Press Release

Critical Win In Lawsuit Against Trump Administration Over Foreign Aid Funding

Contact: [email protected]

WASHINGTON, D.C., February 13, 2025 — This evening, a federal district court granted our motion for a temporary restraining order (TRO) against the Trump administration’s wholesale freeze on foreign assistance funding. The order lifts the freeze and restores funding while our lawsuit against the administration moves forward.

The court order directs the administration not to suspend, pause, or otherwise prevent the obligation or disbursement of appropriated foreign-assistance funds in connection with any contracts, grants, cooperative agreements, loans, or other federal foreign assistance award that was in existence as of January 19, 2025. It also bars the administration from issuing, implementing, enforcing, or otherwise giving effect to terminations, suspensions, or stop-work orders in connection with any contracts, grants, cooperative agreements, loans, or other federal foreign assistance award that was in existence as of January 19, 2025.

“This order is not just an enormous victory for our clients. It is a victory for the world,” said Lauren Bateman, a lawyer at Public Citizen Litigation Group and lead counsel on the case. “Life-saving humanitarian work can resume, and thousands of American jobs will be saved. It is not hyperbole to say that this order saves lives.”

“The freeze on foreign assistance funding is illegal and it is imperative that funding be restored,” said a JDN spokesperson. “For decades, the State Department and USAID support has helped journalists in some of the world’s most repressive and corrupt regimes stay independent of the state and ruling oligarchs. The public has benefited enormously from that work.”

“This decision represents a pivotal moment  for HIV prevention and global health equity,” said Mitchell Warren, AVAC Executive Director. “The Administration has a responsibility to end this massive disruption and harm to work that is essential to global health and national security. Foreign assistance programs don’t operate with an on/off switch, and any changes or modification should be made strategically, not in a chaotic manner that jeopardizes human health, life, and safety and security.”

# # #

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org. 

Press Release

Nonprofits Sue Trump Administration to Reverse Freeze on Foreign Aid Funding

Contact: [email protected]

WASHINGTON, D.C., February 11, 2025 — Today, Public Citizen filed a lawsuit in the US District Court for the District of Columbia against President Trump, the State Department, the US Agency for International Development (USAID), the Office of Management and Budget (OMB), Marco Rubio, Secretary State and Acting Administrator of USAID, and Russell Vought, Director of the Office of Management and Budget, on behalf of the AIDS Vaccine Advocacy Coalition (AVAC) and Journalism Development Network, Inc. (JDN), seeking emergency relief from the freeze on funding for foreign assistance. 

By abruptly freezing foreign assistance funding, the administration has halted the life-saving work of organizations across the globe. The administration’s actions have also cost thousands of American jobs and counting. 

“The Trump administration’s freeze on foreign assistance funding is dangerous and illegal,” said Public Citizen attorney Lauren Bateman, the lead lawyer on the case. “When programs like the ones run by our clients are abruptly shuttered, the impacts are felt throughout the world—with the most vulnerable people bearing the deadliest impact.” 

AVAC is a New York-based non-profit founded in 1995 that works to help end the global HIV/AIDS epidemic by accelerating development and delivery of HIV prevention options. AVAC has been forced to abruptly stop CASPR, a coalition of African civil society organizations that supports research on HIV prevention and provides resources for local communities, including medical research trial participants, journalists, and policy makers. As a result, the rollout of emerging HIV preventative drugs across the African continent may be delayed, risking deadly consequences. AVAC has been forced by the illegal funding freeze to begin laying off members of its 46-person staff. 

“This funding freeze and the draconian actions of this administration are harming global health and security. In the name of economic efficiency, they are destabilizing public health, diplomatic relationships, communities, and economies,” said Mitchell Warren, AVAC Executive Director. “AVAC and many of our African civil society CASPR partners will be irreparably harmed by this pause. It takes time to build up these programs and relationships, but it is taking days to destroy them—and it will take more time to re-build, no matter who funds these efforts. USAID has made America stronger, safer and more prosperous for decades. It’s no time to throw that away.”

