Press Release

Declining Funding and Shrinking Donor Base Imperils Continued Success of HIV Prevention Research; European Countries Called to Renew Support

Contacts

AVAC: Kay Marshall, kay@avac.org, +1-347-249-6375
IAVI: Rose Catlos, rcatlos@iavi.org, +1-212-847-1049

New York and Paris —

A new report released today ahead of the 9th IAS Conference on HIV Science documents 2016 funding and highlights a continuing trend of flat or declining funding and its potential impact on further innovation in HIV prevention research and development (R&D).

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 13th annual report, HIV Prevention Research & Development Investments, 2016: Investment priorities to fund innovation in a challenging global health landscape, documents the lowest annual investment in HIV prevention R&D in more than a decade. In 2016, funding for HIV prevention R&D decreased by three percent (US$35 million) from the previous year, falling to US$1.17 billion.

At a time when the field is moving towards a new slate of efficacy trials across the prevention pipeline and follow-on research for successful antiretroviral-based prevention options is underway or planned this trend is worrisome, particularly in light of uncertainties around the sustainability of public sector support from the US and other funders. Even small declines in funding can delay or sideline promising new HIV prevention options that are needed to end the HIV epidemic.

The US continued to be the major funder of HIV prevention research. In fact, 88 cents of every dollar spent on HIV prevention R&D in 2016, came from just two donors: the US public sector and the Bill & Melinda Gates Foundation. In contrast, European public sector funding fell by US$10 million from 2015, and at US$59 million, accounted for just six percent of all public sector investment. This is the lowest European funding recorded in the last decade and marks a 52 percent decrease from the peak funding (US$124 million) in 2009. In addition, the number of philanthropic donors fell sharply from a total of 27 in 2015 to just 12 in 2016.

The RTWG renewed a call for a greater range of donors to increase the stability of R&D financing and cushion potential impact if any of the major funders were to reduce their investments. Noting increases in public sector funding from the Netherlands and Sweden, the RTWG called on other European countries to increase investment in critical HIV prevention tools to help end the epidemic.

The past year has seen one new HIV vaccine efficacy trial begin and another planned to begin later in 2017; a novel proof-of-concept trial of antibody-mediated prevention underway; a monthly vaginal ring with the antiretroviral (ARV) drug dapivirine proven effective and under review by the European Medicines Agency; a multipurpose technology combining dapivirine and a contraceptive has launched early-stage trials; a long-acting ARV-based injectable PrEP formulation is beginning efficacy trials; and, finally, daily oral PrEP delivery programs are being scaled up in multiple countries. And behind these more advanced R&D activities come many other different HIV prevention modalities poised to prove themselves in early-stage research.
“The latest figures from UNAIDS show us that there has been progress toward meeting the 90 90 90 treatment goals, but there has been less progress – and less reporting – on meeting the prevention goals that are critical to epidemic control,” said Mitchell Warren, AVAC executive director. “We need to not only vastly accelerate roll out of HIV treatment and existing prevention options, we need continued and sustained investment to keep HIV prevention research on track to provide the new tools that will move the world closer to ending AIDS.”

The RTWG has tracked more than US$17 billion in investment towards biomedical HIV prevention since 2000 and warned that the greatest impact of this investment could be lost without continued and sustained support to move promising prevention options from laboratories and clinics into the lives of those who most need them.

“We are at an incredibly exciting time in the field of HIV prevention research and development with more life saving innovations, science and technology coming to the forefront than ever before,” said Luiz Loures, Deputy Executive Director of UNAIDS. “We cannot allow a lack of funding to set back progress. Invest now and we can end AIDS by 2030.”

