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

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.

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.

###

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.

Essential Reading and Resources

AVAC and our partners have been busy the first couple of months of 2022. Here is a round-up of essential reading and new and updated resources including HIV treatment studies, PrEP, stakeholder engagement, research fundamentals and more.

Highlights From CROI

Our coverage of week one at CROI featured updates on data related to the Dapivirine Vaginal Ring, injectable cabotegravir (CAB) as PrEP, vaccine science and cure research. And our week two summary looked at symposia that explored how to reach key populations, the critical role of choice in effective HIV prevention, and the status of research on preventing sexually transmitted infections (STIs).

HIV Treatment Studies During COVID-19

A February commentary in JIAS, coauthored by AVACer Maureen Luba with a host of other experts on the topic, offered recommendations for the ethical continuation of treatment research among people living with HIV in the context of COVID-19: Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

Transgender Voices: Call to action

The Lancet’s February publication included a public letter from leading voices in the transgender community working in HIV research and public health. Titled, Research on transgender people must benefit transgender people, it called out exploitation in academic research and “called in” researchers to pursue priorities that offer direct benefit to transgender communities and to rely on resources such as No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities.

Stakeholder Engagement Must Overcome Tokenism and More

The ethics review process is a critical opportunity for stakeholder engagement. AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors explore three themes that can make or break effective engagement in a new article in the Journal of Empirical Research on Human Research Ethics: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

South Africa Is Talking About Injectable CAB As PrEP and Getting Rollout Right

Leading South African publication on public interest health journalism, Spotlight, reported on the excitement among advocates – and the need to plan now – to add injectable CAB as PrEP to the HIV prevention options currently available. Check out two new stories: Start planning HIV prevention injection rollout, experts say and Prioritise HIV prevention injection, activists say.

Many Angles On PrEP And Resources For Advocacy

For context on injectable CAB as PrEP, resources to support the rollout of the ring, and a look at the research and development pipeline of next generation PrEP, check out PrEP and more PrEP: An update and important resources.

Research Fundamentals

What is an endpoint in clinical research and why does it matter? POZ magazine’s February issue featured a transcript of AVAC’s Px Pulse podcast on this question. Hear the original nine-minute podcast here. And you can find the Px Pulse archive here.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

Virtual CROI 2022 Roundup for Advocates: It’s all about choice

Welcome to Virtual CROI week two!

Here’s a roundup of the exciting science heard last week across the spectrum of HIV prevention, and on cure research (more on this further down) with a groundbreaking new case of HIV remission. We also want to be sure you are all aware of the CROI Margarita Breakfast Club dialogues—both last week and this week. Superb discussions last week and three more this week are not to be missed—recordings from last week’s conversations and registrations for this week are here.

The overarching message coming from CROI last week was clear: no one biomedical strategy will do the job, the world needs multiple options and real choices. In this round up, the importance of choice leads our coverage. (And listen to Carlos del Rio from Emory University put it all in context in a terrific US National Public Radio interview here.)

Choice and the Ring

New data from the REACH study, which incorporated informed choice into its design, made this point unmistakable. Almost all (98 percent) of the 247 adolescent girls and young women in this study where both daily oral PrEP and the Dapivirine Vaginal Ring were offered, chose one of the products over none at all. All participants tried each product for 6 months, followed by 6 months where they could choose their preferred method. Kenneth Ngure, presenting on the REACH Study, said about ⅔ of the participants chose the ring. But most of the women who had very high adherence to the daily oral pill preferred the daily pills to the ring. Ngure said overall adherence in the REACH trial surpassed levels seen in previous studies. More findings on factors driving adherence is under analysis. “REACH is just a small example of what the potential impact could be in the real world of HIV prevention, simply by allowing young women and girls the ability to choose,” said Ngure.

Choice and Injectable PrEP

HPTN 083, evaluating injectable cabotegravir as PrEP among gay men, transgender women and other men who have sex with men (MSM), presented updated data that evaluated new infections that have occurred since the trial unblinded in May 2020. Raphy Landovitz, from UCLA and HPTN 083 protocol chair, reported that adherence went down during this phase of the trial, but break-through infections among those receiving on-time injections remained rare. (He reported a total of 7 such cases in the life of the study that covers 4,660-person years.) The data continue to confirm both the safety and efficacy of cabotegravir for PrEP. Reflecting on the significance of the drop in adherence to both daily oral PrEP and injectable cabotegravir during the unblinded phase, Landovitz said complex barriers to adherence make it clear that “no one biomedical prevention option will address all issues in HIV prevention”.

