Infectious Diseases - Q1 2021

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Q1 / 2021

Infectious Diseases

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Treatments must be effective, accessible and equitable for patients.

Helping support those living with HIV during the pandemic.

The world needs to take a One Health approach.

Professor Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance

Dr Laura Waters, Chair, British HIV Association (BHIVA)

Dr Casey Barton Behravesh, Director, One Health Office, Centers for Disease Control and Prevention, USA

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IN THIS ISSUE

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Why there is no time to lose in tackling tuberculosis

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The world pledged to end tuberculosis by 2030 — but the global pandemic has put that at risk. It’s time to refocus and redouble efforts.

Experts have long warned of the potential threat of a pandemic.

Dr Seth Berkley CEO, Gavi, the Vaccine Alliance

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Infected patients must be identified and treated in order to protect the population.

Emmanuelle Cambau Professional Affairs Officer, ESCMID

12 A global response requires global co-operation.

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r Tereza Kasaeva, Director, Global Tuberculosis Programme, World Health Organization (WHO), has a stark warning. Despite a commitment from world leaders to end TB by 2030, this preventable and curable disease kills around 1.4 million people a year. Now, tragically, the havoc wrought by COVID-19 has made a bad situation worse. It’s why the worrying theme of this year’s World Tuberculosis Day is: “The clock is ticking.”

Before the global pandemic, many countries had made steady progress in tackling TB. “Even so, we weren’t on track to hit 2020 milestones,” cautions Dr Kasaeva. “By 2020 we wanted a 20% reduction in TB incidence, a 35% reduction in TB mortality and no catastrophic costs for people or families affected by TB. Instead, there was only a 9% reduction in TB incidence and a 14% reduction in TB death, 80% of affected people and families still face catastrophic costs.”

Because of COVID-19, global progress is now severely under threat. “In almost all countries with a high burden of TB, we have seen an average 30% drop in TB case notifications,” says Dr Kasaeva. “This means more people are missing diagnosis and care and transmitting TB.” Why screening is vital in the fight to end TB For World Tuberculosis Day, WHO have launched new TB screening guidelines which it hopes will help reach the ‘missing millions’ — the estimated three million people

who fall ill with the disease every year but go unreported, many of whom remain untreated.

Community-wide screening in high burden settings (at least 0.5% TB prevalence) is vital because it can significantly reduce the prevalence of TB and reduce transmission, notes Dr Cecily Miller, Technical Officer, Global TB Programme, WHO. “The new guidelines also include recommendations for new screening tools, such as computer-aided detection software for automated detection of TB on digital radiographs,” she says. “This is an exciting development which allows screening to be implemented and brought to scale in locations that lack trained personnel.”

Further, such innovation is urgently required in the field of TB diagnostics — and prevention.

After all, it’s telling that 2021 marks the centenary of the world’s only available licensed TB vaccine.

Yet, Dr Dennis Falzon, Team Lead, Prevention, Research and Innovation, WHO, believes lessons can be learned from the rapid development of COVID-19 vaccines and diagnostics to benefit TB. “There are significant differences between development of vaccines for TB and development of vaccines for viruses,” he admits. “But the response to COVID-19 shows that research can advance swiftly when different stakeholders put their heads together to overcome seemingly insurmountable challenges.”

Time, however, is critical.

“To end TB, the world needs to redouble its efforts — now,” stresses Dr Kasaeva.

Dr Tereza Kasaeva Director, Global Tuberculosis Programme, World Health Organization

Dr Dennis Falzon Team Lead, Prevention, Research and Innovation, World Health Organization

Dr Cecily Miller Technical Officer, Prevention, Research and Innovation, World Health Organization WRITTEN BY

Tony Greenway

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

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Humans’ oldest foe: fighting malaria in the face of resistance Early markers of drug resistance have been identified in Africa, threatening the long-term efficacy of first line treatments in the continent, which bears around 93% of the global burden of the disease.

T Dr David Reddy CEO, Medicines for Malaria Venture

WRITTEN BY

Meredith Jones-Russell

he total malaria deaths in Africa almost halved between 2000 and 2019, with the fight against the disease focused on three key elements.

Firstly, improvements in vector control, such as the use of mosquito nets and repellents; secondly, improvements in and more routine use of diagnostics; and thirdly, better medicines.

Between 2010 and 2019, around 3.1 billion courses of artemisinin combination therapies (ACTs) were used.

Dr David Reddy, CEO of Medicines for Malaria Venture (MMV), explains, “ACTs are the gold standard. They have a massive impact with greater than 95% efficacy and it would be a tragedy if we lost them.”

The dangers of ACT resistance Nonetheless, artemisinin resistance has been identified, initially in South-East Asia but now in Africa too.

Dr Reddy explains, “What we are seeing in Africa is not frank resistance, but slower parasite clearance and resistance markers. ACTs are combination treatments, and resistance either to the artemisinin component or the partner drug is a cause for concern. The identification of these resistance markers in Africa is a worrisome sign that could undermine all artemisinin-based combination medicines.”

The WHO has named antimicrobial resistance as one of the top 10 global health threats,

estimated to kill 10 million people a year by 2050.

With the threat of other diseases, including COVID-19, also prevalent, Dr Reddy warns the dangers of ACT-resistant malaria are manifold.

“We cannot afford to take our focus off malaria even amid a viral pandemic. Malaria kills over 400,000 people every year and it’s mostly children under five that lose their lives.”

Beyond that, Dr Reddy says, is the challenge of overwhelming healthcare systems, which are weakened already by COVID-19.

“When you face a collision of multiple diseases and the complexity of getting the resources needed, plus the challenge of people delaying treatment for fear of catching a disease like Ebola or COVID, you get a snowball effect where diseases feed off each other and everything becomes worse in terms of infrastructure, treatment and, eventually, outcomes.”

“On the other hand, if you can push malaria down, you create more capacity to manage other diseases and have a far better chance of detecting new threats on the horizon, which is critically important.”

Fighting ACT resistance In response, MMV is focused on understanding the molecular basis of resistance, developing alternative treatments as resistance thresholds are reached and making new treatments available as quickly as possible, shares Dr Reddy.

“We have to keep ACTs alive for as long as we can. MMV and partners are exploring several strategies with this end in mind.

For example, deploying multiple first line therapies simultaneously may slow the development of resistance,” says Dr Reddy.

Other approaches might include combining existing medicines into triple combination therapies, Dr Reddy suggests. Regardless of specific approaches, quality drugs are key throughout because counterfeit or suboptimal drugs with inadequate amounts of active substance are a recipe for disaster.

“They just poke the parasite and give it the time and opportunity to develop a mechanism to escape.”

MMV is also considering the long game when ACT resistance could become widespread in Africa. “While we hope this day doesn’t come, we must be prepared and that’s why we are focused on developing the next generation of malaria treatments.

We plan to be ready within five years to help bring new non-artemisinin combination therapies to the field. We screen every compound we develop against resistant parasites and look for ones with low potential for resistance that will last for the long haul.”

“They say malaria is one of humans’ oldest foes, which is absolutely true, but the face of that foe is changing daily. We need to stay one step ahead,” concludes Dr Reddy.

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Can rapid tests help ease COVID-19 restrictions?

Thirty minute, inexpensive, non laboratory tests for the SARS-CoV-2 antigen can identify people likely to pass on the virus and may augment public health efforts to reopen society.

Which tests are needed to manage COVID-19?

Rapid isolation of infectious cases is central to managing outbreaks of high-consequence diseases like COVID-19. As those infected with SARS-CoV-2 may not have symptoms, testing is essential for identifying cases. Three types of test are being used: nucleic acid; antigen; and antibody detection.

