIV diagnosis. In Europe, 40-60% of HIV positive individuals are not diagnosed until they have a low CD4 count or an AIDS-defining illness. Reasons for such late presentation include fear of discrimination or stigmatization, limited knowledge about HIV risk factors, testing, and treatment together with missed opportunities to offer an HIV test. Among the 84,524 individuals in COHERE 8,187 developed a new AIDS-defining illness or died during follow-up. Late presentation was associated with an increased incidence of AIDS/ death in all regions of Europe during the first and second year after HIV diagnosis - but not in later years; the largest increase in incidence, by a factor of 13, occurred during the first year after diagnosis in Southern Europe. See www.eurocoord.net
Wig Party Does Masked Ball
The annual Wig Party is back raising funds for NAT. It will be held at the Café de Paris in London on Sunday 27th October. Event organizer Josh Rafter said, “The ball is a more low key version of the Wig Party. People can come along but without a full-on costume. It’s a great way to hang out with your mates and meet new people. Deborah Jack, chief executive of NAT said, “ We are very excited to be working with the Wig Party again. The event really will be a celebration of life. This year the party has a Halloween theme. Tickets are on sale now from www.wigparty.org/maskedball/tickets 08
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Autumn 2013
Ph.D certified Proof-reading General service offered with specialisation in academic theses, articles, papers, websites and university / job applications. Your requirements will be satisfied, whether a simple check or comprehensive restructuring. Competitive rates. Contact: michaelduggan3@hotmail.com
KPS Trebullom is a Respite and Retreat B&B for people affected by HIV set in the Cornish countryside. Our recent award from the Big Lottery Fund enables us to offer KPS Enabling Futures Project Adult Personal Development Breaks 3 nights/4 days full board accommodation. For HIV+ clients who are thinking about returning to work, retraining or volunteering, who would like to know how the changes to the benefits system will affect them, and who would gain from attending workshops to help them move forward.
Leeds Skyline is committed to providing quality services for anyone living with or affected by HIV living in Leeds. Our support service includes: 121 emotional support, advice, information and advocacy on a number of issues including HIV medication, housing, benefits. We also offer practical support and befriending on discharge from hospital. We provide a number of support groups, drop-in sessions and workshops to help improve your well being and support you to develop coping strategies. We offer complementary therapies City centre venue. Confidential and welcoming environment. Please contact us for further information: Tel: 0113 2449767 Email: leedsskyline@theBHA.org.uk Web: www.leedsskyline.org.uk Twitter: @BHAleedsSkyline
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Workshops on: Changes to the benefits system – what to expect Disclosing status – how best to do it The Equality Act 2010 – understand your rights Moving towards voluntary work or employment Plus a therapy, craft workshop and trip All fully funded Summer Camps For children aged 5 – 15 and one parent/ guardian. Fully funded weekend activity breaks
T: 01566 86378 E: sjarvis@kpsdirect.com www.kpsdirect.com 17
news: UK
London Lighthouse Up For Sale The Lighthouse in West London, owned and managed by Terrence Higgins Trust (THT) has been put up for sale. It is expected offers could go as high as £1.6m. The Lighthouse in Ladbroke Grove played a huge part in the story of HIV/AIDS in the UK, with its residential unit and the outstanding care that was provided for people living - and dying - with HIV/AIDS. Paul Ward, deputy chief executive at Terrence Higgins Trust, said: “Unfortunately, with ongoing pressure on our finances, we cannot afford to give the building the refurbishment it deserves. Therefore, a decision has been made to close the centre and sell the freehold.” Because the building is registered as an asset of community value, community groups who are interested in bidding will have up to six months to fundraise and enter a bid from September 6. As a charity, THT are legally obliged to accept the highest amount offered. It is thought that bids are being considered from one of the current tenants, the Chelsea and Kensington Social Care Council, and interest from White Eagle Lodge spiritual healing group and a Buddhist group. HIV user groups, such as Str8 Talk and Positive Ageing Forum (PAF) hope to continue to meet at the Lighthouse. Gavin Crymble chair of the PAF said, “We hope that the new owners of Lighthouse put HIV positive people central to their services and breathe new life into the place. THT say only 100 people use the Lighhouse – there’s a lot more than that. Recently it has been run into the ground.’ The award-winning Lighthouse memorial garden has been open to the public for 30 years, and contains the ashes of many people who died 10
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at the Lighthouse scattered and commemorated there. Its future under a new owner is uncertain. The London Lighthouse opened in 1988 and was the first major centre for people with HIV/ AIDS offering respite and terminal care in its residential unit, day care and drop in services. The residential unit closed in 1998, and London Lighthouse and Terrence Higgins Trust merged in 2000 - described at the time by Nick Partridge as the merger of the two biggest and highest profile of HIV organisations. The Lighthouse was at the epicentre of the epidemic. Rob Boylan a therapist at Lighthouse from 1990 to 2001, recalls that there were times of incredible intensity in the building; ‘Whenever someone died in the residential unit, candles would be lit and put on the reception desk; often four or five candles were lit. During the darkest of days the Lighthouse was a beacon of hope and respite.’ The unit, though visitied by celebrities such as Princess Diana and Liz Taylor, had over 1700 people passing through its doors each week during its heyday. Gary Eisenhauer has worked in the Lighthouse garden from the beginning in 1986 and told BASELINE that they had lost track of how many people had been commemorated in the garden by having their ashes spread there. ‘People also sneaked ashes in and had little impromptu services. It was and still is an oasis for people. We have groups from all over the world coming here at one time. Yesterday we had a bus load of pensioners, who brought sandwiches and sat in the garden, I told them about what happened here. The Lighthouse is part of our history.’ +++-
Autumn 2013
Chris O’Connor
Monkey vaccine partially effective
A vaccine for the monkey equivalent of HIV appears to protect a proportion of monkeys acquiring SIV, new research suggests. In 50 per cent of the monkeys in the trial SIV (simian immunodeficiency virus) did not take hold. The researchers gave rhesus macaque monkeys the vaccine, and then exposed them to SIV. The researchers are now testing the vaccine to see if it can be used after SIV exposure to treat and potentially cure SIV positive monkeys. The vaccine is based on another virus called cytomegalovirus (CMV), which belongs to the herpes family – the CMV used has been attenuated - modified to lose its virulence to the point where it is safe. However enough of the infectious power of CMV is retained to sweep throughout the body. But instead of causing disease, it has been modified to spur the immune system into action to fight off the SIV molecules. “It maintains an armed force, that patrols all the tissues of the body, all the time, indefinitely,” explained Prof Picker, whose team conducted the research. The trial was conducted in 16 monkeys and the vaccine was effective in nine of them. The steps through to human trials will be at least two years. Commenting on the research, Dr Andrew Freedman, from Cardiff University School of Medicine, said: “This suggests that prophylactic vaccines - vaccines designed to prevent infection - using CMV vectors may be a promising approach for HIV.” “While they may not prevent the initial infection, they might lead to subsequent clearance, rather than the establishment of chronic infection.” www.baseline-hiv.co.uk
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Sir Nick Partridge to leave THT
Sir Nick Partridge, the chief executive of Terrence Higgins Trust (THT), is to step down after nearly thirty years at the charity. Sir Nick joined Terrence Higgins Trust as its first paid member of staff in 1985 when it operated out of a small London office. THT is now the largest HIV and sexual health charity in Europe with 270 staff, and an annual turnover of just over £20 million. Sir Nick Partridge said: ‘It’s been an extraordinary three decades, and a privilege to serve such a remarkable charity as chief executive. Having led Terrence Higgins Trust through its 30th anniversary, the time feels right for me to move on to other challenges.’ Professor Christopher Bones, Chair of Trustees of Terrence Higgins Trust said: ‘We are hugely grateful to Sir Nick for his enormous contribution to Terrence Higgins Trust over the last three decades. Our environment is one of continual change and we know that the future holds significant challenges. The Board is now looking for the next chief executive to lead Terrence Higgins Trust to 2020 and beyond.’ From 1st November, Paul Ward, currently deputy chief executive at the Trust, will become acting chief executive. ++
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Chris O’Connor
news: UK Ban lifted on HIV positive healthcare workers
‘Outdated’ was the Chief Medical Officer’s (CMO) recent verdict on some of the rules around HIV prevention. Doctors, nurses and other healthcare workers with HIV, who are on treatment, will be able to take part in some procedures from which they are currently banned. The CMO also decided that home testing kits, once they comply with regulations will now be made available. According to the UK government the changes on positive healthcare workers will bring the UK in line with other Western European countries. According to the CMO statement there is more chance of being struck by lightning than a patient acquiring HIV from a positive healthcare worker. There is no record of any individual in the UK becoming HIV positive in this way, and only four cases worldwide of clinicians passing the virus on to patients, and the last of these was more than a decade ago. Strict rules on treatment, monitoring and testing for HIV positive healthcare workers will be in place to ensure safety according to the Department of Health. It is understood a confidential system is for recording HIV treatment and status being worked on by the Department of Health. Deborah Jack, chief executive of the National Aids Trust welcomed the changes, ‘.... (this change) corrects the current guidance which offers no more protection for the general public but keeps qualified and skilled people from working in the career they had spent many years training for.’ Public Health England will now put in place a programme to register and monitor healthcare workers who have HIV to ‘ensure they are able to perform certain procedures when appropriate.’ 12
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HIV Testing Week
HIV Prevention England and THT will launch the second annual HIV Testing Week from 22nd -29th November. This year will see the launch of the first ever European HIV Testing Week, running at the same time. The week is being coordinated by HIV in Europe. Sexual health clinics, community-based testing services and national and local HIV charities and support groups are being invited to take part in the week in a bid to improve testing rates among groups at an increased risk of HIV. For further information, or to take part, please email sara.paparini@tht.org.uk. Check out www.hivitestingweek.eu
‘Disaster’ in Public Health Appointments Three councils in England have appointed heads of their new public health directorates even though they have no training in public health. The Faculty of Public Health (FPH) says moves such as these will undermine the recruitment and retention of public health doctors and branded the appointments a ‘disaster’. In April of this year responsibility for public health in England moved from primary care trusts to local authorities, with many public health doctors roles transferred from the NHS to councils. Public health, in two of the authorities, has been wedded with social services. FPH president John Ashton said that the emerging trend of combining public health with social services would undermine public health, especially as these combined services are being headed up by people with a background in social services. +++-
Autumn 2013
Join NAT’s HIV Activists Network A virtual group of people - passionate about the rights of people living with HIV in the UK.
• Choose from a range of e-campaigns focussing on different issues • Tell us about the issues in your area for targeted local campaigning • In less than 10 minutes each month, you can influence change, stay informed and make a difference Find out more about the network, current campaigns and sign up online at:
www.lifewithHIV.org.uk
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13/08/2012 15:20:37
news: Global WHO Recommend Earlier Treatment
Positive Segregation in Alabama Prison to Stop
The U.S. state of Alabama is to end its policy of segregating HIV positive prisoners at one of its prisons. On August 1, 8 HIV positive female inmates were transferred to the general prison population from the Julia Tutwater Prison for Women. Similar changes will happen in the male prisons in 2014. By segregating HIV positive prisoners a US District Court rules that they faced fundamental discrimination including involuntary disclosure of HIV status to family, staff and other prisoners, loss of liberty by assignment to higher security prisons, denial of work and education opportunities. Court documents in the case indicate that steps will be taken to maintain the confidentiality of inmates who are HIVpositive and will have a “zero tolerance” policy for any threats or abuse directed at those inmates. The documents also indicate the department will conduct mandatory staff and inmate education sessions on HIV. 14
New HIV treatment guidelines by WHO recommend offering antiretroviral therapy (ART) earlier. Recent evidence indicates that earlier ART will help people with HIV to live longer, healthier lives, and substantially reduce the risk of transmitting HIV to others. The move could avert an additional 3 million deaths and prevent 3.5 million more new HIV infections between now and 2025. The new recommendations are presented in WHO’s “Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection”, as new data reveal a total of 9.7 million people were taking these lifesaving drugs at the end of 2012. “These guidelines represent another leap ahead in a trend of ever-higher goals and ever-greater achievements,” says WHO Director-General Dr Margaret Chan. “With nearly 10 million people now on antiretroviral therapy, we see that such prospects – unthinkable just a few years ago – can now fuel the momentum needed to push the HIV epidemic into irreversible decline.” The new recommendations encourage all countries to initiate treatment in adults living with HIV when their CD4 cell count falls to 500 cells/mm³ or less – when their immune systems are still strong. The previous WHO recommendation, set in 2010, was to offer treatment at 350 CD4 cells/ mm³ or less. 90% of all countries have adopted the 2010 recommendation. A few, such as Algeria, Argentina and Brazil, are already offering treatment at 500 cells/mm3. WHO has based its recommendation on evidence that treating people with HIV earlier, with safe, affordable, and easier-to-manage medicines can both keep them healthy and lower the amount of virus in the blood, which reduces the risk of passing it to someone else. If countries can integrate these changes within their national HIV policies, and back them up with the necessary resources, they will see significant health benefits at the public health and individual level, the report notes.
