Press Release

Statement in Response to the US Supreme Court Opinion in Dobbs v. Jackson Women’s Health Organization

Contact

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

Today, AVAC executive director Mitchell Warren issued the following statement in response to the US Supreme Court opinion in Dobbs v. Jackson Women’s Health Organization:

“As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC stands today and always for reproductive justice. We condemn the 6-3 decision by the US Supreme Court, which rolls back decades of protections for those seeking safe abortion services in the US and undermines other landmark rulings that safeguard fundamental human rights, privacy and personal liberty.

The court’s ruling harms public health, full stop. We know that access to sexual and reproductive health care, privacy, and bodily autonomy underpin not only abortion rights, but also our ability to combat HIV and end this epidemic. We are HIV and global health advocates and activists, and our work is fundamentally about intersectional social justice and human rights. We stand in solidarity with the reproductive justice organizations and leaders who are at the forefront of the fight for reproductive rights and with everyone whose lives will be fundamentally altered by this decision.

This is a sad and scary day, but it is not the end. We commit to working with our partners and allies to ensure that the right to abortion, and reproductive rights overall, are protected for all.”

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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

New AVAC Plan Lays Out Priorities for Swift and Equitable Rollout of Injectable Cabotegravir for PrEP

Contact

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

June 9, 2022 — As the HIV prevention field is poised to introduce two promising new options: the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB), AVAC lays out a Plan for Accelerating Access and Introduction of Injectable CAB for PrEP. The plan identifies immediate priorities to support the swift rollout of CAB for PrEP and calls on stakeholders to ensure that it’s delivered to programs at scale at the lowest price possible.

In December 2021, the US FDA approved CAB as PrEP, making it the first injectable PrEP option to be added to a growing range of proven prevention methods. Eight additional applications have been filed for regulatory approval in priority countries with decisions expected later this year. In addition, WHO guidelines for injectable PrEP are expected later this year.

“COVID-19 has shown us that the field can compress timelines and new technologies can be developed, tested and distributed quickly and with urgency, at least for wealthier nations,” said Mitchell Warren, AVAC Executive Director. “The challenge now is to learn these lessons from COVID-19. Can the world respond just as urgently for HIV prevention? Can we speed up the process, with delivery happening in parallel to further research that may be needed? Can access be scaled and programs designed so that injectable PrEP truly impacts the HIV epidemic and is delivered with equity, reaching those who need it most? The answer to all these questions must be yes. But will take all of us, doing our part.”

AVAC’s plan comes on the heels of months-long discussions between advocates and other stakeholders who participated in a series of meetings with ViiV Healthcare, the maker of injectable CAB for PrEP, and in the World Health Organization (WHO) Guidelines Review Group. These discussions prioritized the imperative to make good on the promise of injectable cabotegravir to advance HIV prevention and global health—a number of important statements from advocates emerged from these discussions. In response, ViiV announced last month that it is “actively negotiating voluntary licensing terms” of CAB for PrEP to the Medicines Patent Pool (MPP) and is “committed to supplying” CAB for PrEP at a non-profit price for public programs in low-income and all sub-Saharan African countries until a generic is available.

“This is an example of advocacy at its best, but while this commitment is hugely important, advocates have much more work ahead to ensure that all stakeholders do their part to support swift and equitable access to injectable CAB for PrEP,” Warren added.

AVAC’s plan provides a comprehensive view of all the moving parts involved in delivering CAB for PrEP and identifies priorities for ensuring time is not wasted and opportunity is not squandered in making CAB for PrEP available to all who need and want it. The plan focuses on learning the lessons from the first ten years of delivering oral PrEP and how to move faster, more strategically, and with greater coordination to maximize the impact of injectable CAB for PrEP.

“Injectable CAB for PrEP gives us an important opportunity to advance HIV prevention for populations most at risk. We are committed to ensuring we get rollout right so that a broad range of options are available to people who want and need them, especially young women,” wrote a group of Southern African Women Advocates in a March 2022 statement. “We… will work with all stakeholders, including ViiV, to make a real impact in HIV prevention.”

Members of this group along with colleagues in East Africa, with support from AVAC, Advocacy for Prevention of HIV and AIDS (APHA) and International Community of Women living with HIV Eastern Africa (ICWEA,) have formed the African Women Community Prevention Accountability Board to serve as an ongoing, independent mechanism for stakeholder engagement to provide input into CAB for PrEP planning and implementation among cisgender women in Africa.

Oral PrEP was first shown to be safe and effective in 2010 and first approved in 2012, but the field moved too slowly—and now 10 years since first approved, fewer than 2 million people have used this option, while an estimated 120 million could benefit from it.

AVAC’s plan calls on ViiV, policy makers, normative agencies, donors, program implementers, researchers, civil society, advocates and communities to act on a range of key activities, which include:

  • A transparent commitment from ViiV, and a negotiated guarantee from donors, on a cost-effective and affordable price and volume for CAB for PrEP to support early launch, introduction and rollout.
  • Inclusion of injectable CAB for PrEP in WHO guidelines, which are expected ahead of AIDS 2022.
  • National Programs in priority countries complete CAB for PrEP registration or secure relevant waivers.
  • Voluntary licensing from ViiV to select generic manufacturer(s), including technology transfer as required.
  • Donor investments in generic manufacturing capacity.
  • National Programs in priority countries complete CAB for PrEP registration or secure relevant waivers.
  • Market assessments and demand forecasts are updated with data from initial projects, to inform programming,manufacturing and cost.
  • Operational research and implementation science studies identify successful, scalable delivery channels; a testing algorithm that balances resistance risk with the needs of users and providers; ongoing engagement with communities and civil society; and an independent coordination mechanism.

