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

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.

New Report: HIV Prevention R&D funding drops again

Today, we and partners are proud to release the annual HIV Prevention Research and Development Investments Report, with important findings for our collective advocacy. The report reveals a growing mismatch between the current promise of HIV prevention R&D, and continuing declines in the funding available. This decline affects both funding for research on new interventions and funding to expand access to existing prevention tools. The new report is based on outreach to 215 funders of HIV prevention R&D in the public, philanthropic and commercial sectors and includes 2020 funding data.

The latest data shows 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.”

This high stakes environment includes: new products readying for introduction, such as injectable cabotegravir for PrEP and the Dapivirine Vaginal Ring; international support for ambitious new global targets for ending the epidemic; initial proof of concept of antibody-based prevention; and urgently needed new thinking for HIV vaccine development as recent trials have experienced setbacks and new technologies such as mRNA succeed against COVID-19.

Key findings from the report include:

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, trends over time from the data collected show commercial sector investments is, by far, the smallest piece of the funding pie for HIV prevention R&D.

Funding dropped in 2020 across a number of key 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, injections: While uptake of oral PrEP grew substantially in 2020, and multiple recent research studies have demonstrated the potential impact of a range of PrEP options including long-acting injections, pills and implants, 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 treatment as prevention (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 microbicides. 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.

This is the 16th annual report from the Resource Tracking for HIV Prevention Research & Development Working Group. Go to HIVResourceTracking.org to explore the key findings, funding trends, and previous reports in depth and follow the conversation on Twitter #HIVResearchFunding.

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, [email protected]

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.

WHO Wants To Hear From PrEP Providers

WHO is conducting a survey among people delivering PrEP for HIV prevention. If you are involved in any step of PrEP provision (as a physician, clinical officer, nurse, pharmacist, lay provider, etc.), please consider completing this survey to support WHO in its work on PrEP. Click here for the survey in English. The survey is also available in French or Spanish. You can change the language in the top right corner at any time.

Please share this survey with anyone in your networks who delivers PrEP services, including PrEP providers in any type of service. An individual can only complete the survey once. The survey takes 15-20 minutes to complete. The aim is to gather information on how PrEP is provided in practice and perspectives on new PrEP products. Responses to the survey will be anonymized and not attributed to any individual or PrEP service.

The survey will be closed on 26 November 23.59 CET. If you have any questions, please contact Robin Schaefer at WHO: [email protected].

Thank you so much for your time. Your responses will be critical to inform WHO global guidance on PrEP.

Integration of HIV and Sexual and Reproductive Health in the Era of ARV-Based Prevention: Findings from assessments in Kenya, Malawi and Zimbabwe

New research from AVAC and partners shows promising approaches to reach adolescent girls and young women (AGYW) with comprehensive and integrated services for HIV and sexual and reproductive health (SRH), including expanding access to existing and future PrEP products. On October 14, 8-9am ET, join us and representatives from the Ministries of Health in Kenya, Malawi and Zambia for a webinar to discuss findings, progress to date and context-specific realities. Register here.

Access to the Dapivirine Vaginal Ring: A timeline on progress

This infographic shows the timeline of progress for end user access to Dapivirine Vaginal Ring.

PEPFAR-Funded PrEP and VMMC Services in 14 Priority Countries

This infographic shows that PEPFAR’s increased investment and creation of a budget code resulted in improved scale-up of VMMC (VMMC). A budget code could have the same impact if applied to PrEP initiations.

New Resources on AVAC.org

Here’s a roundup of new resources on AVAC.org and PrEPwatch.org!

Vaccine Equity: More must be done now!

  • More than 175 leading scientists, civil society leaders and organizations, including AVAC, issued a letter to the White House on August 10th demanding bold and immediate new steps to scale up mRNA vaccine manufacturing around the world.
  • The Washington Post also reported on this effort to push the Biden Administration to meet key demands, including a commitment to establish the capacity to manufacture 8 billion doses a year of mRNA vaccines before 2022.

CAB-LA and Implementation Science: New options must be paired with smart rollout

Protecting Global Gains: Resilient health systems look at the whole picture

The latest installment of stories of adaptation among health systems during COVID is up, Flexible programming gives young women in Rwanda the tools they need to get through COVID-19. The story showcases one Rwanda program under PEPFAR’s DREAMS program where the vocational training in tailoring, offered alongside traditional healthcare, gave young women both skills that were needed during the pandemic and critical social support in the midst of lockdown.

The Ethics of Trial Design: Where PrEP fits in for next-generation prevention trials and more

AVAC is taking a long look at two new guidance documents and their implications for HIV prevention trials: The HPTN’s Ethics Guidance for Research and from UNAIDS/WHO Ethical Considerations in HIV prevention trials.

  • Jeanne Baron’s blog, Ethical Guidance in Focus, compares the two, including highlights of what’s new from previous guidance documents and a table summarizing the implications.
  • AVAC’s August 5th webinar, New Ethical Guidelines for HIV prevention trials in people: What’s changed and Why Does it Matter?, takes another step in explaining these updated essential documents provide context for their use. Hear advocates and bioethicists discuss the role of PrEP, community engagement, equity and more in future trial design.
  • This factsheet outlines different trial designs under discussion, provides links to background material, and offers details on three trials being designed to test next-generation PrEP: monthly oral PrEP with islatravir from Merck; a new form of daily oral PrEP with F/TAF from Gilead; and six-monthly injectable PrEP with lenacapavir from Gilead.

From IAS 2021

If you are catching up on the 11th annual IAS Conference on HIV Science, AVAC has the resources you need.

  • IAS 2021: Our Take and Updates rounds up the latest on the prevention pipeline, offers conference highlights on the intersection of COVID-19 and HIV, dives into new findings on PrEP and resistance, looks at how differentiated service delivery (DSD) has advanced and more.
  • Research Literacy Zone Roundup offers links to sessions where researchers and advocates discuss critical questions for the field, including rollout of the Dapivirine Vaginal Ring, the status of vaccine and cure research, new approaches to address the social determinants of health, vaccine hesitancy and more.

The State of the Field for Rectal Microbicides

AIDS Foundation Chicago (AFC) and AVAC teamed up to host a webinar, Butt Stuff – All Gender HIV Prevention for Backdoor Action.

The State of the Field for Multi-Purpose Technology

Next up in the AFC and AVAC webinar series, Can Fantasies Become Realities? The Quest for Multi-purpose Prevention Products, is on Wednesday, October 13 10am–12pm EDT. Researcher Dr. Sharon Hillier and others will discuss the need for products that not only prevent HIV but are contraceptive as well, or prevent other STIs—or all the above. This webinar will also feature performers and a live DJ. Register today!

Enhancing HIV Prevention with Injectable Preexposure Prophylaxis

Quarraisha Abdool Karim, Ph.D. writes about the results of HPTN 083 and the implications of long-acting injectable of PrEP with cabotegravir in the New England Journal of Medicine.

Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

The results of HPTN 083, a trial evaluating the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW), in the New England Journal of Medicine.