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Autumn 2013
Chris O’Connor
Uganda Says No to PrEP
Recent developments in Uganda highlight some of the issues around the use of Pre Exposure Prophylaxis, taking a pill to prevent HIV. A sub study of the Partners trial funded by the Gates Foundation recruited 4,758 sero-different couples, randomized to tenofovir, Truvada (FTC/ tenofovir) or placebo. The study was halted after 18 months because of significant differences in HIV transmission rates among the groups. 78 infections were recorded, 18 in the tenofovir group, 13 in Truvada group and 47 in the placebo arm; providing up to 73% protection against the placebo group. Now a recent sub study of Partners, published in PLOS, saw researchers using unannounced home-based pill counts and electronic pill bottle monitoring to actively monitor the participants’ adherence. In total, 1,147 HIV negative participants were enrolled in three Ugandan sites of the Partners PrEP Study. Every participant had an HIV positive partner, and if their unannounced pill count adherence was below 80%, they would receive counseling on how and why to continue taking the pills. In this particular study, adherence was very high - at 99% in unannounced pill counts and 97% via electronic monitoring - and resulted in only 14 participants becoming HIV positive. All of these individuals were on a placebo drug. However the Ugandan Health Ministry has rejected the PrEp strategy citing high costs and fears that it would lead to ‘increased promiscuity’, according to the allAfrica website. Despite continued promotion of abstinence and condoms, national statistics show that 74,400 (60%) of the 124,000 annual new infections in Uganda occur in stable relationships between HIV discordant couples. Dr. Alex Ario, the antiretroviral therapy (ART) programme coordinator, says a new policy in the ministry prohibits introduction of the PreExposure Prophylaxis. Instead, the ministry has maintained the current treatment strategy, which www.baseline-hiv.co.uk
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focuses on post-exposure prophylaxis (PEP) and providing ARVs to people living with the virus. Dr. Ario also explained that it was not viable to provide drugs to people who do not have HIV, yet many of those who are living with the virus have no access ARVs. “Our guidelines do not recommend it (Truvada) anymore, not because it is a bad drug, but because it is expensive,” Ario explained. “We decided that instead of giving drugs to an HIV negative partner in a discordant relationship, for example, we concentrate on giving ARVs to an HIV positive partner.” Currently, more than half of the money sourced for HIV/AIDS work in Uganda goes to care and treatment. Yet, over half of the 710,000 HIV positive Ugandans eligible for ARVs cannot get them because, officials say, funds are inadequate. However, Lillian Kentutsi, the chairperson of the National Forum of People Living with HIV/AIDS Networks (NAFOPHANU), called the argument irrelevant. “Whoever has done that (rejected PrEP) has not considered the consequences to the discordant couples who participated in our study, the time and sacrifice people put in the research,” Ssebunya said. “We are not saying every person who is HIV negative should be given the drug. We have known discordant couples that must be supported. It is not about being promiscuous. People living with HIV must be able to protect their partners.” Prof. Elly Katabira, who also worked on the PrEP study in 2011, has no problem with the Government rejecting the prevention strategy. He says there are other equally effective measures like abstinence and condoms, which discordant couples can use, and “besides the Government has to have priorities.” “Effectiveness of the drug (Truvada) has been approved, but the health ministry can offer only what it can afford. If the Government cannot afford it, there are other prevention measures like abstinence,” Katabira told allAfrica. ++
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PrEP - Gets Real? PrEP is a pill taken to prevent HIV infection. In some clinical trials it works – it’s up to 90% effective - if taken every day. What does this mean in practice? That is why a number of ‘real world’ trials of Pre-Exposure Prophylaxis (PrEP) are taking place internationally. How will this concept – a daily pill, Truvada, for prevention and not treatment - work or is it even wanted? ARVs for HIV negative at-risk individuals is a divisive issue in HIV prevention, intensely debated in some quarters - largely ignored in others. Critics point to challenges around adherence, risk of more unprotected sex, access to and cost of PrEP. Others see PrEP as an additional prevention tool against a rising tide of new HIV infections. Now demonstration trials will evaluate PrEP in the ‘real world’. PROUD is a UK two-year pilot trial examining the impact on men who have sex with men, taking a Truvada pill daily (tenofovir/emtricitabine). Recruiting 500 volunteers, across England, who will be placed into one of two groups; one will use PrEP from the start; the other will wait 12 months before starting. BASELINE talked to Professor Sheena McCormack, Lead Investigator on the PROUD trial. Sheena is a HIV doctor at the Dean Street clinic in London and a clinical trial specialist at the Medical Research Council. BASELINE: Do we need PrEP? McCormack: We need something, given the rising number of new diagnoses every year. The majority of infectious people in the community, according to Public Health England, are people who are not aware of their HIV status, so we need new and better ways to engage with people who are HIV negative. We have condoms, we have 16
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universal access to HIV testing, and post-exposure prophylaxis, but these are not enough. In many different contexts, for many reasons, people will want sex without a condom. We do people a disservice if we can’t acknowledge that - we need other prevention tools in addition to condoms. BASELINE: Is this a major issue with PrEP - that it dilutes the message on condom use? McCormack: Clinics and advocacy groups have been consistently promoting condoms since the eighties, and it is understandable that it is very hard to discuss anything that might seem like an alternative. People find it hard to promote PrEP as an additional tool, and of course it’s not available in clinics except through the PROUD trial. On the PROUD trial we counsel men that condoms are the only way to reduce the risk of other infections, and my experience so far is that most of the participants still use condoms with some partners, PrEP is another way to take control of your risk, and be responsible for yourself and your partners. BASELINE: Where does the PROUD trial fit in? McCormack: Five studies have shown that a pill taken every day can prevent HIV in a wide range of risk populations – heterosexual men and women, gay men and transgender women and intravenous drug users. Adherence is the key driver of the trial results. Taking all the studies together effectiveness is estimated to be 90% when drug is detected. Two trials failed to show benefit, but less than 30% of the participants had any drug on board – which does rather explain the result. So the next stage is a number of demonstration projects looking at the ‘real world’ adherence to
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Autumn 2013
Chris O’Connor
PrEP. In the UK we are doing something unique in our pilot study called PROUD. Inclusion criteria for PROUD is HIV negative gay man or transgender woman who has had unprotected sex in the last three months. At enrolment participants are randomised to receive daily oral Truvada straight away for 2 years, or after one year, for one year. This design means we can measure real world effectiveness, and importantly whether using PrEP makes a difference to risk behaviours. BASELINE: Can you reproduce ‘real world’ conditions? McCormack: With some difficulty. A trial is a trial and comes with a certain amount of bells and whistles, but we have set the schedule to mimic the real world. In the placebo trials participants had appointments every month - not the real world. If someone knows they are taking a drug that reduces the risk of HIV – unlike a placebo trial - are they more or less likely to take that drug than one that could have no effect? We give similar support as that given to people starting ARV treatment; they get an early consultation at one month, and then every three months. The people on the deferred arm are also seen quarterly, with an extra visit at month 13. With PROUD, people are acknowledging they are at risk as part of the entry criteria, so this helps the discussion. If they are randomised to the immediate start arm, they proceed as would be the case if they were starting ARV treatment. We have three rules. 1) Truvada takes two weeks to reach steady state after starting; 2) Once steady state is reached it will be 3 - 5 days before the drug is gone from your system if you miss pills and 3) Risk is increased for resistance if you are www.baseline-hiv.co.uk
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seroconverting when you start taking Truvada; so if you stop and restart, you must have an HIV test as soon as possible after restarting. There will be a very small subgroup from whom we take blood samples to measure Truvada drug levels, and we will only do this if they say they are taking drug, but it’s hugely expensive; £60 a sample. I have great faith that people will tell us what they are doing, we are an open label trial; people know they are getting drug, it’s different than a placebo trial. Q: There is real unease about PrEP, from clinicians as well as the community, what do you see as the main obstacles? McCormack: There are real concerns, which is
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why everyone agreed we need to do a trial, and why we chose this design. The big issues are: One, there is an understandable feeling amongst clinic staff that having PrEP is going to lead to more sex and more STIs. There are already a large number of sexually active individuals being treated for STIs on a daily basis. Two, the majority of clinical experience in the UK is of prescribing tenofovir as part of a triple regimen for treatment, or for post-exposure prophylaxis (PEP). Clinicians are aware of the possible long-term side effects on kidneys and bones. Three, resistance; HIV negative people taking Truvada for prevention may be more likely to stop and start than people taking it for treatment - this will increase the chance of resistance. We see very low levels of resistance in the UK, and would not want that to change. Then perhaps most important of all is how much will it cost and who is going to pay for it. I think several clinics are already experiencing shortfalls in their funding since the 1st April and inevitably this impacts on clinical services. It is hard to conceive that new money will be found to fund PrEP, and clinics can’t afford it in their current budgets. This is why the scale of demand is important to understand. Using the trial as a barometer, it would seem that demand is very small and the cost therefore relatively insignificant. However, there is still an extremely low level of awareness of PrEP, so I am not sure the trial is predictive of demand. BASELINE: The evidence from the US is that demand for PrEP is much lower than expected. Recruitment to PROUD has been slow. Even if only a few people in the UK want PrEP, funding is still going to be difficult. McCormack: I know, I have to say to people, honestly, it is unlikely that the NHS is going to be paying for this in two years’ time when the pilot finishes. That’s where the activism and lobbying 18
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comes in, but you can’t lobby without data.
‘Using the trial as a barometer, it would seem that demand is very small and the cost therefore relatively insignificant.’ But as we have seen with HIV treatment, things change. There are several things that influence the cost – cost of the drug, the number of people that want it, and the length of time they stay on the drug. Tenofovir on its own may work just as well, and that is coming off patent in 2017. All these factors make PrEP feel more doable, but we need new money or money taken from something else at a time when we’ve have to make overall savings The slow enrolment to PROUD may be predictive of low demand and people might only be at risk for a short period of time – months, or a few years. I think some people have a sixth sense that their life is changing and often it may coincide with other emotional events and that could be a time when people are less likely to assert themselves and ask for help. In other cases it may follow the break up of a relationship, and others are single and very sexually active. BASELINE: What will the findings of the PROUD study tell us about PrEP? McCormack: We wouldn’t be doing the study, if we thought PrEP was a non-starter. It clearly works for individuals, and I hope the study presents clear evidence to extend into a full trial, or to implement PrEP as a public health strategy without a trial. Even a small number of HIV sero-conversions in the pilot could provide compelling evidence. Conversely, if we see a huge increase in numbers of partners with whom condomless sex occurs AND lots of STIs in people on the drug, - this could fuel the concerns already raised. We know it works at a biological level, but PROUD is trying to address whether PrEP should be part of our programme and policy for HIV prevention.
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Support for people living with HIV or Hepatitis C in Scotland From our bases in Edinburgh, Glasgow and Inverness, Waverley Care offers a wide range of support, information and advice across Scotland.
We are here for you –
www.waverleycare.org
Tel: 0131 558 1425 Scottish Charity No. SC036500 www.baseline-hiv.co.uk
Email: info@waverleycare.org ++++
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Photo posed by models
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NAM Launch Online Decision Making Tools Pregnancy and Contraception
The desire to have a child is a powerful emotion. This of course, is no different for a woman living with HIV - or a woman with a positive partner. Knowing what to expect and how your condition interacts with these desires is invaluable to women living with HIV. Contraceptive choices are a little more complex for positive women but effective and safe methods can be tailored to each woman’s needs. Making these decisions around controlling safe and healthy conception, pregnancy and delivery need access to clear, up to date information. There are now more fertility choices available for positive women but navigating the range of options can be confusing. HIV and Pregnancy and its sister resource, HIV 20
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& Contraception, are new interactive online tools from NAM-Aidsmap; designed to help HIV positive women or HIV negative women with a positive partner, make good choices about when and how they have children. After answering a series of questions about her health, medication and preferences, the user is given detailed personalised feedback. Women in Control These interactive, web-based tools, are ideally suited to positive women exploring their options, says Roger Pebody, Editor, Patient Information Materials at NAM. ‘Lots of people now have a smartphone or an iPad, or can get access online. Women seeking information around HIV,
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Chris O’Connor
Which of the following best describes you? Which of the following best describes you? Which of thewoman following best describes you? HIV-positive Which of thewoman following best describes you? HIV-positive Which of thewoman following describes male you?partner HIV-positive HIV-negative woman who has best an HIV-positive HIV-positive woman HIV-negative woman who has an HIV-positive male partner HIV-positive woman OtherHIV-negative woman who has an HIV-positive male partner OtherHIV-negative woman who has an HIV-positive male partner OtherHIV-negative woman who has an HIV-positive male partner back next Other back next Other back next back next back next
especially around fertility, want to be in control of their privacy and confidentiality - they enjoy having the device literally in their own hands - they control it.’ The resource is based on the latest guidance on pregnancy and contraception by the British HIV Association (BHIVA). ‘We can keep the information updated, which is evolving all the time - that’s the beauty of being online. At the moment the tool is aimed at women, but it could be informative for partners. In the future we would like to extend this and develop an online resource for men living with HIV who are exploring how to safely start a family.’ www.baseline-hiv.co.uk
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Created on 11 March 2013
Thank you for answering those questions. Based on the information you provided, we’ve compiled a personalised guide with information on HIV and pregnancy. We’ve tried to include information that will be particularly relevant to you, in line with what you’ve told us about your health and your circumstances. Created on 11 March 2013
The guide will be more or less complete, depending on the number of questions you Thank you for answering those questions. Based on the information you provided, answered. If you didn’t have the information to hand to answer some of our questions we’ve compiled a personalised guide with information on HIV and pregnancy. We’ve (for example, questions on CD4that cellwill count and anti-HIV drugs), tried to include information be particularly relevant to you,you in linemay withfind whatit helpful you’ve told us about your health your circumstances. to complete the questionnaire againand when you are able to answer those questions. (You can update your answers now, by clicking on the ‘update’ button.) The guide will be more or less complete, depending on the number of questions you answered. If you didn’t have the information to hand to answer some of our questions
The guide(for gives information onCD4 your hope it will talk about example, questions on celloptions. count andWe anti-HIV drugs), youhelp may you find itto helpful to with complete thehealthcare questionnaireteam. again when you are able to is answer those questions. your plans your The information intended to support, rather (You can update your answers now, by clicking on the ‘update’ button.) than replace, consultation with a healthcare professional. The guide gives information on your options. We hope it will help you to talk about your plans with your healthcare team. The information is intended to support, rather
than replace, consultation with a healthcare professional. Planning a pregnancy
Planning a pregnancy • Women with HIV can have healthy pregnancies and HIVnegative babies. • Women with HIV can have healthy pregnancies and HIVnegative babies. • It’s a good idea to talk to other women with HIV about their • It’s a good to talk to and othermotherhood. women with HIV about their experiences of idea pregnancy experiences of pregnancy and motherhood.
