What’s Next for the Dual Prevention Pill (DPP)

Dear Advocate,  

The latest edition of the Journal of the International AIDS Society features 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 article, Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape, 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. 

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. 

Navigating the PrEP Landscape

PrEPWatch is here to help!

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.
  • Long-Acting PrEP Status Update: Quarterly dashboard produced on behalf of the Coalition to Accelerate Access to Long-Acting PrEP with graphics on regulatory approvals, volumes, ongoing and planned implementation science studies, and non-profit prices for currently available long-acting PrEP products.

The resources on PrEPWatch come from projects and partners from around the world; if you have information to share or resource needs, please email [email protected]. And we are grateful for support to AVAC from the Gates Foundation via BioPIC and from PEPFAR via USAID and the Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) project that makes PrEPWatch possible. 

Choice, Access and Equity at AIDS 2024

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.

Key Steps for Choice

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 session Integrating 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.

AVAC’s AIDS 2024 Resources for Advocates

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.”  

We couldn’t agree more. 

First Full Day of AIDS 2024

Lenacapavir for PrEP has taken center stage at the 25th International AIDS Conference, #AIDS2024, which opened Monday with many highlighting its potential for long-acting PrEP for HIV prevention. Some advocates took to the halls in protest calling on LEN’s maker to price the product low. Leaders across HIV voiced the need for urgency in galvanizing support for the introduction of lenacapavir. “It is gobsmackingly exciting to see zero in a clinical trial” AVAC’s Mitchell Warren told Forbes. The potential to bend the curve of the epidemic depends on speeding access to prevention options like LEN, that show high efficacy. 

At the same time, it’s imperative to remember that neither lenacapavir, nor any other single product, now or in the future, will ever be a ‘miracle drug’, and LEN must not be equated with a vaccine, as seen in some conference media reports.  

Ongoing investment in the pipeline for HIV prevention must be founded on the principle of choice, offering a range of products to meet diverse needs among people facing the risk of HIV. We hope that vaccines will one day be among those choices, as will long and short-acting products, and topical and systemic products. Clear communication that allows product users to understand how products are different supports widespread adoption of HIV prevention and moves the world toward finally ending the epidemic.  

See 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. Our primer, the Lens on LEN, also offers advocates a guide in explaining the findings from the Purpose 1 trial and next steps for advocacy. 

As Albert Liu from UCSF’s Center for AIDS Research told delegates in the symposium on breakthrough and insights in long-acting technologies, “It’s never just the ‘product.’ New options can’t solve everything.” Atul Gawande of USAID reiterated a similar message at the satellite focused on women’s prevention, “The critical message to understand is that there isn’t going to be a magic bullet for prevention. What we have to understand is that there are also considerations that affect the likelihood that women will have what they want and what they’re likely to use.”

People First

The conference theme, “Put People First,” is the main message we all must hear. Lillian Mworeko of the International Community of Women living with HIV/AIDS East Africa (ICWEA) captured the essence of the meeting: “I am not just a recipient of care. I need a seat at the table to meaningfully engage and tell people what I need and how I need it.” 

Monday’s opening session underscored the vital role of community engagement and the necessity for inclusive policies that address disparities affecting marginalized populations. Jay Mulucha of Fem Alliance, Uganda, the first trans man to speak at the International AIDS Conference, delivered a compelling message to the 12,000+ delegates attending both in person and online: “As a trans man living in Uganda, I am asking you to stop leaving us behind. Nothing about us, without us.”

New UNAIDS Report

UNAIDS released a report, The Urgency of Now, AIDS at a Crossroads calling out funding disparities and the need to dismantle the discrimination and stigma that are pushing the most marginalized people away from health care. The report warned of the peril in delayed funding decisions; investment needs to happen urgently for long-acting treatment and prevention options to reach all low- and middle-income countries and meet 2025 targets.

Money, Money, Money

Making the most of investment in HIV prevention fundamentally depends on political will, but the field needs the right data, too. Monday’s satellite session, Money, money, money: Building towards a sustainable end state for HIV prevention, called for better data that goes beyond PrEP initiation numbers. “[PrEP initiations] alone do not tell us how much product is needed or how long people stay on PrEP. We are not collecting the right data,” said Katherine Kripke of Avenir Health. AVAC’s Mitchell Warren described the vicious cycle of small pilot projects generating limited data on PrEP use, resulting in unpredictable demand and cautious investment. “We have lots of small examples, and then we don’t scale it up because governments don’t know what it will cost. And still the world has 1.3 million new infections. We have to break the cycle.”