The Journalism Development Network, Inc. (JDN) is a Maryland-based non-profit corporation that supports a global consortium of journalists from more than 70 non-profit investigative centers and regional news organizations across the world. JDN receives funding from USAID for its Strengthening Transparency and Accountability Through Investigative Reporting (STAIR) program to support collaborative investigative journalism networks in Europe and Eurasia. 

The USAID funding freeze has shut down JDN’s operations in a number of countries, slashed nearly a third of its budget, forced it to lay off 20% of its staff and reduced salaries and work time for most of the remaining employees. If funding is not restored, JDN will have to permanently close some programs, including  operations in countries in Asia, the Pacific, Latin America and Europe.

“This illegal action by the government deprives small investigative media in low-income countries around the world of the funds they badly need to operate. These centers are critical to holding power to account in some of the toughest places in the world to report. Many are ex-pat journalists who could be deported back home where they risk arrest and torture.” said a JDN spokesperson.

# # #

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org. 

Press Release

2024 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy Presented to Advocate who is Raising the Research Profile of Latin America 

First Latin American Recipient, Gastón Devisich, Receives Award at HIVR4P Conference in Lima, Peru

Lima, Peru – Gastón Devisich, an advocate, activist, educator, trainer, and researcher who has exemplified commitment to service above self, particularly in efforts to involve gay, bisexual, and other men who have sex with men in scientific research and HIV prevention advocacy is the recipient of the 2024 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy. Devisch works as the Community Engagement Coordinator at Fundación Huésped, in Argentina.  

Devisich accepted the award during a plenary session October 9, 2024 at the 5th HIV Research for Prevention Conference in Lima, Peru. He has been recognized as a catalyst for emerging community-driven demands that could lead to the design of new interventions, as well as for consistently reporting back to the community with scientific updates and promoting their meaningful participation in HIV research and development. 

This year the Falobi Award committee chose to focus on Latin America as the region hosts the HIVR4P conference. Despite significant progress to reduce new infections and expand access to antiretroviral therapy (ART), Latin America still experiences persistent barriers, especially among key populations, including gay men, transgender people, and sex workers. Most new infections in the region were concentrated in these groups. The award committee hopes to shed light on this and on the stigma, discrimination, and legal barriers that continue to hinder access to HIV prevention and treatment services for vulnerable populations in Latin America.   

“I was deeply moved when I learned that I was the 2024 recipient of the Omololu Falobi Award because it is an acknowledgment from my peers,” Gastón Devisich said. “Having grown up surrounded by trauma and rejection, I spent much of my childhood feeling unseen and unheard. I often felt invisible or had to remain unnoticed in order to survive. The HIV community was the first place where I truly felt like I belonged, which is why putting my experience to the service of others—hoping to make their journeys easier—has always been my main motivation to give back.”  

“Since joining Fundación Huésped in 2019 and working full-time in HIV R&D, my primary goal has been to create opportunities for people who lack access to prevention tools: either because they are denied access to the combination prevention strategies we currently have, or because those strategies simply don’t meet their specific needs, highlighting the ongoing need for an HIV vaccine,” Devisich added.   

The award was presented by Luciana Kamel, Community Engagement Coordinator at Instituto Nacional de Infectologia Evandro Chagas/ Fundação Oswaldo Cruz in Rio de Janeiro. 

“I met Gaston during the implementation of the Mosaico vaccine study in the region. He has always been highly engaged and attentive to issues of access, equity, gender minorities and social justice, not only in terms of HIV prevention but also in treatment, and more recently, in cure. I can’t imagine a better person to receive this award and to represent advocacy in Latin America on the global stage,” Kamel said. 

Devisch’s nominators highlighted his service to the community, citing contributions to the Argentinean Network of Young People and Adolescents Living with HIV (RAJAP), representation of Latin America and the Caribbean in the NGO Delegation to the UNAIDS Coordinating Board, and pioneering efforts in vaccine advocacy and in creating a South American regional consortium for cure advocacy. ]“Gastón is passionate about serving the Latin American community! He is raising the research profile of Latin America to make sure those communities are not left behind,” said one nominator. 

