Press Release

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People  

AVAC Calls for Accelerated Regulatory Review and Ambitious, Equitable Access Plans

New York City, September 12, 2024 – AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.

Preliminary safety and efficacy results were reported today by Gilead Sciences, the drug’s developer. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with a 96% lower HIV rate compared with the expected background incidence of HIV infection and 89% lower compared with oral TDF/FTC. These results follow the results of PURPOSE 1, released earlier this year, that showed 100% efficacy of lenavcapavir among cisgender women in South Africa and Uganda.

“This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them,” said Mitchell Warren, AVAC’s executive director. “Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit. But these data only matter if the field moves with speed, scale and equity.”

“Having results from a trial population that includes trans men and women, nonbinary people and gay men is an important milestone for community inclusion in HIV prevention studies,” said Kenyon Farrow, AVAC communications director and PrEP user since 2015. “I am excited that people who want to use PrEP or who fear stigma or discrimination, may soon have the possibility of another option that could be much easier to use and provide more discretion. It is imperative that we accelerate planning for rollout of lenacapavir. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out to all who need and want to use it.”

The study evaluated the safety and efficacy of twice-yearly injectable lenacapavir for PrEP compared to once-daily oral emtricitabine/tenofovir and background HIV incidence. All trial participants will now be offered lenacapavir. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who inject drugs, are also underway. It will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

“We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies, especially through the inclusion of multiple populations in the PURPOSE studies and a commitment to including community voices in trial design and in access plans” said Stacey Hannah, AVAC director of research engagement. “Access and implementation plans must be shaped and informed by continuous, robust participatory engagement. AVAC and our partners look forward to continuing engagement with Gilead and other key stakeholders in this process.”

Importance of Access and Equity 

Gilead said it is committed to making lenacapavir available for prevention in countries where it is needed most and to granting direct voluntary licenses for longer-term availability. Today’s results make it clear that Gilead, along with regulatory and normative agencies, funders and civil society, must work on an accelerated timeline to ensure broad and timely access to individuals and communities everywhere.

“In an updated access statement today, Gilead committed to beginning global regulatory filings by the end of 2024 and to facilitating faster access to target populations and countries,” Warren said. “This raises the stakes to accelerate speed, scale and equitable access. Gilead needs to urgently grant these licenses even before regulatory approval and name its prices, so that funders can prepare to accelerate product introduction. And WHO must urgently initiate its guideline review process so that lenacapavir, if approved by regulatory agencies, can be immediately added into the PrEP method mix. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact.”

“We now know that lenacapivir for PrEP is safe and highly effective among a range of populations,” Farrow added. “Even as we await regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products—including oral PrEP—must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from rollout of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP. 

“For many years, AVAC and a coalition of international partners have been planning for successful, accelerated introduction of PrEP at scale and with equity. There can be no excuses, no delays, and no repeats of the failures of oral PrEP rollout. We must move with speed, scale, and equity to ensure lenacapavir has the impact we need to prevent new HIV infections,” said Warren.

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About 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. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org. 

Avac Event

Restrategizing Civil Society Engagement for Pandemic and Global Governance

As we are building back from the aftermath of the COVID-19 pandemic, current and future generations face multiple grand-scale challenges, including the climate crisis, related disasters, pollution, and biodiversity loss. These challenges also heighten the threat of future pandemics from emerging or re-emerging diseases. On the 14th of August 2024, the WHO has declared the Mpox outbreak as a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR), which highlighted the growing concerns.

The recent amendments to the IHR (2005), agreed upon during the 77th World Health Assembly, are pivotal in enhancing global health regulations. These amendments aim to address the shortcomings revealed by the COVID-19 pandemic. Fundamental changes include a broadened definition of pandemic emergencies, principles of solidarity and equality, and reinforced WHO authority.

We aim to draw lessons from the successful experiences of diverse CSOs in enhancing inclusivity in multilateral discussions and implementation of agreements/treaties on topics such as one health, other health issues, climate, human rights, and more. For example, the processes leading to the Paris Agreement have set important precedents for integrating diverse voices and ensuring meaningful participation in global decision-making. Indigenous groups have also been involved in the inception to implementation processes of the Convention on Biological Diversity (CBD).

This side event aims to serve as a consolidation platform for civil society to share and find strategies that redefine civil society roles in global decision-making processes that address health threats such as future pandemics, climate crises, and others.

