Avac Event

HIVR4P 2024

The 5th HIV Research for Prevention (R4P) conference is being held in Lima, Peru from 6 to 10 October. Held every two years, HIVR4P is the only global conference to focused exclusively on biomedical HIV prevention, including AIDS vaccines, microbicides, PrEP, treatment as prevention and other approaches. 

See below for conference highlights, recaps and announcements. 

Conference Highlights and Recaps

Announcements

The Future of ARV-Based Prevention and More

The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.

Click here for a view of all large-scale prevention trials.

The Lens on LEN

The Basics on Injectable Lenacapavir as PrEP

In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.

Download the report.

SRH + HIV integration advocacy, Pandemic Accord, GPP and more!

AVAC’s round-up of resources, updates and insights this week includes a new roadmap for sexual and reproductive health (SRH) and HIV integration, resources to support an equitable Pandemic Accord, innovations in Good Participatory Practices (GPP) and more!

The power of choice in contraception, sexual health and HIV prevention this World Contraception Day

Roadmap: Sexual and Reproductive Health (SRH) Integration Roadmap

Copper Rose Zambia, as a part of CASPR and AVAC launched a new resource addressing the critical need for integrated SRH and HIV services. This roadmap provides key steps for success, focusing on collaboration, strategic mapping and targeted advocacy.

Read the roadmap

Advocate’s Guide: Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)

MPTs are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.

Read more

What will it take for an equitable Pandemic Accord?

Call to Action: Pandemic Accord Priorities from the Coalition of Advocates for Global Health and Pandemic Preparedness

A group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness, shares five priorities in Pandemic Accord negotiations.

Read more

UNGA Side Event: Restrategizing Civil Society Engagement for Pandemic and Global Governance

AVAC’s Sam Rick moderated CISDI’s event alongside Nina Schwalbe, Lawrence Gostin, Eloise Todd and others, reminding the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR.

Read the summary

Good Participatory Practices in action

Call for Applications: Now Accepting Applications for the 2024 Good Participatory Practice Online Course

The 2024 Good Participatory Practice Online Course is now accepting applications for 30 spots! This course offering will run 14 October – 20 December 2024. The application deadline is 9 October.

Apply now

Recording: Innovations in GPP

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

Avac Event

Integrating HIV and PrEP Services in US Correctional Facilities

This webinar explored the integration of HIV prevention and PrEP services in diverse US correctional settings and during the critical period following release. It also highlighted innovative HIV status-neutral approaches, fostering holistic and comprehensive HIV care, treatment, and prevention services in these settings.

Presenters:

  • Jeannette Webb, BS, University of Chicago
  • Russell Brewer, DrPH, University of Chicago
  • Chad Zawitz, MD, Cook County Health, Chicago
  • Gjvar Payne, Capitol Area Reentry Program, Baton Rouge
  • Louise Bienvenu, JD, Frontline Legal Services, New Orleans

Recording / Slides / Resources

Brand-new PxPulse Podcast on LEN’s Impact on HIV Prevention

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an injectable antiretroviral known as lenacapavir (LEN). 

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. 

Avac Event

Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention

This UAN Call, titled Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention, brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.

This webinar was hosted by Unitaid.

Lenacapavir: The case for investing in delivering HIV prevention

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN).

This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 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 PURPOSE1 trials 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 is, as hard as it is, is still the easy part. To break 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.

Listen

Resources

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective

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.

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.

###

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.