Oral PrEP Prices in LMICs

This chart tracks pricing for oral PrEP as tenofovir disoproxil and emtricitabine (TDF/FTC) as compared to generic pricing in low- and middle-income countries (LMICs) since 2005.

Avac Event

I Am More Than HIV Prevention – Results from the HPTN 091 Study with Transgender Women

HPTN 091, the I Am study, evaluated the impact of a multicomponent HIV prevention strategy to increase the uptake and adherence of pre-exposure prophylaxis (PrEP) among transgender women. The strategy included HIV prevention services, gender-affirming hormone therapy, and peer health navigation.

This webinar featured Dr. Tonia Poteat, study co-investigator, who will review the study findings and discuss implications.

Speakers:

  • Tonia Poteat, Ph.D., Duke University School of Nursing, Division of Healthcare in Adult Populations

This webinar featured Portuguese and Spanish translation thanks to HPTN.

Video Recording and English Audio / Spanish Audio / Portuguese Audio / Slides / Resources

Introducing the Gears of Lenacapavir Rollout and The People’s Research Agenda

This World AIDS Day, the HIV/AIDS response stands at a crossroads, with injectable lenacapavir set to transform HIV prevention. But as the new UNAIDS report highlights, it also comes at the same time as restrictive policies, economic instability, and geopolitical challenges threaten to frustrate access and rollback so much of the progress that has been achieved over the past two decades. 

AVAC’s 2025 advocacy agenda prioritizes collaboration and strategies for equitable and accelerated product introduction that maximize the public health potential of new prevention options and simultaneously sustains investment in critical research and development. AVAC’s newest publication, The Gears of Lenacapavir for PrEP Rollout, provides a clear pathway for the speed, scale and equity needed to translate exciting science into public health impact, while our recent The People’s Research Agenda (PRA) meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed in the future. 

Despite the challenges, 2025 holds immense potential for ensuring the equitable rollout of new options and the accelerated development of a pipeline of additional options, the combination of which can help move the field closer to ending HIV/AIDS.  

For the latest information on injectable lenacapavir for PrEP, be sure to join us for our webinar Tuesday, December 3. And read more below about both the Gears of LEN for PrEP Rollout and The People’s Research Agenda. 

The Gears of Lenacapavir for PrEP Rollout: Driving Speed, Scale, and Equity

Lenacapavir’s rollout is not just about making a new drug available as quickly as possible; it is about ensuring that it reaches the people who need it most, as swiftly and equitably as possible. Gilead has announced its readiness to manufacture up to 10 million doses for 2026, but this potential hinges on coordinated action by governments, donors, and civil society. The roadmap outlines the essential gears driving this effort, from robust demand generation and procurement strategies to equitable distribution and community-driven implementation. Crucially, the roadmap emphasizes lessons learned from previous PrEP interventions: that availability alone is not enough. With global HIV targets still unmet and disparities persisting, this effort demands decisive action and long-term planning.

Download the infographic

The People’s Research Agenda: A Community-Driven Vision

The People’s Research Agenda (PRA) brings the voices of affected communities to the forefront of HIV prevention research and product development. With limited resources, the stakes for decisions about which products to develop and eventually deliver become even higher for funders, communities, policy makers and governments. The PRA offers a bold vision for aligning scientific innovation with community needs. By amplifying the perspectives of those most affected by the epidemic, the PRA is a tool for driving accountability among funders, developers, and policymakers. As a living, adaptable framework, it ensures that evolving needs and challenges in the prevention landscape remain at the center of decision-making.

A Call to Action

The rollout of lenacapavir and the implementation of the PRA come at a critical moment in the global HIV/AIDS response. Achieving their full potential will require sustained collaboration, strategic investments, and unwavering commitment to equity. Together, we can transform this pivotal moment into lasting progress.

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.

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.

LEN Generics — Can we go faster?

The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. Read more in PxWire.

PrEP Initiations in Latin America, 2019-2024

Latin American countries account for 306,000 cumulative PrEP initiations in the Global PrEP Tracker as of Q2 2024, which represent 4% of the global total. Since 2019, PrEP initiations across the region continue to increase at a steady rate, with Brazil reaching about 194,000 cumulative PrEP initiations (63% of regional total) since the inception of its National PrEP Program. Read more in PxWire.

PrEP Approval Status in Latin America, 2024

Since 2019, rates of HIV acquisition in Latin America have been trending upward, from 110,000 annually in 2019 to approximately 120,000 in 2023. At the same time, Latin America has taken strides to combat this trend, from increasing PrEP initiation rates to preparing for longer acting PrEP products, such as injectable cabotegravir (CAB) and lenacapavir (LEN). Learn more in PxWire.

PxWire Volume 14, Issue No. 4

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

The HIVR4P 2024 conference, hosted this year in Lima, Peru, put a spotlight on PrEP delivery in Latin America. Since 2019, rates of HIV acquisition in the region have been trending upward, from 110,000 annually in 2019 to approximately 120,000 in 2023. At the same time, Latin America has taken strides to combat this trend, from increasing PrEP initiation rates to preparing for longer acting PrEP products, such as injectable cabotegravir (CAB) and lenacapavir (LEN).