The Future of Women’s Prevention

At the session organized by CASPR (Coalition to Accelerate & Support Prevention Research) and MATRIX (Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and Excellence), New ways for the next wave: Innovative R&D for the future of women’s prevention, MATRIX laid out their innovative approach that involves very early engagement of all stakeholders in the research, development and delivery of new products for HIV prevention. The session emphasized the equitable inclusion of women in all phases and in every aspect of R&D—as researchers, potential users, and advocates.

Sharon Hillier of Magee-Women’s Research Institute noted, “What we’ve learned in our research is that women care about efficacy, but it’s just one element of what they consider when they decide on prevention. They’re quite interested in safety, ease of use, discretion, price, availability, and accessibility.”  

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage, which includes new resources and summaries of the preconference sessions.

AIDS 2024 Preconference Highlights

AIDS2024, this year’s annual conference of the International AIDS Society opened with a spotlight on troubling trends. A series of preconferences took on critical topics including supporting key populations in a time of increasing discrimination; new and novel research and implementation of STI prevention and treatment, witnessing a soaring rise in incidence; and the importance of implementing new PrEP options to create more choice for people who need HIV prevention most.  

Key Populations at the Center of the Response

Breaking Barriers: Insights and Realities from Key Populations in HIV Prevention, organized by Global Black Gay Men Connect (GBGMC) and AVAC, featured the voices of speakers representing migrants, people who inject drugs, sex workers and LGBTQI+ people and the release of a new report, Making Rights a Reality: A GBGMC Roadmap. GBGMC executive director and former AVAC staffer, Micheal Ighodaro said the report challenges the “misinformation and complacency that assume the world can achieve HIV sustainability, biomedical HIV prevention progress and global health security without key populations’ leadership and insight.”

AVAC’s Cindra Feuer offered context on impending reductions in global spending on the HIV response, occurring not because resources are limited but because of waning interest. Inform your advocacy with AVAC and GBGMC’s 2023 Global HIV Prevention Roadmap for Key Populations.  

AVAC’s Kenyon Farrow presented on why researchers, implementers and community advocates can and should all play a role in shaping the PrEP pipeline, and how innovation in the pipeline should be implemented.  

Why STIs Matter

The preconference, Mobilize for Action on Sexually Transmitted Infections addressed the urgent need to confront the global spike in STI rates, particularly syphilis, gonorrhea, chlamydia, and trichomoniasis. Epidemiological data shows alarming growth in STI rates, and speakers discussed the morbidity and mortality that they’re causing, and an underfunded infrastructure for researching new diagnostics, antibiotics, vaccines and other treatments.  

Perhaps no more sobering of a statement was made than by Dr. Jeanne Marrazzo, director of NIAID, when discussing the number of global deaths from something as treatable as syphilis. “I think some of the more staggering statistics here, in addition to the sheer number of new infections, is the fact that we had in 2022 over 200,000 syphilis-associated deaths, which to me is practically medieval.”  

In addition to research for new treatments and increases in STI program funding, Alison Footman, AVAC’s senior program manager of STIs said it’s equally important to strengthen the capacity and role of community advocates in fighting STIs. 

“AVAC partners with many organizations across East and Southern Africa who are raising the profile of STI advocacy. From their guidance, we know there’s a need for community advisory boards [to be] involved in STI research. It can and will improve essential research.” 

Alison Footman, AVAC

A rigorous debate explored the question of implementing DoxyPEP, given there’s no efficacy data for cisgender women in light of fears of creating drug resistant strains of STIs from wider use of doxycycline. Strong arguments were made on both sides, but this controversy is one of the reasons AVAC recently published an Advocate’s Guide to Doxycycline to Prevent STIs. 

Cure and the Next Berlin Patient

With researchers announcing what appears to be the seventh person potentially cured of HIV following a stem cell transplant, a preconference on cure research, Towards a Truly Global HIV Cure, captured a feeling of momentum driving cure research today. Donors discussed new investments in African-based infrastructure and initiatives. Scientists explained where cure research is headed in both adult and pediatric populations. But none of these topics were more important than comments from a South African participant in the FRESH cohort trial that includes an analytic treatment interruption, one of the first in Africa, emphasizing that a strong commitment to communication was the foundation to building the trust necessary for these trials. ”Sharing strategies for communication and advocacy across the field of HIV cure research will be essential for it to advance.” 