There are also three purposes for testing: clinical testing to guide care; public health testing to control the virus; and research testing to understand immunity against future infection.1 The mainstay of testing has been reverse transcriptase polymerase chain reaction (PCR) technology – a nucleic acid test for the virus’ genetic material, usually on nose/throat swabs. Results are reported in one to three days as positive/ negative. PCR amplifies complex molecules of nucleic acid, doubling it across each of a series of cycles, detecting even single fragments of dead virus. Counting the cycles needed to detect the nucleic acid – the cycle threshold (Ct) – also allows quantitation of viral load. Comparing Ct between laboratories, however, is difficult as there is currently no adoption of an international standard.2

Antibody tests reflect historical rather than current infections by looking at the body’s immune response to the virus. Their value in COVID-19 management is being assessed.

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

Lateral flow is the most common technology for detecting SARS-CoV-2 antigens, usually nucleocapsid protein.1 A monoclonal antibody to the antigen is stuck on a line across a nitrocellulose membrane at the result window of a small plastic device. The sample and buffer are placed in a well

and flow laterally along the nitrocellulose picking up test ingredients. If the antigen is present the line changes colour within 30 minutes – darker if there are more antigens but designed to be read as positive/negative. Thorough swabbing of the nose/throat, sufficient mixing of the swab with the solution and timing of reading are vital for good performance of the test. Lateral flow tests (LFTs) have been validated in a wide variety of settings and viral loads.1 Antibody tests reflect historical rather than current infections by looking at the body’s immune response to the virus. Their value in COVID-19 management is being assessed.

Do rapid SARS-CoV-2 antigen lateral flow tests (LFTs) work?

The accuracy of LFTs have been debated – a complex topic, we recently clarified.2 In the absence of a practical gold standard test for live virus, LFTs have been compared with PCR, which looks for evidence of the virus, alive or dead, in samples from a person’s nose or throat. Whereas LFT looks for evidence that a person is shedding larger amounts of live virus and may pass it on.1 In the typical course of infection, symptoms appear a median five-day incubation after exposure to the virus, however, 30-50% of people do not show classic symptoms.

PCR usually detects virus nucleic acid one to two days after infection, with LFT detecting antigen a day later, both before symptoms may appear. Viral levels peak at symptom onset and wane over the next few days. In the four to eight day transmission window when a person is shedding substantial amounts of virus, with or without symptoms, both PCR and LFT are likely to be positive. Thereafter, their immune system controls the virus and, for the next 17 days or longer, they often have dead virus RNA in their nose/throat giving a positive PCR and negative LFT. The infectiousness of individuals with different viral loads has been determined by testing their

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contacts.Most infectious individuals have moderateto-high viral loads, which LFTs reliably detect (including current viral variants) with sensitivities >90%, whilst individuals with low viral loads are not very infectious and not detected by LFT. These studies indicate that LFT identifies at least eight out of 10 contagious individuals. LFT results are also reliably specific, with fewer than one in 1000 false negatives. A common error is to assess LFT performance against PCR as the ‘gold standard’ when PCR identifies both infectious and post-infectious periods – a starkly different reason for testing.2 Can society reopen sooner by using rapid antigen tests?

LFTs can be manufactured quickly, cheaply, in vast quantities and can be used with minimal training.

Getting results within 30 minutes anywhere enables SARS-CoV-2 transmitters to isolate quickly. This allows safer lifting of COVID-19 restrictions with reduction in the harm to the health, social fabric and wealth of society.

A test is only as good as how it is used in a public health programme, cognisant of behaviours not just biology. Ideally, everyone should know how to test and respond to the results. The 24+ hours quicker results from LFT vs PCR is valuable when test-positive people isolate promptly and encourage their contacts to get tested. Similarly, understanding among workplace teams (e.g. fire crews) of how to test daily instead of quarantine after contact with a case can secure key services.

LFT offers the scale and speed needed to crowdsource safer reopening of society, reducing the harms from current restrictions. The challenge is to ensure equity of access to testing and support isolate for disadvantaged communities.

References 1. Crozier A, Rajan S, Buchan I, McKee M. Put to the test: use of rapid testing technologies for covid-19. BMJ. 2021 Feb 3;372:n208. doi: 10.1136/ bmj.n208.

2. Mina MJ, Peto TE, García-Fiñana M, Semple MG, Buchan IE. Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19. Lancet. 2021 Feb 17:S0140-6736(21)00425-6. doi: 10.1016/ S0140-6736(21)00425-6.

Iain E Buchan Professor of Public Health and Clinical Informatics, University of Liverpool

Malcolm G Semple Professor of Outbreak Medicine and Child Health, University of Liverpool

Tim E Peto Professor of Medicine, University of Oxford

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The growing threat of pandemics Whilst COVID-19 caught the world off guard, the speed at which it spread and the extent of its impact on people’s lives came as a great shock to most. However, some were not surprised at all.

C Dr Seth Berkley CEO, Gavi, the Vaccine Alliance

OVID-19 is the third recent jump of an animal coronavirus into humans, after SARS and MERS, plus other coronaviruses that are part of our normal respiratory seasonal infections. Global health and infectious disease experts have long warned of the potential threat of a pandemic, arguing that not only was one long overdue, but that the risk of pandemics was actually increasing.

This may seem counterintuitive, given the progress that has been made in reducing the impact of infectious disease; smallpox has been eradicated, the number of cases of polio has reduced by more than 99.99%. Thanks to the efforts of organisations like Gavi, the Vaccine Alliance, diseases like measles, diphtheria and tetanus have been in steady decline in recent decades.

The emergence of new infectious diseases is not something we can control; the rate at which pathogens mutate makes this an evolutionary certainty. Since the

1940s more than 330 emerging infectious diseases have been identified, of which 60% were zoonotic, meaning they originated in animals but jumped the species barrier to humans.

The ease with which a disease can be transmitted increases proportionally with urban density.

Increasing infection spread When a new infectious disease does emerge, human migration, population growth, urbanisation and dense urban slums, rapid global travel and climate change can all hasten its spread. The ease with which a disease can be transmitted increases proportionally with urban density.

So, as more people are drawn

to live in cities to seek economic prosperity or driven there by conflict or are climate disaster, the risk of outbreaks raging out of control increases. When you factor in that pre-COVID-19, more than a billion people crossed international borders each year, pathogens can now cross the globe as fast as a jet plane.

Improving surveillance of diseases The reality is that it has never been easier for outbreaks to spread globally. Given the relentless speed at which viruses can mutate, it’s not a question of if there will be a next time after COVID-19, but only when.

The only way to avoid this is to learn from this crisis, build stronger disease surveillance and invest in vaccine research and anti-viral therapeutics.

Ultimately the only way to prevent a pandemic is to stop outbreaks from escalating in the first place.

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

©IMAGE PROVIDED BY GAVI

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Why working together is the best way to beat infectious disease The global pandemic has shown there is no use trying to control infectious diseases in isolation.

Collaborative international expertise and trust will be vital in the years ahead.

Professor Alison Holmes President, ISID (International Society for Infectious Diseases)

WRITTEN BY Tony Greenway

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fter the catastrophe of the last year, is the world finally getting the message? To successfully fight infectious diseases, it’s not enough to have pockets of awareness and scientific expertise in certain countries. Stopping outbreaks before they start — or controlling them when they do — requires a truly global, joined up effort between specialists of all kinds.

“Approaches to research and interventions have to be collaborative and strong,” stresses Professor Alison Holmes, President of ISID (International Society for Infectious Diseases), an organisation supporting health

professionals and bodies around the world in their work to prevent, investigate and manage infectious diseases and outbreaks. “Just look at the amount of international expertise, data-sharing and research collaboration needed to drive vaccine development.

It proves this can’t been done in isolation.”

The role that women play in this struggle must not be undervalued either. “There has to be diversity in global representation, including the representation of women, in medicine and research,” says Professor Holmes.

Trust will play a big part in infectious disease control Excellent global disease detection and surveillance is critical, too.

ISID’s Program for Monitoring Emerging Diseases (ProMED) is the leading innovative infectious disease surveillance network based on the One Health principle that human, animal and environmental health are inextricably linked.