The report documents some critical increases in funding, including the highest annual investment in preventive HIV vaccines since 2007, which includes the highest investment by the US public sector in preventive vaccine research since 2000, in part because of the start of the first vaccine efficacy trial in almost a decade. Yet European public sector investment in vaccine research was the lowest since 2001. The increase in support for vaccine research comes at a critical time in vaccine R&D and is an example of funders responding to the need for investment to keep promising research moving forward. The RTWG noted this level of investment should be occurring across the field to support the broadest possible pipeline of promising new HIV prevention options.
“A true end to AIDS will only be possible if we can develop and deploy an effective HIV vaccine and other innovative biomedical products for HIV prevention” said Mark Feinberg, President and CEO of the International AIDS Vaccine Initiative (IAVI). “With growing risk of increasing rates of HIV infection due to demographic trends and incomplete reach of HIV treatment programs, advances being made in HIV R&D needs support and acceleration. Progress can only happen with sustained public and private sector investment in HIV prevention R&D.”

The HIV field comes together in Paris next week at IAS2017 at a time when there is both much to be optimistic about in HIV science and in the accumulated knowledge of what and how we need to deliver treatment, prevention and care to the people who need it most. Yet, as the title of the report notes, this optimism faces a volatile global health landscape. Funding constraints, policy changes, shifting donor priorities and shifting demographics will all play a role in the world’s ability to respond to the continued challenges that HIV presents.

“After years of prudent and increasingly high-impact investment in HIV prevention and treatment, we have seen amazing dividends in lives saved, families kept together, communities revitalized and economies boosted,” added Warren. “We cannot lose that momentum. We have the innovative science. Now we need an expanded cadre of innovative funders who will work with us to ensure a continued return on investment in more lives saved and more infections averted.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking 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.

HIV Testing: A portal for treatment and prevention

Mitchell Warren is the Executive Director of AVAC. This post first appeared on TheBody.com.

For years, HIV testing has been the cornerstone of plans to end the HIV/AIDS epidemic. Widespread testing programs have helped connect millions of people to HIV treatment and care and have been the first step in saving lives. However, an estimated 14 million more people who are living with HIV still haven’t been tested and remain unaware of their status and unconnected to the treatment and care they need, according to the World Health Organization.

As those of us in the US gear up to celebrate National HIV Testing Day — a day intended to remind us all of the importance of knowing our HIV status — it’s important to look at ways to leverage HIV testing, whatever the result, to link more people to the services they need.

The benefits of immediately linking people who test HIV positive to care and treatment are clear. With evidence and guidelines pointing to the benefits of “test and start,” should an individual want it, more people are being linked directly to antiretroviral treatment (ART) programs — ideally, the same day they get test results. This has a positive impact on the health of the individual being treated and an added effect of preventing onward transmission once an individual on treatment achieves viral suppression, a concept also known as Undetectable = Untransmittable, or U=U.

But what about those who test negative? HIV testing is not, in and of itself, a prevention service. However, HIV testing linked to comprehensive prevention services is — or at least it should be.

Comprehensive prevention is not just condoms, referrals for sexually transmitted infection (STI) treatment and — depending on where an individual lives in the world — possible counseling about voluntary medical male circumcision (VMMC) or pre-exposure prophylaxis (PrEP). It includes male and female condoms, condom-compatible lubricant, daily oral PrEP, STI treatment and linkages to the most appropriate and needed services, including VMMC, ART for partners living with HIV, opportunities to build social capital, financial support, harm reduction and much more.

In fact, if programs could leverage HIV testing expansion as an entry point for effective prevention, HIV prevention could be transformed and many of those most at risk of HIV could be reached with effective prevention options to protect themselves.

The key to this is regular and ongoing HIV testing for those most at risk. Many people in the US will hopefully heed the call for HIV testing on June 27th and take advantage of programs that make it easy to test on that day. But, will they be linked to effective prevention that is also right for them? Will they commit to ongoing testing as part of that prevention package?

The era of PrEP is also the era of regular HIV testing, since safe and effective PrEP use requires HIV testing on a regular basis to ensure that the mono- or dual-therapy is not being used by someone who has acquired HIV. As PrEP use is increasingly seen as an important and empowering act of self-protection for anyone who uses it, how can that same empowerment principle be extended to regular HIV testing for all who are at risk, regardless of the prevention options they access?

