An Overview of Lenacapavir for PrEP Trials

The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1. Read more here.

Advocates’ Guide for PPPR

Pandemic Prevention, Preparedness and Response in 2024

If you’re having trouble making sense of all of the initiatives around pandemic prevention, preparedness, and response (PPPR) this year, don’t worry—you’re not alone! This Advocates Guide provides a reference for the relevant information all in one place. The contents explain the major initiatives, key dates for involvement, how to get involved and make sure your priorities are heard by decision makers.

Tracking PrEP Rollout & Learning Lessons

Accelerating the rollout of the full range of proven HIV prevention options depends on learning from what’s been done in the past and investing in coordination and innovation to put improved solutions in place. The Biomedical Prevention Implementation Collaborative (BioPIC) is doing just that. Over the last two years, BioPIC—a project led by AVAC with support from the Gates Foundation—has been gathering and sharing evidence on these critical lessons to ensure the next generation of HIV prevention products reaches everyone who needs and wants them with much greater speed and equity.  

What We’re Learning—Highlights from 2024 Convenings

An ongoing series of think tanks, convened by BioPIC and WHO since 2021, are generating key insights for people-centered product delivery. Below, read the latest reports from these think tanks that are informing decision-making on priorities for accelerating access to PrEP. Go to the BioPIC’s page on PrEPWatch to find reports on all think tanks since 2021.  

  • Early Insights from EBONI and PILLAR, February 2024: Early insights from ViiV Healthcare, the manufacturer of CAB for PrEP, from two CAB for PrEP implementation studies, EBONI and PILLAR. Conducted by ViiV in the US, these are among the first studies gathering data in real-world settings. Learn more
  • Taking Stock of PrEP Evidence, March 2024: An analysis of current data and priority evidence gaps. This inquiry was not focused on any one PrEP product, and its findings are informing the focus of future think tanks. Learn more
  • Linking Modellers with the Latest Implementation Science Evidence, March 2024: A consideration of the latest modelling data and insights on injectable cabotegravir (CAB) for PrEP. Read about the biggest takeaways from CAB for PrEP modelling here, and learn more about the big questions that require further inquiry here
  • Discussing Early Results from the SEARCH Dynamic Choice Study, April 2024: Professor Moses Kamya of Makerere University shares early insights from the SEARCH Dynamic Choice Study in Kenya and Uganda, which gave participants a choice between oral PrEP, PEP, and CAB for PrEP, and analyzes the role of choice in PrEP coverage. Watch here
  • PrEP and the Role of HIV Self-Testing, May 23: Highlights from the WHO guidance on use of self-testing (HIVST) as an innovative way to increase PrEP access and coverage and further simplify PrEP delivery. Panelists also share experiences with procurement, costing, rollout and scale-up. Watch Here

As other new biomedical HIV prevention products roll out, BioPIC will continue to hold strategic convenings, identify and address evidence gaps, and work to accelerate equitable product introduction. To learn more efforts to coordinate the introduction of CAB for PrEP, check out the JIAS article Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC). To learn what’s needed to better coordinate rollout for not-yet-approved products in Phase III clinical trials, check out BioPIC’s Adaptable Product Introduction Framework

We hope you will book mark these resources, and stay up to date on findings from future think tanks and webinars in 2024 on the BioPIC page of PrEPWatch.

PxWire Volume 14, Issue No. 2

A Quarterly Update on HIV Prevention Research

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

New research provides reassuring evidence that oral PrEP can reliably prevent HIV infection in cisgender women even with non-perfect adherence. Prior to becoming the director of NIAID, Dr. Jeanne Marrazzo led a team in a study assessing the effectiveness of F/TDF for PrEP (brand name Truvada) among cisgender women across a wide range (11) of studies. This paper—HIV Preexposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women, which she also presented on a recent Choice Agenda webinar—dramatically shifts the conversation away from the need for women to be “super-adherers” to oral PrEP. The data also reinforce the need to support an array of options for women.

These graphics show the very high effectiveness of oral F/TDF for women with daily adherence and also for those who had consistently high adherence. Data comes from 11 demonstration projects of 2,954 cisgender women across six countries (Botswana, India, Kenya, South Africa, Uganda, USA) over eight years (2012-2020).

The data also demonstrates comparable effectiveness of F/TDF found in cisgender men who have sex with men (MSM).

Global and Country Milestones

January-March 2024

  • Global cumulative PrEP initiations surpassed 6.7 million, which includes CAB initiations (12,075) and DVR initiations (1,797).
  • Mexico and the United Arab Emirates approved oral F/TAF (or Descovy) in April.

For more comprehensive PrEP initiation data, see our tracker, data.prepwatch.org.

PrEParing for New Products

It has taken over a decade from positive efficacy results for daily oral TDF/ FTC to reach scale globally—and six years post-efficacy just to become available, in limited quantities, in lower-and middle-income countries (LMIC). During this time, nearly 20 million people acquired HIV. How many of those infections would have been prevented with faster, more efficient rollout of PrEP?

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR) and injectable cabotegravir for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and the graphic at right does show that the field is beginning to apply past lessons to accelerate introduction of injectable cabotegravir.

Having multiple options for users to choose from is critical to increasing PrEP coverage, as seen from the early results of the SEARCH dynamic choice study, where coverage among participants featured a choice of products and settings for receiving oral PrEP, PEP, or injectable cabotegravir. The study showed 70% PrEP coverage in contrast with 13% coverage among those only offered oral PrEP or PEP from standard programs.