The plan also lays out advocacy priorities and calls on advocates to hold decision-makers on CAB for PrEP—and on prevention generally—accountable. Is there clarity about next steps? Are there targets and milestones in place? Is there adequate funding to support rollout? How might decisions be made about who would get the product first, if it’s licensed and introduced through phased rollout?

“We welcome the recent announcement by ViiV to start negotiations with the MPP to potentially open the door for generic injectable CAB- LA. While it’s notable progress, this is NOT a license agreement,” said Kenly Sikwese, Executive Director at the Afrocab Treatment Access Partnership and a member of AVAC’s board of directors. “New HIV prevention options, in particular injectable cabotegravir for PrEP, hold the promise to transform HIV prevention in our communities. For years, communities have advocated for diverse HIV prevention options that respond to the needs, lifestyles, and unique experiences of our community members at greatest risk for HIV infection. Affordable, widespread access to injectable CAB can represent a step change for HIV prevention, if we can collectively move faster and more strategically.”

In the days to come, advocates will continue to engage with ViiV, WHO, donors and other decision-making bodies focused on the future of CAB for PrEP. AVAC will be tracking the progress, investing support, and putting a spotlight on the key priorities as information becomes available.

AVAC has worked on PrEP advocacy and introduction since the design of the earliest studies on the efficacy of oral PrEP beginning in 2004. In 2007, AVAC partnered with UNAIDS to develop the Good Participatory Practice Guidelines, offering a roadmap and principles to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. Nearly 15 years later, with growing advocacy calling for greater political and financial support to introduce and rollout the dapivirine vaginal ring, or PrEP ring, along with injectable CAB for PrEP, many of the initial principles of GPP—transparency, accountability, community stakeholder autonomy, and mutual understanding—continue to be more important than ever.

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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 Applauds Confirmation of Dr. John Nkengasong as US Global AIDS Coordinator

Contact

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

New York City, May 5, 2022 – AVAC applauds the US Senate in officially confirming Dr. John Nkengasong as the new US Global AIDS Coordinator leading the President’s Emergency Plan for AIDS Relief (PEPFAR), the largest funder of HIV/AIDS programming in the world. President Biden nominated and the Senate voted to confirm Nkengasong.

“This confirmation is long overdue. COVID-19 has had a devastating impact on the HIV pandemic,” said Mitchell Warren, executive director of AVAC. “We are very hopeful that with John’s leadership, vision and experience, we can maintain the urgency and impact in ending the AIDS pandemic, continue responding to COVID, and build the sustainable health infrastructure that we so desperately need.”

With consistent bipartisan support and a dynamic, data-driven approach, PEPFAR has transformed foreign aid programs, strengthened global health security, and saved more than 20 million lives since it was created by President George W. Bush in 2003. Its impact is so great, and leadership so important to US efforts to advance global health and security, that its program director holds the title of ambassador—unique among US global health employees, and its activities are coordinated by the US Department of State.

“It’s a real win for the global AIDS response that the US government chose someone to lead PEPFAR who is from the region where much of its work actually is. It shows a commitment to truly listening to and learning from the people PEPFAR is meant to serve,” said Warren.

Nkengasong is the first person of African origin nominated and confirmed for this position. He directs the Africa Centers for Disease Control and Prevention (CDC), part of the African Union and before that, served as the chief of the international laboratory branch in HIV/AIDS and TB at the US CDC, and as acting deputy director at its Center for Global Health.

“John is exceptionally well qualified to confront the enormous challenges ahead, including increasing PEPFAR’s impact in the face of COVID-19 and building a foundation for pandemic preparedness and global health equity,” Warren added. “He is a highly accomplished scientist and administrator, known and respected in both the global North and South, with a strong commitment to global health equity. AVAC fully supports John’s leadership in this critical post and looks forward to working with him toward our shared goals of ending the AIDS epidemic and ensuring global health equity.”

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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 Applauds South Africa Approval of Dapivirine Vaginal Ring as HIV Prevention Option for Women

Contact

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

New York City, March 11, 2022 – AVAC enthusiastically welcomes the South African Health Products Regulatory Authority’s (SAHPRA) approval of the monthly Dapivirine Vaginal Ring for use by women ages 18 and older to reduce their HIV risk. The Dapivirine Vaginal Ring is a much-needed addition to a proven HIV prevention method mix that also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and injectable cabotegravir (CAB) in some countries. South Africa joins Zimbabwe as the first countries to approve the ring, which is also under review in several other Eastern and Southern African countries, and is recommended by the World Health Organization as an additional prevention option.

“This is a critical step forward in providing a new prevention option that many South African women need and can use,” said Mitchell Warren, AVAC executive director. “It will be important for South Africa to ensure that the Ring is integrated into HIV prevention guidelines and made available to women as quickly as possible. Regulatory approval of the Ring must be accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the women most in need of HIV prevention.”

