PxPulse’s new episode, Lenacapavir: The case for investing in delivering HIV prevention, goes deep on LEN. Recorded just days before Gilead’s announcement that PURPOSE 2, its second major trial of LEN as injectable PrEP, also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
The PURPOSE 1 trial announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.
LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this, as hard as it is, is still the easy part. Breaking the back of the HIV epidemic demands overcoming an altogether different challenge — coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.
Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.
Explore STIWatch.org and get the latest resources to navigate the IUSTI & STI Prevention meetings!
Rates of sexually transmitted infections (STIs) continue to rise globally with too little public health intervention and investment. While many STIs are curable, they often go undiagnosed and untreated because they tend to cause few or no initial symptoms. Available diagnostics are often too costly to use for routine screening and testing in many low to middle-income countries (LMICs), and few vaccines exist to address the most common STIs.
Discover STIWatch.org!
STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts.
Scroll down for more STI prevention resources advocates need to navigate these two conferences.
Resources
Follow the STI Prevention Conference events in real time in Atlanta on Twitter at #STIConf24 and on AVAC’s feed at @HIVpxresearch
STIWatch.org is an initiative of AVAC with funding and support from the World Health Organization, the Bill & Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases.
HIV self-testing and PrEP, fighting health misinformation, innovations in GPP, and more!
This week AVAC is hosting a webinar on Innovations in GPP, sharing two new briefs to support PrEP access, a new podcast on strategies to counter health misinformation, and much more!
Inform your advocacy on HIV self-testing & PrEP, PrEP for girls and women, and health misinformation
Scale-up of PrEP since 2021 has allowed implementers and researchers to generate significant new evidence on opportunities and challenges for reaching adolescent girls and young women (AGYW) in Eastern and Southern Africa with PrEP services. This brief summarizes these insights.
In a new podcast by Health Nonprofit Digital Marketing, AVAC’s Director of Communications, Kenyon Farrow discusses how nonprofits can combat medical mistrust and disinformation around infectious diseases in a time of increasing epidemics and pandemics.
This webinar will feature site-level, national, and funders from across the globe who have non-traditional approaches to GPP. Examples multiple perspectives – sponsor to site-level, will illustrate the evolution of GPP from CABs and town hall meetings to more innovative and partnership-based approaches.
Join AVAC and the Center for Indonesia’s Strategic Development Initiatives (CISDI) for a side event during the 79th UNGA High-Level Meeting. This event will draw lessons from the successful experiences of CSOs in enhancing inclusivity in multilateral discussions and implementation of agreements/treaties on topics such as one health, climate, human rights, and more. AVAC’s Samantha Rick will moderate alongside Eloise Todd of Pandemic Action Network, Lawrence Gostin of the O’Neill Institute for National and Global Health Law, Neil Vora of Preventing Pandemics at the Source and Olivia Herlinda of CISDI.
A big win for U=U in South Africa, learn how it was done
Podcast: PxPulse: An Advocacy Chronicle on U=U in South Africa with Mandisa Dukashe
Tune into to this episode to learn why U=U represents a vital strategy in the HIV response and how Mandisa Dukashe’s advocacy influenced the South African government to launch a national U=U campaign.
This month, AVAC will be presenting at the UN General Assembly and the STI Prevention Conference, hosting a handful of webinars and sharing important resources, so be sure to look out for our weekly roundups.
HIV leaders say it’s time to end the long wait for long acting products
Major advances in long-acting HIV treatment and prevention, including the latest PURPOSE 1 results of lenacapavir for PrEP, hold great promise for achieving global targets. However, planning to coordinate among stakeholders, including pharmaceutical companies, governments, and multilateral organizations to deploy and ensure equitable access to these products, particularly in low- and middle-income countries, requires immediate action.
“Civil society organisations and HIV activists have been instrumental in holding pharmaceutical companies, financial donors, governments, and international organisations accountable for commitments to the international HIV treatment response for decades,” the authors write. “These organisations and activists are needed to promote transparency in pricing, challenge restrictive patent practices, advocate for affordable and widespread availability of drug innovations, prevent companies from restricting broad access to medications, and require funding to allow this work to be done independently.”
Key Messages
Long-acting antiretrovirals are perhaps the greatest advance in HIV care in over a decade and provide great promise towards achieving global HIV prevention and control programme targets.
Current long-acting agents are firmly under the control of originator pharmaceutical companies and remain unavailable or cost-prohibitive across much of the globe.
If action from the broader HIV community is stagnant, the populations who are most in need of these long-acting agents are unlikely to receive any benefit until well into the 2030s, resulting in a large number of preventable HIV infections.
