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.

Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans

Adding additional HIV prevention options means more people may find an option that is right for them. 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.

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.

Tracking PrEP Rollout & Learning Lessons

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.  

New Product Introduction Update

Spotlight on Eastern and Southern Africa

A graphic showing ongoing studies of injectable cabotegravir and the dapivirine vaginal ring in eastern and southern Africa.

Top Vaccines Funders

Total US dollars invested by each of the top 10 global funders of vaccine research in 2022.

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

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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.

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.