“We know that the most effective intervention is the one someone picks for themselves among an array of effective choices,” said Nandi Luthuli, AVAC’s Regional Stakeholder Engagement Manager, based in South Africa. “It’s very exciting that South African women will soon have a broader choice in HIV prevention options. More choices can mean more HIV infections averted, which will help South Africa control the HIV epidemic.”

“The SAHPRA approval is a critical step in translating scientific research into public health impact,” said Manju Chatani-Gada, AVAC’s Director of Partnerships and Capacity Strengthening. “We hope that other countries currently reviewing the Ring will follow the examples of South Africa and Zimbabwe and take the necessary steps to provide this important HIV prevention option to women. At the same time, we hope countries reviewing injectable cabotegravir as a new prevention option will move quickly to add yet another proven effective and much needed HIV prevention option to the toolbox.”

“We thank the thousands of women who participated in the trials that provided the evidence that the Ring works as well as dozens of advocates and community members in South Africa and across the globe who have tirelessly advocated for this important new prevention option for women,” Chatani-Gada added.

Developed by the International Partnership for Microbicides (IPM), the monthly Dapivirine Vaginal Ring is a longer-acting HIV prevention product that women can control and use discreetly to reduce the risk of HIV transmission during vaginal sex. Women insert the product themselves and replace it every month. Made of flexible silicone, the ring slowly releases the antiretroviral (ARV) drug dapivirine directly in the vagina at the site of potential infection, with minimal exposure elsewhere in the body. The Ring was proven effective in two Phase III studies, received a positive opinion from the European Medicines Agency (EMA) and is recommended by the World Health Organization (WHO) as a prevention option for women.

Recent data from the REACH Study showed that nearly all of the adolescent girls and young women aged 16-21 in the study accepted the Ring and daily oral PrEP as prevention options and that when young women had access to and experience with two biomedical prevention options, almost all of them chose to continue using one of them – and most of them actually chose to use the dapivirine vaginal ring.

“SAHPRA’s approval for women over 18 is great news, but we hope that soon the ring can also be made available to adolescent girls as young as 16,” said Maureen Luba, AVAC’s Senior Policy and Advocacy Manager and a member of the IPM Board of Directors. “We know that in South Africa and other Eastern and Southern African countries the HIV infection rates among girls and young women are very high in many communities. The Ring could also be an important option to help empower adolescent girls to protect themselves.”

AVAC looks forward to working closely with civil society partners, the South African National Department of Health, IPM, the USAID-funded MOSAIC and CASPR Projects, and many other partners to ensure this regulatory milestone can be rapidly translated into public health impact.

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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 Applauds US FDA Approval of the First injectable Form of HIV Pre-exposure Prophylaxis

The First in a Series of Necessary Steps to Translate Exciting Science into Impact

Contact

Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, December 20, 2021 – AVAC welcomes the US Food and Drug Administration (FDA) approval of injectable cabotegravir (CAB-LA, and brand name “Apretude”), the first injectable form of HIV pre-exposure prophylaxis (PrEP). As another form of HIV PrEP that does not require taking a daily pill, CAB-LA is a much-needed addition to a proven HIV prevention toolbox that now also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.

“The approval of CAB-LA is a welcome and much-needed boost for HIV prevention,” said Mitchell Warren, executive director of AVAC. “With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention most.”

CAB-LA is an injectable antiretroviral given to adults and adolescents who are confirmed to be HIV-negative at two-month intervals to reduce the risk of HIV. While today’s FDA action approves CAB-LA for use in the United States only, AVAC and its partners will be working in the months ahead to support the review of CAB-LA by regulatory authorities in other parts of the world where new HIV prevention options are sorely needed. AVAC is heartened that ViiV Healthcare, the developer of CAB-LA, has submitted applications to multiple regulatory authorities, including Brazil and several in sub-Saharan Africa that hosted the pivotal clinical trials led by the NIH-funded HIV Prevention Trials Network (HPTN).

“The experiences of oral PrEP for HIV prevention and from COVID vaccines are stark reminders that the US FDA approval is just one small, albeit important, step in translating exciting science into public health impact,” said Warren. “Without global regulatory approvals, clear guidance from WHO, a commitment to equitable access and fair pricing, and resources to deliver innovation, the best science does not prevent or end pandemics.”

The US approval of CAB-LA is an important and welcome milestone in HIV prevention, however, it is just the first in a series of steps needed to ensure that injectable PrEP can help reduce the 1.5 million new HIV infections that occurred in 2020. Supporting access to injectable PrEP, oral PrEP and the full range of proven prevention options requires programs that are strategically designed, user-centered, appropriately resourced, and promoted and designed to reach those who need prevention most, as outlined in the work of the Biomedical Prevention Implementation Collaborative (BioPIC). Lessons learned from nearly ten years of experience in supporting access to oral PrEP will be particularly important in shaping broad and effective access to injectable PrEP, alongside oral PrEP and the vaginal ring, and are detailed at prepwatch.org.

Effective global use of CAB-LA for HIV prevention will also require a significant and long-overdue upgrading of global HIV testing capacity, as injectable PrEP can only be used safely if the recipient is HIV-negative and is tested before every dose. It will also require advocacy around self-testing and lower age of consent to testing policies, which has been significantly correlated with oral PrEP initiations.