AlthoughAlthough you have HIV, it is still possible for you to have a healthy pregnancy, and you have HIV, it is still possible for you to have a healthy pregnancy, and for your baby tobaby be healthy andand HIVHIVnegative. Without treatment, HIV be passed for your to be healthy negative. Without treatment, HIV can be can passed on, but the treatment right treatment andcare, care, the the risk transmitting HIV toHIV yourto baby is baby is on, but with thewith right and riskofof transmitting your low.would If you would likehave to have a baby, it’s it’s very to find how you can you can very low.very If you like to a baby, veryimportant important toout find out how reduce the risk of your baby being infected with HIV. You can discuss your concerns reduce the of your babydoctor. being with HIV.these Youdiscussions can discuss your andrisk options with your It’sinfected a good idea to have before youconcerns and options with your start trying to getdoctor. pregnant.It’s a good idea to have these discussions before you start trying to get pregnant. Talking to other women living with HIV who have had a baby can help you to make informed decisions about pregnancy, birth and looking after your baby’s health. For
Talking toexample, other women living with had toa make babysure canyou help other women could giveHIV youwho ideas have about how takeyou yourto make informedtreatment decisions about andformula looking after your baby’s health. For in the rightpregnancy, way, or how tobirth manage feeding. example, other women could give you ideas about how to make sure you take your also want to talk through your plans, and any concerns or questions you treatmentYouinmight the right way, or how to manage formula feeding. may have, with a midwife, health adviser, or someone else at your HIV clinic.
You might also want to talk through your plans, and any concerns or questions you may have, with a midwife, health adviser, or someone else at your HIV clinic.
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The questions and personalised information can be used by women who are gently testing the waters, around having a baby, finding out what to expect, before they have speak to anyone else. Others may want factual answers to specific questions. The tool produces a personalised factsheet in response to the information you have provided. NAM point out that the information entered into the questionnaire is not kept, no name, date of birth or address is needed. A PDF of the factsheet can be saved or emailed to the user’s email account - this information is not retained by NAM. A Normal Life ‘We know there is massive interest in conception,’ says Roger ‘and in terms of living with HIV and living a ‘normal life’ and a full life, the ability to conceive and have a family, at the right time, are key. It’s as personal an issue as it can be. The beauty of using an interactive format is just that – it can give a personal response.’ The tools, rather than trying to cover every circumstance, focus on the needs of an individual. Too much information can be overwhelming. The interactivity highlights the specific needs of the user and filters out topics that are not relevant. For example, if a woman is looking for advice on maximising her chances of conception information on pregnancy can be accessed further down the line. Similarly if a woman is already pregnant a lot of scenarios are not relevant and she can focus on her health and delivering a healthy baby. 22
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One benefit of the tool is its role in helping a woman share the decision making process; with her partner, with a nurse or doctor in her HIV clinic. Some women may not be comfortable talking about their HIV status outside of her regular HIV clinic, GP or family planning services for example. A factsheet with her ARV medications, possible interactions and her individual circumstance can help her more confidently discuss her HIV status and her family planning needs. Certain HIV drugs, for example, can make some hormonal contraceptives less reliable, up-to-date information then is vital. A future option, says Roger Pebody, is the potential for women accessing the tool when they arrive for a consultation at their clinic, ‘We have had talks with staff at St Georges hospital in South London, about integrating the tool into their work. A woman could use a device or ipad in the waiting room, during the appointment. It could highlight useful areas for conversation and give the consultation more focus.’ The key though, says Pebody, is that this is in the control of the women who access it - it’s information, literally in their hands. ‘It might be a springboard to starting a conversation with her partner or her doctor, but that’s her choice. We want to help her make the best choices.’ www.aidsmap.com/contraception www.aidsmap.com/pregnancy This article has been sponsored by AbbVie with no editorial control or input.
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Autumn 2013
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Equity in access to HIV Care in the 21st century Equity in access to health care on the basis of need alone has long been one of the celebrated core values of the National Health Service.
‘The UK HIV community has great care because we fought for it. Don’t take past successes for granted, it’s important we say what matters to us most, what we value and need, what we, as people living with HIV want to protect.’ HIV treatment and care, similar to a number of other specialized conditions is commissioned nationally, rather than by local GP-led commissioning structures called Clinical Commissioning Groups, a move, many hope will ensure England continues to provide equitable access to treatment and care for all people living with HIV regardless of where we live or access HIV care A large number of changes are soon to take place; changes to how services are provided, how frequently we access care, changes to national treatment guidelines. It’s really important that people with HIV, as health consumers, are aware of treatment guidelines, national standards and respond to relevant consultations about service reviews or changes which will impact the care we receive. The UK HIV community has great care because we fought for it. Don’t take past successes for granted, it’s important we say what matters to us most, what we value and need, what we, as people living with HIV want to protect. BASELINE spoke with a number of leading experts working in HIV policy, commissioning and care to ask how will equity in access to high quality care be assured, at a time of rising patient 24
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numbers, rapidly increasing proportions of ageing HIV patients, significant budget constraints, increasing availability of generic drugs and service reconfiguration? What do we mean by equity? The concept of equity differs from that of equality which simply implies similarity of status, capacity, or opportunity; equity also communicates a sense of fairness. Equity in health care means that resources should be allocated on the basis of medical need, not just a ‘per head’ allocation. . In order to achieve equal health outcomes some patients or groups may need more resources then others, such as people living with HIV with other illnesses, older people or women living with HIV. In essence you should have access to the treatment and care you need regardless of which clinic you attend. For example in the recent past there were subtle differences in which medicines you could access when depending upon which clinic you attended. After the London HIV drugs tender in 2010, it was easier to access the integrase inhibitor raltegravir for first line therapy in Northern Ireland than it was to access it in the capital. Commissioners of health care are constantly faced with decisions regarding equity, largely as a result of the need to prioritise and ultimately ration health care within budgetary restraints. With flat budgets and rising patient numbers the challenge will be for commissioners to find innovative ways to continue afford world-class care for all patients. What do the BHIVA Standards say about equity? At the end of last year, the British HIV Association published its Standards of Care for People Living with HIV. The Standards are clear, ‘people with HIV should expect to have equitable ++
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access to consistently high-quality care no matter where they live.’ The Standards recognise, ‘the demography of HIV within the UK makes it very unlikely that there will be a “one size fits all” model of service delivery, and local arrangements and networks will be necessary to ensure that everyone living with HIV in the UK has equity of access to care that reaches the appropriate standards.’
‘The concept of equity differs from that of equality which simply implies similarity of status, capacity, or opportunity; equity also communicates a sense of fairness.’ Standard 10 lays out powerful arguments for patients to be involved in their treatment and care. It speaks of shared decision making. But it can be a challenge for some patients to be fully engaged in their care; reflecting this perhaps the Standard recommends ‘People with HIV should expect information to be available in language that is understandable and in a format relevant to individual needs, including age and literacy level, of the person receiving care.’ It also recognizes that people may have concerns about taking antiretroviral therapy or using specific medicines and that this can impact on achieving good outcomes. National Commissioning and Audit: Keys to Success? The NHS has long used audits as a systematic and independent way of examining data or the performance of services. The British HIV Association has audited clinical outcomes consistently over the past decade. Claire Foreman, Senior Service Specialist / Regional Programme of Care Lead – Cancer & www.baseline-hiv.co.uk
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Blood (London Region) at NHS England told BASELINE, ‘National commissioning provides a great opportunity to ensure that all patients have access to the same standard of care no matter where they live. The ‘what’ [services people receive] should be consistent as a result of a single national service specification, but there will be local variation on the ‘how’ [the way services are provided] to meet local needs.’ BHIVA’s new Chair Dr. David Asboe told BASELINE,‘BHIVA is committed to facilitating and supporting equality in HIV and treatment across the UK. BHIVA are strongly represented on the HIV Clinical Reference Group (CRG) and are fully involved in the specification/delivery of the national audit programme through HQIP (Health Quality Improvement Partnership). BHIVA guidelines are now NICE accredited and will be a critical reference point along with the BHIVA standards.’ Claire Foreman told us, ‘Audit is key. Commissioners are committed to national quality dashboards which use existing data sources to compare what is happening at trust level and understand variation. We also work closely with BHIVA and others to understand audit programmes.’ It seems the clinical and commissioning voices are clear, but it’s less clear what patients’ fears and expectations are about their care in changing times. People from more vulnerable or marginalized groups tend to be under-represented in patient surveys so less is known about the anxieties and expectations of BME (black and minority ethnic people) compared with UK born white gay men. With rising patient numbers, rapidly increasing proportions of ageing HIV patients requiring more complex care, budget constraints and service reconfigurations may lead to reduced clinic visits and monitoring. The introduction of a number of generic HIV medicines could pose additional ++
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challenges to some patients who already find navigating the healthcare system and adhering to medicines difficult. It’s important we, as people living with HIV stay abreast of changes and begin to have a voice, be stakeholders in decision making which are directly relevant to our care. Generic HIV medicines: What do patients think? One of the key considerations is how the large-scale introduction of generic HIV medicines alternatives will be managed by NHS England and by individual doctors with their patients. Will everyone or just some be asked to switch treatments for cost reasons? How do patients feel about these potential changes?
‘It’s important we, as people living with HIV stay abreast of changes and begin to have a voice, be stakeholders in decision making which are directly relevant to our care.’ A recent survey by NAM provides some insight into how people living with HIV feel about switching to generic HIV medicines. The survey found that people living with HIV in the UK understand why branded HIV drugs might be changed for generic versions, and are sympathetic to the need for cost savings. Importantly, survey respondents would be uncomfortable with a switch to generics if it meant a reduction in how well their HIV treatment worked, resulted in new side effects or food restrictions, or meant they had to take medication more frequently. Almost half of the people who completed the survey (45.5%) said they would find it annoying, confusing, inconvenient or concerning if their doctor asked them to switch to a generic drug. The majority felt uncomfortable about 26
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changes in efficacy (68%) and side-effects (65%) associated with changing from a branded to a generic medicine; respondents generally felt more uncomfortable about a change in how their regimen would be taken (56%), such as the number of pills a day, or food restrictions, than a change in medication appearance or packaging (8%). However the survey was only completed by a small number of positive people with certain groups (people from BME communities being underrepresented). The first widely used HIV drug to lose its patent protection was lamivudine (3TC) in January 2011. Generic versions became available in the UK in July the following year. A generic combination AZT/ lamivudine pill is now available in the UK (you may remember the original as Combivir). The NNRTI nevirapine (Viramune) is available in generic form, but perhaps most important of all as it is the third drug in most people’s initial HIV combination, efavirenz (Sustiva), (also a component of Atripla) will become available as a generic medicine later this year. More importantly patents of a number of commonly used ARVs will expire over the coming years. There will need to be effective communication to ensure that people are informed about changes in product supply and to address any concerns they may have about their on-going treatment and care. Some may find a change to the look of their medicine confusing. To support patients there will be a need for new patient information to take the arrival of generic alternatives into account? BHIVA Chair Dr David Asboe told BASELINE, ‘The transition to generics has some challenges, ‘Generics are an issue which will be addressed by the treatments guidelines group who are reviewing these guidelines currently.’ Generics tend to offer significant cost savings compared with branded drugs. However, the potential cost-saving needs to be balanced
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against any disadvantages to switching that might affect someone’s ability to take their medicine, or tolerate side effects. Poor adherence is associated with worse health outcomes, increased clinic visits and care needs which all cost the NHS money. Research from Nottingham suggests a switch to generic medicines may not always represent a clear cut cost saving. In 2010/2011, HIV Commissioners in the East Midlands region withdrew payment for the antiretroviral fixed drug combination Combivir, (AZT/3TC) forcing patients to switch to individual components. This was deemed clinically acceptable despite the additional pill burden. The change affected 46 patients- 74% (34 patients) decided to switch to AZT and 3TC, others switched to alternative fixed-dose combinations. Annual savings of up to £44,000 were forecast.
polypharmacy.’ Jacqueline Stevenson, Head of Policy at the African Health Policy Network told BASELINE, ‘‘Cost pressures pose a double risk: firstly in potentially curtailing access to some treatments based on costs, and secondly in terms of an inequitable impact. The more informed about treatment a patient
‘The more informed about treatment a patient is, and the more vocal they are, the less likely they are to be affected negatively by the impact of cost pressures.’
HIV service reconfiguration in London For London with its 28 HIV outpatient services, service reconfiguration is well underway. Claire Foreman told BASELINE, ‘The London HIV Service Review is an on going priority for London in view of changes in epidemiology and the need to ensure that that the service model is appropriate to managing HIV as a long term treatable condition.’ ‘A project team has been working with the HIV Expert Advisory group who are providing the expert clinical input into the development of the reconfiguration options for London. The planned implementation based on the current timelines will be during 2014/15.’ At a HIV Service Review stakeholder event in December 2012 ‘the preference,’ Claire told us was, ‘for reconfiguration into networks,’ echoing recommendations in the BHIVA Standards. ‘The project is working to a timeline of consultation starting October 2013 for a 3-month period although the timeline will be to a large degree determined by the NHS England Transformation Board who will be meeting to
On average, patients needed more visits to their doctor after the switch compared to preswitch, required more monitoring and increased staff time. The researchers calculated the yearly total cost of care per patient post-switch is relatively more expensive by £93. 13% of patients reported problems with the switch, including confusion around dosing and development of new side effects. The researchers concluded, ‘the additional clinical costs involved in this may outweigh or negate the simple cost savings of drug acquisition. Also, price changes in other ARV drugs when a generic becomes available are not always easy to predict. Increasing pill burden has also been associated with poorer adherence, and this may be a more significant problem for an aging cohort with a higher incidence of non-ART www.baseline-hiv.co.uk
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is, and the more vocal they are, the less likely they are to be affected negatively by the impact of cost pressures. This leaves the more vulnerable carrying
a greater burden. The key is information. The HIV sector needs to recognise that not all patients are informed about treatment, and that in fact some patients may not want to be, so we cannot rely on standards of care being maintained by patients being engaged in their care. The basic equity of treatment of patients has to be maintained – but this is at risk if advocacy groups aren’t vocal now.’