PrEP Choice

With interim results of the PURPOSE 1 HIV prevention study of injectable lenacapavir (LEN) for PrEP among cisgender women and adolescent girls recently announced, the expanding landscape of PrEP options was the focus of Welcome to the Era of PrEP Choice. Organized by the Gates Foundation, Unitaid, USAID, and the World Health Organization, the message from this session echoed throughout the various presentations: Everyone has a role to play in expanding access to real choices for all who need and want them. Putting in place the right programs, policies and investment to deliver choices at scale and bend the curve of the epidemic utterly depends on a commitment to integrated, equitable, people-centered, and community-led approaches. See the latest quarterly update from The Coalition to Accelerate Access to Long-Acting PrEP, AVAC’s recent webinar on monitoring for PrEP choice to improve and simplify data, and the new Lens on LEN, an advocates guide explain the findings from Purpose 1 and next steps for advocacy.

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage for new resources and ways to navigate #AIDS2024 including our roadmap.

A Champion for the Dual Prevention Pill

The Advocacy Chronicles with Ruth Akulu

We’ve got PrEP. We’ve got contraceptives. But what impact would there be on reducing HIV diagnoses if PrEP and contraception were rolled into one? The development of products and programs that integrate HIV prevention with other critical health-care needs is on the cusp of a new chapter. With advances in the development of the Dual Prevention Pill (DPP), a focus now on the role of multipurpose prevention technologies (MPTs) and how to integrate HIV services with sexual & reproductive health (SRH) is a must. The right conversations and the right commitments will speed investment and innovation in delivering a new paradigm in prevention: one that offers an integrated, person-centered experience for people who need prevention and want solutions that work for them.  

So, what are MPTs, and what is the DPP? 

An MPT refers to a single product (think condoms) designed to simultaneously address more than one health need (think prevention of both pregnancy and sexually transmitted infections). Condoms are the only MPT on the market today. But the DPP may soon change that. Now in late-stage development, the DPP combines an oral PrEP formulation with an oral contraceptive, preventing both transmission of HIV and pregnancy in one pill. 

Our next episode of the Advocacy Chronicles features the work of an unstoppable advocate who mobilized government action to prepare for the introduction of the DPP while also establishing a groundbreaking new initiative for ongoing engagement between regulatory authorities and young women representing their communities.

The field has arrived at a moment when advances in research and development for integrated products can and must be supported and sustained. And these integrated products must be matched with integrated programs, designed by and for the people who need them most. We hope these resources support and inspire your work. 

Advocates’ Primer on Lenacapavir for PrEP

Late last month, we learned of the exciting interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir (LEN) for HIV prevention among cisgender women and adolescent girls after an independent monitoring board found it to be safe and highly effective against HIV. AVAC issued a statement calling for early planning to accelerate its regulatory review and for ambitious introduction plans, and the PURPOSE 1 Global Community Accountability Group (GCAG) and the African Women’s Prevention Community Accountability Board also issued a statement celebrating the crucial role of African women and communities in this study. 

Today, AVAC, the GCAG and the Accountability Board are joined by the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, and the Coalition to Accelerate and Support Prevention Research (CASPR) in issuing a further call to action, with specific priorities about what needs to happen next. 

In addition, AVAC is releasing the Lens on LEN: The basics on injectable lenacapavir as PrEP. This Advocates’ Primer provides background on the product and trials; a summary of the early findings of PURPOSE 1; key remaining questions; and critical next steps.    

Read on for more about these resources.

Primer

Download The Lens on LEN: The basics on injectable lenacapavir as PrEP

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Twice-Yearly Injectable Lenacapavir for PrEP

In this call to action, the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the long-acting PrEP Coalition, the African Women Community Prevention Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) call on all stakeholders to urgently come together to learn the lessons of past PrEP product introduction and apply them to compress the timeline for making this important new option to become widely available to those who need and want to use it. 

New Drug Provides Total Protection from HIV in Trial of African Women

This  New York Times  article provides terrific perspectives from AVAC partners Linda-Gail Bekker, Yvette Raphael and Lillian Mworeko. “For a young woman who can’t get to an appointment at a clinic in a town, a young woman who can’t keep pills without facing stigma or violence — an injection just twice a year is the option that could keep her free of HIV,” said Lillian Mworeko, who leads a group called the International Community of Women Living With HIV Eastern Africa. 

We hope this new primer and our joint call to action are helpful in our collective advocacy to translate these exciting clinical trial results into actual public health impact with speed, scale and equity.

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A Joint Statement

Today a global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

There is much to do before this twice-yearly HIV prevention option can be included in comprehensive prevention programs, and this coalition of civil society groups is calling for all stakeholders to urgently come together to apply lessons of past PrEP introduction to accelerate the timeline for this important new option to become widely available to those who need and want to use it.

“This is an incredibly important day for African women. Twice-yearly injectable lenacapavir will be an important addition to HIV prevention choices and has the potential to expand access to more women who need and want effective prevention options.”