“Transparency and fairness in pricing, advocacy for accelerate global regulatory review and appropriate and feasible testing policies, and supporting access programs and health system upgrades needed to support effective global access to injectable cabotegravir must all be part of the global HIV prevention agenda moving forward,” noted Warren. “Today’s approval announcement is warmly welcomed, but is also just the start of efforts to make long-acting injectable PrEP an accessible choice for all in need.”

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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 Prevention R&D Funding Drops Again, Even as Major Scientific Advances Require Support

A Worrying Trend Toward Overreliance on a Few Funders Increased in 2020

Contact

Kay Marshall, +1 (347) 249-6375, kay@avac.org

December 8, 2021 – The annual HIV Prevention Research and Development Investments Report reveals a growing mismatch between the current promise of HIV prevention R&D, and consistent declines in the funding available to both research new HIV prevention approaches and expand access to the prevention tools available today. The 2020 report, based on outreach to 215 funders of HIV prevention R&D in the public, philanthropic and commercial sectors, is the 16th annual report from the Resource Tracking for HIV Prevention Research & Development Working Group.

According to this year’s report, funding for HIV prevention R&D dropped by US$54 million (4.4 percent) in 2020. This second consecutive annual decrease is part of an eight-year trend of flat or declining funding for HIV prevention R&D. The report also finds that financial support for HIV prevention R&D is almost entirely dependent on public sector funders, notably from the United States, and on one key United States-based philanthropic funder, the Bill & Melinda Gates Foundation. Commercial sector funding, already extremely low, dropped again in this year’s survey.

“These concerning trends in funding come at a promising but very demanding moment in efforts to control the pandemic,” said Mitchell Warren, executive director of AVAC, which coordinates the Resource Working Group with the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). “Funding is declining just as the field confronts a new generation of opportunities and challenges. These include the introduction of injectable cabotegravir for PrEP and the Dapivirine Vaginal Ring, ambitious new global targets for ending the epidemic, initial proof of concept of antibody-based prevention, and the need to rethink HIV vaccine development in light of setbacks in recent trials and the possible promise of mRNA and other vaccine approaches.”

Among the key findings from the annual HIV Prevention Research and Development Investments Report are the following:

HIV prevention R&D is highly overdependent on a few key funders, and much of the world is not contributing at the levels seen in prior years.

  • HIV prevention R&D funding relies almost exclusively on the public sector, particularly the US public sector. The trend toward an overdependence on a small number of large investors, which the Working Group has surfaced and cautioned against in the past, intensified further in 2020.
    • Globally, the public sector accounts for 86 percent of prevention R&D funding, with 92 percent of that coming from the US public sector.
    • European public sector investments represent only 7 percent of the global total. While European public sector investment increased by 57 percent in 2020, it is still barely half of the US$124 million the European public sector contributed in 2009.
    • The entire rest of the world accounted for only US$14 million, or just 1 percent of total public sector funding.
  • Philanthropic funding, consisting almost exclusively of funding from the Bill & Melinda Gates Foundation, declined 20 percent in 2020 to US$127 million or 12 percent of the total global investment.
  • Reported commercial sector support for HIV prevention R&D, already the lowest segment of investment, fell by 55 percent to US$31 million, or just 3 percent of the total, in 2020. While total commercial investment may be underreported, it is still the smallest piece of the HIV prevention R&D funding pie.

Funding dropped in 2020 across a number of key HIV prevention R&D segments, including:

Preventive vaccine R&D: With two large-scale HIV vaccine trials underway, and dozens of new approaches under investigation, funding for preventive HIV vaccine R&D decreased by 5.5 percent or US$46 million in 2020 to US$802 million. While different European countries have increased or decreased their investments, overall European public sector investment in HIV vaccine R&D decreased 31 percent in 2020, to US$48 million.

R&D for PrEP, including pills, implants and injections: While uptake of oral PrEP grew substantially in 2020, and multiple recent research studies have demonstrated the potential impact of PrEP in the form of long-acting injections, pills, implants and rings, global investment in PrEP R&D declined 2 percent in 2020 to US$107 million. While US public sector donors increased funding for PrEP R&D by 5 percent, and commercial sector investment increased by 21 percent to US$24 million, neither was enough to overcome a 42 percent decline in funding from the philanthropic sector.

Voluntary Medical Male Circumcision (VMMC): As a number of studies affirmed the efficacy of VMMC over a decade ago, funding in the field is focused on implementation science, behavioral studies and advocacy and policy, each of which is vital to extending the reach and impact of this highly effective prevention tool. Yet investment in VMMC decreased by 37 percent to just US$6 million in 2020, almost all of which came from a single donor, the Bill & Melinda Gates Foundation.

Preventing vertical transmission: Prevention of mother-to-child transmission of HIV (PMTCT) remains a key prevention priority, but funding for PMTCT R&D decreased by 29 percent in 2020, from US$35 million to US$25 million. The decline is attributed to the loss of the Bill & Melinda Gates Foundation from the list of PMTCT R&D funders, and to decreases in funding from public donors. US public sector funding for PMTCT R&D fell 22 percent to US$22 million in 2020. European funding also fell more than 60 percent, from US$3.4 million in 2019 to US$1.3 million in 2020.

