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.

Press Release

AVAC Condemns Court Decision that Endangers Access to PrEP and Other Critical, Life-Saving Prevention Services

Contact

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

March 24, 2023 — A new ruling by a US federal judge in Texas strikes down a provision of the Affordable Care Act that required insurance coverage of many preventive services, including HIV testing and the prevention drugs use for Pre-exposure prophylaxis (PrEP), and doubles down on the judge’s previous ruling in a separate case that PrEP provision violates some individuals’ religious freedom. The current ruling will not only affect HIV prevention services, but endangers access to contraception, vaccinations, routine health screenings and a wide range of prevention services.

“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.

“At a time when science has given us the tools to advance towards the end of the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s continued biased and discriminatory decisions endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with all those whom this decision affects. We firmly believe that the ruling must be called out as a dangerous infringement of the rights of individuals to determine their own healthcare needs with their healthcare providers and that every effort must be made to ensure that it does not stand.”

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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 the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Press Release

AVAC Condemns Uganda’s Anti-Homosexuality Bill 2023

Contact

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

March 24, 2023 — This week, Ugandan Parliament took steps toward implementing an anti-gay policy change that would further criminalize and endanger the lives of LGBTQIA+ people. AVAC condemns the proposed legislation and stands in solidarity with the LGBTQIA+ community in Uganda who face threats to their lives, draconian prison terms, and even the prospect of death sentences if this legislation goes forward.

“This new legislation is a direct violation of the health, rights and humanity of the LGBTQIA+ community, and we urge President Yoweri Museveni not to sign it into law,” said Angelo Kaggwa-Katumba, Senior Program Manager at AVAC. “As LGBTQIA+ people and allies, we’ve 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 legislation duplicates and expands on a previous attempt to legislate hate and oppression of the LGBTQIA+ community in Uganda nearly a decade ago. That legislation was overturned by the Constitutional Court, and we hope to see justice upheld again.”

This “Anti-Homosexuality Bill 2023”, passed earlier this week by the Uganda Parliament, makes it a crime to even identify as lesbian, gay, bisexual, transgender and queer, and gives authorities sweeping power to crackdown on any form of LGBTQIA+ advocacy. This new bill, criminalizing same-sex relations between consenting adults, is a harsher revision to Uganda’s 2014 Homosexuality Act, which outlawed the “promotion of homosexuality,” but was struck down. Ugandan President Yoweri Museveni now has a 30-day window to either approve the bill, return it to Parliament for reevaluation, or veto it – or, by not acting, the bill will be considered approved.

“We are seeing a tsunami of discrimination and oppression of basic human rights around the world right now,” said Mitchell Warren, AVAC executive director. “The proposed 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 we don’t deal with the fundamental reality of stigma, discrimination and criminalization, we will never end the epidemic.”

In Zambia, police arrested leaders of an approved demonstration condemning violence against women in observance of International Women’s Day. Authorities claimed the protest was promoting LGBTQIA+ rights. Same-sex sexual acts have been prohibited under Zambia law since the British colonial period. In Kenya, a February decision by its Supreme Court to bar discrimination on the basis of sexual orientation when it comes to registering LGBTQIA+ organizations has been followed by intense homophobic backlash. The uproar comes as a high court decision that criminalized same sex relationships is being appealed. The US is similarly swept up in a period of terrorizing legislation dismantling the rights of gender diverse populations and threatening their well being. Overall, 2023 has seen a record number of bills in states across the US that target LGBTQIA+ people.

“We stand ready to support the LGBTQIA+ community and their allies in every way that will not only help them survive this moment, but overcome these challenges to turn the tide from hate and fear to global health equity 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 the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Press Release

HIV Vaccine Research Must Continue Following Disappointing Result from Mosaico Trial

Renewed Commitment to Expanding Access to All Existing HIV Prevention Options Must be a Global Priority

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

January 18, 2023 — Today, Janssen Pharmaceutical Companies of Johnson & Johnson and partners announced that the Mosaico study, a large-scale HIV vaccine efficacy study also known as HVTN 706/HPX3002, was stopped early for non-efficacy. The study took place in several countries in North and South America and Europe to test the safety and efficacy of the adenovirus26-based vaccine regimen among 3,900 cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals. An independent data and safety monitoring board, at a scheduled review of the trial data, found the regimen to be safe, but that it did not meet the pre-defined criteria for efficacy and recommended that the study be stopped and trial participants informed.

