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 gkumwenda@avac.org. 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

PxPulse: The Advocacy Chronicles with Danielle Campbell from PrEP in Black America

In this episode of the Advocacy Chronicles, we’re putting the spotlight on the US, on the dismal statistics on access to PrEP in Black communities, on the state of HIV prevention among Black Americans overall, and the work of one advocacy group— PrEP in Black America (PIBA). Danielle Campbell is one of the founders of PIBA and a long-time advocate for HIV prevention and health equity. She joins the Advocacy Chronicles to talk about PIBA’s call to action for an HIV research agenda that prioritizes the needs of Black communities. And we also explore the tactics that have led this group to quickly rise as a powerhouse, bringing together communities and government to find solutions that improve the US HIV response.

Danielle is a member of the research faculty at the Charles R. Drew University of Medicine and Science and a member of the community scientific subcommittee for a global HIV research network. She is an experienced clinical research manager who integrates principles of health equity and implementation science into biobehavioral research into HIV treatment, prevention and cure research and she is a past Chair of the HIV/AIDS Section of American Public Health Association (APHA) and has served as Chair of the Science Board and Co-Chair of the Joint Policy Committee.

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Avac Event

PIBA Presents Reimagining the HIV Prevention Blueprint for Black Communities in Arkansas, Mississippi, and Tennessee

PrEP in Black America (PIBA) with regional Partners will host a Virtual Town Hall titled, Reimagining the HIV Prevention Blueprint for Black Communities in Arkansas, Mississippi, and Tennessee.

This is designed to offer a virtual platform for leaders in Mississippi, Tennessee, and Arkansas to share the narrative of PrEP within Black communities. The town hall will concentrate on three main objectives: 1. Motivating the Black public health workforce to spearhead the public health response. 2. Educating the broader Black community about the science and efficacy of PrEP. 3. Advocating for a federally funded national PrEP program.

Local Partners Include:

  • Community Health-PIER (MS)
  • FABRIC, Incorporated (MS)
  • Mississippi AIDS Education and Training Center (MS)
  • WeCare TN
  • Ryan White Part A Program Memphis (TN)

PIBA requests that only residents of Mississippi, Tennessee and Arkansas (US) attend this virtual town hall.

Avac Event

From Promise to Progress: Overcoming Barriers to Long-Acting PrEP Uptake among Black Gay Men in the US

GBGMC and partners are hosting a webinar on Monday, October 21, titled: “From Promise to Progress: Overcoming Barriers to Long-Acting PrEP Uptake among Black Gay Men in the US.”

This event will delve into the challenges preventing Black gay men from accessing and adopting long-acting PrEP.

By bringing together insights from product developers like ViiV, the CDC, AVAC, healthcare providers, and advocates, the webinar will explore strategies to address these barriers. Key topics include healthcare access, stigma, and the need for culturally competent care.

Our discussion will focus on identifying actionable steps to ensure equitable access to long-acting PrEP, with the goal of improving health outcomes for Black gay men in the US.

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 (CAB) and lenacapavir (LEN) 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 PrEP options.

This is an updated version of a graphic excerpted from PxWire.

From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP

This plan provides a comprehensive view of all the moving parts and identifies priority actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

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 and PURPOSE 2.

Press Release

National PrEP Advocates Applaud CDC PrEP Pilot Launch

For media inquiries contact Michael Chancley at Michael@PrEP4All.org

Thursday, October 4th, 2024- Advocates applaud the announcement of the five jurisdictions to receive funding as part of a first-of-its-kind Centers of Disease Control and Prevention (CDC) PrEP pilot. While the original notification of funding opportunity (NOFO) allocated $7M in funds for four jurisdictions, in the face of overwhelming demand from 17 health departments who applied, the CDC increased the investment to $10M–$2M each for five jurisdictions—a clear sign of the urgent need for more PrEP funding. The initiative has the potential to show how a National PrEP Program, as championed by advocacy organizations all over the US, could transform equitable PrEP access by greatly simplifying cost coverage, expanding access to providers, and creating more effective and community-driven education and awareness initiatives. PrEP4All, PrEP in Black America, HIVMA, and AVAC stand ready to work alongside key stakeholders in the five jurisdictions chosen—Baltimore, Houston, Florida, Oklahoma, and South Carolina—and provide insights from the last three years of multi-stakeholder discussions led by our organizations.

“The fact that so many health departments took the time to apply for this funding with a short one-month submission window shows how badly jurisdictions need more funding for equitable PrEP access,” says PrEP4All Executive Director Jeremiah Johnson. “Unfortunately, this pilot is a one-time funding opportunity that only scratches the surface of what is required to expand PrEP access and end HIV as an epidemic nationally. We urge Members of Congress, the Administration and other key policy makers to find additional funds to address this demonstrated need by broadening this pilot right away and fully funding a National PrEP Program.”

“I think what is particularly exciting here is that the states and cities chosen have a real need for innovative approaches to PrEP access,” explains John Meade, Senior Program Manager for Policy at AVAC and a co-founder of PrEP In Black America. “Four of the five locations have not expanded Medicaid, meaning that a program emphasizing simplified access for un- and underinsured individuals can make a real difference in the lives of people who don’t have the time to navigate broken and fragmented cost-coverage options that make PrEP access impossible for so many individuals.”

“This is an amazing next step in the story of PrEP and ending HIV as an epidemic,” said Michael Chancley, PrEP4All Communications and Mobilization Manager and co-founding organizer of PrEP In Black America. “But one thing that has become clear as we’ve convened multi-stakeholder discussions around the nation, is that funding alone will not lead to equitable access. PrEP in Black America published For Us, By Us: A Master Plan for HIV Prevention in Black America that outlines key strategies for an equity informed response to address disparities in HIV prevention among the Black community as an accompaniment to funding and other investments. In the next few weeks PrEP4All will be releasing a comprehensive report on best implementation practices for PrEP programs that will provide key recommendations and insights from the past three years of community-led discussions. We’re hopeful that these will be useful guidance documents for everyone working on implementation.”

“It’s not lost on us that this announcement comes just as more and promising scientific developments in long-acting injectable forms of PrEP become available,” explains Danielle M. Campbell, Science Equity Activist, researcher, co-founding organizer of PrEP In Black America. “We must acknowledge that in the US, there is a longstanding history of innovative preventive health interventions not reaching the communities who need them the most, in particular Black people. The establishment of this kind of PrEP infrastructure creates an opportunity for greater coordination of access to other essential disease prevention innovations, such as novel PrEP, doxyPEP for the prevention of bacterial STIs, and mpox vaccination and treatment.”

“Our frontline workforce needs this type of support to improve access to PrEP and to ensure that every community has a path toward ending their HIV epidemic. Having simpler, more accessible pathways to cover PrEP services means less time, effort, and money spent on navigating cumbersome, fragmented and inadequate programs,” explains HIVMA Chair Allison Agwu, MD, ScM. “While this is an important step, we still have significant work to do to grow, train and support the public health workforce, and we’re eager to support jurisdictions to make sure that providers have the tools they need to offer and provide PrEP services.”