WHC News Journal - August 2024

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NEWS JOURNAL

August 2024 Edition

Dear Colleagues,

Since many of you were away attending and participating in the recent International AIDS Conference in Germany recently, we thought it appropriate to focus this issue of our WHC news journal on some of the work that is being done in the battle against this disease.

While some of the latest work and breakthroughs show very encouraging results, the harsh realities of costs and accessibility, especially on the African continent, remain consistent thorns in the proverbial side. A couple of our stories (YouTube clips) in this edition feature Professors Francois Venter and Helen Rees who provide their own thoughts and insights into the realities and challenges.

Then we have a piece from HE2RO who share encouraging news relating to projects that they have been involved with, where since 2010, some countries in eastern and southern Africa have seen a 57% decrease in new HIV infections and a 58% drop in AIDS-related deaths.

“Changing it up” a little, we have a contribution from Wits VIDA reporting on two clinical trials around RSV prevention, which have delivered valuable insights and opportunities for further exploration in this area.

Finally, we have an interesting article from this year’s AIDS Conference in Germany where a new case of long HIV remission was reported, fueling optimism for an eventual HIV cure.

Lastly, our sincere and hearty congratulations to Professors Helen Rees and Sinéad DelanyMoretlwe who were respectively appointed as Co-Chair of the MPox Incident Management by the Minister of Health and selected as a co-principal investigator for the groundbreaking HIV Prevention Trials Network (HPTN)! Well done on recognition well-earned!

Researchers optimistic about early findings of HIV prevention injection study

Early results from an HIV prevention trial show that an injectable antiretroviral drug given twice a year can prevent infection in cisgender women.

$40,000 per person HIV drug can be made for $40

Scientists at the world AIDS conference in Munich have revealed that a groundbreaking new drug to prevent HIV infection, marketed at $40,000 per person, could be made for just $40.

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Inequality of vaccine access in Africa

04 Making inroads in the fight against AIDS

Health Economics and Epidemiology Research Office (HE2RO) shares some encouraging results in the fight against HIV.

05

06 Leading the way in RSV Prevention A seventh case of HIV cure reported at AIDS 2024

Wits VIDA Research Units shares details of some trials that it was involved with in the field of RSV prevention.

During the 25th International AIDS Conference (AIDS 2024), being held in Munich, Germany (July 2024), a new case of long HIV remission was reported and fuels optimism for an eventual HIV cure. 01

Prof. Helen Rees, Wits RHI Executive Director, highlights the challenges of delayed vaccine access in Africa during an interview with Al Jazeera.

Acknowledgements We would like to thank the following for their contributions to this issue:

Theranne van Vuren (Wits VIDA) theranne.vanvuren@wits-vida.org

Deshni Naidoo (Wits RHI) DNaidoo@wrhi.ac.za

Holly Fee (Ezintsha) hfee@ezintsha.org

Boipelo Moticoe (HE2RO) bmoticoe@heroza.org

Nicole Moyo (HE2RO) nmoyo@heroza.org

Al Jazeera www.aljazeera.com

The Internationals AIDS Society www.iasociety.org

If you would like to share any information or news that may be considered for inclusion in future issues of our news journal or any suggestions on how we may improve this communication platform, please direct them to:

Bradley Aigner baigner@witshealth.co.za

Researchers optimistic about the early findings of HIV prevention injection study

Early results from an HIV prevention trial show that an injectable antiretroviral drug given twice a year can prevent infection in cisgender women.

This is the first HIV prevention trial ever in history to show zero HIV infections with an intervention,” says Professor Thesla PalaneePhillips, director of clinical trials at Wits RHI in a statement.

The trial, known as the Phase 3 PURPOSE 1 trial, was conducted among more than 5 300 adolescent girls and young women in 25 sites in South Africa and three in Uganda. Palanee-Phillips is a lead researcher on the trial who comanaged the Wits RHI Research Centre Clinical Research site in Hillbrow Johannesburg where more than 200 young women were enrolled.

Sub-Saharan Africa is home to two thirds (25.6 million) of people living with HIV. Women and girls make up 77% of new infections among youth aged 15-24 in the region.

“After over a decade of working on HIV PrEP trials, it’s extremely fulfilling to get such amazing results from the PURPOSE1 study,” says Dr Flavia Matovu Kiweewa, director of research at Makerere University–Johns Hopkins University (MUJHU) Research Collaboration. Kiweewa is also the Uganda national principal investigator for the study.

The study tested the effectiveness of the injectable lenacapavir versus two oral drugs that must be taken once a day: Descovy and Truvada. “I’m overwhelmed. It’s difficult catching any sleep over the past two nights, thinking of how far we have come with the PURPOSE 1 study, the amount of effort by study teams, how well the study has been executed,

and what these results mean to the HIV prevention field,” she says.

Gilead, the pharmaceutical company behind the drug, says more detailed data from PURPOSE 1 will be presented at a future conference.

“The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally,” the company says in a statement.