Eighteen years ago this week, Omololu Falobi was killed and since 2008, the Omololu Falobi award has been presented as ongoing legacy that recognizes his commitment and lasting contributions to HIV prevention research advocacy and honors those who follow in his footsteps. Manju Chatani-Gada, Director of Partnerships & Capacity Strengthening at AVAC and one of the co-founders of this award said, “Omololu was a visionary leader, journalist and HIV prevention activist, who accomplished much in his too-short life. He dedicated himself to HIV prevention research advocacy in Nigeria, Africa and worldwide and to championing the voices of civil society. As we honor Gastón’s work, we continue to honor Omololu’s work. He would be proud of Gastón’s passionate advocacy and commitment to linking science and communities.” 

The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was established in 2008 by the African Microbicides Advocacy Group (AMAG) and partner organizations to recognize advocates’ contribution to the HIV prevention research field through advocacy. Today the award is presented by AMAG, AVAC, Journalists Against AIDS Nigeria (JAAIDS), the New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) and The Choice Agenda. 

Learn more about Devisich’s work and that of Fundación Huésped and read more about the Omololu Falobi Award and past recipients here. 

# # # 

Press Release

National PrEP Advocates Applaud CDC PrEP Pilot Launch

For media inquiries contact Michael Chancley at [email protected]

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.”

Press Release

AVAC Calls on Gilead and Global Stakeholders to Accelerate Access to Generic Lenacapavir Following License Agreements

New York, NY, October 2, 2024 — AVAC welcomes Gilead Sciences’ announcement in granting multiple, non-exclusive licenses to generic manufacturers to produce lenacapavir, their investigational twice-a-year injectable for PrEP, while it is still in clinical trials. This reflects longstanding community advocates’ calls to speed up access to PrEP options immediately following regulatory approval.  

On October 2, Gilead Sciences announced their plan to work with six generic medicines manufacturers to produce and market injectable lenacapavir for PrEP in 120 countries. This process of granting licensing agreements with generic manufacturers prior to regulatory submissions could reduce the time to market for generic products by up to three years.  

“Today’s announcement from Gilead is positive momentum in moving forward with injectable lenacapavir for PrEP. But while voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact,” said Mitchell Warren, AVAC’s executive director. “The six licenses announced today demonstrate that the field is learning what needs to go faster, and pharmaceutical companies are listening and acting.”  

“This is notable improvement both in timelines for licensing and in geographic coverage, with LEN licenses being granted before regulatory approval, compared to the two-year gap after approval for injectable cabotegravir. Additionally, the six generics for LEN come from three different countries, whereas the three cabotegravir licenses were concentrated in one country. Expanding manufacturing across multiple regions can hopefully further enhance efforts to accelerate global access,” Warren added. 

However, key countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir, are left out of the license geographies. This challenges the field’s ability to use this new option at the scale needed to drive down HIV incidence as quickly as possible to meet global targets. In addition, the price of lenacapavir for prevention – for both the originator product and the future generics – is still unknown, another critical piece of information in building a sustainable, impactful market. 

Various cost-effectiveness analyses have shown that injectable PrEP must be priced in the range of generic daily oral TDF/FTC to be considered cost-effective. Modeling studies suggest that the generic price of LEN for PrEP could be as low as $100 per person year of protection, but only when the number of vials produced is equivalent to those needed for one million LEN users.  

This represents a significant increase in the current PrEP market and would require scaling up additional investment in product procurement and programming by donors and governments. While this may not be possible at product launch, the field needs to collaborate to reach this price point as quickly as possible and then move to the price of daily oral PrEP, as the number of LEN for PrEP users rises to over ten million people per year.  