  • At least 15 Latin American countries have approved oral PrEP. Brazil and Peru also approved CAB for PrEP, and it is under review in Chile, Mexico, and Colombia.
  • Four countries and one territory in the region, Argentina, Brazil, Mexico, Peru, and Puerto Rico, have trial sites participating in the PURPOSE 2 trial, which showed LEN reduced HIV incidence by 96% compared to a background incidence, with 2 incident cases among 2,180 participants receiving LEN.
  • Latin American countries account for 306,000 cumulative PrEP initiations in the Global PrEP Tracker as of Q2 2024, which represent 4% of the global total.
  • Since 2019, PrEP initiations across the region continue to increase at a steady rate, with Brazil reaching about 194,000 cumulative PrEP initiations (63% of regional total) since the inception of its National PrEP Program.

Latest Trends in PrEP Uptake?

Find the latest trends on 2024 data in AVAC’s Global PrEP Tracker. Watch for the next update on November 22.

PrEParing for New Products

  • On October 2, Gilead Sciences announced six licenses to generic manufacturers in Egypt, India, and Pakistan to produce and market lenacapavir (LEN) for PrEP in 120 countries.
  • What’s new about this announcement? This marks an increase in speed, as compared to generic licenses for injectable CAB for PrEP. Gilead awarded these licenses even before submitting LEN for PrEP for regulatory approval in any country. Gilead’s license applies to 120 countries, which is more than the 90 countries covered by the generic license for CAB for PrEP. However, CAB for PrEP’s license also allows for generic supply in countries without patent barriers—by the time generic CAB for PrEP is available, this will be an additional 51 countries. Many countries with high HIV incidence have been left out of Gilead’s licensing deal; notably Argentina, Brazil, Mexico, and Peru, countries in which the PURPOSE 2 Phase III trials took place. In addition, Gilead’s licenses are more restrictive than ViiV’s, in terms of where generics can be marketed.
  • The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, versus the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline.
  • Generic regulatory approval submission for LEN for PrEP may begin as early as the second half off 2026, two years after Gilead announced positive trial results. Generic CAB for PrEP is on track to submit for regulatory approval around the same time, approximately six years after the announcement of trial results.

Product Updates

  • CAB for PrEP has been approved in Cote d’Ivoire, Kenya, Myanmar, Namibia, and Ukraine. See AVAC’s Planning Matrix for more!

The Latest R&D in the Prevention Pipeline

Launched at HIVR4P in Lima, Peru in October 2024, the People’s Research Agenda (PRA) is a collaboratively developed framework for aligning the needs and priorities of affected communities with the agenda for HIV prevention research. 130 advocates from more than 20 countries contributed to the framework, which offers guidance on both research conduct and what products to develop.

PRA priorities include:

  • Support a choice-based prevention agenda with clear and realistic target product profiles that reflect the current and future landscape of HIV prevention. Begin with the end in mind by identifying and anticipating trial design issues (feasibility, cost, size, regulatory pathways) and implementation science questions so that the timeline from evidence to impact and to widespread access is as short as possible. Initiate access planning during efficacy trials to ensure expeditious rollout.
  • Center and invest in social and behavioral science that explores end users’ needs and preferences, informs target product profiles, and identifies and addresses social and structural barriers in HIV prevention.
  • Maintain advocacy across product categories to fill important gaps in a comprehensive HIV prevention toolbox. We must make newly efficacious products accessible, and vaccines, bnAbs, implants, and other products in early-phase development will also play an important role for a sustainable end to the epidemic.

Key considerations:

  • Invest in continuous learning so that advocates and communities where research is planned are equipped to weigh in on complex and evolving trial designs and approaches.
  • Novel trial designs using external controls are important in developing new prevention products. However, they must meet the rigorous standards of randomized controlled trials (RCTs) to ensure they provide reliable answers to key research questions without compromising quality.
  • Trial designs must address the needs and concerns of highly impacted communities.
  • Products moved into trials should be ones that fill community-informed gaps, such as improving upon existing prevention methods with innovations in cost, mode of delivery, duration or level of protection and other parameters.
  • Participants should be supported to clearly understand how novel design elements, such as run-in or opt-out phases, may impact their involvement.
  • Ensure that regulators are prepared to review and react to the data generated by future trials, especially if it is a novel design.

The PRA is a living document—emerging priorities, challenges and opportunities will be reflected in ongoing updates. Please share your thoughts, reflections, and comments by emailing Grace Kumwenda at [email protected]. For more information on the People’s Research Agenda visit avac.org/peoples-research-agenda.

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

True Choice in HIV Prevention Involves More than Product Options: Novel strategies in service delivery

The Choice Agenda and presenters from Brazil, Kenya, and South Africa discussed novel strategies for the delivery of HIV prevention interventions. All HIV prevention products have their “Achilles Heels.” Differentiated service delivery supports reaching a wide range of potential users and can overcome challenges with product attributes. Offering different strategies can also make the interface with health care easier and more community friendly.

Speakers:

  • Ines Dourado, Universidade Federal da Bahia
  • Catherine Verde Hashim, AVAC
  • Catherine Martin, Wits RHI
  • Katrina Ortblad, Fred Hutch
  • Adriano Queiroz, City of São Paulo Municipal Health Secretariat
  • Daniel Were, Jhpiego

Thanks to WHO for providing live simultaneous Ukrainian translation and to PAHO for providing live simultaneous translation in Portuguese and Spanish.

Video Recording and English Audio / Ukrainian Audio / Portuguese Audio / Spanish Audio / Slides / Resources