Coordination by international agencies, with assistance from relevant financial donors and stakeholders, will be needed in the complex research and access programmes required to provide widescale use of these indispensable products to people living with HIV or affected by HIV.
Resources on Long-Acting HIV Prevention
The Lens on LEN: this primer for advocates shares the basics on injectable lenacapavir as PrEP.
Long-Acting PrEP Status Update: this webpage shares graphics and information synthesizing the current status of long-acting PrEP products. It’s updated quarterly.
PrEP Products Overview: this page on PrEPWatch shares the status of PrEP products in development and approved. Injectable Cabotegravir Evidence Gap Tracker: this webpage summarizes the latest insights from the Biomedical Prevention Implementation Collaborative (BioPIC) on injectable CAB for PrEP, links to learn more, and information on where evidence is still needed, mapped against priority evidence gaps.
The Long Wait for Long-Acting HIV Prevention and Treatment Formulations
This commentary in The Lancet HIV calls on WHO, financial donors, manufacturers, and governments to take coordinated action to make long-acting HIV prevention and treatment available at scale in lower- and middle-income countries.
Harnessing Private Sector Strategies for Family Planning to deliver the Dual Prevention Pill
The latest edition of the Journal of the International AIDS Societyfeatures newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The research demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV.
Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials
CASPR partners authored new research published in AIDS and Behaviorhighlighting the need for clinical trial teams to balance the goals of generating scientific evidence with participants’ fertility choices. The authors argue that to better support participants, trials should adopt strategies that accommodate changing fertility preferences, plan for pregnancies, and consider the ethical implications of allowing pregnant participants to continue in studies. This approach would contribute to a more gender-transformative approach to pregnancy in HIV prevention trials.
Mark Your Calendars: Upcoming Webinar
TOMORROW, August 27: Opportunities to Expand Equitable Access to HIV Prevention Services through Community Pharmacies Join The Choice Agenda and RxEACH, a national coalition effort working to expand and sustain access to HIV prevention and linkage to care services in community pharmacies for a webinar discussing the opportunity to expand equitable access to HIV prevention services, including PrEP, and what is needed to grow and sustain community-based HIV prevention service programs in pharmacies.
August 29: PrEP Your Booty Join The Choice Agenda and HPTN 106 (REV UP), an innovative clinical trial from the HIV Prevention Trials Network that will investigate the safety and acceptability of a tenofovir-based rectal douche for HIV prevention, for a discussion with researchers leading the study.
September 11: Innovations in GPP Join AVAC and champions of Good Participatory Practices (GPP) as they illustrate the evolution of GPPS from CABs and town hall meetings to more innovative and partnership-based approaches.
The DPP is the Multipurpose Prevention Technology (MPT) closest to market and the first-ever with PrEP. Following the recent successful conclusion of a bioequivalence study, where researchers demonstrated the active ingredients functioned in the body the same as when PrEP and oral contraception are taken separately, the DPP could be approved by regulators by late 2025. The DPP could be a desirable choice for women seeking an option that will meet multiple needs in their sexual and reproductive health (SRH).
The research found that a significant proportion of family planning (FP) services in Kenya (22%), South Africa (11.4%) and Zimbabwe (17.3%) are delivered using the private sector (such as private provider networks, pharmacies, e-pharmacies and telemedicine). But these channels remain underutilized and represent a largely untapped — yet growing — delivery channel with great potential to expand access to PrEP.
“Addressing the underlying reasons why this is the case will be a prerequisite to DPP rollout, not just in these three countries, but in all countries with high HIV incidence where the private sector is a popular source for FP, such as Eswatini, Lesotho, Malawi, Namibia, Uganda and Zambia”.
The authors write.
Based on these findings, regulators should update national guidelines to allow for more diverse PrEP delivery. Training on PrEP delivery could be expanded among nurses and other providers, as well as doctors. Clinics, pharmacies, telemedecine and e-pharmacies could offer PrEP. Implementers and researchers should also undertake research to better understand willingness and ability to pay, how these factors align with the cost of DPP delivery, and what additional subsidy may be needed to ensure successful rollout of the DPP.
This research supports a Market Preparation and Introduction Strategy that is guiding plans for how, where and to whom the DPP is introduced. Providing users a range of options to access the DPP in non-traditional channels will minimize stigma, improve convenience, and offer discretion — all of which are features that will increase overall uptake and continuation. See our resources on the DPP below.
With a growing number of PrEP products in development and approved for use in various countries, and an increase in PrEP initiations worldwide, the future of PrEP has never been more exciting. Check out our newly redesigned PrEPWatch website to help navigate the latest research, policy developments, implementation strategies, and advocacy efforts worldwide. The updated site features an array of expanded PrEP resources and improved navigation. We hope PrEPWatch and its resources will be helpful in your advocacy.