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Robert Fieldhouse consider a paper in early September 2014.’ Parminder Sekhon, Deputy Chief Executive at the NAZ Project London recognizes ‘more vulnerable patient groups who are not as visible run the risk of being marginalised in this massive reconfiguration and falling of the public health radar altogether.’
‘The basic equity of treatment of patients has to be maintained – but this is at risk if advocacy groups aren’t vocal now.’ A needs assessment carried out by the London Specialised Commissioning Group found that heterosexuals are more likely to access care local to where they live, while gay men are more likely to travel to large London clinics. It’s likely that the London service review will recommend reducing the number of clinics providing outpatient HIV care, arguably affecting heterosexuals moreas they will likely need to travel further, will experience increased travel costs and time. What does My Care, I Care tell us? Sigma Research’s survey My Care, I Care tells us something of what people accessing care in London value about they way HIV services are currently provided to them. You can see the full report at http://sigmaresearch.org.uk/files/ report2013f.pdf Rather worryingly, none of the black African respondents were aware when they were diagnosed HIV positive that they could access care from any clinic they wished. The Sigma study found that people who were born in African countries were more likely to report missing doses compared to others (23.8% vs. 19.3%). Is it possible that some African people will experience greater problems taking treatment therapy if their HIV medicines are switched from drugs which are familiar to them, to medicines which look different? 28
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What can community groups do to support vulnerable patients? AHPN’s Jacqueline Stevenson thinks that, ‘achieving equal outcomes depends on community advocacy groups continuing to push for equity. Health inequalities are persistent, and most affect those least able to speak up for themselves. That is where the role of community advocacy groups like Ffena – the national activist network of African people living with and affected by HIV – comes in: providing information and peer support to enable people to call out the inequalities that affect them.’ Final thoughts Change is afoot and is gaining pace. Let’s hope the increasing use of clinical networks and robust auditing can ensure everyone has access to the highest quality HIV care regardless of where they live.
. .
What you can do Proactively discuss any treatment concerns with your doctor, nurse or patient representative Do feed into any BHIVA and relevant NHS consultations and provide your personal expertise. Engage with your patient representatives at the Clinical Reference Group Look up the BHIVA Standards and challenge if you don’t think your clinic is making the grade.
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We can all play an integral part to help commissioners and clinicians continue to ensure the best clinical outcomes for people living with HIV and ensure the excellent quality of care we have grown used to does not diminish over time. This article was sponsored by a grant from Gilead Sciences Ltd UK: 001/UK/13-09/MM/1135 Date of Prep: Sept 2013
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Autumn 2013
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Community clinics improve access to rapid HIV testing and support A pioneering charity in the north of England is finding new ways to improve access to rapid HIV testing by expanding its ‘drop in’ and ‘pop up’ clinics into wider range of community and social settings including pubs, clubs, saunas and football grounds. Yorkshire MESMAC, whose work has recently been recognised with a GSK Impact Award, is continually looking for ways to make more people aware of their HIV status. Tom Doyle, Chief Exec explained; “We offer a range of sexual health services to the local community at clinics in youth centres, university campuses, drugs clinics etc. but are primarily focused on making people aware of their HIV status and helping them to reduce the risk of infection. Undiagnosed HIV represents a huge challenge, both in terms of reducing onward infection but also in delaying access to effective treatment. Eight out of 10 gay men who get HIV, get infected from men who don’t know they are HIV positive. By going out into the community in a more pro-active way we are making it very easy and convenient for people to take a test and with a highly trained support team we can provide them with all the help they need to better manage their sexual health.” MESMAC is one of the agencies working with HIV Prevention England to deliver a nationally coordinated “It starts with me”, HIV prevention programme, which will run until 2015. Working with UK-based African people and with gay men/ men who have sex with men, the programme features high impact ‘supercampaigns’ focused on increasing HIV testing, sustaining condom use and improving HIV prevention behaviors. “We just need people to go and get tested,” Tom Doyle emphasized, “but gay men don’t always feel comfortable going to their local GP or engaging with other NHS services. People whose immigration 30
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status isn’t clear can be fearful of ‘government services’ and concerns about confidentiality and potential stigma can be enough to stop people taking a test, but we offer a very convenient, accessible and independent service. People can just ‘drop in’ to one of our regular or ‘pop up’ clinics or can call us at any time, including weekends, and if someone is available we will see them within the hour. What’s more, our HIV service is run by folk from the most ‘at-risk’ communities, which helps to break down some of the communication barriers.” MESMAC has 17 community workers, all of whom are trained in motivational interviewing, to provide pre and post-test discussions or refer people to specialist counseling support if required. Most are also trained to perform rapid ‘on-the-spot’ HIV tests that provide results in 20 minutes. The team uses a fourth generation ‘combo’ test from Alere1 which simultaneously detects two types of HIV marker (viral antigen and antibodies) making the test capable of detecting HIV infection several days earlier than third generation ‘antibody only’ rapid tests. Tom reports that response to their community programme has been overwhelmingly positive. “The charity has been using the ‘friends and family test’ for some time and more than 99% of service users have said that they would recommend it. Being able to ‘drop in’ and take a quick HIV test and getting the results ‘there and then’ without being pressured into a full genitourinary (GU) screen are cited as key benefits, as is the immediate access to support and counseling. Our users value the convenience, confidentiality and friendliness of our approach and we hope to build on this success by finding new venues for clinics and encouraging more people to come forward for testing.” 1. Alere Determine™ HIV 1/2 Ag/Ab Combo This article was supported by Alere www.alere.co.uk
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Optimising HIV diagnosis and management Our aim at Alere is to improve the diagnosis and management of people with HIV by delivering critical lab quality results in the clinic or community.
Š 2012 Alere. All rights reserved. All trademarks referenced are trademarks of their respective owners. REF020-SH-010/02/12 SC
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Which HIV Life Assurance is right for you or your family? Some of the most common questions that HIV positive people ask when applying for Life Assurance are related to the amount of cover that they should apply for and also the term of the policy? These are some of the key areas that we offer advice to people who are looking for HIV Life Insurance. Our recent survey established that the average sum assured for a HIV Life Assurance policy has remained fairly stable in the last 12 months at £143,130. For the first time in the survey we also established that the average term of a HIV Life Assurance policy is 10 years. We have noted recently that some insurance companies have been offering insurance policies over very short periods of only 5 years. Here’s an example of one of our recent cases where someone had been offered a short term policy. Yakini Said … “I’ve had my existing policy for only a few months but have concerns about the advice I received. I’m currently paying £100 per month for £140,000 of cover, which is fine. However, the length of the policy is only for the next 5 years, which seems very short.” Yakini Continued … “I would like to make sure my policy is for a more significant period of time than only 5 years and would like you to look at alternative insurance providers for me if possible? My CD4 is fairly strong and my viral load has been undetectable for some time”. Here’s some advice for those looking for the right HIV Life Assurance … When HIV Life Assurance was launched in 2009 the majority of insurance companies limited 32
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the maximum amount of insurance to £250,000. Over these last two years barriers have gradually fallen with companies now willing to offer higher amounts of insurance cover. There are quite a number of options for people looking to take out HIV Life Assurance with seven providers all offering slightly different things. The price of cover does vary considerably between insurance companies, so it’s advisable to ask an adviser to compare them all for you. If you are offered a HIV Life Assurance policy for only a 5 year term then you should definitely seek further advice. There are some companies that regularly cut the term of new policies to 5 years, where a number of other companies are offer the same cover over a longer 10 year period. We realise that the length of HIV Life Assurance polices is an important issue for the HIV community and we are always monitoring all of the companies in regards to any changes. We will keep you informed of any updates as they happen and any new policies that become available. Unusual Risks are independent mortgage and insurance advisers and always research the whole of the market before recommending products to you. We have specialist knowledge of Insurance and Mortgage products for people living with either HIV or hepatitis C. And Yakini? We arranged a replacement Life Assurance policy for Yakini with a similar sum assured to the existing policy she already had. The new policy was for £140,000 of cover over a longer period of 10 years, which doubled the term of her cover. The final policy we offered had a premium of £90.00 and we also offered her quotations for
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Chris Morgan
£50,000 of cover at only £30 per month and £100,000 at only £60 per month. We always arrange HIV Life Assurance for the maximum term available for our clients. Unusual Risks make donations to charities NAM/ AIDSMAP and Hepatitis C Trust from every Life Assurance and Mortgage we arrange. We have brochures and PDF Fact Sheets now available to charities, support workers and medical professionals. Chris Morgan is the Marketing Manager of Unusual Risks Mortgage & Insurance Services. www.unusualrisks.co.uk, Editor of Positive Finance Magazine www.positivefinance.info and was a consultant to the Association of British Insurers HIV Working Group for over five years. He may be contacted by phone 0845 474 3075 or by Email chris@unusualrisks.co.uk
Unusual Risks Mortgage & Insurance Services The UK’s Leading HIV Life Assurance Specialists
Call us: 0845 474 3075
Web: www.unusualrisks.co.uk e-mail: enquiries@unusualrisks.co.uk AUTHORISED AND REGULATED BY THE FINANCIAL SERVICES AUTHORITY – please note most buy to let mortgage are not regulated by the Financial Services Authority. Think carefully before securing debts against your home. Your home may be repossessed if you do not keep up repayments on your mortgage. Baseline Ad Unusual Risks.indd www.baseline-hiv.co.uk
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Robert Fieldhouse There’s so much going on at Positive East in London, we decide to donate the hotline pages to them. If you’ve an event you’d like to publicise, contact editor@baseline-hiv.co.uk
Kilimanjaro
East London’s HIV charity Positive East has places up for grabs for avid trekkers to take part in its Kilimanjaro Challenge 2014. The fundraising 6-day hike involves a trek through stunning tropical rainforest, before a final ascent to the world famous Uhuru Peak at an altitude of almost 6,000 meters. The 10-day challenge departs London on 21st February, also includes free time for sightseeing the local area. Funds raised from the challenge will help Positive East continue to deliver their range of support services for African men and women affected by HIV in east London. For more information about the challenge, call Melissa Cubbon on 020 7791 2855, email melissa.cubbon@positiveeast.org.uk, or visit: www.positiveeast.org.uk
Apply Yourself:
Thinking about getting back in to the job market? Getting back in to the job market can be stressful, especially if you’re unsure about what you should say about your HIV status. Positive East run a great course called Apply Yourself, with advice about what career options you have, help with your CV and guidance on interview techniques. So whether you need a bit of support with your job searching, or one-to-one guidance on training, and educational opportunities, this is the course for you. For more details about Positive East’s Apply Yourself course, please contact Ruth on 020 7791 2855, email: ruth.wampamba@positiveeast.org.uk or visit: www.positiveeast.org.uk 34
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Have you got an event or product you’d like us to promote? Email: editor@baseline-hiv.co.uk
5k Red Run: Get your running shoes ready!
Celebrate World AIDS Day 2013 by joining Positive East in its annual 5K Red Run. Held on Sunday 1st December at Victoria Park, London, participants are asked to raise £50 or more in sponsorship. All entrants will get personalised chip times, so it’s a great way to find out exactly how far behind Mo Farrar you would have been. Costs £10 to enter. To register for the run or for more details, call Melissa Cubbon on 020 7791 2855, email melissa.cubbon@positiveeast.org.uk, or visit: www.positiveeast.org.uk
In-store HIV testing: Expectations
Positive East and the GMI Partnership have teamed up with the leading fetish store in London, Expectations and have started free weekly HIV testing in the store. The service launched to coincide with London Fetish Week in July and in the first two months over 30 tests have been given. It’s part of Positive East’s commitment to normalize having an HIV test as well as reaching out to those who don’t want to go to a clinic. Positive East now test in more places than anyone else in London. Testing in Expectations is every Thursday, from 4pm to 6.30pm. For more details about all Positive East’s testing sessions, visit: www.iwantanhivtest.org.uk www.baseline-hiv.co.uk
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Robert Fieldhouse
news: Treatment Stribild Strong at 96 Weeks
The 4-in-1 single-tablet regimen Stribild, (elvitegravir, tenofovir, emtricitabine, cobicistat) maintains HIV viral load suppression through 96 weeks and remains well-tolerated, according to latest research. Stribild was compared against another singletablet regimen, Atripla (efavirenz/tenofovir/ emtricitabine), and against the ritonavir-boosted protease inhibitor atazanavir (Reyataz), also combined with tenofovir/emtricitabine (the medicines in Truvada). At 96 weeks, rates of undetectable HIV viral load remained impressive for all 3 combinations: 83%-84% for Stribild, 82% for Atripla, and 82% for atazanavir/Truvada. CD4 cell gains were similar across the three treated groups: with gains of 275, 273, and 261 cells/mm3, respectively. Neuropsychiatric side effects; a significant side effect of efavirenz (Sustiva, Atripla) were
less common among people treated with Stribild compared with people treated with Atripla; with 14% vs 1%, respectively experiencing abnormal dreams. Treatment discontinuations due to kidney-related side effects were uncommon overall through 96 weeks, but occurred more often among people treated with Stribild (1.4% vs 0% with Atripla and 0.6% with atazanavir/Truvada). NHS England recently announced that it will pay for Stribild in ARV-experienced patients with no prior history of virological failure or drug resistance who require a switch from their current regimen where there is a clinical advantage of Stribild over alternative switch options and where the use of the individual components is not contraindicated as well as in ARV-naïve patients with high viral loads who are not suitable for NNRTIs (or others on NNRTI who need to switch for reasons unrelated to resistance).