“ProMED was the first surveillance

programme to discover what was going on in Wuhan,” says Professor Holmes. “It’s another powerful demonstration of international, collaborative expertise, with local and regional intelligence networks of highly trusted, knowledgeable people identifying and monitoring early signs of infectious disease.”

Professor Holmes is optimistic that there will be a new focus on infectious disease and their prevention and control going forward. “However, infectious disease programmes need support and investment,” she says. “I don’t just mean cash investment, vital though that is. There also needs to be sustained global capacity building in infectious disease expertise, because it’s crucial for our public health. There also needs to be a strong foundation of trust; trust between global research collaborators and trust between the public, the science community and policymakers. That could be harder to achieve.”

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Protecting the world from the pandemics of the future The effects of COVID-19 will be felt for generations, but the virus could be the wakeup call we need to respond quickly and effectively to the next big threats.

Dr Melanie Saville Director of Vaccine R&D, CEPI WRITTEN BY

Meredith Jones-Russell

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aunched in 2017, the Coalition for Epidemic Preparedness Innovations (CEPI) has overseen breakthroughs in vaccine development including advancing the first ever Nipah and Lassa virus vaccines into clinical trials.

Most recently, the coalition has worked with its partners to rapidly respond to COVID-19.

“When we launched, we focused on some known threats without vaccines, but also on rapid response platforms to the novel ‘Disease X,’” explains Dr Melanie Saville, Director of Vaccine R&D at CEPI. “That meant when COVID-19 hit, we were able to hit the ground running and build one of the

world’s largest and most diverse vaccine portfolios.”

Through its work as co-leader of COVAX, a global initiative aiming for equitable access to COVID-19 vaccines, CEPI is committed to delivering 2 billion vaccine doses to participating countries worldwide in 2021.

“As an organisation, it is part of our DNA to ensure vaccine access for the world’s most vulnerable populations,” Dr Saville explains.

“No one is safe until everyone is safe.”

Prepare, transform, connect The organisation is now seeking $3.5 billion funding for its five-year plan to continue its work to tackle the COVID-19 crisis and reduce the risks posed by future pandemics.

The plan’s three pillars will see CEPI focus firstly on preparation, which will include the development of a universal coronavirus vaccine in case a similar pandemic should strike again.

“This would give us a ‘one bug, one drug’ approach that would be more broadly protective and

drastically reduce the threat,” Dr Saville explains.

It will prioritise transformation by reducing vaccine development timeframes by two-thirds to 100 days from the 324 days it took for the first emergency use approval of the Pfizer BioNTech COVID-19 vaccine.

“With coronaviruses just one of 25 virus families, we will also build libraries of prototype vaccines to get a head start, understand how they work, and discover the right antigens,” says Dr Saville.

Finally, CEPI will work to connect and enhance the global outbreak response architecture.

“One organisation cannot do everything and it’s important we continue to connect with partners to make a more secure world,’ Dr Saville adds.

“Often, pandemic preparedness is better in high-income countries, so building infrastructure and connections in low- and middleincome countries is also going to be critical to minimise the impact of future pandemics.”

The Urgency of Now: endpandemics. cepi.net

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How we can learn from long COVID for Lyme disease

The need for medical expertise to tackle infectious diseases

The large number of people with long COVID, many of them health professionals, has facilitated recognition of this complex condition.

Many infections, such as tuberculosis, have cases and deaths in the millions, but they are neglected as the world is suffering from COVID-19.

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hose with longstanding, persistent symptoms from Lyme disease look on with interest. Currently dismissed from follow-up and with studies purporting to show they are no worse off than healthy controls, will things now change for this growing cohort?

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The socio-economic burden A significant proportion of those contracting Lyme borreliosis have residual, multi-system symptoms fluctuating over time. These can last for months or years and impose a significant cost on states, healthcare systems and families.

Emmanuelle Cambau, MD, PhD

Professional Affairs Officer, ESCMID (European Society of Clinical Microbiology and Infectious Diseases)

What symptoms and signs persist?

Ask the patients! We need to acknowledge that relapsingremitting symptoms, some dismissed as “subjective”, are both real and can be disabling.

There is no core outcome set enabling consistent recording in clinical studies.

Science only finds a solution if it looks.

Biomarkers may illuminate The complexity of Lyme disease is poorly understood; long COVID research may forge a path.

Identifying relevant biomarkers may shed light on immune dysfunction and lead to effective treatment.

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

Stella Huyshe-Shires Chair, Lyme Disease Action

Paid for by Lyme Disease Action Find out more at lymediseaseaction.org.uk

©IMAGE PROVIDED BY ESCMID

What needs to be done?

We must develop a core outcome set for use in research, specialist multi-disciplinary clinics with long term follow-up and biobanks for samples. All designed with the involvement of clinical methodologists and patients.

Above all, an acknowledgement that persisting symptoms, as with COVID-19, are worthy of attention.

OVID-19 has caused about two million deaths; tuberculosis (TB) causes numbers like this annually.

Although TB has a “World Day” on 24th March, was characterised as a global WHO emergency and received a specific UN recommendation, most governments, organisations, diagnostic and pharmaceutical companies do not pay much attention to this infection. This is contrary to what has been observed for SARS-CoV-2 this year.

Medical expertise needed for all infections A first inventory concerning country capacities for microbiological diagnosis, patient management and disease control shows that many of them were surprised and unarmed when COVID-19 appeared.

This slow start has been previously observed when the human immunodeficiency virus (HIV) was discovered, was repeated with the hepatitis C viral infection, and now with the SARS-CoV-2 infection.

Medical specialties to resolve issue of infection Clinical Microbiology (CM) and Infectious Diseases (ID) medical specialties exist in many countries with university diplomas, specific training curriculum and professional expertise.

In Europe, these specialties are represented as sections of the European Union of Medical Specialists (UEMS) and roughly 9,000 individuals are also members of ESCMID. CM and ID act in synergy to answer adequately to all needs in patient

Infected patients must be identified and treated in order to protect the population. management and detection of infectious agents for better diagnostics and prevention.

They also have competencies in infection control (IC) management and antimicrobial stewardship (AMS). These specialities need to be better supported, increased in size and established across all countries.

Expertise to control present and future pandemics Having CM and ID specialists in each country (hospitals and organisations) would help in all problems caused by transmitted infections; from rare diseases such as Ebola, where highly specialised expertise is required, to pandemics where transmission must be stopped, infected patients must be identified and treated in order to protect the population. Since these medical specialties are one expertise for all infections, it should be a priority to promote them globally to deal with new crises such as COVID-19 and older ones such as TB.

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Urgency of collaborative science to save millions of lives Not-for-profit drug development is key to addressing R&D gaps for neglected diseases and drug-resistant infections.

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he global response to COVID-19 has led to the development of vaccines, treatments and diagnostics at unprecedented speed, but it has also revealed the ugly truth about the inequalities of our global biomedical innovation system. It is therefore timely that DNDi has just launched its new strategic plan to continue to address unequal access to innovation.

As we face the coming decade, we must brace ourselves for future pandemics, climatesensitive diseases and neglected diseases – all of which exact a disproportionate toll on vulnerable communities.

We must advance a robust R&D agenda that drives gender-responsive drug development and delivers often-overlooked childfriendly drug formulations.

Fair global access to treatment In order to respond to neglected patient needs, we need to involve more R&D actors in low- and middle-income countries, champion an open, transparent approach to drug development and continue to advocate for equitable global access to treatment.

We must advance a robust R&D agenda that drives gender-responsive drug development and delivers often-overlooked child-friendly drug formulations.

Through this collaborative model, we have already delivered eight game-changing treatments – including the first all-oral treatment for sleeping sickness. We now aim to deliver 25 treatments by our 25th anniversary in 2028.