To reach these price points, it is essential to build volume in the global market with supplies from Gilead at close to $100 per person per year of protection beginning next year. Simultaneously, donors must procure and program large quantities and support generic manufacturers to prepare for production at scale, with market entry by 2027 to catalyze even lower prices.    

“Advocates must push for equitable and speedy PrEP access, including pricing transparency from Gilead and generics, accelerated investments by donors to design and implement integrated programs that offer LEN as part of choice of product and service delivery models, for everyone, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location,” said Wawira Nyagah, AVAC’s director of product introduction and access.  

AVAC will continue to monitor the research, approval processes and product implementation of lenacapavir as part of its quarterly Long-Acting PrEP Status Updates. Please read our Lens On LEN Advocates’ Guide, which will be updated as the process toward lenacapavir access moves forward and stay tuned for our forthcoming comprehensive plan to accelerate introduction and access. 

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org. 

Press Release

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People  

AVAC Calls for Accelerated Regulatory Review and Ambitious, Equitable Access Plans

New York City, September 12, 2024 – AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.

Preliminary safety and efficacy results were reported today by Gilead Sciences, the drug’s developer. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with a 96% lower HIV rate compared with the expected background incidence of HIV infection and 89% lower compared with oral TDF/FTC. These results follow the results of PURPOSE 1, released earlier this year, that showed 100% efficacy of lenavcapavir among cisgender women in South Africa and Uganda.

“This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them,” said Mitchell Warren, AVAC’s executive director. “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 – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit. But these data only matter if the field moves with speed, scale and equity.”

“Having results from a trial population that includes trans men and women, nonbinary people and gay men is an important milestone for community inclusion in HIV prevention studies,” said Kenyon Farrow, AVAC communications director and PrEP user since 2015. “I am excited that people who want to use PrEP or who fear stigma or discrimination, may soon have the possibility of another option that could be much easier to use and provide more discretion. It is imperative that we accelerate planning for rollout of lenacapavir. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out to all who need and want to use it.”

The study evaluated the safety and efficacy of twice-yearly injectable lenacapavir for PrEP compared to once-daily oral emtricitabine/tenofovir and background HIV incidence. All trial participants will now be offered lenacapavir. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who inject drugs, are also underway. It will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

“We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies, especially through the inclusion of multiple populations in the PURPOSE studies and a commitment to including community voices in trial design and in access plans” said Stacey Hannah, AVAC director of research engagement. “Access and implementation plans must be shaped and informed by continuous, robust participatory engagement. AVAC and our partners look forward to continuing engagement with Gilead and other key stakeholders in this process.”

Importance of Access and Equity 

Gilead said it is committed to making lenacapavir available for prevention in countries where it is needed most and to granting direct voluntary licenses for longer-term availability. Today’s results make it clear that Gilead, along with regulatory and normative agencies, funders and civil society, must work on an accelerated timeline to ensure broad and timely access to individuals and communities everywhere.

“In an updated access statement today, Gilead committed to beginning global regulatory filings by the end of 2024 and to facilitating faster access to target populations and countries,” Warren said. “This raises the stakes to accelerate speed, scale and equitable access. Gilead needs to urgently grant these licenses even before regulatory approval and name its prices, so that funders can prepare to accelerate product introduction. And WHO must urgently initiate its guideline review process so that lenacapavir, if approved by regulatory agencies, can be immediately added into the PrEP method mix. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact.”

“We now know that lenacapivir for PrEP is safe and highly effective among a range of populations,” Farrow added. “Even as we await regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products—including oral PrEP—must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from rollout of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP. 

“For many years, AVAC and a coalition of international partners have been planning for successful, accelerated introduction of PrEP at scale and with equity. There can be no excuses, no delays, and no repeats of the failures of oral PrEP rollout. We must move with speed, scale, and equity to ensure lenacapavir has the impact we need to prevent new HIV infections,” said Warren.

###

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org. 