The company says late this year or early 2025 it’s expecting the results from the PURPOSE 2 which is assessing lenacapvir among expanded population groups including cisgender men who have sex with men, transgender men, transgender women. Filing for regulatory approval of the drug will include findings from PURPOSE 1 & 2.

“This is going to change the approach to HIV preexposure prophylaxis worldwide. I’m confident that as we continue to promote PrEP uptake and adherence in our setting, long-acting formulations like the six-monthly injection will address most of the challenges currently faced by young women and other populations,” says Kiweewa. – Health-e

$40,000 per person HIV drug

made for $40

If you had the tools to fight a disease that kills 630,000 people a year, would you share them? Scientists at the world AIDS conference in Munich have revealed that a groundbreaking new drug to prevent HIV infection, marketed at $40,000 per person, could be made for just $40.

Trials show that the twice yearly injection, from pharmaceutical giant Gilead, is 100% effective against HIV. Gilead has not told us how much they spent on developing or purchasing the drug. But the current price puts it out of reach of those who would benefit most.

We are going to be marching on the streets for this struggle. This is how strongly we feel. This is not something we can let lie when it comes to too big a change for us. Watch the full news clip at https://youtu.be/DbCUGnM_QyQ

Professor Francois Venter, Executive Director at Wits Ezintsha made the following comments relating to the news of the new drug. “We still have a raging HIV epidemic. We've made gains in prevention, but we still need new technologies.

The current prevention technologies have hit their ceiling and particularly amongst young women in this kind of 18 to 32 year old age group and in key populations among sex workers, amongst gay men, amongst drug users. That's where we need these new drugs.

Inequality of vaccine access in Africa

The African Vaccine Manufacturing Accelerator, launched in Paris on 20 June 2024, aims to enhance local vaccine production in Africa through financial incentives. Prof. Helen Rees, Wits RHI Executive Director, highlights the challenges of delayed vaccine access in Africa during an interview with Al Jazeera.

The following question was put to Professor Rees during the interview: “Professor Rees, we saw it painfully clearly during the covid pandemic the level of inequality when it comes to vaccine access. I understand this push has been in the works now since 2021. Why has this all taken so long?”

Watch the full interview at: https://www.youtube.com/watch?v=TfxDXBv2xZE (Source: Al Jazeera)

Professor Helen Rees is the founder and Executive Director of Wits RHI and a Personal Professor in the University of the Witwatersrand’s Department of Obstetrics and Gynaecology,

Professor Rees has been a South African National Advisory Group on Immunisation (NAGI) member since 2010.

She is also a member of three NAGI Working Groups, namely Mpox, COVID-19 and the HPV NAGI Working Group which she chairs.

Professor Rees also chairs the South African Health Products Regulatory Authority Board and the World Health Organisation’s AFRO Region Immunisation Technical Advisory Group.

Professor Rees was recently appointed as CoChair of the MPox Incident Management by the Minister of Health in June 2024.

Making inroads in the fight against AIDS

The Post-2030 HIV Response Working Group, which includes Professor Gesine Meyer-Rath, highlights the progress made in eastern and southern African countries most affected by HIV due to the goal of ending AIDS by 2030. Since 2010, these countries have seen a 57% decrease in new HIV infections and a 58% drop in AIDS-related deaths.

Some nations in the region are close to meeting the UNAIDS 95-95-95 targets by 2030 and to sustain this progress, countries with high HIV burdens must keep reducing new infections. This means ensuring timely HIV diagnosis, adjusting prevention strategies, and providing comprehensive services for key populations, addressing health equity and human rights. Ongoing innovation, like long-acting antiretrovirals and digital health systems, will also be vital.

Considerable gains have been made in responding to HIV in eastern and southern Africa, but current progress is fragile. As 2030 approaches, the focus of—and terminology used in—regional and national HIV agendas should evolve from referring to the “end of AIDS” to building momentum for decades of sustained and resilient HIV epidemic control. These efforts need to include concerted actions towards integrated long-term services for millions of people living with HIV, minimising new HIV infections, and confronting HIV stigma and discrimination.

A baseline survey was conducted to measure the satisfaction with service delivery among HIV treatment clients enrolled in differentiated and conventional models of care in South Africa

The AMBIT project's SENTINEL survey compared patient satisfaction in DSD models versus conventional care across 21 primary healthcare clinics in four South African districts.

At the time of the study by Dr Idah Mokhele, Dr Amy Huber, Prof Sydney Rosen, Mr Nkgomeleng Lekodeba, Ms Vinolia Ntjikelane, Ms Cheryl Hendrickson, Dr Sophie Pascoe, and their team, South African HIV treatment guidelines included up to three DSD models: facility-based medication pick-up points, decentralized medicine delivery to external pick-up points, and adherence clubs. Some clinics also offered homebased medication delivery.

Most participants (74%) reported being satisfied with their care, and most (90%) said they received high-quality care. Participants in DSD models reported higher satisfaction levels than those in conventional care.

When combined with research showing similar or better health outcomes and lower costs, these findings suggest that policymakers should focus on enrolling more eligible patients in DSD models, broadening eligibility criteria, and improving the features of existing models.