Alcohol Does Not Diminish Treatment Outcomes
People living with HIV who drink alcohol don’t appear to have a poorer CD4 response or be less likely to achieve an undetectable HIV viral load compared with non-drinkers, though people who drink heavily appear to have a tougher time achieving good treatment adherence. Most doctors recommend keeping alcohol consumption within recommended healthy limits, or complete abstinence if you are also living with hepatitis. Researchers in Switzerland looked at the records of approximately 5000 people living with HIV who are enrolled in the Swiss HIV Cohort Study and who received care between 2005 and 2012. During that time 2982 people had started antiretroviral therapy. Approximately 55% reported sometimes drinking alcohol, while only 2% reported drinking excessively to a point that may constitute a health risk. The researchers found no association between CD4 cell count changes and alcohol consumption, though heavy drinkers were twice as likely to report taking a treatment interruption. The researchers concluded, “Efforts [related to] ART continuation should be especially implemented in individuals reporting high alcohol consumption,” they recommended. But as heavy drinkers were not shown to have a higher risk of virological failure, “ART should not be withheld” from these individuals. 36
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Robert Fieldhouse
news: Treatment Dual HIV Therapy Shows Promise
US Approval for Dolutegravir
ViiV Healthcare announced in August that the U.S. Food and Drug Administration (FDA) has approved dolutegravir (Tivicay) 50 mg tablets. Dolutegravir is an integrase inhibitor indicated for use in combination with other antiretroviral drugs for the treatment of HIV in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). The wide-ranging Phase III drug development programme included two trials in people who were taking treatment for the first time: one where a once-daily dolutegravir-based regimen was compared to twice-daily raltegravir and another where the regimen of once-daily dolutegravir and abacavir/lamivudine was compared to once-daily Atripla (efavirenz/emtricitabine/ tenofovir disoproxil fumarate). It also included treatment-experienced patients who had not previously been treated with an integrase inhibitor, where a once-daily, dolutegravir-based regimen was compared to twice-daily raltegravir. The fourth trial studied treatment-experienced patients with resistance to multiple classes of HIV medicines, including resistance to integrase inhibitors, where the effectiveness of twice-daily dolutegravir on viral load was evaluated. Dolutegravir is expected to be licensed in the European Union in early 2014. 38
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A combination of the integrase inhibitor raltegravir (Isentress) plus the NNRTI etravirine (Intelence) without a ‘nuke backbone’ (drugs like Truvada or Kivexa) or protease inhibitors kept HIV under control among people who had switched from a triple combination regimen as long as they did not have any NNRTI drug resistance mutations. Nukes and protease inhibitors can cause a range of side effects, prompting researchers to test protease- and nuke-free treatment combinations. 91 people were enrolled in this observational study at the Pite Salpetriere Hospital in Paris starting in January 2008 to switch to a dual regimen of 400 mg twice-daily raltegravir plus 200 mg twice-daily etravirine. The main reasons for switching therapy were metabolic abnormalities or lipodystrophy (21%), wanting to simplify treatment (10%), kidney toxicity (9%), gastrointestinal toxicity (9%), bone toxicity (7%), liver toxicity (6%), and neurological side effects (6%). 98% of participants who stayed on the treatment maintained viral suppression at 6 months and 92% did so at 12 months after switching. 21 people (23%) stopped taking raltegravir/ etravirine, including 3 due to virological failure and 5 due to possibly related side effects. One person experienced virological failure by month 6, and 2 more did so by month 12. The 3 patients (3%) with virological failure all had a history of previous NNRTI use, though not NNRTI treatment failure with drug resistance. The researchers concluded, “Dual therapy with raltegravir plus etravirine represents a potentially safe NRTI/PI-sparing strategy in virologically suppressed patients with sensitive strains.” However, they cautioned, “Before switching clinicians should check for potential prior resistance to NNRTIs.” A larger prospective study of this approach is currently underway. ++
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ARE YOU LOOKING TO FUNDRAISE? Open Charity Challenges Would you like to run a calendar of professionally organised charity challenges? With little or no financial commitment? Large Outdoors is one of the UK’s leading providers, working with charities of all sizes.
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Celebrating Success: SHE
The SHE Programme is developed at the discretion of the Faculty. Funded by Bristol-Myers Squibb
Two years ago at the International AIDS Society (IAS) Conference in Rome, a group of advocates, all women living with HIV launched “SHE” – Strong, HIV Positive, Empowered Women – the first comprehensive European patient education programme to address the growing challenges faced by women living with HIV across Europe. This programme is developed and written by a faculty of both People living with HIV and HCP treating women living with HIV it is funded by Bristol-Myers Squibb. The wide-ranging advocacy and educational programme has two strands. The first, a medical education programme delivered by medics to medics across 60 European SHE units based in hospitals as far flung as the UK to Romania. “SHE Units bring together a woman’s entire healthcare team – HIV specialists, peer support workers, gynaecologists, family planning, fertility specialists, clinical trial nurses, psychologists and more – as a way to offer better care and support for women living with HIV,” according to Professor Margaret Johnson, Clinical Director of the HIV Clinic at the Royal Free Hospital, London. “This way of care is distinct in its approach and addresses the particular needs of women living with HIV.” The second, a peer support programme, developed by women living with HIV and community advocates provides much needed information and tools for women to train other HIV positive women, empowering and inspiring them in the process. The peer toolkit has 9 sections; an introductory section, a section on why peer support is good, diagnosis, accessing healthcare services, sex and relationships, physical, sexual 40
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and reproductive health, living well with HIV, HIV treatment and human rights.
‘I hope that through this alliance the quality of life for women living with HIV in Russia will improve and that they will have more opportunities to increase in confidence and strength and be more visible and heard.’ The toolkit is supplemented by a slide deck slide for peer support facilitators leading SHE “train the trainers” meetings that provides practical guidance on how to run peer support sessions. This cascade training approach is the method used to train an increasingly large number of women who mentor other HIV positive women. All of the materials, including a number of short films featuring women living with HIV are free to download from the website www.shetoshe.org Professor Jane Anderson of Homerton University Hospital in London told BASELINE, ‘As a clinician, I have seen the advantages that appropriate peer support can provide to women, including increased sense of empowerment, becoming better informed and enhanced selfesteem. Peer support can enable women living with HIV and their healthcare teams to maximise the benefits of treatment and care and make the best use of available resources. We hope that this resource will enhance communication between healthcare providers and women living with HIV.” Positively UK’s Deputy Chief Executive Silvia Petretti was involved with the programme from
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the outset, “After my HIV diagnosis I felt very alone and just wanted to hide; I had so many questions,” said Silvia Petretti, a member of the SHE community advisory board. “Today, women like me across Europe, in countries where HIV is still highly stigmatized, can turn to SHE to seek answers, support and learn from others who have faced the same situation,” she told BASELINE. More than 90 women attended the Rome launch and over the course of the first year the programme was delivered in six European countries- the UK, Italy, France, Spain, Germany and Poland. Following on from a meeting in Madrid last November to strengthen the SHE network, bringing it to new European countries, increasing the number of SHE units and strengthening clinical and community partnerships, the programme now has 60 SHE units in countries across Europe. Over the course of this year the programme has launched in a number of new settings; Switzerland, Belgium, Greece, Austria, Romania, Russia, and Belgium. Silvia Petretti spoke at the recent launch in St Petersburg, she told BASELINE, “Russia has the fastest growing HIV epidemic in the world and people who use drugs and women are still hugely affected. I was really happy that there are some women doctors who are really supportive of women living with HIV and the SHE programme. I really hope that through this alliance the quality of life for women living with HIV will improve and that women living with HIV in Russia will have more opportunities to increase in confidence and strength and be more visible and heard.” The www.baseline-hiv.co.uk
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translation, adaptation and roll out of the peer support toolkit will be done by EVA; the Russian Network of Women Living with HIV. The SHE programme took centre stage at this year’s British HIV Association Conference in Manchester. Leading trainer, writer and advocate SHE community representative Thandi Haruperi led an interactive workshop with attendees to raise awareness of the peer support element of the project. SHE’s in the House: EU Parliament, that is Back in January, SHE community representative Silvia Petretti attended a Hearing on Sexual and Reproductive Health and Rights (SRHR) organised by the FEMM Rights and Gender Equality Committee at the European Parliament. At the meeting Silvia presented the current challenges faced by women living with HIV in Europe and the following call was include in the committee’s draft Sexual and Reproductive Health Rights Report: ‘Calls on the Commission and the Member States to address the specific SRHR of people living with HIV/AIDS, with a focus on the needs of women, notably by integrating access to testing and treatment and reversing the underlying socioeconomic factors contributing to the risk to women of HIV/AIDS, such as gender inequality and discrimination.’ The report is due to be voted on by the Parliament’s Plenary in October. SHE’s in Leicester Dr Fatima Ibrahim is a GU (genitourinary medicine) physician at Leicester Royal Infirmary. ++
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With a population of one million people, the clinic based in the centre of town Leicester HIV service is a busy one; half of the 1,000 patients at the clinic are women. Having identified specific issues in obstetrics the medical toolkit was used in this setting to update healthcare worker’s knowledge, counter myths and bust stigma. ‘We are the champion of women with HIV in Leicester’, Dr Ibrahim told BASELINE, “The SHE Programme provides up-to-date information on the care of HIV positive women in Europe. It’s evidencebased and current and adaptable. You can adapt it to most situations, and different audiences too. I don’t have the time to go and trawl through data. It’s practical- down to telling you how to arrange meetings. I use it increasingly in my consultations with HIV positive women. Take things in bite-sized chunks.” Next a SHE unit meeting with medics and local peer educators is planned to build on the clinical/ community links. SHE’s in Leeds Alison Perry Fetal Screening Coordinator/ Obstetric Counsellor from St James’ Hospital in Leeds told BASELINE; ‘We deliver around 10,000 babies annually, seeing between 35 and 60 positive women each year. I always look for ways to can improve the support I give. I used to give my mobile phone number out and never switch it off. Due to the nature of my job I was only with the women throughout their pregnancy, support needs to continue post delivery and that’s where the SHE programme comes in.“ Alison worked with local HIV support charity Leeds Skyline who began sending peer support workers into the antenatal clinic. Training of the peer toolkit took place back at Skyline’s offices to enable Skyline’s peer support workers to train the toolkit at the regular women’s group or mums and tots group. Fiona who is based at Leeds Skyline told BASELINE; “We’ve had women giving feedback 42
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about increased knowledge and skills. We organised 3 sessions over 3 weeks to build women’s confidence and skills.” Skyline went one step further by setting up a new support group in the community to reach women who were ‘hard to reach.’ Fiona recognizes that for some women it was challenging to begin accepting support from nonmedical staff outside the clinic. “We use the same hair salons, use the same shops- but in the end it helped to beat down the barriers.” SHE’s in Brighton Support workers at Sussex Beacon see the transformative potential of the SHE programme; ‘With 260 women in the Brighton area who could benefit from the programme, we recognize that women will experience a role change as they move from being members of a support group to ‘mentors’ or ‘leaders.’ Where’s SHE heading next? The launch of the SHE Programme in Ireland is imminent. At the start of 2013, an additional three SHE websites launched in: Germany: www.sheprogramm.de Poland: www.programshe.pl Portugal www.sheprograma.pt The SHE websites in Greece and Russia are expected to launch in the coming months. If you’d like to get involved, either as a woman living with HIV who’d like to introduce the SHE Programme to your local HIV support organisation or as a medic who’d like to learn more about becoming a SHE unit, all the materials are free to download from the website www.shetoshe.org The SHE Programme is developed at the discretion of the Faculty. Funded by BristolMyers Squibb.
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VIRUK13NP07935-01 September 2013
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p l e H
e k a M istory H Give your time and together we could advance the prevention of HIV Sign up now
to join our new network of clinical trial volunteers. The Medical Research Council has been making history for over 50 years. To find out more go to
www.helpmakehistory.mrc.ac.uk
www.baseline-hiv.co.uk
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This issue we focus on taking hepatitis treatment. If you need treatment now it’s likely you’ll be offered pegylated interferon and ribavirin and one of the protease inhibitors telaprevir or boceprevir. An interferon-free era is on the horizon but it could be some time until people living with HIV and hepatitis C are able to access the drugs. The two personal accounts of taking treatment proved so popular last issue that we commissioned Gemma Peppé from the Hepatitis C Trust to write up her experience of being one of the fortunate and inspiring individuals who took part in a trial including a number of investigational drugs currently being developed by Abbvie. Gemma finds out in a few weeks whether she has cleared the virus; at BASELINE we will be keeping our fingers crossed that the treatment has worked. Wish her luck. We’ve started tweeting about hepatitis from a new twitter account @BASELINEHEP Please do follow us there. We are always looking for personal opinion pieces so if you have something you’d like to submit, please send to robert@baseline-hiv.co.uk We’d like to say a big thank you to Janssen, Gilead Sciences, AbbVie and Alere for their ongoing support of our sponsored editorial series which helps us keep the magazine in printed format. An extra special thanks to news editor Chris O’Connor for the great work with the current issue.