We invite you to join us on this journey. DNDi’s 2021-2028 Strategic Plan is available here: dndi.org/strategy Dr Bernard Pécoul Executive Director, Drugs for Neglected Diseases initiative (DNDi)

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OVID-19 has brought into sharp focus the failure of not preventing and preparing for pandemics. As the world reels from the tragedy and economic fallout of COVID-19, a new GARDP report explores how to apply the vital lessons we are learning to the fight against drug resistance.

The unchecked growth of drug-resistant infections is a silent pandemic with long-term implications for global public health and the global economy. These infections kill an estimated 700,000 people a year, a number set to rise exponentially as drug resistance grows and weakens our ability to treat even common infections.

Like COVID-19, antibiotic-resistant bacteria can infect anyone of any age, in any country.

We have the opportunity to mobilise and take collective responsibility to prevent a health catastrophe fueled by drug resistance.

Drug resistance affects everyone COVID-19 has clearly shown that a single country cannot solve the challenges of a rapidly moving pandemic on its own. We need to join forces as countries, organisations, institutions and companies to identify and develop new ways to prevent, test and treat.

GARDP is addressing critically underfunded and unfilled gaps to deliver new treatments to tackle the drug-resistant infections that pose the greatest threat to global health. This includes developing treatments for babies with sepsis, sexually transmitted infections and hospital-acquired infections. GARDP is seeking €500 million to develop these treatments –

gardp.org

Dr Manica Balasegaram Executive Director, Global Antibiotic Research & Development Partnership (GARDP)

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ollaborative partnerships are vital to meet the urgent need to develop treatments for neglected diseases and drug-resistant infections, while ensuring they are affordable and tailored to the communities who need them.

In order for this to happen, low- and middleincome countries need to be in the driving seat for research. We must deepen industrial, regulatory and clinical trial capacity while leading on conducting studies for diseases that affect our populations.

In Africa, DNDi and GARDP are paving the way for this type of collaborative research.

We are helping to build an ‘innovation ecosystem’ in Africa that can support future research for other neglected diseases.

Promoting collaborative research We are working with local partners to run trials for sleeping sickness, leishmaniasis, river blindness, paediatric HIV and mycetoma, while we are helping to build an ‘innovation ecosystem’ in Africa that can support future research for other neglected diseases. We have also launched the largest trials in Africa to find treatments for early-stage COVID-19.

GARDP and partners have completed one of the largest ever studies on the care of babies with sepsis across 11 countries including Kenya, Uganda and South Africa, which will provide evidence to help transform treatment for new-borns.

We are also involved in a global trial to treat gonorrhoea, a curable sexually transmitted infection. Every year there are 87 million new gonorrhoea infections globally.

We must continue to push research for Africans, by Africans.

Dr Borna Nyaoke Senior Clinical Project Manager and Medical Manager, DNDi and GARDP

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Scientific research and collaboration will accelerate solutions to the global challenge of AMR.

Innovation for patients’ futures Infectious diseases are everyone’s business. That’s why treatments must be effective, accessible and equitable for patients who need them.

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ffective antibiotics treat common infectious and historically life-threatening illnesses. They also enable safe cancer chemotherapy, organ transplants and caesarean sections.

Drug-resistant pathogens are emerging and spreading globally, threatening how effective our treatments are and rendering infections more complex and costly to treat. According to the World Health Organization, at least 700,000 people die each year due to drug-resistant infections, though many of these are preventable.

The antibiotic market is broken The cost of developing, registering and marketing antibiotics is high, but pricing has seen a race to the bottom. Pharmaceutical companies have few incentives to invest in antibiotics, seeing a net loss of $100m from 2014 to 2016.

Compounded by declining research and development investment into new antibiotics and increasing shortages of existing, cheaper generics, there are fewer drugs left in our medicine cabinet. In the noughties, more antibiotic molecules were made obsolete than were developed. This lack of innovation compromises access for patients and undermines modern medicine for every country.

The UK is investing in innovation The UK is one of the first countries in the world to trial a

On the way to a pre-antibiotic-age Professor Dame Sally Davies UK Special Envoy on Antimicrobial Resistance

new system to secure a pipeline of innovative treatment options for NHS patients. The so-called ‘Netflix’ model will pay for antibiotics by subscription - based on an assessment of their value to society, not on the volume of pills used.

Now, we need global action The UK project cannot deliver meaningful incentives for global investment on its own. We need more countries to implement similar innovative mechanisms, hopefully starting with the US PASTEUR Act, that would establish a de-linked payment model. Collectively, this would give the world’s healthcare systems the best chances of treating patients, securing a sustainable pipeline of treatment options for generations to come.

Scientific research and collaboration will accelerate solutions to the global challenge of AMR. The pharmaceutical industry is stepping up - through the AMR Action Fund, the world’s leading pharmaceutical companies are funding a sustainable pipeline of antibiotics.

Innovation will hopefully restock our global medicine cabinet. Globally, and as individuals, we’ll then need to handle antibiotics with care.

AMR does not respect borders.

Countries need to work together to prepare for infections, prevent and treat them.

AMR is a key cross-border health issue for Europe and the world. This silent pandemic is already affecting our health today and will continue in the future. Without effective action, AMR will take us back to a pre-antibiotic age when death by infection was much more common.

E

ach year, already more than 700,000 people die globally as a consequence of drug-resistant bacteria. The COVID-19 crisis has exposed the weaknesses in our healthcare systems, revealed underlying inequalities and reminded the world of the serious threat that emerging infectious diseases can pose to human health and our economies.

Tiemö Wolken Member of the European Parliament Vice Chair of AMR Interest Group

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

Antibiotics are not a cure-all drug The awareness of the relationship between the use of antimicrobials and the development and spread of antimicrobial resistance (AMR) is still very low.

Among other things, we need to stop the misuse and overuse of antibiotics. We need better information campaigns so the public is aware that antibiotics are not a cure-all drug.

In addition, we need to offer alternative treatments and stewardships for healthcare professionals.

Monitoring and surveillance also need to be strengthened as well as infection prevention and control. A focus needs to also be put on better access to rapid and affordable diagnostic tools.

Support for needs-driven models is essential AMR-related challenges will only increase in the years ahead. Effective action is reliant on continued, cross-sectoral investments in public and private research and innovation so that better tools, products and devices, as well as new treatments and alternative approaches, can be developed.

The current antibiotic innovation pipeline is broken. This is why we need to support the development of needs-driven models to fix the antibiotic development pipeline next to ensuring both prudent use of new drugs, as well as equitable and affordable access for patients.

We will need to support needs-driven models to finance and stimulate antibiotic research and put forward new models that delink research and innovation cost from the price of products through alternative mechanisms, such as milestone prizes.

AMR is a key area where European citizens rightly expect firm European action, as it cannot be tackled efficiently at national level. The Commissions pharmaceutical strategy will play a key role in combating AMR in the years to come.

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How consolidated information can help improve coordination and collaboration in AMR R&D The global information hub that provides researchers and funders with a new weapon in the battle against antimicrobial resistance.

Dr. Elmar Nimmesgern Secretariat Lead, Global AMR R&D Hub

Dr. Magdalini Moutaftsi Scientific Programme Officer, Global AMR R&D Hub

WRITTEN BY Linda Whitney

I

nformation is a major weapon in fighting the silent pandemic of global antimicrobial resistance (AMR). It’s essential that researchers and funding decision makers know what work is being funded, not just in their own country, but worldwide. The Global Antimicrobial Resistance Research and Development Hub, or Global AMR R&D Hub for short, answers this need.

“The Hub offers an online dashboard where researchers and funders can easily discover in one place what funding has already been offered and where,” says Dr. Elmar Nimmesgern, lead of the Global AMR R&D Hub-secretariat.

“Finding information about R&D funding within a researcher’s country of residence is relatively easy, but it’s harder for other countries,” he says.

“Funding information about

highly-publicised areas such as cancer or Alzheimer’s disease is also more easily found. It’s far harder to find out about AMR research funding. The amount of information about funds for phage therapy research, for instance, is quite limited.”