Explore the Latest on PrEPWatch
Enhanced Resource Library: An extensive collection of updated tools, research, and guidelines, making it easier than ever for users to access the latest information on PrEP implementation and best practices. Check out some of the most used resources like the Integrated Study Dashboard.
Interactive Global PrEP Tracker: Provides up-to-date information on PrEP initiations by country and delivery model, offering insights into the progress and impact of PrEP programs around the world.
Country Planning Tracker: Navigable matrix showing where PrEP products are currently approved and where approval is pending. It also tracks key indicators for the introduction of new PrEP options by country, including late-stage clinical trials and implementation research, procurement plans, and more.
CAB for PrEP Evidence Tracker: Summarizes the latest insights from the Biomedical Prevention Implementation Collaborative (BioPIC) on injectable CAB for PrEP, links to learn more, and information on where evidence is still needed, mapped against priority evidence gaps.
Updated Product Pages: Updated product information addressing frequently asked questions about PrEP options that are currently available and those in late-stage clinical development – including updates on the latest news related to injectable lenacapavir.
Choice, access, and equity were central themes during the sessions and discussions at #AIDS2024 on Wednesday and Thursday. Highlights included new data on long-acting cabotegravir, a plenary calling out the need to move with speed, scale and equity in the rollout of new PrEP options, updated guidelines to improve access to post-exposure prophylaxis (PEP), a renewed commitment to the African Women’s Choice Manifesto, new data highlighting the omission of key populations from sustainability planning, and much more.
Click below to access AVAC’s daily reports from #AIDS2024 and read on for Wednesday and Thursday highlights.
The African Women’s Prevention Accountability Board (AWPCAB) continued to raise their voices and call on the international community to prioritize expanded access to existing products such as the dapivirine vaginal ring and injectable cabotegravir and developing new methods to ensure a range of prevention options for women and girls. Winnie Byanyima of UNAIDS pointed to her commitment to the Choice Manifesto, a declaration put forward by AWPCAB calling for sustained political and financial support for more choice in HIV prevention.
At a Thursday satellite, HIV Prevention in the Time of Choice, Michelle Rudolph from WHO said they are “supporting PrEP options, also PrEP choice, prevention choice, and that includes the [dapivirine] ring, and we’ll continue to include the ring in all of our guidance moving forward.” Next steps for making choice a reality included curricula for training healthcare workers; more PrEP options for pregnant and lactating people; reducing costs through local manufacturing and technology transfers; and of course, community engagement.
2 for the Price of 1: DPP as the next MPT
In a workshop on the Dual Prevention Pill (DPP), Two for the price of one: Simplifying access to HIV prevention and contraception with multipurpose prevention technologies(MPTs), attendees brainstormed how to address real-world dilemmas that may come with rolling out the DPP, such as how to train HIV and family planning providers to deliver it; how will governments and donors balance the delivery of all proven methods for HIV prevention, including CAB for PrEP and the ring. Proposed solutions touched on the role of stakeholder engagement, models for demand creation and more. To learn more about the DPP and the full pipeline of MPTs, see AVAC’s Advocates’ Guide to MPTs.
Pushing for Equity in Access: All PrEP & PEP
As the international community hailed the results of the PURPOSE 1 trial of injectable lenacapavir for PrEP in Wednesday’s Co-Chairs’ Choice session and called on its maker and international partners to plan for equitable access in its rollout (pending additional data and regulatory reviews), WHO published updated guidelines aimed at expanding access to post-exposure prophylaxis (PEP), a critical and under-used intervention in reducing new infections. These guidelines come on the heels of UNAIDS’ newest report showing an estimated 1.3 million new HIV infections in 2023, with increases seen in countries where investment in prevention was lower.
“We cannot say that we are doing well until we are doing well,” Jhpiego’s Elizabeth Irungu shared in Thursday’s plenary, HIV Prevention Strategies, speaking to the current state of PrEP choice, access and uptake globally. Irungu decried the historical delays in the rollout of oral PrEP and called on all stakeholders to break the 12-year cycle of squandering opportunities in prevention.
