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.

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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 Michael@PrEP4All.org 

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, kaymarshall@mac.com

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.” 

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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, kaymarshall@mac.com

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. 

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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

The Search for an HIV Vaccine Must Continue

Field Will Learn for Halted PrEPVacc Arm

New York, 6 December 2023 – Today the PrEPVacc trial team announced at a special session at the International Conference on AIDS and STIs in Africa (ICASA) in Harare, Zimbabwe, that they were stopping vaccinations in the study following a review by an independent data safety committee that determined there was little chance the vaccines being tested could stop HIV acquisition. The oral PrEP arms of the study will continue. 

PrEPVacc was testing two different vaccine strategies against a placebo: one regimen combining a DNA vaccine with a protein-based vaccine (AIDSVAX), and another regimen combining DNA, MVA and a protein-based vaccine (CN54gp140). 

“We always hope for a positive outcome in HIV prevention trials, and this news is disappointing,” said Mitchell Warren, AVAC executive director. “We look forward to seeing the full PrEPVacc data in 2024 and hope it will add to the body of evidence that is helping scientists understand how to develop better vaccine candidates that will one day protect against HIV.”  

“The PrEPVacc outcome underscores yet again that the science of HIV vaccine development is extremely challenging,” he added. “Now is not the time to step back from vaccine research. There are several promising strategies in early-stage research that must continue, along with research for other HIV prevention options. We will not end HIV without ensuring that everyone who is vulnerable to HIV infection has a choice of effective and desirable prevention options.”  

Importantly, PrEPVacc’s PrEP arms will continue. The study is testing two different formulations of daily oral PrEP, looking to see if a new formulation – F/TAF (also known as Descovy) – is at least as good in the trial population at protecting against HIV acquisition as F/TDF (also known as Truvada and the most widely used version of PrEP). The trial will provide the first data for F/TAF among cisgender women (who make up 87% of the just over 1,500 PrEPVacc trial participants). F/TAF is approved for use in the US and UK, but not for those individuals who have receptive vaginal sex, since previous trials regrettably did not enroll cisgender women. 

The PrEPVacc study is scheduled to conclude in 2024 and data from all arms of the study are expected to be reported in the last half of 2024. 

“The PrEP arms of PrEPVacc will provide important insights into the potential of expanding access of F/TAF for PrEP to women in East and Southern Africa who need additional options to protect themselves from HIV. Equitable access to new interventions should be a goal of every research program,” said Stacey Hannah, AVAC’s director of Research Engagement. 

“PrEPVacc is a complex, innovative trial design, and, while the vaccine result today is disappointing, the trial team has worked from the outset to implement the Good Participatory Practice (GPP) Guidelines. The team’s hard work on the front-end to apply GPP to this trial is paying off especially now in the ability to deliver complex, disappointing results to trial participants, advocates, policymakers and other key supporters of PrEPVacc and of HIV prevention broadly.” 

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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

AVAC Applauds the Selection of Dr. Jeanne Marrazzo as New Director of NIAID  

Wednesday, August 2, 2023 

AVAC enthusiastically applauds the selection of Jeanne Marrazzo, MD, to serve as the new director of the NIH’s National Institute of Allergy and infectious Disease (NIAID). Dr. Marrazzo brings unparalleled leadership and research expertise to this pivotal role at NIAID, which oversees some of the largest investments to advance research on HIV and sexually transmitted infections in the world, at such a critical moment in global health science and politics. 

“Jeanne has been a pioneer in both HIV prevention and STI research and advocacy for many years. This news of her selection as NIAID Director just does not get any better,” said Mitchell Warren, AVAC’s Executive Director. “Given her distinguished career, NIAID’s selection signals a commitment to pursuing a research agenda that is aimed squarely at defeating HIV while safeguarding principles that advance global health equity. Moreover, her appointment reflects the important intersection of science, policy, communications and advocacy that has defined her career thus far.” 

“Perhaps most importantly, her longtime championship of community engagement and person-centered research provides a fantastic foundation for this role,” said Manju Chatani-Gada, AVAC’s Director for Partnerships & Capacity Strengthening. “She has always been accessible and provided time, mentorship and support to civil society advocates in breaking down and interpreting science. Ultimately, it is not just what science gets supported at NIAID, but how the science happens and how it is communicated, and Jeanne is the right leader at the right time to build on Dr. Fauci’s legacy.” 