Only two areas of prevention R&D funding showed small increases in funding, including:

Treatment as Prevention (TasP): Long neglected in HIV prevention investment, funding for TasP R&D increased from $1.7million to US$9 million in 2020. The increase came from philanthropy, notably the Bill & Melinda Gates Foundation (US$5 million) and the Wellcome Trust (US$1 million).

While TasP R&D funding is small overall, this increase is a hopeful sign that TasP may once again receive its appropriate focus as priority for HIV prevention research.

Microbicides: After multiple years of decline, investment in microbicide R&D registered a very small increase (0.4 percent or US$ 0.6 million) to US$145 million in 2020. Concerningly, there is even less diversity in microbicide funding than in HIV prevention R&D overall, with the public sector providing 99 percent of microbicide R&D resources.

While this tiny increase is a hopeful sign, it does not match the scope of the promise of this approach. One key product, the Dapivirine Vaginal Ring, is now recommended by the WHO as an additional HIV prevention option. In addition, a range of promising microbicide strategies are under investigation. One, a 90-day dual-purpose vaginal ring designed to confer both contraceptive and HIV protection, was found to be effective in early testing.

Pandemic preparedness requires greater investment in HIV, other current health crises

“The response to the COVID-19 pandemic has demonstrated that when there’s political will, global solidarity, and significant financial investments, rapid developments of new prevention technologies such as vaccines happen,” said Shannon Hader, deputy executive director of programme, UNAIDS. “This is the time to mobilize investments in HIV service delivery/prevention research and galvanize momentum to achieve the broader 2025 AIDS targets.”

Methodology: HIV prevention R&D investment figures are collected annually by the Resource Tracking for HIV Prevention R&D Working Group through an email survey. For the present report, the Working Group reached out from February to June 2020 to 215 funders in the public, philanthropic and commercial sectors. Two different types of resource flows were tracked: investments, defined as annual disbursements by funders; and, when available, expenditures, defined as resources directly spent on R&D activities by funding recipients. More information about the report methodology is at www.hivresourcetracking.org/about/methodology.

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About the Resource Tracking Working Group: In its 16th annual report, the Resource Tracking for HIV Prevention Research & Development Working Group (“Working Group”) documents research and development spending for the calendar year 2020 and analyzes funding trends spanning twenty years. The Working Group is led by AVAC in partnership with the International AIDS Vaccine Initiative and UNAIDS.

Press Release

AVAC Applauds the Selection of John Nkengasong as PEPFAR’s New Leader

Contact

Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, September 27, 2021 – AVAC applauds the Biden-Harris Administration on the nomination of John Nkengasong, a bold and inspiring choice, as the next US Global AIDS Coordinator to head the President’s Emergency Plan for AIDS Relief (PEPFAR), one of the most dynamic and effective foreign assistance programs ever developed.

Through four presidential administrations, PEPFAR has provided lifesaving HIV treatment to more than 18 million people in 50 countries and ensured access to prevention for tens of millions more. John Nkengasong is the right person at the right time to lead a program that has demonstrated its unique and unmatched value in the global AIDS response, but which also faces significant challenges in the future.

“John is exceptionally well qualified to confront those challenges, including increasing PEPFAR’s impact in the face of COVID-19 and building a foundation for pandemic preparedness and global health equity,” said AVAC Executive Director Mitchell Warren. “He is a highly accomplished scientist and administrator, known and respected in both the global North and South, with a strong commitment to global health equity. His work in establishing the African Society for Laboratory Medicine provided a critical foundation for PEPFAR effectiveness, and the rapid response to COVID under his leadership of the Africa CDC has been a shining light in the global pandemic response.”

“PEPFAR has been conceived as a partnership with other governments and communities, and Dr. Nkengasong has shown in his leadership at the Africa CDC that this is core to his approach. And hopefully his connections, relationships and track-record will help PEPFAR move even further and faster to ensure mutual accountability, co-financing with local governments and sustainability in building health infrastructure for HIV and pandemic response and prevention generally,” said Warren.

As the first person of African origin nominated for this position, John’s appointment also represents a major step toward the goal of ensuring that programs such as PEPFAR continue to incorporate and benefit from the perspectives and leadership of people from the regions in which these programs work.

“John has the passion, vision and experience to build on the noteworthy accomplishments of his predecessors and the unyielding commitment to following the data and engaging communities of current Acting US Global AIDS Coordinator Angeli Achrekar,” said Warren. “AVAC welcomes John’s appointment to this critical post and looks forward to working with him toward our shared goals of ending the AIDS pandemic and ensuring global health equity.”

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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.

Press Release

HIV Vaccine Research Must Continue Following Disappointing Result from Imbokodo Trial

Underscores need for expanded access to proven, available HIV prevention options, says AVAC

Contact

Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, August 31, 2021 – Today, Johnson & Johnson and partners announced that the Imbokodo study, a large-scale HIV vaccine proof-of-concept trial also known as HVTN 705/ HPX2008, did not significantly reduce the overall risk of HIV acquisition among over 2,600 women in five sub-Saharan African countries. The Adenovirus26-based mosaic vaccine regimen was shown to be safe, but it did not meet pre-defined criteria for efficacy to warrant moving forward for longer follow-up. A companion study, the Phase III Mosaico trial, will continue.