Objectives

The side event will reassess the strategies utilized to expand the role and involvement of civil society in global governance for health, climate, and other development sectors. The event’s objectives are further detailed in the following:

  • To explore and develop concrete strategies that enhance participatory, inclusive global governance for health, climate, human rights and other global challenges, starting from the Pandemic Agreement through meaningful civil society engagement, particularly in the face of shrinking civic spaces.
  • To foster collaborations among CSOs from multiple sectors to advance health and health-related development agendas.

Moderator:

  • Samantha Rick, Multilateral Engagement and Pandemic Preparedness Advocacy Specialist, AVAC

Speakers:

  • Eloise Todd, Co-Founder and Executive Director of Pandemic Action Network
  • Lawrence O. Gostin, Faculty Director O’Neill Institute for National and Global Health Law
  • Neil Vora, Executive Director of Preventing Pandemics at the Source
  • Olivia Herlinda, Chief Research and Policy at CISDI

Avac Event

Sustainability of the HIV/AIDS Response – Getting to 2030 & Beyond

The state of the HIV/AIDs endemic is reaching a critical point requiring evaluation of the current state of the global response, progress made thus far, and planning for post-2030 goals. The National Academy of Medicine is hosting a timely international meeting to facilitate discussion on these issues.

This one-day workshop is being held on September 18, 2024, from 9:00 AM – 5:00 PM US Eastern. Ambassador John N. Nkengasong, the Senior Bureau Official for Global Health Security and Diplomacy at the US State Department, will deliver the opening remarks. His address will set the stage for discussions across three subsequent panels.

Broadly, the goals of this workshop are to:

  • Explore how we can re-energize the global HIV response to reach the 2030 goals but also to look beyond.
  • Craft strategies to increase and sustain political commitment.
  • Highlight global accountability and domestic-donor financing.

AGENDA HIGHLIGHTS:

Introduction and Welcome

  • Victor Dzau, National Academy of Medicine
  • Carlos del Rio, Emory University and National Academy of Medicine

Opening Remarks

  • John N. Nkengasong, U.S. State Department

Post-2030 Strategy: Achieving 2025 Goals & Optimizing Future Response

  • A summary of response since the setting of the 2030 agenda – successes, shortfalls, areas to evolve – and discussion of how to build upon momentum to design impactful, sustained response post-2030.

Sustaining Political Commitment to Ending HIV as a Public Health Threat

  • Discussion of how to sustain and increase global political support for prioritizing the HIV response to end the epidemic and sustain support post 2030.

Global Accountability: Domestic and Donor Support

  • A conversation on strategies to garner joint accountability as well as domestic and donor support for current and future financing of the HIV response.

Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

Avac Event

Vaccinology of HSV

Akiko Iwasaki, PhD, a professor of immunobiology at Yale School of Medicine and an investigator of the Howard Hughes Medical Institute, turned her focus to SARS-CoV-2 soon after reading the first reports coming out of China, before COVID-19 surfaced in the United States. Though she has long been recognized for her work within the scientific community, her work around COVID-19 has raised her media profile considerably. She is frequently quoted by newspapers and reporters, and has amassed a huge Twitter following of people seeking out her research updates. (Iwasaki believes that public education is a key ingredient for slowing the spread of the virus.)

This webinar is in partnership with Herpes Cure Advocacy.

Registration link coming soon.

PrEP Initiations by Country Worldwide

AVAC tracks global PrEP use by conducting quarterly surveys of ongoing oral PrEP demonstration and implementation projects, and collecting data from manufacturers and government agencies. This graphic shows data on PrEP initiations around the globe. For more trends in oral PrEP uptake, visit PrEPWatch.

Avac Event

Innovations in GPP

This webinar featured speakers from around the world with experience implementing GPP at research sites, within networks, and at the sponsorship level.

They illustrated how GPP can expand beyond the more familiar (but always reliable) CABs and town hall meetings to newer ideas like partnership-based approaches, the creation of a community scorecard, and more.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Generic Cabotegravir Timelines

As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown in this timeline graphic, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster.

PxWire Volume 14, Issue No. 3

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

Oral PrEP initiations in Uganda were among the highest in the region, with sizable increases each quarter, until the enactment of the Anti-Homosexuality Act (AHA) in March 2023. Since then, the number of new PrEP initiations plummeted, and have since struggled to sustain rates seen in 2023. Public policies clearly matter.

