PrEP Justice

Updates on the US v. Gilead case and the fight for equitable PrEP access

In a major twist that could potentially result in as much as $1B for equitable PrEP access in the US, the government has just made the decision to appeal last year’s jury verdict in the US v. Gilead case. The Choice Agenda and PrEP4All discussed the origin of US v. Gilead, the reasons for the government appeal, and what the case means for PrEP users in the United States.

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Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

From The Lab To The Jab: Lessons learned and what’s next in HIV vaccine research

On 3 June 2024, AVAC hosted a webinar highlighting its Lab to Jab issue briefs on research and development, production and equitable global access to vaccines.

Platforms, Not Pathogens

“[Our approach to access and equity] has to be intentional, not incidental, and it has to be empowered, not vulnerable.” — Dr. Jerome Kim, International Vaccine Institute

Panelists stressed an intentional, rather than incidental approach to ensuring global vaccine access and equity, going from pathogens to platforms, and having LMICs move from consumers to actors. They described ways to transform vaccine R & D from a financial imperative of pharmaceutical corporations into a system that addresses health needs through medical innovation. They underscored the importance of new, equity-based models to move low- and middle-income countries from being recipients of vaccine technology to co-creators from the very beginning of the R & D process. These models can work through in-country partnerships for vaccine development and production, shared technology and know-how, use of TRIPS flexibilities, intellectual property waivers and access conditions, and establishing a local production ecosystems.

The webinar featured Dr Jerome Kim, Director General of the International Vaccine Institute, Othoman Mellouk, Access to Diagnostics and Medicines Lead at the International Treatment Preparedness Coalition, and Dr Els Torreele, Founding Director of æqua, a recently created think tank on equity and economic justice for health. The panelists discussed international initiatives for vaccine development, the current state of vaccine research and access, and how they can be improved. 

From Consumers to Actors

“Driving innovation at the regional R&D hubs means creating access to the technology platforms that can be adapted to new pathogens or the local health needs.” — Dr. Els Torreele, æqua

As of December 2023, only 56% of the world’s population received a complete series of COVID-19 vaccines, and only 28% had at least one booster dose. Many low- and middle-income countries (LMIC) were last in line to purchase overpriced vaccines. Lack of access to Mpox vaccines in Africa, where it is endemic, continues. These inequities are driven by the current profit-driven model and intellectual property barriers—but there could be a different way.  

One major initiative discussed is being spearheaded by the International Vaccine Initiative (IVI), a UN-chartered organization dedicated to accelerating vaccine R&D for global health. Through its robust partnerships, and funding from the Gates Foundation, it has developed two approved vaccines (for cholera and thyphoid)–for less than $30 million each. The IVI also hosts the Advancing Vaccine End-to-End Capabilities in Africa (AVEC) Initiative, which aims to accelerate the development of the African ecosystem for vaccine R&D. Its aim is to support a powerhouse of continental manufacturing through a sustainable pan-African alliance that executes on the ground. 

For more information, see:

On Access and Equity

“The problem is, until now, our countries are thinking mostly as consumers, not as actors. We only heard a little bit about some initiatives during COVID, because everybody woke up.” — Othoman Mellouk, International Treatment Preparedness Coalition

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.

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Doxycycline, an oral antibiotic commonly referred to as DoxyPEP, is a post-exposure prophylaxis used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access. This guide seeks to explore and address these critical questions.

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.

PxPulse: The Advocacy Chronicles with SMUG’s Allan Mwasa

On this episode of The Advocacy Chronicles, we’re speaking with Nsubuga Allan Mwasa, a Ugandan activist, clinical psychologist and an advocate for mental health and LGBTQ+ rights. Allan serves as Strategic Initiatives Manager at Sexual Minorities Uganda, or SMUG, which has been at the forefront of the fight for LGBTQ rights, often facing severe challenges including legal battles and violent opposition.

Despite these challenges, SMUG continues to advocate for the fundamental human rights of the LGBTQ community. It does this through legal action, public awareness campaigns, and international advocacy. SMUG is also part of Convening For Equality Uganda, or CFE, a coalition of civil society groups dedicated to challenging Uganda’s Anti-Homosexuality Act. The Anti-Homosexuality Act (AHA), signed into law in May 2023, significantly increased discrimination and violence against the LGBTQ+ community. Despite widespread international condemnation and ongoing legal challenges, the law was upheld by the Constitutional Court in April 2024. Petitioners have since filed an appeal to the Supreme Court seeking to overturn the law, which remains one of the strictest in the world, including life imprisonment and death penalty for certain offenses.  

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Follow the Conversation at Convening For Equality Uganda’s Social Media Accounts

What’s Next for the Pandemic Accord? A civil society and communities perspective

This side event, co-sponsored with Care and Frontline AIDS, was part of the World Health Assembly and featured expert panelists discussing what’s promising in the Pandemic Accord, what we expect from governments, and what’s missing for successful implementation. Selected panelists came from different health areas but all have experience in pandemic prevention, preparedness, and response.

This panel also helped civil society prepare for the coming year and gain capacity to meaningfully engage in advocacy around implementation of the Accord.

Watch the recording.

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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