Press Release

Heeding Community Advocates’ Calls, CDC Funds PrEP Pilot Program, Allows Funds to Pay for Generic Medications

For media inquiries contact Michael Chancley at [email protected] 

Tuesday, August 6th, 2024 – For the first time ever, the U.S. Centers for Disease Control and Prevention will allow for funding to pay for generic PrEP medications as part of a new supplemental funding opportunity aimed at quickly scaling up equitable PrEP access in four jurisdictions. Advocates have been calling for such an initiative to serve as a pilot for a National PrEP Program for un- and underinsured individuals; a key component of which would involve the implementation of a user-friendly PrEP Pass that could eliminate cost and complexity as a barrier to medications, HIV testing, necessary lab work, and provider visits. 

Along with a previous decision by CDC allowing for grant funds to go toward ancillary PrEP services, this initiative marks the first time that jurisdictions will be able to purchase affordable, high quality generic medications– priced at less than $20 per month– to create a common sense public health approach to PrEP scale up that avoids navigating complex, fragmented coverage options. 

The initiative will also fund coordinators within health departments to advance the project in partnership with community partners and empower them to conduct a comprehensive review of insurance barriers to PrEP coverage.   

Leading advocacy organizations for a National PrEP Program, including PrEP4All, AVAC, HIVMA, and the PrEP in Black America coalition, enthusiastically support the initiative and urge eligible health departments to apply before the August 31st deadline. 

“This is a real opportunity to make an impact in our national efforts to scale up PrEP and end HIV as an epidemic. The entire advocacy community, after years of building an evidence base for this sort of approach to equitable uptake, is ready to take the successes and lessons learned from this initiative to Congress to advocate for a national program.” explains John Meade, Senior Program Manager for Policy at AVAC and co-founding member of PrEP In Black America.

Although both the application and project implementation timelines are short, advocates are hopeful that health departments will apply to be part of this historic initiative. 

“We think it’s important for any department thinking of applying to note that the notification of funding opportunity (NOFO) specifically includes selection criteria prioritizing jurisdictions in the Deep South and states that have not expanded Medicaid- meaning that it’s well worth it for those priority jurisdictions to get an application in. Also, there is flexibility on the timeline for grant implementation through 2026, so the short window shouldn’t discourage anyone.” says Michael Chancley, Communications and Mobilization Manager for PrEP4All and co-founding member of PrEP In Black America. 

“Our organizations want to sincerely thank the CDC for listening to our advocacy for this pilot and for also affirming that expanding PrEP infrastructure can help scale up novel sexual health interventions like doxy PEP. In particular, we really appreciate the efforts of Dr. Robyn Neblett Fanfair, who as the Director of the Division of HIV Prevention has undoubtedly worked hard to get this NOFO released after Congressional delays in passing the FY24 complicated matters further,” added Colleen Kelley, MD, MPH, FIDSA, HIVMA Chair-Elect.

In addition to the PrEP Pass, advocates have called for the initiative to expand prescriber access points throughout communities, including through leveraging innovative use of telehealth, and to develop campaigns made by and for PrEP users and potential PrEP users from underserved communities. 

“This initiative aligns squarely with what the PrEP advocacy community has identified as what’s needed. Our organizations are ready to work with health departments to help provide context on how this grant opportunity came to be and why it is so important in advancing our movement for a National PrEP Program. We look forward to doing everything we can to support the innovative public health leaders who are ready to take full advantage of this opportunity.” says Jeremiah Johnson, MPH, PrEP4All Executive Director.

Read the full press release in PDF format here.

Press Release

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

Contact: Kay Marshall +1 (347) 249-6375, [email protected]

New York City, June 20, 2024 – AVAC welcomes the groundbreaking results of the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda. Preliminary safety and efficacy results were reported today by Gilead Sciences, the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir. 

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “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 – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. “We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies. While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out,” says Sikwana.

The PURPOSE 1 study enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda. The study is evaluating injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP. A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who use injection drugs, are also underway, and it will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results reported today make this urgent. “We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren said. “We also call on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”

“We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added. “Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.

“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir. Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need. The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren. “We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.” 