The Mosaico study used a similar version of the vaccine regimen in its companion study, the Imbokodo trial, which was stopped in August 2021 as it also did not significantly reduce the overall risk of HIV acquisition among over 2,600 cis-gender women in five sub-Saharan African countries.

“We always hope that efficacy trials will show positive results that lead to new prevention options,” said Mitchell Warren, Executive Director of AVAC. “It is disappointing that this particular vaccine candidate did not work, but Mosaico was an important, well-designed and well-conducted trial, especially in the midst of the COVID-19 pandemic and the roll-out of oral PrEP. The trial demonstrated that it is not only possible to design and conduct an HIV vaccine trial in the current environment, but that it is essential to do it.”

“The hard truth is the science of HIV vaccine development is extremely challenging,” Warren added, “but this is not the time to dial back support for ongoing research. Far from it – HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to provide a durable end to the pandemic. At the same time, we now have more proven HIV prevention options than ever before, but they are not reaching everyone who needs and wants them. Even as researchers continue the necessary work of accelerating HIV vaccine research, the broader HIV response must act as if we may never have a vaccine and prioritize the roll out of existing prevention options and research for additional ones. Ending this pandemic requires simultaneous action on multiple fronts of research, development and delivery.”

HIV vaccine research is complex and difficult. It is imperative that researchers work together and glean as much information as possible from the research process and from each study. Mosaico and the ongoing PrEPVacc efficacy study will both provide important information to help refine future vaccine research; various antibody studies are providing key information to inform both antibody-based prevention and vaccine development; and basic science research and early phase human studies are providing still more clues to what is needed to develop a safe and effective HIV vaccine.

“While this outcome is a disappointment, it must be seen as a result of the necessary effort to find, and keep the hope alive for, an HIV vaccine. This is, therefore, not an end, but one more addition to the knowledge it will take to find an HIV vaccine. We salute the nearly 4,000 Mosaico trial participants and the communities that were part of this important study. They join hundreds of thousands of previous HIV vaccine trial participants who have selflessly helped in this important global health endeavor,” said Ntando Yola, from the Desmond Tutu Health Foundation and Advocacy for Prevention of HIV in Africa (APHA) in South Africa. “As advocates we stand with communities across the globe who want to see an end to HIV. Working through the Coalition to Accelerate and Support Prevention Research (CASPR), we will continue to work with researchers, funders and policy makers to ensure that community voices, concerns and needs are at the forefront of ethically conducted, participatory HIV prevention research.”

“AVAC congratulates the trial teams at sites across the globe for their work on a superbly run study,” said Stacey Hannah, AVAC’s Director of Research Engagement and CASPR Project Director. “We applaud Janssen for working in collaboration with the HIV prevention community, for their leadership in HIV vaccine research and for their longstanding commitment to robust stakeholder engagement through the Good Participatory Practices (GPP) Guidelines that must be continued to maintain trust in vaccines and in research, irrespective of trial results. In fact, this commitment to GPP helps ensure all of us navigate disappointing results.”

“We’re proud to have worked with the Mosaico trial team to ensure advocate and community voices were heard in the design of the trial, especially around integrating oral PrEP into the design,” added Hannah. “While it is very disappointing that this vaccine will not move forward, this trial was a success in its innovative design and conduct, and provides important lessons for HIV prevention efficacy trials in the years to come.”

The Mosaico study evaluated whether an adenovirus26-based vaccine with a Clade C and mosaic gp140 vaccine regimen could safely and effectively reduce the rate of new HIV infections among cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States. Participants received a total of four vaccines over twelve months of either a prime-boost vaccine regimen of a mosaic viral-vectored vaccine, Adeno26.Mos4.HIV (Ad26 prime) together with an aluminum phosphate-adjuvanted Clade C and Mosaic gp140 HIV bivalent vaccine (boost) or a placebo.

“As the HIV prevention field – researchers, funders, policymakers, advocates and communities – has done for decades, we will take the lessons learned from Mosaico and move forward in the quest for an end to HIV and improved health equity in communities across the globe,” said Warren.