Contact the team: Editor: Robert Fieldhouse robert@baseline-hiv.co.uk Associate Editor: Jane Phillips editor@baseline-hiv.co.uk News Editor: Chris O’Connor chris@baseline-hiv.co.uk
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46 headline: UK news 47 headline: treatment news 52 interferon free trial: Gemma Peppé 54 starting hepatitis C treatment
For magazine and web advertising please contact robert@baseline-hiv.co.uk
Editorial Administrator: Tom Matthews Proof reader / Social Networking Michael Duggan / Rebecca Gibson
Copyright of all articles remains with the publisher. All other rights recognised. Views expressed by individual contributors are not necessarily those of the publisher. The mention, appearance or likeness of any person or organisation in articles or advertising in BASELINE is not to be taken as any indication of health, HIV or hepatitis status or lifestyle.
Designer: Gareth Williams Intern: Daniel Jon
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Summer 2013
Steve Akehurst
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UK: hepatitis news
Scots Launch Big Red C Campaign
An estimated 18,000 people in Scotland are unaware they have contracted Hepatitis C. A new campaign The Big Red C is targeting people from the “baby boomer” and “generation X” years in the 1970s-1990s with the slogan: “Ever injected? Get tested. Hep C - it can be cured.” The campaign is targeting anyone who may have ever used an unsterilised needle, including people who injected steroids and tanning products. Big Red C bus advertisements were seen in Glasgow, Lanarkshire, Edinburgh and Aberdeen, alongside a washroom poster campaign in Dundee and a website www.hepcscot.org Leon Wylie, lead officer of campaign leader Hepatitis Scotland, said: “It is vitally important that anyone who has ever injected drugs, even once, accesses testing.
Welsh Assembly votes in favour of presumed consent for organ donation
The Welsh National Assembly has voted in favour of a move whereby people will be presumed to have consented for organ donation, unless they opt out. Wales is the first nation in the UK to adopt this system. However, the move has not been met with universal acclaim. Joyce Robbins of Patient Concern was quoted in the Telegraph as saying that the legislation will result ‘in human bodies being treated like clapped-out cars’, and warned it could lead to mix-ups that would trigger a national scandal. Nevertheless, Health Minister Mark Drakeford has insisted that the new system would be safe as well as fair, adding that ‘the legislation makes it clear if you are uncomfortable with being an organ donor, you have an absolute right in the simplest way possible to opt out of the system’. The presumed consent system could come into force by 2015. 46
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New HCV diagnoses up by one third in 2012
Low Hep C Rate in HIV Negative Gay Men
The number of new hepatitis C diagnoses in England hit a new high in 2012. In total 10,873 people were diagnosed with hepatitis C up from 7,882 cases in 2010. One in four new diagnoses were made in London, Cases there have almost trebled to 2,844 cases in 2012, up from 954 in 2010. The report suggests that around 160,000 people are living with chronic hepatitis C virus infection in England – many of whom are unaware of their infection. Across the UK more than 215,000 individuals are thought to be chronically infected. Over the past 15 years, hospital admissions for hepatitis C-related end stage liver disease and liver cancer in England have increased from 574 in 1998 to 2,266 in 2012, while deaths have risen from 115 in 1998 to 326 in 2012. An increase in registrations for liver transplants has also been observed, with 52 in 1998 to 114 in 2012 – although figures have been relatively stable over the past 5 years. Hepatitis C related end stage liver disease and the number of liver cancer patients could be substantially reduced by increasing access to treatment. If the number of people being treated is doubled over the next 10 years, around 6,000 new cases of hepatitis C related end-stage liver disease could be averted over the next 30 years. In the UK, the greatest risk of hepatitis C infection is through sharing equipment for injecting drugs. Data from the Unlinked Anonymous Monitoring (UAM) survey of people who inject drugs suggest that levels of infection in this group remain high in 2012, with around half of those surveyed in England being infected. To help reduce the levels of sharing, Needle and Syringe Programmes continue to be developed throughout the UK and latest figures from national surveys of people who inject drugs across the UK suggest that levels of sharing are falling.
Community sampling, carried out in 2008 suggests only 1% of HIV negative men in London have antibodies to hepatitis C. This rate is not significantly higher than in the general population. Sampling found a rate of 8% among gay men living with HIV. As prevalence of HCV was higher among men who reported unprotected sex with a casual partner and in those with a history of syphilis, investigators suggested HCV testing should be offered to these men at a GU clinic, despite the current recommendation that HCV testing is not offered routinely to HIV negative men. The researchers acknowledge that they did not ask about injecting behaviour, a route many doctors now believe is responsible for a proportion of the infections diagnosed as sexual infections among gay men living with HIV.
www.baseline-hep.co.uk
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Autumn Hep C Health Days The hepatitis C health day is a free oneday workshop run by patients with extensive knowledge of the virus, doing treatment and living with the virus. The workshop is suitable for anyone affected by hepatitis C - just diagnosed, those who have chosen not to do treatment, for whom treatment is contra-indicated, for whom treatment has failed, waiting to do treatment, on treatment, friends or family who wish to learn more and give support and also professionals working with people with hepatitis C. The dates are Saturday 12th October and Saturday 9th November at Hepatitis C Trust, 27 Crosby Row, London SE1 3YD. For more information contact, Catherine Corr on 0207 089 6220 or email catherine.corr@hepctrust.org.uk +
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treatment: hepatitis news
Faldaprevir/Deleobuvir and Ribavirin for Genotype 1b An interferon-free combination of the directacting hepatitis C still-in-development antivirals faldaprevir and deleobuvir with ribavirin cured hepatitis C in a majority of patients treated over a range of time (between12 to 40 weeks), with the best results seen among people with HCV genotype 1b. Faldaprevir is a hepatitis C protease inhibitor and deleobuvir is a non-nucleoside NS5B HCV polymerase inhibitor. Though new direct-acting hepatitis medicines will initially be licensed for use in combo with interferon therapy for people with hepatitis C alone, many doctors and patients are waiting for all-oral, interferon-free regimens and intend to use them in people also living with HIV. The study included 362 people with genotype 1 chronic hepatitis C who had never taken hepatitis C treatment before. A majority were men; almost all were white. About 10% had cirrhosis, about one-quarter had the favorable IL28B CC gene pattern, and approximately two-thirds had the easier-to-treat HCV subtype 1b. The researchers tested 5 different variations of treatment. The most impressive results were seen among people treated with faldaprevir 120 mg once-daily
plus deleobuvir 600 mg twice-daily plus ribavirin for 28 weeks. In total 69% of people taking this combination achieved a sustained virological response 12 weeks after the completion of treatment (SVR12). The response rate was significantly lower in the ribavirin-sparing arm compared with the groups that used ribavirin. The proportion of people who achieved clearance of hepatitis C 12 weeks post completion of therapy were similar for patients with and without liver cirrhosis. All medicines; faldaprevir, deleobuvir, and ribavirin were generally safe and well-tolerated. The most common side effects were skin rash, photosensitivity, nausea, vomiting, and diarrhoea. 9% of participants experienced severe adverse events and 12% discontinued treatment because of this. The researchers concluded, “The rate of a sustained virologic response 12 weeks after the completion of therapy was 52% to 69% among patients who received interferon-free treatment with faldaprevir in combination with deleobuvir plus ribavirin.”
Telaprevir Triple Therapy for Genotype 4
The HCV protease inhibitor telaprevir (Incivo) in combination with pegylated interferon and ribavirin reduced hepatitis C viral levels significantly in people with genotype 4 hepatitis in a short Phase 2a study, new research suggests. The 24 trial participants had never taken hepatitis treatment before and were randomised to take either 750 mg telaprevir as a single medication every 8 hours, the same dose of telaprevir in combination with pegylated interferon alfa-2a (Pegasys) and ribavirin, or pegylated interferon/ribavirin plus a telaprevir placebo, all for 15 days, followed by pegylated interferon/ribavirin alone for 46 or 48 weeks. The people who received triple therapy saw the greatest reductions in hepatitis C RNA (viral load) during the first 15 days of treatment, with one patient achieving an undetectable hepatitis viral load during this short treatment period. The researchers recommended; “Further investigation of telaprevir combination therapy in patients with HCV genotype 4 infection is warranted.” 48
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www.elpa-info.org
treatment: hepatitis news
Developmental Hold on VX-135 200mg Dose
Simeprevir/Sofosbuvir Combo Looks Good
Vertex Pharmaceuticals Incorporated recently announced that the company has received notice from the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on Vertex’s ongoing Phase 2 U.S. study of the nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. The partial clinical hold prevents evaluation of a 200 mg dose of VX-135 in the U.S. study following observation of reversible elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in a Phase 2 study in Europe. Evaluation of a 100 mg dose of VX-135 in combination with ribavirin as part of the 12-week Phase 2 study in the U.S. is continuing as planned. Vertex recently completed dosing of 100 mg and 200 mg of VX-135 in combination with ribavirin as part of the 12-week Phase 2 study in Europe, and both doses were well tolerated with no discontinuations. No serious adverse events have been reported and no liver or cardiac safety issues have been identified. Vertex also recently initiated dosing of 100 and 200 mg of VX-135 in combination with daclatasvir as part of a Phase 2 study in New Zealand. “Developing safe and effective medicines for patients is our goal,” said Robert Kauffman, MD, PhD, Senior Vice President and Chief Medical Officer at Vertex. “We are committed to continuing to work closely with the FDA to provide the data needed to support evaluation of a 200 mg dose of VX-135 in the U.S.”
Impressive interim results from the ongoing COSMOS study evaluating a once-daily combination of the HCV protease inhibitor simeprevir and the nucleotide sofosbuvir with or without ribavirin in hard-to-cure hepatitis C (HCV) patients have just been released. SVR4 results (a sustained virological response at week 4 following completion of therapy) from the 12-week arms of Cohort 2, including people who have never taken hepatitis C treatment before and people who previously did not respond to HCV therapy with METAVIR score F3F4 (severe scarring and cirrhosis of the liver, have recently been announced. Treatment for 12 weeks with simeprevir and sofosbuvir, with or without ribavirin, led to SVR4 rates of 96% and 100%, respectively. At the time of the interim analysis, SVR4 results were available for all patients (n=41) in the 12week arms of Cohort 2. In this Cohort, 78.2% of patients had genotype 1a subtype, 47.1% had METAVIR score F4 (cirrhosis) and 54.0% were prior null responders to treatment. “The high SVR rates seen in genotype 1 prior null responders and treatment-naive patients with advanced liver disease in the COSMOS study and the safety profile of the combination are highly encouraging. We look forward to the final results of this study in difficult to cure patients,” says Charlotte Edenius of pharmaceutical firm, Medivir AB. 50
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He shows all the signs of hepatitis C
Robert Fieldhouse
Hepatitis C can cause fatal liver disease With HIV it does it faster Get tested. Get treated.
hepctrust.org.uk 0845 223 4424
The Hepatitis C Trust is a registered charity UK 1104279 Scotland SCO39914
www.baseline-hep.co.uk
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Try and Trial Again: Testing Experimental Hepatitis C Meds
mad wondering if I was taking the right drugs or not.