“AVAC recognizes the enormous contribution of the 2,637 women from five countries in Southern Africa who participated in the trial, and we congratulate the trial teams at sites and across the globe for their work on a superbly run study,” said Nandisile Luthuli, AVAC’s Regional Stakeholder Engagement Manager. “We applaud Johnson & Johnson for working in collaboration with the HIV prevention community, for their leadership in HIV vaccine research and for their longstanding commitment to Good Participatory Practices (GPP) that must be continued to maintain trust in vaccines and in research.”

“We always hope that efficacy trials will show positive results that lead directly to new prevention options,” said Mitchell Warren, Executive Director of AVAC. “It is very disappointing that this particular vaccine candidate did not work in this trial, but the trial was well-conducted and got an answer quickly. HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to contribute towards curbing new infections and providing a durable end to the pandemic.”

“This is in no way the end of the search for an HIV vaccine,” added Warren. “We still hope for a positive outcome from the ongoing Mosaico and PrEPVacc studies. Yet, now more than ever, the vaccine field needs diversity and creativity — and even more collaboration — in deciding what comes next as research priorities as there are no other vaccine candidates currently on a clear track to licensure. The field must focus on new hypotheses driven by this result and the recent antibody-mediated prevention study results, both of which showed some trends towards efficacy.”

“Just as decades of HIV research paved the way for effective COVID-19 vaccines, HIV vaccine developers now need to draw on the creativity, speed, agility and decision-making of COVID-19 vaccine development in product development, trial design and regulatory pathways,” said Stacey Hannah, AVAC’s Director of Research Engagement. “AVAC calls on donors, research groups and industry to join in strategic discussions with civil society and trial communities to map out a comprehensive strategy for the future of HIV vaccine research, product development and selection, and trial designs.”

A renewed commitment to this type of engagement within the HIV vaccine field would build on lessons learned from COVID-19 vaccine development and lead to a strategy that is coordinated, appropriately resourced, includes relevant target product profiles, and commits to share data across research groups and trials.

“For the last two decades, we have seen HIV prevention trials reporting annual incidence rates of four percent or higher among women trial participants in various East and Southern African countries. Sadly, Johnson & Johnson noted a high rate of HIV infections in this trial as well. There is a moral and ethical obligation to provide women living in contexts of HIV risk with prevention options that work for them,” added Warren. “The Imbokodo study is yet another stark reminder of the need to work harder and faster to roll out effective HIV prevention options at scale to the people who need them most, and to provide appropriate support to those using prevention options, even and especially within clinical trials.”

Safe and effective HIV prevention options, including male and female condoms, voluntary medical male circumcision and daily oral PrEP are all available now, but not rolled out to scale. Additional prevention options are nearing availability, including the Dapivirine Vaginal Ring and injectable cabotegravir, and several next-generation PrEP options are now entering advanced clinical trials.

“As the Imbokodo study participants return for their final visits, it is essential that they not only receive the research results, but are offered access to all available prevention options, including oral PrEP – which is available in all countries where the trial took place – and linked directly to these services,” added Luthuli. “In addition, the trial team and sponsors should explore innovative approaches to offering these trial participants the opportunity to enroll into new introduction projects offering the Dapivirine Vaginal Ring and injectable cabotegravir. The Imbokodo study team did a remarkable job of recruiting participants at high risk of HIV infection, and they now need to link the women to prevention options that work and can help them remain HIV-negative.”

The recent results of the HPTN 084 trial of injectable cabotegravir showed very low incidence rates among women in both the intervention arm and the comparative daily oral PrEP arm, making it clear that both forms of PrEP are effective prevention options. These options need to be taken to scale with urgency where they are most needed. In addition, going forward, AVAC calls for HIV prevention researchers, funders and sponsors to learn from the HPTN 084 success and better integrate these options into all future trials, even though this will require larger and more innovative trial designs.

The Imbokodo study evaluated whether an Adenovirus26-based mosaic vaccine regimen could safely and effectively reduce the rate of new HIV infections among 2,637 cisgender women in 23 sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe. Participants received a total of four doses over 12 months of either a prime-boost vaccine regimen of a mosaic viral-vectored vaccine, Adeno26.Mos4.HIV (Ad26 prime) and an aluminum phosphate-adjuvanted clade C gp140 protein (boost), or a placebo. Johnson & Johnson reported today in a press release that primary analysis of the data showed an efficacy estimate of 25.2 percent, but with a wide confidence interval that crossed zero (-10.5% to 49.3%). The press release also noted high HIV incidence rates among the women in the trial.

The Mosaico study uses a similar regimen with the same Ad26 platform for the prime vaccine, but using a different form of protein boost. The Phase III study, also known as HVTN 706/HPX3002, is currently enrolling 3,800 men and transgender people in eight countries in the Americas and Europe.