Among 134 countries reviewed, 42 have comprehensive anti-discrimination policies covering a broad range of populations, while 24 lack any such policies. The remaining countries have adopted partial measures. Nations with comprehensive anti-discrimination policies, document significantly higher rates of PrEP initiation compared to those without such protections. Key studies show a strong link between supportive policies (which can enable PrEP eligibility, HIV self-testing, and lower age of consent for treatment, for example) and higher PrEP initiations.

An analysis presented at AIDS 2024, HIV Pre-Exposure Prophylaxis Policies Worldwide, by the Georgetown University Center for Global Health Policy & Politics and AVAC found that 69% of the 194 countries reviewed have approved at least one PrEP product. However, only 52% of these countries adhere to WHO guidance on PrEP eligibility, with regulatory approvals and national policies that support PrEP use for all populations or people at risk. This data reinforces the critical need for policies that support PrEP uptake.

PrEParing for New Products

Advocacy to accelerate licensing for new products can speed the process of generics manufacturing.

Three generic manufacturers—Aurobindo, Cipla, and Viatris—have licenses via the Medicinces Patent Pool to develop generic versions of injectable cabotegravir (CAB) for PrEP. These generic products are currently in development and expected to be submitted to regulatory authorities in the second half of 2026, with possible approval in 2027.

Does the Timeline Have to be this Long?

As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown on the timeline graphic below, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster. It is critical that generic manufacturers for new PrEP products, such as lenacapavir, star as soon as possible. This requires Gilead to pursue licensing even before regulatory submission, and to accelerate technology transfer and API development.

Product Updates

  • Data from HPTN 084 show that CAB for PrEP was generally well tolerated and safe for both pregnant cisgender women and their babies.
  • China has approved CAB for PrEP.
  • With PEPFAR support, Eswatini, Nigeria, and Ukraine are poised to introduce CAB for PrEP into their national PrEP programmes this quarter, and the South African government announced CAB supplies from PEPFAR will be launched in Q1/Q2 2025.

See AVAC’s Planning Matrix for more!

The Latest R&D in the Prevention Pipeline

Results from the PURPOSE 1 trial of injectable lenacapavir showing 100% efficacy in preventing HIV among cisgender women and adolescent girls dominated headlines at the AIDS 2024 conference. This Phase 3 trial, conducted by Gilead Sciences, involved over 5,000 participants from South Africa and Uganda and demonstrated superior results compared to daily oral PrEP options. See the New England Journal of Medicine publication, accompanying Editorial and our advocates’ primer to learn more about the results and what needs to happen next: Lens on LEN: The basics on injectable lenacapavir as PrEP.

Gilead’s PURPOSE 2 Phase 3 trial is ongoing and testing injectable lenacapavir as PrEP in the US, South Africa, Peru, Brazil, Mexico, Argentina, and Thailand, among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary individuals. With 3,000 participants enrolled, initial results are anticipated in late 2024 or early 2025. Two other trials (PURPOSE 3 & 4) are currently recruiting in the United States, enrolling cisgender women and people who inject drugs, respectively. Enrollment for PURPOSE 5 in France and the UK is expected to commence in the latter half of this year. For more information about the lenacapavir trials, visit: An Overview of Lenacapavir for PrEP Trials.

Meanwhile, the bioequivalence study for the Dual Prevention Pill (DPP), designed to prevent both HIV and pregnancy, has concluded successfully, with each of the drugs functioning together in the body in a similar way to how they function alone. The promising results pave the way for regulatory submission and potential large-scale adoption, offering another significant tool in the fight against HIV and unintended pregnancies. Learn more about the DPP and find resources for your advocacy.

Prevention Playlist

AVAC develops a wide range of resources to inform decision making and action. Check out the latest:

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Avac Event

PrEP Your Booty – The Launch of HPTN 106 “Rev Up”

HPTN 106 (REV UP) is 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 among cisgender men and transgender women who have sex with men. This webinar featured researchers leading the study.

Speakers:
Dr. Craig Hendrix, Johns Hopkins University School of Medicine
Dr. Mark Marzinke, Johns Hopkins University School of Medicine

Moderator:
Jim Pickett, The Choice Agenda

Co-sponsor:
HIV Prevention Trials Network

Recording  / Webinar Slides / Resources