Product Updates

  • So far this year, Canada, Mozambique, Tanzania, and the United Kingdom approved injectable cabotegravir, and it’s now under review in Taiwan.
  • Malawi, Zambia and Zimbabwe are the second, third and fourth countries now rolling out injectable CAB outside the planned and ongoing implementation science studies. This is due to initial quantities supplied via PEPFAR.

See AVAC’s integrated study tracker for more at prepwatch.org/resources/product-introduction-country-planning-matrix.

The Latest R&D in the Prevention Pipeline

The PURPOSE efficacy trials are expected to report results later this year or in early 2025. If the six-monthly injectable lenacapavir demonstrates safety and efficacy, it will be the next long-acting injectable PrEP option to enter the market—and it is not too early to plan.

[UPDATE] June 2024: Read our blog post with the latest news, Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

  • PURPOSE 1 is evaluating the safety and efficacy of both twice-yearly injectable lenacapavir and daily oral F/TAF in cisgender women in South Africa and Uganda.
  • PURPOSE 2 is assessing injectable lenacapavir 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 in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
  • PURPOSE 3 is studying injectable lenacapavir for PrEP among cisgender women in the United States who are disproportionately affected by HIV, with a focus on Black women and other women of color.
  • PURPOSE 4 is evaluating injectable lenacapavir in adults who inject drugs in the United States.
  • PURPOSE 5 will evaluate injectable lenacapavir compared to F/TDF in people who may benefit from PrEP but who are not currently taking PrEP in Europe. The study has an intentional focus on recruiting participants from groups across France and the United Kingdom that are disproportionally affected by HIV and often underrepresented in clinical trials.

Prevention Playlist

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

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Oral PrEP in Cisgender Women

Displayed in these two graphics: researchers documented patterns of adherence for oral PrEP and we graphed HIV incidence based on weekly F/TDF adherence in cisgender women. Excerpted from PxWire.

Moving a Product to the Real World

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR) and injectable cabotegravir for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable cabotegravir.

Excerpted from PxWire.

Join us as we Commemorate HIV Vaccine Awareness Day

As we prepare to commemorate HIV Vaccine Awareness Day (HVAD) on May 18, the field continues to see some modest scientific breakthroughs, while still facing extraordinary challenges.

Diversity, Equity and Access to HIV Research

On May 2, 2024, AVAC staffer Jessica Salzwedel gave a presentation on diversity, equity and access in HIV research at the Ending the HIV Epidemic Conference at Weill Cornell Medicine. Check out the full presentation in PDF format.

“When we think about what engagement is important for research, it involves building systems of trust.” – Jessica Salzwedel

Advocacy to Accelerate Prevention R&D for Sexually Transmitted Infections

AVAC Case for Support

AVAC accelerates the development and delivery of STI prevention options by fostering collaborations with STI and HIV research advocates, developing new STI vaccines and diagnostics, and creating tools to monitor STI research and investment activities.

Biomedical HIV Prevention Summit and PrEP in Black America Summit

AVAC Highlights

Last week, 1,000+ community advocates, researchers, policy experts, federal public health leadership, medical and service providers from around the US and Puerto Rico attended the NMAC annual Biomedical HIV Prevention Summit in Seattle, Washington. The discussion and debate on PrEP access, especially for racial and ethnic minorities and key populations, PrEP research, care, policy and community-based programs are ones to follow. AVAC’s John Meade (Senior Program Manager, Policy), Jessica Salzwedel (Senior Program Manager: Research Engagement) and Kenyon Farrow (Communications Director) presented in workshops and satellite sessions at the Summit and at the PrEP in Black America preconference

The Summit included sessions that updated community advocates on the latest in biomedical research for new diagnostics, PrEP, PEP, STIs and vaccines. Meade co-presented a Clinical Trials 101 for community advocates to learn more about the research process. Farrow presented an epidemiological overview on HIV and Disparities in the United States for NMAC’s Gay Men of Color Fellows. 

AVAC’s John Meade Jr. and Danielle Campbell at the PrEP in Black America: The State of HIV Prevention Research in the Black Community pre-conference

All three AVAC staff contributed to the PrEP in Black America: The State of HIV Prevention Research in the Black Community pre-conference, organized by PrEP in Black America (PIBA). PIBA began in 2022 as a community-led effort to increase Black community mobilization and engagement in PrEP research, policy and access programs. Farrow and Meade are PIBA cofounders, and Meade facilitated the day’s agenda, with more than 200 attendees focused on identifying the research gaps that need to be addressed to increase knowledge, access and use of PrEP. Data shows that while Black people in the U.S. make up 42% of all new HIV diagnoses in 2021, they were only 14% of all PrEP users. By comparison, white Americans are 65% of all PrEP users, but only 26% of all people diagnosed with HIV in the same year.  

Salzwedel co-led the closing consensus session at PIBA, a discussion where attendees named research priorities to be later released as part of a National Black-Centered Biomedical HIV Prevention research agenda. One of the most important priorities named, however, goes beyond singling out the right research questions. Attendees showed strong consensus that the research process itself needs to change. Attendees expressed a need and desire for more investment and commitment to community-led research, that can reflect non-traditional ways of gathering data and designing trials and ending the extractive approach that characterizes conventional researcher/community relationships.  

To stay up to date with PrEP in Black America, follow them on Instagram and Facebook

Join AVAC, The Choice Agenda, PrEP4All and HIVMA on Friday, April 26 for a special follow-up webinar, We Can’t End HIV in the United States Without Equitable PrEP Access: Strategies for success. Register here.