Ntokozo Zakwe, Community Media Trust in South Africa and a member of the PURPOSE 1 Global Community Advisory Group (GCAG)

“African women need and want new HIV prevention options. We need everyone who has a role to play in bringing lenacapavir to our communities to prioritize the most progressive timeline the world has seen for rollout of a new prevention option, while collaborating with civil society and advocates to ensure introduction plans will result in uptake and impact.”

Chilufya Kasanda Hampongo of Treatment Advocacy and Literacy Campaign in Zambia and a co-leader of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP

Leaders of the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, the African Women Prevention Community Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) have partnered with AVAC to identify the following actions for Gilead, regulators, normative agencies, funders and national policymakers:

  • All stakeholders must prioritize and uplift community voices and community choices for including lenacapavir in the range of HIV prevention options that offer the widest choice to the most people.
  • Gilead should prioritize and quickly share analysis of the data from PURPOSE 1 and begin submission to multiple regulatory agencies on an accelerated and parallel schedule, with the potential to add data from PURPOSE 2 (among other studies) on a rolling basis to the regulatory portfolio. At the same time, national regulatory agencies need to be ready to review the data once submitted and act swiftly in making regulatory decisions.
  • WHO must begin preparations now for including lenacapavir, once approved, in HIV prevention guidelines as swiftly as possible, in time for regulatory approval.
  • Gilead should transparently share clear plans for pricing of lenacapavir and access for communities most in need, and commit to providing enough drug to support early launch and rollout.
  • Following Gilead’s announcement last week that they are developing a direct voluntary licensing program for lenacapavir, it is imperative that Gilead grants non-exclusive licenses to multiple generic manufacturers in multiple geographies before the end of the year; that license agreements are made publicly available; and that the licenses include access to finished product based on public health imperatives, and not on World Bank country classifications or geographical location. 
  • PEPFAR and the Global Fund should work urgently with other donors and Ministries of Health to negotiate price and volume guarantees with Gilead to ensure there is a sustainable supply for the initial introduction period until generics are registered and readily available.
  • Funders, Ministries of Health, implementers and civil society partners need to collaboratively ​​design a comprehensive introduction strategy that breaks the sequential nature of traditional approaches to scale and speed up introduction. Part of accelerating speed is moving toward a parallel approach where research, implementation science, and scale-up programs are designed, funded and implemented in parallel. All stakeholders, working through the Coalition to Accelerate Access to Long-Acting PrEP, should commit to developing a robust introduction strategy ahead of regulatory approvals and WHO guidelines to ensure time is not lost.
  • Ministries of Health and policymakers must work together and with donors to ensure lenacapavir is integrated swiftly into national guidelines and prevention programs and made available to all populations for which the drug is approved and recommended.
  • Ministries of Health, policy makers and donors must work to ensure strategic demand creation and health-systems strengthening to support robust HIV prevention programs that provide a full range of HIV prevention options that allow people to choose what works best for them.
  • All stakeholders must commit to speeding long-term access to lenacapavir to trial participants and to the women in the communities that hosted the study in parallel with increasing access to a full range of HIV prevention options to those who need and want them.

Advocates know that there are many more actions that will be needed to ensure lenacapavir and other HIV prevention options are widely available. Transparency, speed, scale and cooperation are essential as we work to end HIV as a public health threat.

“We have never seen such a good outcome from an HIV prevention trial, and to see such a result first among African women is groundbreaking. Gilead listened to advocates and followed Good Participatory Practice Guidelines to include two of the populations most in need of  HIV prevention – adolescent girls and pregnant women – in the study. National prevention programs must also prioritize these populations in PrEP programs that will provide lenacapavir.”

Lillian Mworeko, ICW East Africa and a leader of the African Women Prevention Community Accountability Board

“Results like this are what we’ve been waiting for throughout decades of HIV prevention research. We know what is needed now to move this drug swiftly to communities. Civil society stands ready as watchdogs of the process and as essential partners in a successful rollout.”

Stacey Hannah, director of the Coalition to Accelerate and Support Prevention Research (CASPR) and AVAC’s director of research engagement

Results from the ongoing PURPOSE 2 study among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth are expected in late 2024 or early 2025. This second pivotal study will provide data, not just for gay men, but for trans and gender non-binary people, populations that have often been ignored by HIV prevention studies. Data for PURPOSE 2, along with PURPOSE 3, 4 and 5 studies, will provide the most comprehensive range of data across populations that has been seen to date. A schematic of the suite of studies is here.

“We eagerly await the PURPOSE 2 data and hope to see similar results for the populations represented in that study who also need new choices for HIV prevention. Lenacapavir has the possibility of transforming the HIV prevention landscape and changing the lives of millions of people around the world. There must be no delays in making it available globally. Now more than ever, we need speed, scale and equity to ensure we get impact.”