While the Imbokodo study did not provide sufficient protection to continue, there were no safety concerns with the Adenovirus26-based mosaic vaccine candidate. The Ad26 platform delivers a protein, known as an antigen, to stimulate an immune response. The platform has proven effective in other successful vaccines, including for Ebola and COVID-19. There is every reason to have confidence in the effectiveness of the Ad26-based Ebola and COVID-19 vaccines that have been important in helping to curb Ebola outbreaks and blunt the current COVID-19 pandemic. It is important to remember it is not the platform that provides protection, it is the immune reaction to the antigen within the platform. Unfortunately, HIV is a particularly challenging virus that more easily evades the immune system compared to many other viruses.

“We need an HIV vaccine to provide a durable end to the HIV pandemic, but we can’t wait for a vaccine,” added Warren. “Now is the time to go all in on providing comprehensive HIV prevention options that already exist and the programs needed to support people in using their chosen options, while also re-engaging in vaccine research. If we’ve learned one lesson from the COVID-19 response, it is that political will, sufficient funding and unprecedented cooperation in the face of a global threat is possible. HIV has been for decades — and remains — a global threat; it is past time to act boldly to confront it.”

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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.

Press Release

New Manifesto, No Data No More, Compellingly Analyzes HIV Research Gaps and Biases Against Trans and Gender-Diverse Communities

Embargoed for release: Monday July 19, 2021 at 11:00 ET / 17:00 CEST

Manifesto offers practical guidelines for change

Contact

Kay Marshall, +1 (347) 249-6375, kay@avac.org

Worldwide, trans and gender-diverse (TGD) people face a highly disproportionate burden of HIV but are frequently and often systematically left out of HIV prevention research and responses. That ongoing exclusion is a major barrier to efforts to end the global HIV pandemic, according to No Data No More, a new HIV prevention manifesto written by TGD advocates from South Africa, Europe and the United States, with support and solidarity from AVAC. The embargoed report and materials are available here.

No Data No More analyzes how TGD communities are left out of HIV prevention research and responses through structural barriers such as discriminatory attitudes and punitive laws, non-inclusive language, failure to recognize the diverse and unique identities of different members of TGD communities and a lack of understanding of the role of gender-affirming hormone therapy (GAHT) in TGD health.

“Whether through ignorance or bias, the engagement of trans and gender-diverse people in HIV research and responses continues to fall behind the devastating impact of the pandemic on our communities,” said Tshepo Ricki Kgositau of Accountability International. “No Data No More presents a clear analysis of these obstacles from the perspective of those directly affected, along with concrete recommendations to enhance global HIV prevention by making TGD communities an essential part of the response.”

The need for change in HIV research and prevention for TGD people is clear. Trans women, for example, are 49 times more likely to be living with HIV than the general population. HIV prevalence among trans men in the U.S. is a startling high 3%, and reaches 38% in some communities, such as among trans male sex workers in Zimbabwe. And data on HIV impact on gender nonbinary people, which may make up 25-30% of trans populations, is virtually nonexistent.

Yet TDG communities continue to be underrepresented in or excluded entirely from HIV prevention research and programs. To date, no HIV-primary endpoint trials have focused specifically on transgender individuals. The number of TGD participants in efficacy trials has historically been too small to derive statistically significant data. And trans and gender diverse researchers and community members are often excluded from positions of power in trial design, prioritization, funding and analysis.

“The gap between the extremely high impact of HIV on TGD communities and the extremely low level of engagement of our communities in HIV research and responses can only lead to more infections and a prolonged epidemic,” said JD Davids of JD Strategies and The Cranky Queer Guide to Chronic Illness. “No Data No More is a global wake-up call for HIV prevention researchers, funders and program implementers.”

“Some laudable efforts, such as those led by NIAID’s Cross-Network Transgender Working Group, are important steps forward in increasing trans representation in research,” said Immaculate Mugo, consultant on gender, intersectional sexual & reproductive health and rights. “Globally, however, too much research and too many HIV prevention access efforts are informed by only a passing knowledge of or interest in TGD communities and issues, and most lack real participation from TGD individuals and leaders. The result is an epidemic that continues to disproportionately affect TGD people worldwide.”

No Data No More provides a vision for a relevant and inclusive TGD research agenda that can change that trajectory. The manifesto includes clear and practical recommendations to:

  • Track epidemiological data on HIV incidence and prevalence that accurately reflects the large and growing HIV acquisition rates of TGD populations.
  • Support best practices in language use, informed by TGD researchers, advocates and trial participants.
  • Address fundamental structural barriers that limit TGD people’s access to HIV research and prevention.
  • Provide GAHT across the HIV research, prevention and care continuum, resolve existing questions about potential interactions between HIV PrEP and GAHT and ensure future studies address potential interactions between HIV prevention products and GAHT.
  • Improve TGD-inclusion in randomized clinical trials and ensure that these recognize, address and evaluate the impact of differences among sub-groups of TGD people.
  • Include TGD leadership in clinical research, including study design and implementation.
  • Fund and strengthen the capacity of local research sites to recruit TGD participants in alignment with the Good Participatory Practice Guidelines.

“Forty years into the global HIV pandemic, which is endemic to most trans communities, it’s beyond time to align HIV prevention research with trans and gender-diverse realities,” said Max Appenroth of Global Action for Trans Equality (GATE). “The best way to reduce HIV in TGD communities is to invite our communities to participate meaningfully in the response. The No Data No More manifesto is an invitation to recognize the fundamental and critical role that empowered TGD communities can play in protecting our own wellbeing and reducing the global toll of HIV.”