The Hub was launched in May 2018 to foster global priority setting and evidencebased decision-making on the allocation of resources for AMR R&D, including identifying gaps, overlaps and potential for crosssectoral collaboration.

Now a partnership among 17 countries, the EU and two philanthropic foundations, it uses a One Health approach, covering research on people, animals, plants and the environment.

The COVID effect “The COVID-19 pandemic highlighted the benefit of pooling resources and how technology can be used,” says Dr Nimmesgern. “For instance, the type of COVID PCR tests now going into schools could be developed to detect resistance patterns for multiple types of microbes.”

There are currently a number

The COVID-19 pandemic highlighted the benefit of pooling resources and how technology can be used. of focuses including the addition of more data that span the full One Health spectrum. As well as diving deeper into the analysis of dashboard data to identify gaps and opportunities in research and determine future priorities, it also looks to find practical solutions to the lack of financial incentives for discovering and bringing antibiotics to market.

Lessons from other infectious diseases Dr. Magdalini Moutaftsi, a Hub scientific programme officer, says: “Experience with diseases such as HIV and Tuberculosis show how product development partnerships and public-private partnerships can fill the gaps in the development of drugs, vaccines and diagnostics. We can draw lessons from experiences with these instruments to see what might work in tackling AMR.”

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Lessons from the pandemic: Managing infectious diseases and the use of POC testing

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The worldwide COVID-19 response has provided a blueprint for the management of infectious diseases moving forward.

A Tony Cambridge MSc., BSc. Lead Biometrical Scientist, Pathology Management, Blood Sciences and Point of Care Testing. Managing Director Thornhill Healthcare Events and Consultancy

lthough rapidly devised and rolled out, the systems for testing, recording and sharing infection data has led to strategies in each global territory for controlling the spread of infection during the pandemic. Clearly that response can be refined and applied to outbreaks of many other communicable infections, promoting containment and avoiding pandemics.

infection to be understood in most territories.

In combination with laboratory confirmatory testing, there is now a move towards decentralised tests (point of care tests) including rapid PCR and lateral flow devices which seek to identify both symptomatic and asymptomatic infections.

Widespread roll out may offer future assurance around the extent of community infections to avoid imposing restrictions.

Rapid diagnostics and point of care tests Research and commercial diagnostic sectors have been in overdrive, providing novel tools required to identify infections whilst establishing reliable supply of equipment and testing consumables.

Similarly, healthcare providers have worked tirelessly to grow the capacity to test, relying heavily on staff to work around the clock in supporting patient care. The wide adoption of new platforms has occurred at an astonishing rate, from evaluation to roll out, and has allowed the scale of

Sustainable diagnostics Future contingency plans must ensure that the diagnostics sector is well established to respond to new challenges. The COVID-19 pandemic has shown what can be achieved from a standing start.

Now is the time to develop a global network of research, diagnostics and manufacturing capacity capable of responding to novel infectious diseases.

The design of contingencies must include the rapid mobilisation of key components: workforce, manufacturing, testing capacity and vaccinations. Investment in these areas, where capacity can be

expanded quickly, is essential for an effective response.

Future diagnostic accessibility A global response requires global cooperation. Although a standardised approach may not fit all territories, the concept of establishing a united response must be high on the agenda for leaders in governments and health organisations.

Following the NHS England publication, Diagnostics: Recovery and Renewal, consideration is being given to a new diagnostics model creating diagnostic hubs in locations away from main hospital sites.

The emergence of home testing and tests performed in nonhealthcare settings may become common place in the future.

As this concept is realised, it is paramount that standardisation is maintained, avoiding a diagnostics lottery associated with geographical regions. Striking the balance globally is essential for socio-economic consistency and protecting public health.

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Looking for ways to support the recovery of NHS diagnostic services The pandemic has increased the backlog of people waiting for diagnostic tests. New ways of delivering these services are needed to increase efficiency and keep patients safe.

WRITTEN BY Tony Greenway

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

I

n 2019, the NHS Long Term Plan — a report from frontline health and care staff, patients and other experts — identified the need for a radical overhaul of NHS diagnostic services. Rising demand had put this area of healthcare under increasing strain and, as a result, many patients were waiting longer than six weeks for a diagnostic test.

Unfortunately, the global pandemic has made things markedly worse. Because of the need to deep clean equipment and facilities, diagnostic patient backlogs have increased (particularly in CT scanning and endoscopy) while the numbers of people waiting more than six weeks for a test have risen further.

A major review called Diagnostics: Recovery and Renewal notes that radical changes to the system need to be made — and urgently.

Diagnostics: Recovery and Renewal has been published by NHS England and includes 24 recommendations which the report’s authors believe will improve diagnostic services delivery. Major expansion

and reform of these services is required over the next five years to aid recovery from the pandemic and meet rising demand from patients and GPs, yet this is only part of the answer.

New ways of getting diagnostic tests to patients are also needed to keep people safe in a COVID-19 endemic world.

Importance of COVID testing for diagnostics patients A key takeaway from the review is that Community Diagnostic Hubs (CDHs) should be established across the country to act as a ‘one stop shop’ for patients. CDHs should be located away from hospital sites (in available space on the high street or in retail parks, for example) to lower infection rates, improve efficiency and reduce delays.

Diagnostic services should be organised so that patients only have to attend once; and, where appropriate, they should be given a COVID-19 test before their diagnostic test. Indeed, the review believes that availability of COVID-19 testing for patients and healthcare professionals is “likely

New ways of getting diagnostic tests to patients are also needed to keep people safe in a COVID-19 endemic world. to be critical, especially when community prevalence of the virus is high.” It also recommends that pathology and genomics equipment and facilities should be upgraded to help with the introduction of new technologies and support COVID-19 testing.

“The COVID-19 pandemic has further amplified the need for radical change in the provision of diagnostic services,” says Professor Sir Mike Richards, Chair, Independent Review of Diagnostic Services for NHS England. “But (it) has also provided an opportunity for change.”

This content was put together by Tony Greenway for Mediaplanet based on content from: Diagnostics: Recovery and Renewal by NHS England https://www.england.nhs.uk/ wp-content/uploads/2020/11/diagnosticsrecovery-and-renewal-independent-review-ofdiagnostic-services-for-nhs-england-2.pdf

ID NOW™ delivers lab-accurate results faster than any other molecular method. As a result, you can make confident, effective and meaningful decisions for your patients.

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References: 1. Internal clinical data held on file. 2. Moore N, et al. Evaluation of the Alere™ i Influenza A & B 2 Assay.

2018 ASM Clinical Virology Symposium, West Palm Beach, FL. Poster. 3. ID NOW™ Strep A 2 clinical trial data, held on file.

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Learning from COVID-19 – from panic to preparedness

©ELENABS

Whilst we are still in the midst of COVID-19, the worst pandemic since 1918 which is affecting every part of our lives, we can draw some lessons that will allow us to be better prepared for the future.

T Thomas B. Cueni Director General, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

he first lesson of the pandemic is the importance of translational research; applying basic science and research into scalable solutions for patients. Known for almost 20 years, with the Pfizer/BioNTech and Moderna vaccines, we have witnessed the first successful application of mRNA to vaccines.

Drawing on decades of scientific research into vaccine science and technology, and experience in fighting other outbreaks such as SARS and Ebola, we have compressed a decade of normal development times into just ten months.

The evolution of the virus is a stark reminder that we will have to adjust our scientific approaches.

So continued innovation will be key.

Today, we have several vaccines already approved and in use, with more on the way. This is a remarkable achievement. The evolution of the virus is a stark reminder that we will have to adjust our scientific approaches, so continued innovation will be key.

Importance of a common system During the past months, we have also realised the critical role that diagnostics play to identify, slow and prevent the spread of viruses. The lesson here it that we need to continue to invest into the development of accurate, fast diagnostics that can also be produced in large volumes.

The swift, timely and unrestricted pathogen sharing has proven to be critical in this crisis.