Mitchell Warren, AVAC’s executive director.

About

  • PURPOSE 1 Global Community Accountability Board (GCAG): The PURPOSE 1 and 2 efficacy trials each include Global Community Accountability Groups (GCAGs). Members of the GCAGs include leaders in HIV advocacy and experience with engagement in research and  development. Individual trial sites also have their own community-specific community advisory board, creating multiple layers of advocacy feedback.
  • Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP: Established in 2022 to ensure civil society expertise influences the rollout of long-acting PrEP options, this Caucus includes representation from many civil society groups working on longer-acting PrEP introduction. These include, but are not exclusive to, the following: African Women Community Prevention Accountability Board; AfroCAB; APCOM; AVAC; Coalition to Accelerate and Support Prevention Research (CASPR); Frontline AIDS; Global Black Gay Men Connect (GBGMC); the Global Key Population Advisory Group; and ITPC.
  • African Women Prevention Community Accountability Board: The Accountability Board led the development of the Choice Manifesto and works ensure that the manifesto is translated into reality for all women, and is composed of 12 women from 7 countries representing East and Southern African nations.
  • Coalition to Accelerate and Support Prevention Research (CASPR): CASPR is an Africa-led coalition of 13 partners, funded by USAID and supported by AVAC, working together to change how HIV prevention is pursued and delivered. CASPR activities are focused primarily in key African countries with the highest burden of new HIV infections, and where biomedical HIV prevention research is ongoing or planned.
  • AVAC: AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.

Upcoming Webinars and a Roundup of New Resources

Last week’s interim result of the PURPOSE 1 HIV prevention study of injectable lenacapavir is captivating headlines. Check out AVAC’s statement here and one from the PURPOSE 1 Global Community Accountability Board and the African Women’s Prevention Community Accountability Board here. But there are LOTS of other things also happening in HIV prevention, and we’re delighted to share this roundup.

Upcoming Webinars

Responding to Project 2025’s Threats to Science, Rights and Resources

Project 2025 is part of an ongoing multi-pronged backlash to the sexual and reproductive health, gender and LGBTQ+ movements. Building on the experience of the HIV movement in fighting these same far-right forces, join this Choice Agenda webinar discussing potential responses through the lens of HIV affected communities and programs. Register here

You Get What You Measure: Why Monitoring for PrEP Choice Helps Tell Our Story

The data collected on a program determines its path and priorities. This Choice Agenda webinar will cover the current state of PrEP monitoring and evaluation, and efforts to improve and simplify data-gathering to better reflect how people use PrEP and to support choice amongst the growing array of PrEP methods. And the discussion will also focus on how data can be used to enhance the stories we tell about PrEP program implementation. Register here

Recordings and Resources

From The Lab To The Jab Webinar and Issue Briefs

Earlier this month, AVAC hosted a webinar highlighting our series of issue briefs, From The Lab To The Jab, covering research and development, mRNA technology, vaccine production, issues relevant to equitable global access to vaccines. The webinar featured panelists from the International Vaccine Institute, International Treatment Preparedness Coalition, and æqua, a think tank focused on equity and economic justice for health. Panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. Read more

The GPP Body of Evidence: GPP Monitoring and Evaluation Frameworks, REAL and REAL2

GPP is an essential part of clinical trials research, and an ethical imperative to creating equitable and effective clinical trials. GPP is created by and for communities, so it looks different and takes multiple forms in different cultural contexts. This kind of responsiveness is inherent to GPP, but it also makes it difficult to measure and evaluate. In this webinar, participants will learn from the Realist Review of Community Engagement and the REAL2 review of participatory research. Each examined frameworks for evaluating community engagement efforts. We’ll also learn about the Global Health Network’s new course on evaluation, and other efforts in the field to evaluate the impact of GPP. View the recording

It’s Not Just about the Trial: GPP from discovery to delivery in TB research

GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB Alliance, SMART4TB, and THINK shared experiences, lessons learned, and innovative approaches in integrating GPP at the organizational, network and situational level, from drug development through delivery. View the recording

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions. Read the guide

Episode 3: The Promising Science

Our Mitchell Warren speaks to ViiV’s Kimberly Smith in this episode of the Foreign Policy podcast series ‘can we end epidemics?’ about the future of HIV science and the challenges we need to overcome on our journey to finding a cure. Listen

We hope these conversations and resources are helpful in your advocacy. Stay tuned for our upcoming advocates’ primer on lenacapavir and our roadmap to the AIDS 2024 conference in Munich.