“AVAC is proud to support the development of No Data No More as part of our ongoing commitment to inclusive, representative HIV research and the Good Participatory Practice Guidelines,” said AVAC Senior Manager for Partnerships Cindra Feuer. “Much work remains to make the perspective and participation of trans and gender diverse communities central to HIV response, but this manifesto charts an essential path forward for researchers, advocates and implementers worldwide.”

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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.

Press Release

Little Change in HIV Prevention R&D Funding in 2019, New Analysis Finds

Continued investment in HIV prevention research critical for keeping the HIV response on track in the coming decade

Contact

Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York, February, 4, 2021 – Funding for HIV prevention research and development (R&D) in 2019 followed familiar patterns seen for almost a decade – overall funding declined slightly in 2019, reversing a slight upward trend seen in 2018 and continuing the overall trend of flat or declining funding since 2012. Total funding for HIV prevention R&D in 2019 was US$1.13 billion according to a new analysis from The Resource Tracking for HIV Prevention R&D Working Group highlighted today at the HIV Research for Prevention Conference (HIVR4P Virtual).

This analysis comes at a time when the field has delivered important clinical trial results that will in coming years broaden the range of HIV prevention options for many people and help the field determine critical next steps in research, development and delivery. Decades of funding for HIV prevention research also helped jumpstart research for COVID-19 interventions, including vaccines and antibody research.

The report found that funding increased for preventive HIV vaccines and female condoms in 2019, while investment in all other evaluated technology categories declined from the previous year. A detailed breakdown of investment by technology category is available on a newly launched website that provides detailed breakdowns of investment accompanied by graphics.

As in the past, public funding made up the majority of funding at US$902 million (80 percent of total funding) and 95 percent of that funding came from the US government. US government funding increased in 2019, with a notable ¬¬increase of five percent from the US National Institutes of Health. Funding in almost every other category, including from European governments, global philanthropies and industry, declined.

New HIV prevention options are moving from labs and clinics toward people’s lives and exciting new products are moving forward in the research pipeline. Decades of sustained funding for HIV prevention R&D has made this possible, although the pace of research has often been slowed by falling or static funding.

It is unclear what impact the turn to COVID-19 R&D support by many of the key funders of HIV prevention R&D will have on funding in 2020 and beyond, but the Working Group warned that funders must continue to support HIV prevention to build on the important gains being made in current research.

The Working Group also noted the running start HIV vaccine R&D gave to the COVID vaccine enterprise. The three-decades-long US$15 billion-dollar-plus quest for a preventive HIV vaccine laid the groundwork for COVID-19 vaccine R&D through advances in computational vaccinology, genetic and vector-based vaccine platforms, antibody assays, viral imaging, clinical trial site infrastructure and other innovations that were successfully repurposed to develop safe and effective COVID-19 vaccines in record time.

Conversely, cutting-edge platforms and technologies developed to combat the COVID-19 pandemic offer new tools and promise in the quest for vaccines against HIV and other infectious diseases, but research to repurpose these advances for HIV R&D must be adequately financed now.

“Even as unprecedented amounts of funding and support continues to flow into the COVID-19 pandemic response, funders must continue – and increase – funding for HIV prevention research and development. Responding to this new pandemic must not take resources away from the ongoing HIV pandemic or the world will see an even greater public health crisis. We’ve learned from COVID-19 that unprecedented funding and cooperation among governments, industry and research groups can speed development of new technologies. Just as COVID research benefited from long-term HIV research investments, lessons learned most recently in COVID vaccine development must now urgently be applied back to HIV prevention R&D,” said Mitchell Warren, AVAC executive director.

“The COVID-19 response has given us incredibly valuable insights and approaches for accelerating the development vaccines and monoclonal antibodies—the foundations of which were significantly enabled by decades of HIV vaccine research innovation,” said Mark Feinberg, President and CEO of IAVI. “As we’ve seen throughout HIVR4P Virtual, the current HIV prevention research pipeline is rich, and the technologies and collaborations that facilitated the rapid discovery and development of efficacious COVID-19 vaccines and therapeutics are already being applied in efforts to advance the development of HIV vaccines and broadly neutralizing antibodies. To build on decades of research progress, we must sustain cross-sectoral investment and collaboration and dedicate increased focus on partnership innovation – which will be as critical as scientific innovation in hastening the end of the HIV pandemic.”

“COVID 19 response has demonstrated that focused efforts and investments can result in the roll out of multiple preventive options against SARS-COV-2 within a record time. Addressing HIV response needs similar efforts and urgent scale-up of investments for HIV interventions and research to end the epidemic.” said Shannon Hader, Deputy Executive Director, Programme at UNAIDS.

The Resource Tracking for HIV Prevention R&D Working Group has employed a standardized methodology since 2004 to generate comprehensive statistics on investment in HIV prevention research and development. Investment estimates that allow comparison across years, prevention options, sectors, and countries provides greater transparency for funders and helps assess the trajectory and impact of policies and funding decisions. The trends documented by the Working Group help predict future funding scenarios that can impact the progress of the historic scientific agenda to find new prevention options to help end the HIV pandemic.

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About the working group: Since 2000, the Resource Tracking for HIV Prevention R&D Working Group has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government.