Press Release

HIV Vaccine Research Must Continue Following Disappointing Result from Mosaico Trial

Renewed Commitment to Expanding Access to All Existing
HIV Prevention Options Must be a Global Priority

Contact

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

January 18, 2023 — Today, Janssen Pharmaceutical Companies of Johnson & Johnson and partners announced that the Mosaico study, a large-scale HIV vaccine efficacy study also known as HVTN 706/HPX3002, was stopped early for non-efficacy. The study took place in several countries in North and South America and Europe to test the safety and efficacy of the adenovirus26-based vaccine regimen among 3,900 cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals. An independent data and safety monitoring board, at a scheduled review of the trial data, found the regimen to be safe, but that it did not meet the pre-defined criteria for efficacy and recommended that the study be stopped and trial participants informed.

The Mosaico study used a similar version of the vaccine regimen in its companion study, the Imbokodo trial, which was stopped in August 2021 as it also did not significantly reduce the overall risk of HIV acquisition among over 2,600 cis-gender women in five sub-Saharan African countries.

“We always hope that efficacy trials will show positive results that lead to new prevention options,” said Mitchell Warren, Executive Director of AVAC. “It is disappointing that this particular vaccine candidate did not work, but Mosaico was an important, well-designed and well-conducted trial, especially in the midst of the COVID-19 pandemic and the roll-out of oral PrEP. The trial demonstrated that it is not only possible to design and conduct an HIV vaccine trial in the current environment, but that it is essential to do it.”

“The hard truth is the science of HIV vaccine development is extremely challenging,” Warren added, “but this is not the time to dial back support for ongoing research. Far from it – HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to provide a durable end to the pandemic. At the same time, we now have more proven HIV prevention options than ever before, but they are not reaching everyone who needs and wants them. Even as researchers continue the necessary work of accelerating HIV vaccine research, the broader HIV response must act as if we may never have a vaccine and prioritize the roll out of existing prevention options and research for additional ones. Ending this pandemic requires simultaneous action on multiple fronts of research, development and delivery.”

HIV vaccine research is complex and difficult. It is imperative that researchers work together and glean as much information as possible from the research process and from each study. Mosaico and the ongoing PrEPVacc efficacy study will both provide important information to help refine future vaccine research; various antibody studies are providing key information to inform both antibody-based prevention and vaccine development; and basic science research and early phase human studies are providing still more clues to what is needed to develop a safe and effective HIV vaccine.

“While this outcome is a disappointment, it must be seen as a result of the necessary effort to find, and keep the hope alive for, an HIV vaccine. This is, therefore, not an end, but one more addition to the knowledge it will take to find an HIV vaccine. We salute the nearly 4,000 Mosaico trial participants and the communities that were part of this important study. They join hundreds of thousands of previous HIV vaccine trial participants who have selflessly helped in this important global health endeavor,” said Ntando Yola, from the Desmond Tutu Health Foundation and Advocacy for Prevention of HIV in Africa (APHA) in South Africa. “As advocates we stand with communities across the globe who want to see an end to HIV. Working through the Coalition to Accelerate and Support Prevention Research (CASPR), we will continue to work with researchers, funders and policy makers to ensure that community voices, concerns and needs are at the forefront of ethically conducted, participatory HIV prevention research.”

“AVAC congratulates the trial teams at sites across the globe for their work on a superbly run study,” said Stacey Hannah, AVAC’s Director of Research Engagement and CASPR Project Director. “We applaud Janssen for working in collaboration with the HIV prevention community, for their leadership in HIV vaccine research and for their longstanding commitment to robust stakeholder engagement through the Good Participatory Practices (GPP) Guidelines that must be continued to maintain trust in vaccines and in research, irrespective of trial results. In fact, this commitment to GPP helps ensure all of us navigate disappointing results.”

“We’re proud to have worked with the Mosaico trial team to ensure advocate and community voices were heard in the design of the trial, especially around integrating oral PrEP into the design,” added Hannah. “While it is very disappointing that this vaccine will not move forward, this trial was a success in its innovative design and conduct, and provides important lessons for HIV prevention efficacy trials in the years to come.”