Dr. Marrazzo’s research included landmark investigations of pre-exposure prophylaxis (PrEP) for cisgender women as well as discovery and implementation science research focused on complex issues including hormonal contraception and HIV, antimicrobial resistance in gonorrhea, and other efforts especially as they effect women’s health and livelihoods and exacerbate the impact of infectious diseases. She provided pioneering leadership of the Microbicide Trials Network’s groundbreaking Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, one of the most complex HIV prevention studies ever designed and conducted. 

“Jeanne is a remarkable physician, researcher and advocate. We are so optimistic about her ability to connect the dots—between HIV prevention, sexual and reproductive health, and pandemic preparedness, and help solve for the threats of disparities in access, stigma, discrimination and criminalization of key populations,” Warren added.  

Dr. Marrazzo will be the first new director of NIAID in nearly 40 years and the first woman in this position. She will also be the first openly gay director of any institute at the NIH. The position was held by Dr. Anthony Fauci, whose vision, passion and commitment to ending the AIDS epidemic and advancing global health research has been an inspiration to AVAC and to so many. Dr. Marrazzo is expected to assume the post as NIAID Director later this year. 

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About AVAC: AVAC is an international non-profit organization that leverages its independent voice and 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

AVAC Condemns Uganda’s Anti-Homosexuality Act 2023

Contact

Kay Marshall, +1 (347) 249-6375, kaymarshall@mac.com

May 31, 2023 — AVAC strongly condemns Uganda’s new Anti-Homosexuality Act of 2023 that President Yoweri Museveni signed into law and stands in solidarity with the LGBTQIA+ community in Uganda.

“This newly signed legislation expands on a previous attempt to legislate hate and oppression of the LGBTQIA+ community in Uganda nearly a decade ago,” said Angelo Kaggwa-Katumba, Senior Program Manager at AVAC. “As LGBTQIA+ people and allies, AVAC and our partners have been tireless in our work to change attitudes and policy – in Uganda and around the world – because we’ve seen the direct link between criminalization and stigma and the devastating impact both have on HIV incidence. This new law is a direct violation of the health, rights and humanity of the LGBTQIA+ community, and will undermine and reverse Uganda’s progress in HIV prevention, destroying community wellbeing and taking lives along the way.”

The new law increases penalties for consensual sex among same-sex individuals, provisions that Uganda has had on the books as anti-sodomy laws from the British colonial era. It also criminalizes advocacy that supports LGBTQIA+ Ugandan rights, and could even bring death sentences, for so-called “aggravated homosexuality,” a clause that can be applied to people living with HIV, intensifying stigma and a cascade of other harms. Such provisions drive people underground, discouraging the most vulnerable populations from seeking testing, treatment and prevention, and they will setback the fight against HIV.

Advocates have pledged to challenge the constitutionality of the law before the courts, as detailed in this statement from Convening for Equality (CFE), a Ugandan LGBTQIA+ community-led Coalition working alongside a broad range of national and international partners. In addition, leaders of the Global Fund, UNAIDS and PEPFAR have also issued a Joint Statement by the Leaders of the Global Fund, UNAIDS and PEPFAR on Uganda’s Anti-Homosexuality Act 2023, stating their “deep concern about the harmful impact” of the law “on the health of its citizens and its impact on the AIDS response that has been successful up to now.”

“We must come together and make our voices resoundingly clear: we must stand as one, united in our determination to dismantle this oppressive regime of intolerance,” said Richard Lusimbo, a Co-Convener of CFE, Director General of the Uganda Key Populations Consortium (UKPC), and long-time AVAC partner. “Today, we reaffirm our unwavering commitment, declaring that we will not rest until the shackles of this dangerous law are broken. We will tirelessly strive until equality and justice prevail over discrimination and hate. Let this be the rallying cry igniting change, fueling our collective efforts to create a future where everyone is celebrated for their uniqueness and embraced unconditionally.”