To prepare for future pandemics, we must remove bilateral barriers to accessing pathogen samples and agree on a common system.

Equally, we need to share best regulatory practice and harmonise in more efficient approaches; this is inclusive of clinical trials, testing and approving efficacious, quality vaccines. Such regulatory convergence does not mean

cutting corners, it is setting gold standards.

A collaborative mindset is key The real heroes of this pandemic have been the healthcare workers, be it in ICUs or those involved in testing and vaccinating entire communities.

Resilient primary healthcare systems with qualified personnel are the best defence against the spread of infectious diseases.

To control the spread of diseases we need to invest in healthcare infrastructures and frontline health workers so that we will be better equipped to contain unpredictable outbreaks and deliver life-saving tools.

Last but not least, we have seen the importance of partnering; not just partnerships in R&D or manufacturing, but also partnerships in deployment. Governments, health organisations, scientists, businesses, civil society and philanthropists are collaborating like never before. If we want to be better prepared for future crises, we need to retain this collaborative mindset.

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

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Helping biotechs ensure a successful vaccine journey

Menzo Havenga, CEO, Batavia Biosciences

WRITTEN BY Linda Whitney

Biotech companies starting the vaccine development journey need to look at the whole process right from the start.

claims that reducing risk of failure starts with a hard think on the process from beginning to end.

R

• Bench-scale processes used for generating preclinical data are not scalable. Every unit operation needs to be evaluated for its fit for purpose at perceived final scale.

• Regulatory and quality compliant raw materials and process strategies must be selected in an early stage to ensure a smooth transition from bench to clinic.

“

esearch shows that about 22% of novel therapeutics never progress beyond their first clinical trials, for various reasons. This includes lack of commercially viability,” says Menzo Havenga, CEO, Batavia Biosciences. Contract development and manufacturing organisations (CDMOs) typically have extensive knowledge and experience in the field. Their CMC expertise in the early development stages helps to bring this high attrition number down. Havenga, who co-founded the CDMO Batavia Biosciences after having witnessed the hurdles of outsourcing while working on vaccines and viral vector-based products in biotech companies,

Addressing the hurdles Some of the challenges of working on viral vaccines include:

Biotech companies themselves, certainly in the start-up phase, do not have the expertise in-house to understand the manufacturing challenges. They typically focus their investment money on the expansion and solidification of their patent position(s) and to

rapidly increase company value by obtaining proof of efficacy in human trials. As such, external resources like CDMOs are brought in to deliver a first manufacturing process and bring the product to patients.

No time to lose The increasing world population, close proximity to animals and intense global travel all contribute to an ever-increasing number of virus outbreaks. With the current SARS-CoV-2 pandemic in mind, we know how important it is to minimise the risk of failure.

Havenga therefore advises biotech companies: “Include a CDMO early in the process to help create a robust and detailed manufacturing plan. Their experience of the regulatory landscape and technological manufacturing options that are available ensure a smooth transition from bench to clinic.”

Paid for by Batavia Biosciences

Read more at bataviabio sciences.com

©IMAGE PROVIDED BY GAVI

The only way to avoid this is to learn from this crisis and build stronger disease surveillance and invest in vaccine research and anti-viral therapeutics.

Dr Seth Berkley, CEO, Gavi, the Vaccine Alliance

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Diagnostic tests are vital in the fight against antimicrobial resistance The coronavirus pandemic has focussed the world’s attention on the role and importance of diagnostic testing.

Doris-Ann Williams MBE Chief Executive, British In Vitro Diagnostics Association

Keeping the focus on the AMR crisis Diagnostic testing is also critical to managing antimicrobial resistance (AMR). During this year, AMR, like so many other healthcare issues and diseases, has been overlooked while the global population struggles with the COVID-19 pandemic. Yet AMR remains a global health disaster that is already killing 700,000 people a year. It is predicted to cause 10 million deaths each year by 2050 if the current situation is not improved.

Hence it is vital to remember that this huge threat to public health has not gone away. We need to reduce the inappropriate use of both antibiotics and antimicrobials, to ensure they remain active against pathogens when needed most.

70% of patient information comes from diagnostic tests.

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

Helping to diagnose patients more efficiently Diagnostic testing can play a key role in antibiotic stewardship.

For example; managing winter hospital admissions with influenza or pneumonia. Tests can

distinguish between a bacterial or viral infection, allowing their symptoms to be treated most appropriately.

Using diagnostic tests gives clinicians confidence to stop inappropriate antibiotics much earlier, helping the fight against AMR. Critically ill patients with suspected infection need to be tested to diagnose the underlying pathogen, or alternatively to rule-out sepsis which can rapidly become fatal or leave people with life changing damage.

Furthermore, with COVID-19, almost all patients admitted to hospital are given a five-day course of empiric antibiotics despite the low incidence of bacterial superinfections. Using diagnostic tests gives clinicians confidence to stop inappropriate antibiotics much earlier, helping the fight against AMR. Diagnostic tests provide critical pieces of information to support patient treatments and to monitor if treatments are effective. While the tests can seem simple, there is an entire segment of the life sciences industry concentrating on developing and manufacturing these tools and the equipment required to perform them using the latest biotechnology. These are the weapons we need to deploy on the frontline in this ongoing battle against AMR.

©ROST-9D

D

iagnostic tests provide essential data to support treatment decisions; 70% of patient information comes from diagnostic tests.

Many tests are done in hospital laboratories, but increasingly technological improvements are enabling access to tests outside traditional settings.

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Sepsis: why new technology is needed to battle the silent killer Sepsis, a syndromic response to infection and frequently a final common pathway to death for many infectious diseases, accounts for almost 20% of all global deaths. Only fast, targeted treatment can be sure to keep patients safe.

Stéphane Rougale Vice President and Chief Marketing Officer, QuantaMatrix Europe

WRITTEN BY

Meredith Jones-Russell

Fighting antimicrobial resistance While this testing process is taking place, patients have often initially been prescribed broadspectrum antibiotics, which are not specifically targeted to their condition.

Reducing the time a patient spends on these medicines is important, not only to treat an identified condition, but also to lessen the chance of antimicrobial resistance build-up.

As increasing exposure to antibiotics and other antimicrobial medicines renders many ineffective, and infections become increasingly difficult or impossible to treat, the WHO has called antimicrobial resistance one of the top 10 global public health threats facing humanity.

Rougale explains, “If we reduce exposure to broad spectrum antibiotics by targeting the exact treatment patients need, we can get really focused treatment, reduce antimicrobial resistance, reduce healthcare costs and increase survival rates.

Paid for by QuantaMatrix

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third of hospital deaths are due to sepsis, and rising. The World Health Organization (WHO) projects that at current rates, sepsis will be the top cause of death worldwide by 2050.

With mortality rates increasing by 6% every hour for a patient with sepsis, it is vital that clinicians have fast access to the right medicines.

However, current methods for sepsis testing take between 48 and 72 hours to process and return.

Stéphane Rougale, Vice President and Chief Marketing Officer of QuantaMatrix Europe, explains, “Currently, you have to draw blood from a patient, culture the bottle and isolate any bacteria you find, run it through a system, and then take sub-cultures, and more. The process can be very time-consuming and complex.

If you find bacteria in the sample, it very quickly becomes an emergency and you need to act fast.”

“These antibiotics also come with a lot of side effects. The shorter patients can be on them and the quicker they can be switched to a dedicated treatment to help, the better. A dedicated treatment for sepsis will therefore be a big advantage for a patients, clinicians and hospitals.”

New, fast, innovative testing New rapid response testing can now use microbiology platforms to test for sepsis. While the sample taken from the patient is similar to current methods, the process used for testing it is much quicker. dRAST is a new test that has been developed using reinvented, fully automated reference methods, alongside time-lapse imaging of the bacteria mixed with antimicrobial sample gel to see how they respond.