Leading the way in RSV prevention

RSV is a leading cause of hospitalization in children under five, especially those younger than six months. Currently, there is no specific antiviral treatment for RSV infection, making prevention through vaccination crucial. Wits VIDA continues to play a leading role in the field for RSV prevention.

‘Matisse’ Clinical Trial

The Matisse study, conducted in 18 countries including South Africa, aimed to determine whether immunizing pregnant women against RSV could protect their unborn babies in the months after birth.

Led by researchers at the University of the Witwatersrand, Johannesburg, the study evaluated the efficacy and safety of Pfizer's Bivalent Prefusion F Vaccine in preventing RSVassociated lower respiratory tract illness in infants. Pregnant women (24-36 weeks) were randomly assigned to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based vaccine or placebo.

The study found that vaccinating pregnant women with the RSV vaccine was safe and the vaccine efficacy for severe medically attended RSV-LRTI was 81.8% (95% CI: 40.6–96.3) at 90 days after birth, and 69.4% (95% CI: 44.3–84.1) at 180 days after birth.

‘Melody’ Clinical Trial

Wits VIDA led the South African involvement in a phase 3 study, investigating the efficacy and safety of Nirsevimab, a monoclonal antibody against RSV, in healthy late-preterm and term infants.

Nirsevimab, is a long-acting monoclonal antibody, which is targeted against site Ø of the F-protein.

The efficacy of Nirsevimab was 78.4% (95% CI: 51.9–90.3) against RSV LRTI hospitalization in infants born at 29 to <35 weeks, and 76.8% (95% CI: 49.4–89.4) in near term or term infants. Nirsevimab presents a promising intervention to safeguard infants against the most common cause of hospitalization for LRTI globally.

Notably, Nirsevimab is the first potential immunization for all infants to offer sustained protection across the entire RSV season with a single dose, offering hope for high-risk groups, including premature infants and those with chronic health conditions, against RSVassociated morbidity and mortality.

Wits VIDA Research Unit aims to continue to save lives across Africa and low and middleincome countries through translational research that informs local and global policy recommendations on infectious diseases and the use of next-generation and novel vaccines.

Our research is focused on the clinical and molecular epidemiology of vaccinepreventable disease, clinical development and evaluation of vaccines, the study of the immunology of vaccines including in people living with HIV, and basic science research aimed at the discovery of potential vaccine epitopes.

A seventh case of HIV cure reported at AIDS 2024

During the 25th International AIDS Conference (AIDS 2024), being held in Munich, Germany (July 2024), a new case of long HIV remission was reported and fuels optimism for an eventual HIV cure.

In 2007, Timothy Brown, the so-called first Berlin patient, was the first person to be considered cured of HIV. He underwent a stem cell transplant to treat leukaemia from a donor carrying a rare genetic mutation CCR5-delta 32, which is known to provide genetic resistance to HIV – making his reconstituted immune cells (CD4 cells) unable to be infected with HIV.

Although Timothy died due to recurrent leukaemia in 2020, the success of his treatment has led to four other people following similar treatments and being in sustained remission. One additional case reported in 2023 has been treated with a non-HIV resistant stem cell transplant (taken from a donor who does not carry this mutation) and is also in prolonged HIV remission.

The new case (1) presented at AIDS 2024 is a 60year-old German man living with HIV who was diagnosed with acute myeloid leukaemia and underwent a blood stem cell transplant in 2015 from a donor with the CCR5-delta 32 mutation. However, the stem cell donor had a single instead of a double CCR5-delta 32 mutation, which is an important difference, as the cells were not fully immune to HIV. He stopped his antiretroviral treatment in late 2018 and since then, HIV has not been found in multiple samples, including biopsies of intestinal tissue and ultrasensitive viral techniques.

This case does not have immediate or direct clinical implications, as stem cell transplant procedures are complex,

carry significant risk and have been reserved only for those patients requiring the transplant due to the presence of a malignancy. However, the results reinvigorate the call for continued research into techniques that can simulate these resistant cells in HIV patients, such as gene editing techniques.  This report confirms the existence of several routes to explore different interventions to stimulate specific stem cells to reach long-term HIV control and cure. If patients can use stem cell transplant donors with only a single mutation in the CCR5 receptor, this potential HIV cure strategy could be more widely used, as this genetic profile is more frequently found.

“The second Berlin patient confirms that we are moving in the right direction, but we have to support more research before long-term HIV remission or HIV cure becomes a reality for people living with HIV,” said Dr Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes. “While we are very excited about this next case of potential HIV cure, we recognize that to achieve the goal of ending the AIDS epidemic by 2030, the global HIV response must continue to promote HIV testing, expand effective ART coverage, and focus on reaching the people most affected and at greatest risk.”

Reference

1. Gaebler C et al. The next Berlin patient: sustained HIV remission surpassing five years without antiretroviral therapy after heterozygous CCR5 WT/Δ32 allogeneic hematopoietic stem cell transplantation. 25th International AIDS Conference, Munich, Germany, 22-26 July 2024. Oral abstract.

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