Uganda’s Anti-Homosexuality Act is one of the world’s most extreme anti-gay laws, in a period when several other countries, including the US, are seeing an increasing number of anti-LGBTQIA+ laws proposed.

“This law is part of a global increase in extremism focused on moralizing behavior related to sexual and reproductive health that could set back decades of progress in building community-focused health services,” said Mitchell Warren, AVAC executive director. “The now signed anti-gay bill in Uganda is the latest in a wave of anti-LGBTQIA+ actions in several countries, from arrests in Zambia to a backlash in Kenya, to anti-trans laws in several US states and elsewhere, all of which threaten lives and livelihoods, and our ability to connect key populations with the resources they need and deserve to prevent and treat HIV and to live their fullest lives. If this were happening in any one country, it would be alarming, but the fact that it’s happening in multiple countries, in multiple parts of the world, is downright chilling.”

“Global, regional, national and local leaders must stand up and fight back against these heinous laws. If we don’t deal with the fundamental reality of stigma, discrimination and criminalization, we will never end any epidemic. We stand in solidarity with all allies and partners committed to turning the tide from hate and fear to global health equity for all,” Warren added.

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About AVAC: AVAC is an international non-profit organization that leverages its independent voice and 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

AVAC Condemns Court Decision that Tramples Human Rights, Endangers Evidence-Based Medical Care and Sets a Dangerous Precedent

Contact

Kay Marshall, +1 (347) 249-6375, kaymarshall@mac.com

New York, April 10, 2023 – As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC strongly condemns the decision by a federal judge in Texas who issued an unprecedented preliminary injunction that suspends the US Food and Drug Administration’s (FDA) approval of mifepristone, a safe and effective abortion medication approved more than 20 years ago. If this decision is allowed to stand, it will restrict access to the most widely used method of abortion and undermine the FDA’s authority on drug regulation generally.

A counter ruling issued shortly after the Texas decision by a judge in Washington state called for the FDA to maintain access to mifepristone. It is unclear how these competing rulings will play out, but it is assumed this will force the issue to the Supreme Court where it is uncertain how a conservative majority may rule.

“The Texas decision throws open the door to reversals of other drug approvals based on one individuals’ personal or political beliefs rather than science and evidence. It’s yet another blow in a campaign to roll back bodily autonomy and human rights and cannot be allowed to stand,” said Mitchell Warren, AVAC’s executive director. “In solidarity, we stand with the millions of individuals and families who will be affected by this highly political decision, and we stand with science and medical evidence, which is increasingly under attack in the US.”

More than 20 years ago, the FDA reviewed the scientific evidence and approved mifepristone for medication abortion as a safe and effective product. In the intervening time, a tremendous amount of additional evidence has been added to the safety and efficacy profile of the drug, and its effective use outside of a clinic setting.

“The FDA’s job is to evaluate reams of scientific evidence and conduct unbiased, stringent review of new drugs and devices.” said Suraj Madoori, AVAC’s director of policy advocacy. “Friday’s ruling would take decision-making out of the hands of experts and put it into the hands of misguided activist judges, endangering access to other FDA-approved medications. AVAC is especially concerned about implications for access to contraception, treatments used by transgender individuals and HIV prevention drugs.”

“The FDA is recognized as the global leader in stringent, objective review of drugs and devices. Today’s ruling not only endangers public health and access to safe, effective medication, it jeopardizes our national standing and well-earned respect for our regulatory body,” said Madoori.

AVAC calls on the Biden Administration to take immediate action to safeguard access to mifepristone and to the sanctity and credibility of the nation’s drug approval process. AVAC also calls for appellate courts and the Supreme Court to uphold the FDA’s jurisdiction over drug regulation.