The Mosaico study evaluated whether an adenovirus26-based vaccine with a Clade C and mosaic gp140 vaccine regimen could safely and effectively reduce the rate of new HIV infections among cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United States. Participants received a total of four vaccines over twelve months of either a prime-boost vaccine regimen of a mosaic viral-vectored vaccine, Adeno26.Mos4.HIV (Ad26 prime) together with an aluminum phosphate-adjuvanted Clade C and Mosaic gp140 HIV bivalent vaccine (boost) or a placebo.

“As the HIV prevention field – researchers, funders, policymakers, advocates and communities – has done for decades, we will take the lessons learned from Mosaico and move forward in the quest for an end to HIV and improved health equity in communities across the globe,” said Warren.

###

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 the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Press Release

Thousands Sign Letter Calling for National PrEP Program

Movement for Equitable PrEP Access Gains Momentum Ahead of World AIDS Day

Contact

Jeremiah Johnson, Jeremiah@PrEP4All.org
Rachel Klein, rklein@taimail.org

November 29, 2022. Washington, DC—Over 6000 individuals and 300 organizations representing all fifty states, Washington DC, Puerto Rico, and the US Virgin Islands have signed on to a letter calling for the establishment of a national PrEP program. The letter builds on months of advocacy from a large national coalition of HIV/AIDS advocacy organizations calling for federal fiscal year (FY) 2023 funding for a PrEP program that will increase access to medications, labs, and direct services for uninsured and underinsured individuals; expand a provider network including nonclinical sites and telePrEP; and create demand through both national and local campaigns.

“Nearly 400,000 new HIV transmissions have occurred in the United States since PrEP was first approved by the Food and Drug Administration (FDA) on July 16th, 2012.” states the letter. “Over those ten years, Black, Latinx, and queer communities have continued to bear the brunt of this devastating epidemic. It is critical that the nation address this long-standing crisis by creating a national PrEP program to expand access to PrEP so that it reaches every person in need.”

The letter–promoted by PrEP4All, AVAC, The AIDS Institute, NMAC, the National Coalition of STD Directors, NASTAD, and AIDS United—notes that of the 1.2 million Americans estimated by the CDC to be most in need of PrEP only 9 percent of Black individuals and 16 percent of Latinx people had PrEP prescriptions in 2020 compared to 66 percent of White individuals.

“This persistent, never-ending crisis has come at great financial cost to our healthcare system. A national PrEP program would avert many of these costs while improving the lives and health of thousands of people nationwide,” the letter continues.

The letter is being delivered to the White House and Congressional leadership as Congress moves to finalize appropriations for FY23, providing a key opportunity for appropriators to invest critical funding toward a national PrEP program. A downpayment on a national PrEP program in FY23 is a necessary first step to promote equitable access to this proven HIV intervention that prevents new HIV infections that are costly to both personal health and healthcare systems.

We call on Congress and the Administration to fund a national PrEP program now so that we can advance this critical intervention and realize the bipartisan goal of ending HIV as an epidemic in the US. A decade has been too long to wait. We need a #NatlPrEPProgramNow.

logos of sign on organizations

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Press Release

AVAC Condemns Court Decision that Tramples Human Rights, Reinforces Homophobia and Denies Life-Saving PrEP Drugs to Individuals in Texas

As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC condemns the decision by a federal judge in Texas who ruled in favor of a historically homophobic, misogynistic, and discriminatory plaintiff. A conservative activist sued on behalf of a Texas company claiming that adhering to a provision of the Affordable Care Act requiring employers to provide coverage for HIV pre-exposure prophylaxis (PrEP) drugs violates their religious rights.

“This shocking ruling defies evidence, logic, public health and human rights and sets back enormous progress made in the fight to end the HIV epidemic in the US and globally,” said Mitchell Warren, AVAC’s executive director. “It is a blatantly homophobic and misogynistic ruling that will endanger the lives of many gay men and others who rely on PrEP to protect themselves from HIV.”

“This ruling is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the American people. The Supreme Court overturning of Roe v. Wade earlier this year was a wake-up call that individual rights are under attack by the far right,” Warren added. “This decision likely won’t be the last we see in a campaign to impose some individuals’ religious beliefs on the broader population. Access to contraception, vaccinations, routine health screenings, prevention services and patient privacy are all under attack.”