###

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org.

Press Release

Funding for HIV Survives Extreme Cuts Proposed By House Republicans

Final FY24 Bill Includes Calls for HHS/CDC to Increase PrEP Access

21 March 2024 – PrEP4All, AVAC, HIVMA, and the PrEP in Black America coalition celebrate Congress’ decision to both fund domestic HIV programs at the same level as last year and to lift up calls for a National PrEP Program. The final 2024 Health and Human Services bill rejects extreme cuts to HIV funding proposed by House Republicans in July of last year. The organizations have led the charge on the #SaveHIVFunding campaign following efforts to eliminate $767M in critical funds to end HIV as an epidemic. We additionally thank House and Senate LHHS Appropriations Subcommittee leaders Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV) and Representatives Robert Aderholt (R-AL) and Rosa DeLauro (D-CT) for working to ensure an effective and ultimately bipartisan outcome.

“Our movement for a National PrEP Program and to end HIV as an epidemic remains strong,” says PrEP4All Executive Director Jeremiah Johnson. “The final bill ultimately shows strong bipartisan support for HIV funding, including PrEP, and rejects the flawed effort by some House Republicans to zero out the Ending the HIV Epidemic Program. We created the #SaveHIVFunding campaign in collaboration with AVAC, HIVMA, and PrEP in Black America knowing that everyone in Congress needed to hear from community advocates in order to be successful in fighting these unnecessary deep cuts. Without this work and the concerted and brilliant efforts of so many HIV organizations within the Federal AIDS Policy Partnership, this win would not have been possible.”

The outcome means that a previous $25M increase going toward CDC’s efforts to improve equitable PrEP access will be preserved, which is critical as advocates continue to engage with CDC on ways to establish a foundation for a National PrEP Program using existing funds. Congress also included final report language directing CDC to increase access to PrEP and cited previous calls from the Senate to establish the “building blocks of a national program to increase awareness of PrEP, increase access to PrEP medication, [and] laboratory services…”

“This outcome is a win for Black communities across the nation who are disproportionately impacted by HIV. Making life-saving treatment and prevention a reality for Black Americans is a possibility because of our relentless advocacy work to #SaveHIVFunding,” says Raniyah Copeland, Founding member of the PrEP in Black America Coalition and Founder of Equity Impact Solutions. 

“This has been a long process, and we are grateful to have an outcome that leaves us on firm footing to realize the vision of a National PrEP Program,” says Andrea Weddle of HIVMA. “However, the fight for FY25 is already upon us following this prolonged budget process; meaning that advocates will have to remain vigilant, fight to protect our existing funding, and continue to ensure a clear, immediate, and fully funded pathway toward equitable PrEP access.”

“This is very encouraging news for PrEP advocates, especially following the President’s reintroduction of his proposal for a National PrEP Program last week.” Explains John Meade, Senior Program Manager for Policy at AVAC . “Combined with HIV/AIDS housing advocates’ victory in achieving an FY24 funding increase, I am so proud of our movement and our ability to rally in the face of these threats.”

A National PrEP Program would be a cost effective means to achieve our national goal of Ending the HIV Epidemic by 2030. Pre-Exposure Prophylaxis (PrEP) is a 99% effective use of medication to prevent HIV. Unfortunately 64% of people who could benefit from PrEP do not have access to it. A new study shows that states with the highest PrEP coverage showed an annual percentage decrease in HIV diagnoses of 8% from 2012 – 2021. In contrast, states with low PrEP coverage increased 2% annually. A National PrEP Program will increase access among people who could benefit and address major disparities in access related to race, gender and geographic location.  “In the current political environment, this Congressional action is especially noteworthy. But we must never confuse this progress with success; our fights for funding, equity and impact in treating and preventing this epidemic must continue, and funding and implementing a national PrEP program at scale and with urgency remains a huge priority,” said Mitchell Warren, Executive Director of AVAC.

Read the full press release here.