I have been living with hepatitis C for over 25 years. I’ve done treatment before. I was a partial responder, meaning when I did interferon and ribavirin I had a 4 log drop 12 weeks in but the virus was still present in my blood by the end of the 48 weeks. My son, who also lives with hepatitis C, was a non-responder meaning he didn’t respond at all to interferon and ribavirin. His status as a nonresponder, which had seemed so dismal in 2006 put him first in line for the new treatments without interferon in 2012. My son started the AbbVie phase II trial in January 2012 and was finished by April 2012. His treatment was non eventful and without drama. The main side effect seemed to be that he began to feel better over the 12 weeks that he’d taken the drugs. I was recruited for the AbbVie phase III trial in February 2013. After seeing how easy it was for my son I couldn’t wait to start treatment. I’d had hepatitis C for a quarter of a century and since completing my first treatment, I’d gradually felt worse each year. My main symptom was chronic fatigue but I also had fibromyalgia syndrome which I took painkillers for every day. Unlike my son’s trial, my trial had a control arm meaning one in four people would get a placebo. The drugs needed to be taken at the same time every day 12 hours apart. I took mine at 7am and 7pm to fit in with my work hours. It drove me a bit 52
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‘In the first week of treatment my viral load dropped from 17 million to just 76 copies of the virus in my blood’ After the first month on the drugs I was sure I was taking the active drugs. I had constant headaches, I had a blotchy, bloated face and I felt more tired than usual (if that was possible). My symptoms didn’t correspond with my son’s but I put this down to my age and the fact that I’d felt so ill beforehand. Over the three months I put on a lot of weight, partly because I was eating fatty foods, something I’d been told to do with the protease inhibitors, and partly because I was too tired to get off the sofa much. At the twelve week appointment when the trial was due to become unblinded, meaning I would find out if I’d been on the placebo or active drugs. I was certain I’d be told I was clear of hepatitis C, plus I was dying to stop taking the drugs so that I could start to feel better. I felt so toxic and tired and I was due in Ibiza within the following 2 weeks to organise the Hepatitis C Trust’s annual fundraising auction. On the way into the hospital my son said to me +
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Gemma Peppé
Gemma Peppé by Boy George ‘What if you are on the placebo?’ This was the first time in a while I’d even considered the placebo as a possibility. Half an hour later I was told that I was on the placebo and I would be starting the real drugs in the morning. When you start treatment you get a thrill from knowing that you’ve taken control of something unmanageable. I was robbed of that feeling as, contrary to how I felt, I thought I had been getting better. Actually my viral load had gone up from 9 million to 17 million in those 12 weeks. I wasn’t excited at all to be starting the new drugs. I was dreading my work trip to Ibiza and I was annoyed to be back at square one. However in the first week of treatment my viral load dropped from 17 million to just 76 copies of the virus in my blood. By the second week my viral load was just 26 copies and at week four I was clear. My work trip to Ibiza was hellish. I was more exhausted then I knew it was possible to be and still be standing. But when I got home I was surprised by how quickly I recovered. The second two months of treatment went by quickly. My energy increased and I found myself working longer hours. I didn’t have any serious side effects other than headaches, stomach upsets www.baseline-hep.co.uk
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and I’d suddenly get very tired, usually after about 5pm. I lost the weight I’d put on during the three months I’d been on the placebo. I finished treatment just over four weeks ago and I’ve had a busy time since I took my last pills. I went on a family holiday to Sardinia followed by another busy work trip to Ibiza. The main thing I’ve noticed since completing treatment is that I don’t feel ill all the time. I don’t have as much joint and muscle pain and I’m not as tired. I still get tired but it’s usually a response to a lot of activity instead of following a good night’s sleep. I’ve been told it takes 3 months to fully recover and I feel well on the way now. I’m at a point now that I know I need to start a regular exercise regime to help my recovery along. By this time next year I aim to be bicycling around London and running up and down the Thames – far more preferable to lying on the sofa scoffing painkillers. By the way my son was informed in March 2013 that he is now cured of hep C. Not one person from his trial at Kings College Hospital relapsed. I’m expecting the results from mine. Good times are on the way for people with hepatitis C. Soon we will all be able to be cured. +
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Starting Hepatitis C Therapy It’s an exciting time in hepatitis C. There are many new hepatitis C medicines in development, but it may be some time until these new, oral, direct acting antiviral medicines are available in clinic, and potentially several years later that they are licensed for people who are also living with HIV. If you have advanced liver disease and opt for treatment now, you will likely receive triple therapy; that is pegylated interferon and ribavirin with a protease inhibitor (telaprevir or boceprevir). At the recent EASL meeting in Amsterdam the message was clear, “Interferon is not dead.” While there are multiple clinical trials currently testing a large number of oral medicines, the trials don’t always go to plan and drugs can fall by the wayside late in their development. But in the future, interferon- and ribavirin-free combinations may be a reality. With strong political will it may be possible to test and treat and eradicate hepatitis C globally. In an increasingly cost-concerned NHS, it’s not certain that all of the upcoming medicines will be available in England despite receiving European Approval. The medicines will also need to be approved by the National Institute For Health and Care Excellence (NICE) a process that could delay their availability in the clinic. The good news is that there are effective hepatitis C treatments available right now. However these treatments may cause some people significant side effects, so it’s important that you weigh up the risks of therapy against the benefits when deciding if- and when to start. Despite the side-effects, it’s motivating to know that treatment response rates have significantly improved for people with hepatitis C genotype 1 monoinfection (just hepatitis C) and people co-infected with HIV following the licensing of two hepatitis C protease inhibitors in 2011. Triple therapy is the new standard of care 54
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and these medicines have been assessed by NICE for their clinical and cost effectiveness. As a result, you should not have any problems accessing them. There is a large body of data on using triple therapy for a wide range of people with hepatitis C with mild to advanced liver fibrosis. What are the benefits of taking hepatitis C treatment now? Ultimately the decision whether to start therapy lies with the person living with hepatitis C. Only you can assess your readiness for treatment. Delaying treatment can be risky for some as liver disease caused by hepatitis C can progress more rapidly in people living with HIV. Hepatitis C can have a major impact on your quality of life, often causing you to be less productive at work and potentially increasing the amount of time you have off. Fortunately many people report feeling much better once they have cleared the virus. The good news is that people who take treatment before developing severe scarring of the liver (known as cirrhosis) appear to experience fewer treatment side effects. Liver disease caused by hepatitis C appears to progress more rapidly if you are also living with HIV, potentially leading to a faster time to liver cirrhosis and liver cancer, particularly if you drink more than 6 units of alcohol (equivalent to approximately two large glasses of wine) each day. People living with HIV who are diagnosed with an acute hepatitis C infection have a ‘window of opportunity’ to take 24 weeks of treatment (instead of 48 weeks in chronic infection). Early treatment increases the chance of you clearing the virus. Even if the virus has not caused too much damage to your liver there is evidence that it can +
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Robert Fieldhouse
be found in your brain. Clearing the virus can have a beneficial effect on your neurocognitive function. Treatment reduces the risk of hepatitis transmission And we should not forget, the sooner you get the virus treated and cleared, the sooner you can stop worrying about passing the virus on. People with HIV who are co-infected often have higher hepatitis C viral loads, potentially making them more infectious to others. Treatment is prevention and clearing the virus will prevent transmission to others. Furthermore, there’s a one in 20 risk of a woman with hepatitis C passing the virus to her baby, so if you are a woman living with hepatitis C, you may wish to clear the virus before you begin planning a family. What if I have taken treatment in the past? Some of you will have taken pegylated interferon and ribavirin in the past. There is evidence that people who relapsed after treatment or did not respond can respond to triple therapy with a protease inhibitor. This is true even among people with cirrhosis. When people were treated with pegylated interferon and ribavirin alone doctors were concerned to keep the ribavirin dose as high as possible for as long as possible, as reducing it was associated with a reduction in the likelihood of clearing the virus. The good news is that with triple therapy doctors are able to reduce the dose of ribavirin. By doing this, your haemoglobin should rise and you should feel some benefit in terms of your day-to-day energy. What about the side-effects? The side effects of triple therapy can be severe www.baseline-hep.co.uk
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for some people and you should discuss the pros and cons of starting treatment now with your doctor. You will also receive intense monitoring from your healthcare team, including regular blood work to monitor side effects and ensure your safety. The most common side effects reported with telaprevir (affecting more than 5% of those treated) include anaemia, rash, pruritus, nausea, and diarrhoea. The most frequently reported side effects with boceprevir include fatigue, anaemia, nausea, headache, and changes in taste sensation. Anorexia, depression, anxiety, insomnia, headache, dizziness, impaired concentration, cough, diarrhoea, abdominal pain, alopecia, arthralgia, irritability, fatigue and injection site reactions are all reported as very common side effects associated with pegylated interferon and ribavirin treatment. Your healthcare team is best placed to advise you how to manage any side effects you experience. What if I am a drug user- does that exclude me from treatment? Treatment guidelines don’t exclude drug users from accessing hepatitis C therapy, and clearing the virus in someone who injects drugs could have substantial benefits in reducing ongoing transmission within a local injecting population. What about drug-drug interactions? It’s likely if you are also living with HIV and taking antiretrovirals to treat it that you may need to change your HIV meds while you are taking triple therapy for hepatitis C. Make sure you speak to your healthcare professional about this. If you decide to start treatment there is plenty of support out there to help you through. We hope you find our tips useful. +
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BASELINE’s Top Tips for people starting hepatitis C treatment
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Getting support from your family and friends can help you get through treatment.
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Go along to your local hepatitis support group. Some may offer group support for people going through treatment. The Hepatitis C Trust and Terrence Higgins Trust run a support group for people with co-infection in London and there are many others around the country. To find a group in your area check out www.helpeverypersonc.org.uk
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Try to talk about how you feel to friends, family or your nurse. Ask for help when you are feeling tired and be honest about how you feel. If you feel tired give yourself permission to do less and rest.
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Explain to your family and friends that you might get side effects from the treatment, sometimes you might feel tired and you may not feel like yourself.
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Try to relax and do things that you enjoy most.
Light exercise can reduce tiredness. Try swimming or even a short walk when you feel like it can help. Start slowly and build up. Aerobic exercise can help you have more energy and may also improve depression. It may be best to avoid any strenuous activities on the day after you take the pegylated interferon injection. If you feel tired whilst you are on treatment, it might be difficult to work. Talk to your employer to tell them how you feel. You may be able to agree flexible hours for when you are feeling better or see if you can work from home. Try to get enough sleep. Avoid caffeine before you want to go to sleep. Have a regular routine at bedtime such as a warm bath to help you relax, reading or listening to music. If sleep becomes a problem, talk to your doctor. If you develop depression during treatment, make sure you talk to your nurse ASAP. Be prepared: Write your clinic appointments on a calendar or in a diary.
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Eat regular, nutritious meals: Sometimes people with hepatitis C have a hard time eating during treatment. You may have no appetite, feel nauseated, or have different tastes than you are used to. Even if you don’t feel like eating, it’s very important to eat small meals throughout the day. Some people have nausea in the afternoon. If this happens to you, try to eat a big, nutritious meal in the morning. Make sure you have food ready to eat at home in case you don’t feel like cooking. If you have cirrhosis, it may not be a good idea to eat salty foods or foods that are high in protein. If you want to know more about which foods to avoid and which foods are good to eat, ask your doctor about meeting with a registered dietitian to discuss a healthy eating plan. If you take recreational drugs or drink alcohol, it is important to stop. If you want to stop using drugs or alcohol and need help to do so, ask your doctor or someone else you trust about drug and alcohol treatment options. Because many medicines can stress your liver, talk to your doctor before you take any prescription or over-thecounter medicines. This includes herbal remedies as well. Keep a list of what you are taking.
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If you develop itchy skin, ask your doctor about taking non-prescription medicines, to relieve itching.
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Stay Hydrated. Drink water throughout the day.
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It’s possible that you may develop sore and bleeding gums during treatment, so keep up with your dental appointments.
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Select the day you take your injection and stick with it. Many people choose the weekends. Your nurse will be able to advise about good injecting techniques.
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Keep an eye on your blood count along with your doctor. If your haemoglobin drops your doctor can reduce your ribavirin dose. There are also separate treatments that your doctor can prescribe to raise your haemoglobin.
Keep taking the tablets on time. Treatment adherence is really important and one of the keys to success. Your doctor will be able to advise you whether to take your tablets twice or three times a day. 57
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Speak to your specialist to help you decide what over-the-counter medicines are safe to use, if needed (i.e. ibuprofen)
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Pamper yourself before you start therapy and give yourself treats during therapy.
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To counter any lack of concentration you may experience, develop your own system for keeping track of things like bill payments due or activities you’ve planned.
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Where can I get more information?
Decide, in advance, what you’ll tell people is happening with you. (Do you want to disclose that you have hepatitis C or that you have a blood disorder for which you are being treated?)
(Some options are shared below, this is not an exhaustive list)
www.infohep.org www.hepcctrust.org.uk www.helpeverypersonc.co.uk www.hivandhepatitis.com www.hepatitisscotland.com
Use the time to get a new hobby.
ww.nhs.uk/hepc
Consider getting a pet; there’s nothing like an animal to take your mind off your own problems. Cats are great company, especially when you are feeling unwell and dogs need walking every day, so they’ll get you out and about. If you need medical certificates or repeat prescriptions tell your doctor or nurse when you have your appointments. Be a support to someone else going through the same therapy; shared experience can be a great source of comfort and information. ++++
www.britishlivertrust.org.uk www.haemophilia.org.uk
This article was commissioned and sponsored by Janssen. The views expressed are those of the author. Janssen is one of the world’s leading research based pharmaceutical companies with a heritage of innovation in HIV. The company seeks to be an innovative and socially responsible participant in the response to HIV/ AIDS in order to improve the lives of those living with HIV and prevent the further spread of the virus. PHGB/HEP/0513/0014 October 2013
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Thandi Haruperi
Can I follow my dream? Persevere till it happens?
When AndyMurray walked onto Centre Court, there were many who laughed at him - the many who didn’t think he could win. But Murray won. Maybe the heavens were on his side that day, but if the truth be told, Murray has grown and his physique and game told a different story. He fought a good fight and played a good game to take the Wimbledon Championship this week. Now, I don’t even know the guy and perhaps will never meet him, but at a human level, I connected with him. I found myself with renewed inspiration. And very challenged too! I think of Murray, and the many times he ‘lost’. How this ‘loser’ would cut a lone figure, waving to his fans before walking off court with his head down, big bag on his shoulder, disappearing perhaps to cry privately. Ridiculed and shamed under full public glare, the media did not make it easy for him either, dissecting his character and lifestyle as they tossed him between his Scottish and British identities, depending on what points he scored. But Murray always regrouped and stayed on course. Blocking his ears to the naysayers, Murray run HIS race, eye on the goal, was resilient and persevering right to the end. He made history for Britain. Scotland was proud and so was Britain. I was stirred, inspired and challenged… and I imagine many others were too. In his post-win interviews, Murray explains that what kept him going was less about the money and more about sticking with something 60
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he loves, and within that HIS (Self ) BELIEF that he could one day create a bit of history (and leave a legacy). In relating with this assertion, I came face to face with my demons - my fear of pain, failure and perhaps ridicule! For many of us the pain and fear of going through difficulties is what makes us abandon our dreams, finding it easier to procrastinate or adjust our expectations or goals to suit our prevailing circumstances. Yes our confidence or self-esteem levels may be tested but ultimately most of us give up because of what the world around us will say and have us believe. But fear is not just about pain, or losing, it’s also about the ecstasy of winning and adjusting to change. Some of us wouldn’t know how to handle the overwhelming emotion of great happiness or joyful excitement that follows great achievement - and some of the things that came along with it. However, whatever we settle for, most of us know when we have lied to ourselves. There is that quiet voice within that won’t go away, reminding us how we have cheated ourselves. It will stir us and challenge us in the still of night, nudging our soul to do what we are truly being called to do. We all have a dream to achieve and the potential to grow and answer our highest calling. We all have a ‘big’ story, one we’ve quietly and repeatedly discussed with ourselves, one that comes from the innermost parts of our being. Some stories are too big to share - others who will only laugh and tell us to stop ‘dreaming’.