While this latest decision is for now limited to the Northern District of Texas, it has ramifications for the rest of the country and for global programs to provide PrEP to people of all genders and sexual orientations who need and want to use it. These kinds of decisions often test the ground for cases that go to the Supreme Court, where the current makeup of the court means such a decision may be upheld and even expanded upon nationally.

“Deciding to use PrEP is a decision between an individual and their healthcare provider, no one else. Another person’s religious beliefs have no place in determining the right to use a safe, highly effective, FDA-approved, life-saving drug,” said Suraj Madoori, AVAC’s director of policy and advocacy.

“Daily oral PrEP was approved by the US FDA a decade ago and still has not reached nearly all of those who would benefit from its use. This decision throws up another substantial barrier between a life-saving intervention and individuals and communities most vulnerable to HIV, further capping the untapped potential of an important prevention option,” Madoori added.

This decision creates enormous, unnecessary barriers for LGBTQ+ people in Texas, as well as heterosexual women who are HIV-vulnerable, from the healthcare they need and is yet another example of oppressive or criminalizing policies in countries around the world that set barriers to health and human rights. We know these barriers drive poverty, epidemics and disenfranchisement from civil society. Policies like this don’t advance anyone’s freedom to live full, healthy lives; rather they undermine community resilience, individual autonomy and public health.

“At a time when science has given us the tools to advance towards the end the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s biased and discriminatory decision could endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with those whom this decision affects. We firmly believe that the ruling must be called out as homophobic and dangerous and that every effort must be made to ensure that it does not stand.”

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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 the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Press Release

AVAC, BMGF, CIFF, MedAccess, Unitaid and ViiV Healthcare announce collaboration to catalyse more affordable access to long- acting injectable cabotegravir for HIV prevention

logos of partners in the Coalition

Montreal, 28 July 2022 – At the 24th International AIDS Conference, AVAC, the Bill & Melinda Gates Foundation (BMGF), the Children’s Investment Fund Foundation (CIFF), MedAccess, Unitaid, and ViiV Healthcare announced a strategic collaboration to speed equitable access to injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). This collaboration demonstrates the commitment of global health partners and ViiV to work together to accelerate access to a new HIV prevention option as part of a comprehensive response to reduce the number of new HIV infections and advance efforts to end the HIV epidemic by 2030.

Cabotegravir long-acting (LA) is an injectable form of PrEP that is given every two months by trained healthcare workers. Cabotegravir LA for PrEP, which was approved by the U.S. Food and Drug Administration (FDA) in December 2021, is the first and only long-acting injectable PrEP option available.

Global health partners and ViiV are committed to making cabotegravir LA for PrEP more accessible in resource-limited settings in the near term, while working in parallel to accelerate market entry of quality-assured generic products. This two-pronged strategy is fundamental to meeting current demand for the product and establishing a sustainable longer-term market.

In order to increase access to cabotegravir LA in the near term, ViiV, AVAC, BMGF, CIFF, MedAccess, and Unitaid will:

  • Hold discussions on pricing, with the aim of identifying a pathway for cabotegravir LA for PrEP to be offered to public sector purchasers at a more affordable price
  • Examine the potential role of innovative financing mechanisms to deliver on this goal
  • Include civil society in planning and decision-making to accelerate equitable access
  • Share responses to frequently asked questions on procurement channels and requirements
  • Track and share regulatory submissions and approvals across priority countries

“Stagnating rates of new HIV infections underline the importance of getting effective prevention tools to the people who need them as quickly as possible,” said Michael Anderson, CEO of MedAccess. “By combining expertise in science, innovative finance and global health, this collaboration has the potential to catalyse access to cabotegravir LA at a sustainable price. MedAccess will work urgently with all partners to find solutions that unlock access for thousands of people as quickly as possible.”

Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for key populations such as women and girls, who account for a disproportionate number of new HIV infections. Every week, 5,000 adolescent girls and women (15-24 years) contract HIV globally. For key populations, who have a 13-30 times higher risk of acquiring HIV infection as compared to the rest of the population, a long-acting prevention method could help overcome pill fatigue, stigma, and adherence issues.