Rougale explains, “We take the same kind of blood culture sample but don’t require any calibration or complex process. You put the sample into the platform, press a button and it does it for you.”

According to Rougale, “Every

hour it takes pictures to see how the bacteria interact with the drug.

Usually, the bacteria circulate in the blood and become hard to locate over time. You lose track of them. This system technology is able to fix the bacteria in gel in the presence of drugs so you can see how they behave over time, find out whether the bacteria are resistant or susceptible to the drug and whether the concentration needed might have side effects.”

At a time when healthcare services are under particular pressure, a rapid response can help ease the burden.

“This technology can save up to two days in the hospital,” says Rougale. “That will free up beds, which can be a huge benefit, especially in COVID-19 times.

“A stream-lined process like this one will help the clinician, help the patient, reduce sepsis mortality rates and reduce the number of days a patient stays in hospital, which in turn will reduce healthcare costs.”

QuantaMatrix is the creator of the direct and Rapid Antimicrobial Susceptibility Test, or dRAST. It is a platform for microbiology against sepsis. It provides same-day results within four to six hours for a patient with suspected sepsis, along with targeted therapy for clinical use. quantamatrix.com

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Helping support those living with HIV during the pandemic Since COVID-19 first emerged as a major health threat, the risk of severe illness, death and who was most at risk were major questions. Especially for those living with HIV.

A Dr Laura Waters

Chair of British HIV Association (BHIVA)

s an organisation, our priorities were to understand the interplay between COVID-19 and HIV, to address uncertainties and anxieties expressed by colleagues and, most importantly, people living with HIV. We have done all we can to share the right information with the right people.

Collaboration with the community Our approach from the start was to collaborate with community organisations and with HIV and non-HIV bodies and societies. Our first statements, based primarily on first principles and experience with other infections, summarised the scant evidence and who we believed to be at the highest risk of worse outcomes (people with advanced HIV). The impact of immunological and virological markers remains uncertain, though limited data supports our initial beliefs.

Activities since then have included:

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

¼ Regular updates to COVID-19 statements covering risk, isolation, shielding, vaccination and prioritising people at highest risk, which were also provided in plain English to meet the needs of the HIV community.

¼ Clinical guidance on prescribing and care during restricted access to clinics and usual monitoring. ¼ Critical care guidelines co-badged with the Intensive Care Society. ¼ Regularly updated evidence summaries and recommendations co-badged with the European AIDS Clinical Society (EACS) and other European national HIV societies. ¼ Successful lobbying of DHSC with other national bodies and community groups to remove online COVID-19 testing restrictions for people with HIV (indeed, for all people with immunosuppressive conditions). ¼ In addition to plain English guidance, producing webcasts and video community Q&A pieces. ¼ A simple vaccine safety video tailored for clinic use, developed

by BHIVA members at the Homerton sexual health service. ¼ Development of a specific COVID-19 chapter to BHIVA’s comprehensive vaccine guidelines.

¼ An international HIV conference symposium covering community experiences, HIV/COVID-19 interplay and myth-busting on potential COVID treatments. ¼ Contributions to analyses of national databases which demonstrated a higher risk of mortality for people with HIV. ¼ A national HIV clinic survey of COVID-19 cases. ¼ Input to a national survey of community COVID-19 experiences.

Persevering through uncertainty Unknowns remain, not least how much the mortality signal is driven by HIV per se, versus other risk factors that impact people with HIV disproportionately. Regardless, we will continue to lobby, inform and to contribute to research to best manage this pandemic in any we may face in the future. Updates to COVID-19 information are featured on the home page of BHIVA’s website, with a link to a COVID-19 specific section in the News section.

Read more at bhiva.org/ CoronavirusCOVID-19

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Issues around testing for early viral infections Diagnosing infection early is important to initiate containment through contact tracing and behavioural modification, as well as allow timely introduction of treatment interventions.

S

imilar themes are relevant across infections; we are focussing on the examples of HIV and SARS-CoV-2 to discuss this.

The early diagnosis of a viral infection can be affected by the following factors:

Dr Julie Fox

Reader of HIV Medicine, Kings College London

1

Time to detect virus after infection varies: Different viruses replicate at varying rates after infection. This affects how quickly a test can detect viral proteins or genes. For SARSCoV-2 this is approximately five days, whereas for HIV it is approximately two weeks.

2 Prof. Sarah Fidler Professor of HIV Medicine, Imperial College London

It is common to have detectable virus and be infectious before developing symptoms: For SARSCoV-2 this is approximately five days and, for HIV, can last years.

This means that only testing symptomatic people can miss a large pool of infection.

3

Diagnostic tests can be negative very early in infection: The time from exposure to when a test can reliably detect infection is critical to timely diagnosis.

Routine HIV testing detects

antibody which usually develops six to eight weeks following exposure. Detecting early infection therefore requires detection of viruses prior to the development of an antibody, either by testing directly for virus or by testing for the p24 virus protein. The latter can be done using finger-prick blood samples using a lateral flow rapid test. For SARS-CoV-2 diagnosis, antibodies develop between 6–15 days after the onset of symptoms (time from exposure is not known), and at this point an individual is no longer infectious.

To detect active infection, nasal or throat swabs which detect either virus or antigen are used.

4

Rapid point of care tests: These types of tests do not require laboratory equipment and provide a quick result. For HIV tests, result time ranges from 1 to 20 minutes For SARS-CoV-2, lateral flow antigen results range from 15 to 30 minutes.

5

No test is 100% accurate: For a test to be introduced, it must be highly sensitive to detect low levels of virus, specific to not make false positive tests and ideally be cheap to allow mass roll out.

Determine™ HIV Ultra is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to HIV-1 and HIV-2 and the detection of non-immunocomplexed (free) HIV-1 p24 antigen in human capillary and venous whole blood, plasma or serum.

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Building a better world — the One Health way

Dr Casey Barton Behravesh Director, One Health Office, Centers for Disease Control and Prevention, USA

WRITTEN BY Tony Greenway

The health of people is inextricably linked to the health of animals, plants and our shared environment, therefore it’s imperative for professionals in different sectors to work closely together.

O

ur world is more connected than ever.

While this has obvious social, cultural and economic benefits, it also has a more sinister implication: it makes it easier to spread diseases which can quickly turn into a pandemic — as devastatingly highlighted by the COVID-19 crisis.

So what’s the best way to prevent another global infectious disease catastrophe? Dr Barton Behravesh has a simple answer: the world needs to take a One Health approach.

“The health of people, animals, plants and our shared environment is interlinked,” explains Dr Barton Behravesh, who is Director of the One Health Office at the USA’s Centers for

Disease Control and Prevention.

“That’s why we call it ‘One Health’ — because it’s the same health for all. The fact is that there are some health threats that can affect people, animals, plants and our shared environment. So, if multi-disciplinary professionals in different sectors coordinate, collaborate and communicate with each other, the outcome will be a safer, healthier world.”

Examples of the One Health approach in action Countries around the world have understood this only too well, creating mechanisms that make it easier for professionals in different sectors to collaborate more effectively and regularly. This means human health partners (doctors, nurses, public health practitioners, epidemiologists and laboratorians), animal health partners (veterinarians and paraprofessionals) and environmental health partners (ecologists and wildlife experts) can easily exchange information with each other.

Other players in different areas are also getting involved

in ingenious ways. For instance, farmers and agricultural workers can be trained to use an app to report early symptoms of animal illness to animal and human health professionals at the local level, thus helping to contain the spread of disease between animals and people.

This type of One Health collaboration is also important for improved animal welfare and stewardship of the environment.

It’s already helping to address zoonotic disease (which can spread between animals and humans) in Uzbekistan and rabies elimination in China.

“Meanwhile, in the US, we’ve been working with our pet industry partners to collaborate to prevent zoonotic diseases spreading between pets and people,” notes Dr Barton Behravesh. “This has made a real difference and kept people — and their pets — safe and healthy. I believe that it’s critical to take a coordinated One Health approach on an international scale if we are to build a healthier world and stop the next pandemic.”