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But honestly, what would we do if we weren’t scared? Murray’s journey has acutely reminded me that failure is a critical stage or process of human development. For me, Murray’s win is not in his trophy, but in the journey he has taken, the character he has developed and the person he has become. With this awakening, perhaps my most important question is... Do I/we have the fortitude to do the work needed for my/ our own journey? To push through to the other side? To be vulnerable, to selfsacrifice? To withstand the most painful stages necessary for my/our wins and growth and ultimately move towards fulfillment as I/we answer my?our highest calling? I’m challenged, and curious to hear about you. @ThandiHaruperi www.restorego.com www.baseline-hiv.co.uk
A Chance to Live
Unfolding Joy, Gratitude and Purpose in the Face of HIV A Chance to Live is the story of one woman’s determination to find meaning in the face of life’s many adversities. Whilst Thandi Haruperi has many life defining moments, it was her diagnosis with HIV that was her rudest awakening; a life changing experience that set her on a personal journey of shame, hope, courage, vulnerability, self-belief, acceptance, self-awareness, learning, growth, self-love, forgiveness, healing, gratitude, joy and the beginning of a more authentic and purposeful existence In surviving this journey, Thandi found the power within her and learnt something about the strength of the human spirit and our capacity to CHOOSE how to respond to life’s events and circumstances. In her own way Thandi’s life story is “testament and affirmation that ultimately, we must learn to trust ourselves and our innermost voices, to dare to dream and have the courage to sing our song, knowing that when we do this, genuinely and wholeheartedly, the world will fully open to give meaning before us and to us. That when our dreams, desires and aspirations come from a place deep within, the universe will conspire with us to make things happen to us, because of us, and for us.” Proof of God’s amazing Grace, 14 years later, Thandi is alive and well, and enjoying all that life offers her, in all its guises. A speaker, educator, witness, activist and mentor, Thandi is a joyfully emerging designer, author and entrepreneur. She is a daughter, sister, aunty, proud mother and grandmother, and a friend and mentor to many. She lives in Surrey, England, dividing her time in between Zimbabwe, Zambia and her other international assignments. Projected book release date December 14th 2013 ++++
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My doctor has suggested changing me onto a new drug that has just been approved, even though I’m not having any bad side effects with my current antiretrovirals (ARVs).
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Are new drugs automatically better than old ones or should I be cautious about changing? What are the reasons that people should change?
i-base response:
This question raises a few interesting points. First off, when should somebody change medication and secondly what should you change to? Generally there are lots of reasons to change medication. Firstly, if you have resistance to one or more of the drugs in your current combination. This could be because you acquired a drug resistant HIV, or because you developed resistance while you were on treatment. You need a new combination to get your viral load down to ‘undetectable’. A second reason is if you have side effects that are affecting your quality of life, especially if there are alternative drugs you could be taking. HIV drugs need to be both effective and easy to tolerate. It is always worth seeing whether there are alternatives to avoid any side effects. A third reason might be if there are better or more convenient options - perhaps because you have been on one treatment for a long time and newer drugs have been developed since. For example, if your current combination is complicated and you want something that is easier to take such as a once-daily combination instead of twice-daily. Sometimes people on older ARVs may change combinations, even if none of the above apply. This is the case with anybody in the UK taking AZT, 62
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ddI or d4T- unless these are the only drugs they can take - because we know that newer drugs are likely to be better for you over time. Most countries in the world are phasing out ddI, d4T and AZT because of side effects. Another reason to change might be if you need other medications that could interact with your ARVs. An example would be if you have a coinfection like hepatitis or need chemotherapy. Also, and this will be increasingly important, might be related to cost. Your treatment is primarily decided based on what is best for your health. However, some options could be equally good, and it is important that the NHS uses the one that is most cost effective. For example, when generic drugs become available, switching to those formulations will be important for HIV care, just as it is for other conditions. In your situation, it is important to ask your doctor why they are suggesting this change. It could be for several of the reasons above but they haven’t explained this. Without knowing your current combination and what your doctor is recommending it is difficult to comment. Sometimes, even when someone is happy with their combination, if research shows advantages for newer treatments, this would be better to change in the long run.
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Rebecca McDowall
i-base 0808 600 8013
ask a question Although a few of the early drugs are still widely used, in general, newer drugs only become approved if they show advantages over existing options. It’s worth checking with your doctor if there is anything s/he is concerned about with your monitoring tests. Then at least you have the information to decide whether you want to change. New drugs are only approved if they are at least as safe and as effective as the current standard of care, but often they are better. The caution with new drugs is that because fewer people have used them we have limited long-term information. This can make some of the older drugs relatively safer because they have been used so widely for many years. This doesn’t mean that new drugs will be worse, just that we don’t have the same body of information as with older drugs. Everybody responds differently to treatment. For someone with drug resistance, a new drug could be life-saving by providing them with an effective treatment to control their virus. For others it could improve their quality of life, even if they are broadly happy with their current treatment, so keeping an open mind to treatment becoming better is a good thing. www.baseline-hiv.co.uk
by email, online or phone
questions@ i-Base.org.uk www.i-Base.info/qa
0808 800 6013
take control of your treatment
HIV (Home Testing) Policy on the Hoof The Department of Health’s recent decision www.gov.uk/government/news/ modernisation-of-hiv-rules-to-better-protectpublic to legalise sales of HIV Home Testing kits in UK high streets from next April provoked debate and saw concerns go viral. www.incidence0. org/2013/08/12/hiv-home-testing-not-a-freecuddly-toy. The announcement www.gov.uk/ government/news/modernisation-of-hiv-rulesto-better-protect-public, couched in terms of modernisation and better public protection, leaves the policy open to questions as to its safety, evidence base, and levels of consultation. Now, after five years of lobbying for change, charities are ‘working hard to ensure that concerns are addressed.’ This decision leaves the UK in a policy minority amongst its European and western neighbours, only the USA having approved over the counter sales thus far. Canada, for example, has follow the evidential base Gay Men’s Attitudes and Perceptions Regarding Rapid HIV Home Testing www.ohtn.on.ca/pages/Knowledge-Exchange/ Rapid-Responses/RR69-2013-Paid-TestingPerceptions of concerns amongst gay men about the lack of immediate professional support in the event of a positive test result, the perceived uncertainty about its accuracy, the incongruence with a sexual situation, and the associated costs of the test. Many in the UK agree. Whilst questioning the DH decision, there is no resistance to the motivation behind the policy change. Many respected agencies www. nat.org.uk/our-thinking/prevention-andtesting/testing.aspx and professionals www. huffingtonpost.co.uk/dr-steve-taylor/hivhome-testing-kits_b_2620246.html support the move pointing to risks in the current unregulated availability of home testing kits, like much on the 64
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internet. But lifting the sales ban is as likely to encourage as it is to deter overseas profiteers and is unlikely to neutralise their market. Safety concerns over FDA approved kits stem from manufacturer warnings of their kit’s one in twelve false negatives and the three-month window period. ‘Choice’ should not trump safety and support. Reducing undiagnosed HIV must be a priority, and we know how to do it. Support for primary care, ensuring that medical staff are alert to indicator conditions, standardisation in specific settings like emergency departments, and building on the success of community testing. Take a look at the NICE guidance on increasing the uptake of HIV testing among men who have sex with men and you’ll see that home testing is not on the list. www.nice.org.uk/nicemedia/ live/13413/53675/53675.pdf How the policy is to be measured is yet to be established. There is no systematic home test study to date evaluating post-testing linkage with counselling and treatment outcomes. (Supervised and Unsupervised Home-testing for HIV in High- and Low-Risk Populations: A Systematic Review www.plosmedicine.org/ article/info%3Adoi%2F10.1371%2Fjournal. pmed.1001414). Surveys www.tht.org.uk/ our-charity/About-us/Media-centre/PressReleases/2013/August/Terrence-Higgins-Trustresponds-to-legalisation-of-HIV-selftestingkits claim a high level of acceptability, but to whom? Testing rates have increased significantly in the UK but it is difficult to see how home testing will help those who experience real barriers www.gaycon.org.uk/images/gaycon/ presentations/1.1_Paul_Flowers.pdf in going for a test or sending off for a home sampling kit. Increased testing per se is not the same as the real goal of increased diagnosis or linkage to and
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Autumn 2013
Roy Kilpatrick
Lisa Power
The THT View retention in care. As home-test kits are unlikely to be supported by public funds, who will fork out near forty quid for a commercial product off pharmacy or supermarket shelves? Think ‘condoms’. Who will use home testing kits is unknown, but we are agreed on whom we must reach. Generally, men who have sex with men, people with links to high prevalence areas, and a number of people who indicate no obvious risk factor. Scottish Government estimates that home testing will be of interest to relatively small numbers. Investment analysts, however, project a US market size of $500 million www.zacks.com/stock/ news/84648/OraSure-UnveilsInHome-HIV-test with unit sales already hitting 25 million. Yet US rates of undiagnosed infection remain stubbornly high. We would all rather get right behind policy than act as touch-line critics, albeit friendly. Governments and charities, regardless of clout, must speak therefore with the communities they serve. When HIV policy is formulated aloof from professional insights, then people with HIV haven’t a look in, and the gulf between policy and reality, leadership and engagement is set to widen. www.baseline-hiv.co.uk
When HIV treatments came along, some HIV activists turned their backs on them and said they wouldn’t work, or wouldn’t last, or wouldn’t suit most people – and how many people are alive today because of them? When opt-out testing in antenatal clinics was first mooted, some HIV activists said it was a breach of human rights, a wedge in the door for forced testing – and how few babies are born with HIV in the UK now as a direct result? To be fair, I don’t think HIV self-testing’s anywhere near as important an advance as either of those. And I think, with any development, it’s sensible to ask what safeguards and checks will be in place. But I think the legalisation and regulation of self-testing is a worthwhile thing to do, for several reasons. Firstly, people want the option to do it. Our research with our members and people who told us they’d have been diagnosed sooner if self-testing had been an option counted with us. And if you believe in patient choice over treatment options and doctors, why suddenly refuse it for this? Secondly, some of them are already doing so, whether we like it or not. Illegal kits are available on the internet and a growing number of people in the UK are buying them. Those kits are poor quality, often with no instructions for use and with no support information. Legalising and regulating the sale of kits is a basic principle of harm reduction to make what people already do safer. We need to regulate the kits, not just for safety but also to ensure the inclusion of decent information that encourages people with a reactive result to get a confirmatory test and talk through their options. Finally, without the option of legalisation in the future there’s no incentive for the companies who make the kits to make the improvements needed to fully reach European safety standards. Nobody wants substandard kits on the market, and companies won’t be granted a license if they are. Legalising and regulating home testing won’t take anything away from all the current options people have. Hopefully it’ll let some people have a bit more control over their lives, get some people diagnosed earlier and reduce the chance of them passing the virus on. It’s not a great breakthrough and it’s not the devil in disguise. It’s just another little bit of progress in the fight against HIV and in ten years time, we’ll look back and be as amazed as we are now at the resistance over whether testing was a good idea at all, or whether people should be allowed to take those scary, uncertain treatments. ++++
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65
A London Lass
The Secret Diary Of A Newly Diagnosed Workshop Attendee (aged 39 And ¾) The invitation had arrived in my inbox two months previously. I’d read it, re-read it, enquired about places available numerous times. Decided I was going, decided I wasn’t. Emailed again to see if there were still places, thought long and hard about if it was really my kind of thing then made the definitive decision I wasn’t going.
‘I came away with such an amazing light heart, I feel better now than I have in years.’ The two-day retreat for those newly diagnosed with HIV, run by people long-term diagnosed with HIV, sounded like everything I didn’t need. I’d also read the agenda on workshops held and thought that a two-day tree hugging pity party wasn’t for me. Yet here I am hurtling at speed along the motorway to a retreat in Stafford. The reason I might add that I was travelling at a speed that would make Marty McFly proud is that I had again that day decided I wasn’t going to attend. You can see my dilemma. As I pull up I find myself thinking my sat nav has given me a bum steer. This place isn’t the Adams Family residence I was expecting but is rather a beautiful, bright, well kept building in cheery grounds. Good, wrong place, I can make enquiries at the front desk, turn around, head home and send an email explaining my absence. I’m greeted by an impossibly nice woman at the reception desk with a smile that would put a Cheshire cat to shame. Definitely in the wrong place. No scowling judgmental looks or accusatory glances. I mumble something about being here for the weekend course keeping my eyes on her for a 66
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flicker of dread in her face. There is none. Instead I’m offered tea or coffee and ushered into a room where people are waiting. Upon entering the room I take a deep breath, I could still turn back, say I’ve made a mistake and ask for directions to Alton Towers. There are 10 or so people cordially chatting and munching biscuits. None of them look sick, none of them are hooked up to hospital machines and there is no looming dark figure in the corner with a scythe. What’s going on? Must be the wrong place. I exhale loudly drawing unwanted attention to myself. People are looking at me, people are smiling, people seem friendly and happy. I’ve been shown into the wrong course surely, although on the plus side if I am in the wrong room I could end up paintballing or quad biking with a team of burnt out execs. And so the weekend began. I was asked to write about my experiences over the two days and as it turns out it was one of the most wonderful times I’ve ever had. I saw no tears but I did see countless smiles. I heard no crying but I did hear endless laughter and excited chatter. Was it tough? You bet! But in the nicest possible way. For the first time I was able to speak openly and honestly about how I was feeling. Share things I’d not shared before. Vocalize ridiculous thoughts I’d had. Each and every workshop or breakout session I did gave me something to take away. People came in who had been HIV positive for many years with a wealth of experience from legal issues to medication knowledge. If you get the chance as someone recently diagnosed to attend one of these weekends run by NLTSG, do it. I came away with such an amazing light heart, I won’t give any spoilers as to what happens but I will tell you this, I have made some genuine friends for life from it. I have an arsenal of coping mechanisms and strategies at my side and I feel better now than I have in years.
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Autumn 2013
A Se r v i c e O f
S A T U R D A Y 30 November 2 0 1 3 S t P a u l ’ s ( T h e Ac t o r s ’ ) c h u r ch 11 a m
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Date of preparation: August 2012