The Inclusion of KPs in Country Planning for Sustainability: A report on pseudo engagement
The voices of key populations (KPs), such as gay men, other men who have sex with men, sex workers and people who inject drugs, are too often left out of sustainability planning, a process pushed by PEPFAR and UNAIDS. This was a finding from an analysis in six countries conducted by the Key Population Trans-National Collaboration (KP-TNC). From the sessionIntegrating social enterprise for sustainability of key population programmes, AVAC’s Richard Muko, talked about some the causes behind this finding. These include cultural and religious beliefs that stigmatize KPs; reactionary policy moves that exclude KP voices; punitive laws targeting KPs; insufficient guidelines on how KP communities will be included in the sustainability framework; lack of political will and lack of understanding of KP needs in relation to HIV programming. “Some minimal communication can amount to pseudo involvement of KPs. But we see a signal that KP needs may be missing from the final sustainability roadmaps under development now.” The abstract on the study, Country HIV response sustainability roadmaps: where are key populations in the conversations?, calls for PEPFAR, Global Fund and UNAIDS to step up with frameworks for KP engagement in the development of sustainability roadmaps.
Making the Case for an HIV Vaccine
Leaders in HIV prevention voiced unwavering support for vaccine development notwithstanding the scientific challenges, even as the world watches ARV-based interventions making enormous strides. In his plenary talk, Devin Sok of the Global Health Investment Corporation equated the HIV epidemic with a fire that can get out of control at any time. “We really need to reduce the embers to the point that we won’t have a fire… a vaccine will be essential for supporting epidemic control and eventually eliminating HIV as a public health threat.”
Later in the day, the satellite session Ending the Epidemic: The role of a vaccine in the era of long-acting PrEP. Participants said the science in broadly neutralizing antibodies is accelerating with implications for vaccine research; investments in vaccine science have yielded unimaginable and enormous benefits (including COVID vaccines); and ultimately the choice of a vaccine remains essential to a sustainable and durable end to pandemic. As NIAID leader Jeanne Marrazzo said, “to understand any process that we can eventually apply to cure or to eliminate HIV, it’s got to involve an HIV vaccine.” And, ultimately, she said, there are populations of people who may never be as comfortable with ARV’s as a vaccine and vice versa.
Stay tuned for more ways to unpack the new data, reports and discussion from AIDS 2024 including an upcoming webinar focused on what’s next in lenacapavir for PrEP advocacy.
LEN in the Spotlight at AIDS 2024
Zero Infections!
Midpoint at #AIDS2024 in Munich, one of the most significant advances in HIV prevention in the history of the response, the efficacy of lenacapavir as PrEP, was presented at the Co-Chair’s Choice session. The findings, zero infections and 100% efficacy among the trial participants in the PURPOSE 1 trial, brought a standing ovation.
Presented by Linda-Gail Bekker of the Desmond Tutu Health Foundation, and published in the New England Journal of Medicine, PURPOSE I enrolled 5,300+ cisgender adolescent girls and young women (ages 16-26) in South Africa and Uganda. PURPOSE 1 also evaluated daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP, which was shown to be safe. Overall adherence in the F/TAF arm of the trial was low and the intervention did not show overall efficacy. But, among those trial participants with medium to high adherence (2-4 doses per week), data showed a significantly lower chance of HIV infection compared to participants with low adherence.
The introduction of oral PrEP has changed the lives of more than 6 million people globally who have accessed it. Despite the promise of PrEP, many young women have found the uptake of daily adherence and persistence to daily PrEP a social, emotional and physical challenge. We need new and diverse PrEP options,” said Bekker.
For more on PURPOSE 1 and the rest of the PURPOSE program evaluating lenacapavir across diverse populations, see AVAC’s primer for advocates, The Lens on LEN.
So now the work must accelerate.
New UNAIDS data released at the meeting calculated that 44% of all new HIV acquisitions were among women and girls in 2023 globally, and young women in Africa accounted for 62% of new HIV acquisitions, making the case that there are millions of women in urgent need of HIV prevention and who must be given the opportunity to benefit from every proven method of HIV prevention.
Data for key populations is just as stark. The latest data from UNAIDS points to marginalization, discrimination and criminalization as drivers pushing the median prevalence of HIV in 2023 to be much higher than the global average among sex workers, gay men and other men who sex with men, and transgender people (3%, 7.7% and 9.2% higher respectively than the global adult prevalence of .8%).
All these populations represent individuals with unique and evolving needs. No single prevention product will ever be a miracle drug. People need real choices in programs tailored to reach them. Implementers, policymakers, donors, advocates and communities must collaborate for the speedy, reliable delivery of every option. Check out AVAC’s statement calling for early planning to accelerate LEN’s regulatory review and for ambitious introduction plans, and the joint civil society call to action with specific priorities about what needs to happen next.
In a satellite session with advocates Wednesday, Winnie Byanyima of UNAIDS recommitted to the Choice Manifesto, a powerful declaration calling for continued political and financial support for more choice in HIV prevention. As Angeli Achrekar also of UNAIDS said at a subsequent session, “Both data and services need to be precisely tailored to the people who need prevention most, and we have to make solutions more affordable. We need a new HIV prevention revolution.”