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

When a new infectious disease does emerge, human migration, population growth, urbanisation and dense urban slums, rapid global travel and climate change can all hasten its spread. The ease with which a disease can be transmitted increases proportionally with urban density. ~ Dr Seth Berkley, CEO, Gavi, the Vaccine Alliance

©IMAGE PROVIDED BY GAVI

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Years of investment in TB lost due to the COVID-19 pandemic Tuberculosis (TB), an airborne infection, has killed over a billion in the past 200 years, more than any other infectious disease.

Dr Lucica Ditiu

Executive Director, the Stop TB Partnership

I

n 2020 another new airborne infection, COVID-19, overtook TB as the leading cause of death among infections, but TB still killed more people than COVID-19 in low- and middleincome countries.

Scaling up treatment In 2018, to accelerate progress towards ending TB, a United Nations High Level Meeting (UNHLM) was convened which led to a political declaration with bold targets to be achieved by 2022.

Treatment was scaled up in 2018 and 2019 to unprecedented levels, reducing the number of untreated people with TB. In 2020, the COVID-19 pandemic disrupted TB services

in high TB burden countries. Staff, health facilities and laboratories were diverted to COVID-19 response. People faced barriers in accessing TB services due to restrictions in mobility, fear and stigma. TB diagnosis dropped sharply in most high TB burden countries. Other areas of TB prevention and care, and TB research and development were also impacted.

In May 2020, a modelling study by Stop TB Partnership predicted that due to the COVID-19 pandemic-related restrictions, the global TB incidence and mortality could increase, setting back the global fight against TB by five to eight years. In early 2021, on review of data from varying countries, the situation seems to be worse as TB diagnosis and treatment declined in 2020 by over 20% and reached levels last seen 12 years ago.

Learning from the COVID-19 pandemic There is urgent need now for

high TB burden countries to recover from Due to the COVID-19 this loss and pandemic-related restrictions, progress further the global TB incidence and to reach the UNHLM targets. mortality could increase, setting Lessons must back the global fight against TB be learnt from by five to eight years. the COVID-19 pandemic.

Countries will need massive scale up of testing and tracing for TB, integrating it with their COVID-19 responses and partnering with affected communities in providing access to care and reducing stigma and fear.

Modern diagnostics and digital tools need to be used and research and development needs to be speeded up. For this to happen, political commitment and increased financing is a must. We need to build back a system that can defend against airborne respiratory infections: TB, COVID-19 and future airborne pandemics.

What will our leaders learn from COVID-19?

For years, those of us working to end tuberculosis have witnessed the damage that comes from viewing public health as a non-priority.

Dr Grania Brigden Director, TB Department The International Union Against TB and Lung Disease

All views expressed in the editorial are the authors own, no companies have influenced editorial copy.

W

idespread failure to invest in public health has left our societies profoundly vulnerable to pandemics of communicable disease.

National leaders must learn lessons from the COVID-19 pandemic that will help accelerate progress toward ending TB, while safeguarding communities from future pandemics.

The most important lessons?

We simply cannot afford to shortchange public health. We must protect the most vulnerable in our communities.

Where poverty and stigma persist, communicable diseases like TB and COVID-19 take an even greater toll. Ensuring equitable access to the tools needed to end

the COVID-19 pandemic will also be the first step in building back our health systems.

But we cannot return to the old normal.

COVID-19 wake-up call If it wasn’t TB, HIV/AIDS, SARS or Ebola, COVID-19 must be the wake-up call policymakers need to permanently place public health on par with national security and economic matters.

To be sure, national leaders have a dizzying number of issues, interests and constituencies to deal with every day, so the scientific community should meet them halfway.

When conducting research, we must think early and often about how findings support policy, and seek out the platforms, avenues and relationships critical for reaching policymakers.

The rise of virtual collaboration makes it easier than ever. It even allows for innovations in advocacy, like virtual policymaker and journalist delegations, where they can see public health

research and interventions anywhere in the world.

We can also make scientific publishing more efficient. The Union, for example, is fasttracking articles on TB and COVID-19, making findings available within days after peerreview so they can better aid decision-making.

Keep COVID-19 at the top of the agenda At the grassroots level, we need more investment in scientific literacy for activists, survivors and affected communities.

An equitable approach to public health is possible only if communities are equipped to advocate for their right to access the perennial fruits of scientific discovery.

COVID-19 has put public health on the top of the global policy agenda. We must do all we can to keep it there.

Read more at globalcause.co.uk

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We need better ways to monitor in real time what is happening to antibiotics in communities and a way to deploy them in a more strategic way.

Why AMR is a major threat to humanity The growing threat of antibiotic resistance could lead to the collapse of modern medicine and worsen our abilities to fight infectious diseases unless new approaches are implemented.

W Professor William Hope Dame Sally Davies Chair of AMR Research and Director of Centre of Excellence in Infectious Diseases Research, University of Liverpool

WRITTEN BY:

Mark Nicholls

Paid for by University of Liverpool

hile pharmaceutical companies have “extraordinary knowledge” to develop antibiotics to tackle infection, imprecise use is creating antimicrobial resistance (AMR) and meaning some drugs are becoming less effective, leaving some patients without treatment options.

Professor William Hope from the University of Liverpool says: “AMR is the one of the two great threats to humanity, the other is climate change. Antibiotics underpin modern society and without these drugs society cannot go on as it is.

It is a massive problem.”

Focus on antibiotics He says a way to tackle AMR is to “keep replenishing the pipeline”, hold some drugs in reserve to use only when necessary and learn more about how populations respond to a drug.

Professor Hope’s group work focuses on antibiotics, drug resistance and how health systems respond to the threats they face, as well as precision therapy enabling “the right antibiotic at the right dose to be used for the right patient.”

Funding is in place to establish a clinical unit to help prevent emergence of drug resistance and tackle it when present at an individual patient level.

A further stream of work looks at deployment of antibiotics at a city-wide or population level.

To control AMR, he says, more

investment is needed in new drugs along with research on how they should best be deployed and better public education about AMR. Adopting new drug models However, what is also important is the progressive adoption of the so-called de-linkage model of drug deployment as is currently being developed by NICE. “Usually, pharmaceutical companies recover their investment from volume-based sales but for antibiotics, that is the opposite of what you want to happen; you want to use the drugs sparingly and precisely,” says Professor Hope, who is Dame Sally Davies Chair of AMR Research and Director of Centre of Excellence in Infectious Diseases Research, University of Liverpool.

The de-linkage model sees a society having a subscription to an antibiotic and buys the right to use them, irrespective of number of doses.

Benefits for society This must be combined with better research on how to deploy antibiotics at a population level and monitoring how ecosystems will respond.

“By the time we see emergence of drug resistance,” he continues, “it is often too late, so we need better ways to monitor in real time what is happening to antibiotics in communities and a way to deploy them in a more strategic way.”

His Centre is studying this by creating integrated secure dataflows across Liverpool which has enabled monitoring of the COVID-19 pandemic in real time.

The idea is to extend that to enable researchers to study how a city responds to the introduction of a new antibiotic and use that information to benefit other healthcare systems.

“When that is understood, you have a chance of figuring out how to deploy an agent so that it can be used sustainably and its clinical and societal benefit and value can be maintained.”

Modern medicine collapse He explains there are a range of ways that organisms can become resistant to antibiotics, but ultimately it is an underlying “fight for survival” from bacteria, viruses or fungi, against the drug.

“We have no way of really being able to understand how resistance may emerge but by the time resistance emerges, it is too late – the clinical utility of drug is compromised,” says Professor Hope.

“The consequences of failure to address AMR are that modern medicine will collapse; leukaemia will not be survivable, transplantation is unfeasible, surgery will become incredibly dangerous; and otherwise, trivial infections will become potentially life-threatening.”

Read more at liverpool.ac.uk/ceidr @LiverpoolCEIDR

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