Press Release

New COMPASS Governance Structure to Accelerate HIV Policy and Advocacy

Pangaea Zimbabwe selected as new Secretariat

Contact: Kay Marshall +1 (347) 249-6375, [email protected]

New York, 25 January 2024 – AVAC and Pangaea Zimbabwe are thrilled to announce Pangaea Zimbabwe’s new leadership of the Coalition to build Momentum, Power, Activism, Strategy & Solidarity (COMPASS) Africa, a historic milestone in the development of innovative models for power-sharing in coalition and an important step toward decolonizing global health.

Launched in 2017, COMPASS Africa is a civil society coalition with 29 organizations working in three countries as well as regionally and globally, using data-driven advocacy to improve the HIV response with high-impact campaigns. Its achievements to date have set new standards for mobilization and advocacy, improving laws and policies, increasing investment in programs, elevating the leadership of affected communities in the HIV response, and holding all stakeholders to account for targets, commitments and impact.

In December 2023, Pangaea Zimbabwe signed a new two-year, $4.9 million grant agreement with the Bill & Melinda Gates Foundation as the new secretariat of COMPASS Africa. For the first 6 years, AVAC served in this role, and worked with a coalition-wide governance committee to develop a clear transition plan for COMPASS to be led by African civil society organizations. 

“Since 2017, we’ve been breaking new ground under COMPASS Africa. We’ve expanded our networks and brought together the superpowers of new and seasoned advocates who have diverse strengths and have joined together to develop and share technical expertise and winning strategies,” said Imelda Mahaka, executive director of Pangaea Zimbabwe. “This is a foundation of collaboration, knowledge-exchange and trust that can and will accelerate innovative advocacy under African leadership. We are so proud to take this step with AVAC and with support and collaboration of the entire consortium.” 

COMPASS Africa supports coalitions and organizations based in Malawi, Tanzania, the United States and Zimbabwe, and COMPASS Africa members are currently leading more than two dozen active campaigns to advance HIV prevention and treatment. 

“From its founding, COMPASS Africa pursued a vision of collective power and shared decision-making that planned for a future in which an African-based organization would assume leadership as a vital step to sustaining this essential work,” said Mitchell Warren, executive director of AVAC. “The communities who are most affected by HIV uniquely understand their context, challenges and opportunities—their leadership is essential to developing solutions that work. With inclusive governance structures formalized, including Pangaea Zimbabwe as the new secretariat, that leadership is in place, and we are excited that AVAC will continue to be part of the coalition in its new form.”

“As planned from the inception of COMPASS Africa, coalition members are taking their highly successful model to the next level. We are jointly investing in the long-term success of African leadership because it is absolutely essential to breaking cycles that perpetuate inequity and that stall progress in the HIV response,” said Justine MacWilliam, senior program manager and COMPASS Africa partner at AVAC. 

Along with the handover of the secretariat from AVAC to Pangaea Zimbabwe, COMPASS Africa has developed a new governance manual strengthening operating structures for the growing coalition. AVAC will continue as a COMPASS Africa sub-grantee and technical partner focused on advocacy strategy and tactics, including ensuring community priorities are influencing global-level HIV policies, funders and programs.

“This effort put a premium on creating structures to deepen and sustain transparency, accountability, effectiveness and continuing growth within the coalition. COMPASS has a track record of remarkable achievements, this new leadership structure ensures we leverage lessons learned, scale up our advocacy, strengthen each other, and set ambitious goals for impacting the HIV response,” said Dr. Lilian Benjamin Mwakyosi, executive director of DARE Organization in United Republic of Tanzania and co-chair of the COMPASS Governance Working Group. 

COMPASS Africa has been unparalleled in testing and succeeding with new models for transnational collaboration. The results have brought campaign after campaign that have marshalled the power of data-driven advocacy to advance community priorities and have convinced policymakers to do the right thing. With these latest innovations, COMPASS Africa is now pioneering a leadership structure that offers the field a sustainable model for decolonizing global health. 

###

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org.