Additional data from Susan Eshleman of John Hopkins University School of Medicine and the HPTN 083 team deepened the discussion on effective and feasible testing. Detecting HIV is a crucial part of prevention strategies that rely on antiretrovirals (ARVs). Exposure to a single ARV, which is the protocol for PrEP (in contrast to combination ARV used in treatment), can lead to resistant HIV. Eshleman reported on data showing that using a highly sensitive RNA-based HIV test to confirm a person is HIV negative could reduce the risk of someone with undetected HIV developing resistance to first line treatment. But she said access to these tests should not limit access to this highly effective intervention, “In the context of proven high efficacy, CAB-LA should be considered for HIV PrEP in settings where HIV RNA screening is not readily available.”

Choice and Vaccines

IAVI’s Mark Feinberg summarized the state of vaccine science. One the one hand, two recent large-scale trials showed no efficacy (Uhambo and Imbokodo). On the other hand, Feinberg said cutting edge approaches offer “a strong and vibrant source of promise” for HIV vaccine development, particularly the development of broadly neutralizing antibodies (bNAbs). Looking ahead, Feinberg predicted the next major priority to make a large-scale trial a possibility will be validating a “correlate of protection”, a mark or sign in the immune system that can be linked to preventing HIV acquisition.

As this research evolves, the need for many options that deliver real choices remains clear. In a later session on immune responses, South Africa Medical Research Council and HVTN leader Glenda Gray said the high rate of HIV in hard-hit places (as high as 4 percent) will mean effective prevention may well require a combination of strategies. “We will likely need a combination of PrEP with vaccines to combat high rates—4 percent incidence rate is just too much for a vaccine alone to overcome.”

Another Step in the Journey Toward a Cure

A fourth person was reported to achieve HIV remission, the first case among women, according to data from Yvonne Bryson from the David Geffen School of Medicine at University of California. The New York woman has no detectable HIV since she stopped treatment 14 months ago. Her treatment interruption followed a stem cell transplant from a donor with an HIV resistant mutation. As in the other three cases, the stem cell transplant was an urgent intervention to treat advanced cancer. This stem cell transplant pioneered an innovation where a family donor provided stem cells in combination with stem cells from umbilical cord blood that had the needed mutation. One possible implication for cure research is confirmation of the role of a critical receptor on white blood cells known as CCR5. HIV relies on CCR5 to enter and infect the cells. Mutations to CCR5 have once again led to a case of remission, and two of these cases have endured long enough to be confirmed as a cure. Want to learn more? One of last week’s Margarita Breakfast Club discussion was River Deep, Mountain High: Pathways Toward a Cure for HIV, with a wonderful discussion about these findings.

There’s more CROI coverage coming and please continue to follow along with us this week, www.avac.org/croi-2022, and check out great summaries from our friends at aidsmap.

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, 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.

New Resources and Opportunities!

In this round-up you’ll find opportunities to register for a webinar on cure research and preview a new course on GPP. In case you missed them, scroll down for resources that cover a spectrum of issues crucial to the progress of HIV prevention today. We hope you’ll watch, read, learn and join the conversation!

Coming up

  • Starting soon! Register for a free live session previewing AVAC’s newest GPP course for funders, sponsors and principal investigators at the Union World Conference on Lung Health, today, October 20, 12:00-12:45pm EDT. Don’t miss the live Q&A with the developers of The GPP Compliance Course from 12:30-12:45pm EDT!
  • Wondering about funding for HIV cure research and how communities can engage on the issue? Register for the webinar, Investment and Engagement in HIV Cure Research: Looking Ahead on Wednesday October 27, 2021 at 10am EDT.

Integrated Products, Integrated Services

Pushing the Frontier of R&D

Many Angles on the Ring

The Dapivirine Vaginal Ring: Gone far, far to go

The Dapivirine Vaginal Ring promises to be an essential new option for women’s HIV prevention. But crucial work lies ahead. In a new blog post, journalist and HIV prevention advocate Anna Miti provides context and perspective on introducing the ring in Zimbabwe, the first country where the approval of the ring has been reported in the press. Read The Dapivirine Vaginal Ring: Gone far and far to go to learn what’s at stake in Zimbabwe and anywhere women need better choices for HIV prevention. Miti’s blog explores the concrete steps that must happen next from Ministries of Health, advocates, providers, policy makers and community organizations to make the ring a reality in women’s lives.

Check out Access to the Dapivirine Vaginal Ring: A timeline on progress, which marks key points in the journey to make the ring available.

Learn more about the ring, the research and evidence behind it, and the advocacy needed for rollout on our dedicated ring page on PrEPwatch.org.

And consider signing up to receive the PrEP Ring Quarterly Newsletter, a quarterly update on efforts to make the ring available, developed by AVAC and FHI 360.

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.

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!