“Cabotegravir for PrEP has the potential to transform HIV prevention efforts by offering people an additional option for HIV prevention, but only if we can make it available with urgency, with equity and at scale. While no one method will work for all people – or for any one person all of the time – this new approach significantly reduces frequency of dosing and may be easier for some people versus taking a pill a day,” said Mitchell Warren, Executive Director of AVAC.

Deborah Waterhouse, CEO of ViiV Healthcare said: “We are pleased to join this ambitious new collaboration as an active partner, working to find solutions to enable at-scale access to innovative HIV prevention options as quickly as possible. Together with our new voluntary license agreement with the Medicines Patent Pool, we are making significant progress towards our common goal of expanding access to cabotegravir LA for PrEP, which we believe has the potential to be a game changer in HIV prevention and to play an important role in ending the HIV epidemic.”

In response to civil society’s calls to make cabotegravir LA equitably available as soon as possible, global health partners and ViiV Healthcare are stepping up their collaboration to accelerate product access. HIV community groups, advocates and ministries of health are eager to add cabotegravir LA for PrEP to the HIV prevention toolkit, as choice is critical to meeting the needs of those most at risk of acquiring HIV.

“We are thrilled to join this important collaboration, which can help ensure that this transformative prevention tool is made available to those most in need as quickly as possible,” said Nina Russell, Director, TB and HIV Prevention at the Bill & Melinda Gates Foundation. “It takes all of us – companies, foundations, governments, civil society and those affected by HIV – working together to overcome the market failures that keep people in resource-limited settings from benefitting from innovation.”

These efforts build on the recent announcement that ViiV and the Medicines Patent Pool (MPP), which was founded by Unitaid, have agreed a voluntary license for cabotegravir LA. This will enable generic cabotegravir LA for PrEP to come to market in the coming years and should significantly expand the reach of this important prevention tool in low- and lower middle-income, least developed, and sub-Saharan African countries.

The collaboration announced today and the voluntary license agreement between ViiV and MPP, are part of a broader package of interventions being discussed by a coalition of partners to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. The coalition, currently being formalized, will comprise a wide range of partners including funders, communities, civil society organizations, ministries of health, and United Nations agencies, and will be co-convened by Unitaid, the World Health Organization (WHO), the Global Fund and UNAIDS. These partners will jointly identify barriers to access for cabotegravir LA and develop a roadmap to overcome them.

“Oral PrEP took over a decade to be accessible in low- and middle-income countries. This strategic partnership and the broader coalition being formed will ensure that we leverage lessons learned from past experiences to make this promising long-acting solution for PrEP quickly available at an affordable price for everyone who could benefit from it,” said Dr Philippe Duneton, Executive Director of Unitaid.

ViiV Healthcare is also donating product to support initial implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes in access markets. The partners in this collaboration will ensure these projects are coordinating to address critical questions across the widest possible range of populations and geographies.

“People need more ways to protect themselves from HIV that fit with their lifestyles and environments,” said Miles Kemplay, Executive Director of Sexual and Reproductive Health and Rights at CIFF. “Cabotegravir promises to be one of those choices – but only if it is available at a cost that health systems can afford. We are looking forward to working with ViiV to figure out how to make cabotegravir accessible to those who need it today.”

About the Partners

AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development of and global access to effective 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.

The Bill & Melinda Gates Foundation (BMGF): Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of co-chairs Bill Gates and Melinda French Gates and the board of trustees.

The Children’s Investment Fund Foundation (CIFF) is an independent philanthropic organisation, with offices in Addis Ababa, Beijing, London, Nairobi and New Delhi. Established in 2002, CIFF works with a wide range of partners seeking to transform the lives of children and adolescents in developing countries. Areas of work include adolescent sexual health, maternal and child health, opportunities for girls and young women, tackling child slavery and exploitation, and supporting smart ways to slow down and stop climate change.

MedAccess is a UK-based social finance company with a mission to make global healthcare markets work for everyone. Its core purpose is to make medical supplies more widely available at lower prices in under-served markets. By applying the rigour and skills of business finance, it provides a novel solution to the challenge. MedAccess offers financial guarantees and debt products that reduce commercial risk and allow medical manufacturers to accelerate supplies into new markets at affordable and sustainable prices. In this way, vaccines, medicines, diagnostic tests and medical devices can reach patients far sooner than existing market forces would allow.

Unitaid is a global health organization engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as shareholders in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.