“This decision cannot be allowed to stand. AVAC commits to working with our partners and allies to ensure that the right to access evidence-based medical care is not infringed and that the right to abortion, and reproductive rights overall, are protected for all,” Warren added.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate ethical development of and global access to HIV prevention options as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Press Release

PrEP Advocates Convene Virtual Town Hall Responding to Braidwood v. Becerra

Media Inquiries: Jeremiah Johnson- Jeremiah@PrEP4All.orgJ; Kyra Sanborn- ksanborn@law.harvard.edu; Kay Marshall- kaymarshall@mac.com

Thursday, April 6th, 2023, New York, NY— Hundreds of HIV prevention advocates nationwide convened on Tuesday to discuss the implications of Judge Reed O’Connor’s ruling in the Texas Braidwood v. Becerra case that could impact access to PrEP and other preventive health interventions for millions of Americans. The ruling states private insurers are no longer required to cover certain preventive care services under the Affordable Care Act, including PrEP.

Advocates called on public and private insurers to maintain coverage to prevent HIV and other conditions no matter the ultimate outcome of the case. Experts from Lambda Legal, the Center for HIV Law and Policy, and the Center for Health Law and Policy Innovation provided preliminary analyses and shared their thoughts on strategies moving forward, including steps in the appeal process. Attendees vowed to take action to raise awareness of this threat to PrEP access, connect with other affected healthcare communities, and get organized for what will likely be a prolonged process to try and undermine preventive health services.

Thirteen leading advocacy organizations sponsored the convening, including the speakers’ organizations, PrEP4All, the PrEP in Black America Coalition, AVAC, HIVMA, NASTAD, Public Citizen, My Brother’s Keeper, Inc, the International Community of Women living with HIV in North America, NMAC, and AIDS Action Baltimore.

“We need to turn the fear, anger, and sadness of this decision into informed action,” explained PrEP4All Executive Director Jeremiah Johnson. “It is heartbreaking to see basic healthcare needs in our communities being litigated once again, and even worse to see PrEP–an essential and powerful HIV prevention tool–uniquely singled out in a twisted attempt to undermine a huge array of preventive healthcare in our nation, including cancer screenings, diabetes screenings, and key medications intended to prevent complications from cardiovascular disease.”

“We are grateful to the Biden Administration for quickly appealing this irresponsible decision by Judge O’Connor,” added Leisha McKinley-Beach, Founder and CEO of the Black Public Health Academy, and co-facilitator for the event. “In case anyone needed more evidence of the clear and pressing need for a National PrEP Program, this case spotlights the extraordinary vulnerability of PrEP access for those who most need it.”

Attendees shared ideas and resources regarding short, medium, and long-term advocacy strategies. Registrations for the town hall ballooned to over 500, reflecting intense concern from HIV advocates across the nation.

“It’s important to let individuals using PrEP know there is no reason to panic at this time. As of now, coverage has not changed, and we believe it is unlikely that insurance plans will stop covering preventive health services mid-year. The Affordable Care Act has survived attacks on it before, but we also can’t take such a threat lightly. We will fight to ensure it endures for our communities,” said Jose Abrigo, HIV Project Director of Lambda Legal.

“We are angry and frustrated by this decision, but we are not powerless,” said Elizabeth Kaplan, Director of Health Care Access for the Center for Health Law and Policy Innovation. “We have an opportunity to come together with partners and stakeholders both within and beyond the HIV advocacy community to ensure life-saving preventive services including PrEP are accessible and affordable for all who need them.”

Recent analysis out of Yale and Harvard has found that for every 10% decline in PrEP coverage caused by the ruling, HIV infections will increase by over 1,140 per year among gay and bisexual men. With lifetime HIV costs estimated by CDC to be $501,000 per each new infection, such an outcome would likely contribute significantly to out-of-control healthcare expenses in the US.

“This decision is the Right’s latest move in their long-term strategy to quell our intersectional movements for justice. Enemies of trans and queer rights, access to healthcare, sexual health literacy, and reproductive justice have been playing a long game and our basic rights are constantly under attack,” said S. Mandisa Moore-O’Neal, Executive Director at the Center for HIV Law and Policy. “But we will be ready and we will not give up. As the litigation unfolds, now is the moment for us to fortify our strategies for continued access, including legislative avenues and engaging invested policymakers.”

“This ruling expands on last year’s shocking decision on PrEP and religious freedom and further undermines the right to health for an even larger group of Americans. It is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the population and will degrade the quality of life for all Americans by denying life-saving preventive care,” said Mitchell Warren, AVAC’s Executive Director.