HIV testing programs have come a long way in the last three decades in cutting down stigma, making testing more accessible and linking people who test positive to care and treatment. But programs, policies and funding have not moved where they need to be to link HIV-negative individuals to the prevention options they need. Everyone who tests for HIV — no matter the result — needs to be linked to comprehensive, integrated and sustained services that are culturally appropriate.

Is this happening? How often is it happening? No one knows. Data on services offered to people who test HIV negative are inadequate. Outside of the US, countries, funders and implementers report on “people reached” by simply counting referrals and condoms distributed, yet data on who is being reached — particularly among populations at greatest risk — are insufficient. In the US, these linkages vary widely based on the availability of funding and other support to often overstretched clinics and local AIDS service organizations that run testing programs.

What is the solution to linking HIV-negative people to effective prevention services? Data show that connecting people to services immediately after testing can help keep them negative. There are global guidelines in place from the World Health Organization, and national guidelines exist in several countries, including from the Centers for Disease Control and Prevention for the U.S. But experience shows that guidelines and policies do not always reflect the reality of programs and, most importantly, people’s lives.

Moreover, funding plays a critical role in the realities of programs. Even as test-and-start treatment has become the standard that testing programs aim for in the U.S. and around the world, budget cuts and health care “reform” threaten to derail these evidence-based and policy-supported programs. Linking HIV-negative people to the services and care they need is likely to suffer even more with health care changes in the U.S. and domestic and global HIV budget cuts.

As advocates for evidence-based prevention, we at AVAC fight for policies that link all people who test to relevant, appropriate and user-friendly services. It’s the right thing to do for individual health and to end the epidemic — and it’s cost effective and cost saving.

So, on this National HIV Testing Day, we call on individuals to get tested, know their status and take appropriate steps to access treatment and prevention. And, we call on funders and policymakers in the US and around the world to support life-saving and cost-saving testing programs that are the cornerstone of a comprehensive, integrated and sustained response to HIV.

Now I Am Not Scared of Testing for HIV

This blog post, written by Thabo Molelekwa, first appeared on What’sUpHIV as part of a series covering the 8th South African AIDS Conference.

When Samkelisiwe Chiliza from Durban heard about Pre-Exposure Prophylaxis or PrEP, she did not hesitate to join the PrEP study through the Centre for Aids Programme and Research in South Africa (Caprisa).

PrEP is the use of anti-HIV medication to keep HIV negative people from becoming infected. PrEP has been shown to be safe and effective in clinical trials that have taken place in many countries, including South Africa, and is approved by the South African Medicines Control Council (MCC). Taken as a single pill once daily, it is highly effective against HIV when taken every day. The medication interferes with HIV’s ability to copy itself in one’s body after one has been exposed. This prevents HIV from establishing an infection and making one sick.

Samkelisiwe is one of the young women who are currently on PrEP in South Africa and she is encouraging other young women to participate in one of the PrEP projects taking place around the country so that they can help stop the spread of HIV and keep themselves safe.

“I have been taking one pill every night for the past 14 months and I am not willing to stop as I am saving my life,” said Samkelisiwe, adding that she is not scared of testing for HIV because she knows what results to expect since she is on PrEP.

According to Samkelisiwe, many young women are already infected and are not eligible for PrEP as it is only for HIV-negative people.

“Lots of people don’t know about these kind of studies but I do spread the word as much as I can,” she said.

She said that her grandmother was happy to hear that she is taking a pill to protect herself from contracting HIV.

According to Professor Linda-Gail Bekker of the Desmond Tutu HIV Centre, PrEP is a prevention option, not a treatment. It works properly when taken correctly and consistently, but that, currently, only 13,000 people who are receiving PrEP from the government. These are sex workers and men who have sex with men. And there are only 1,387 people who are taking PrEP through demonstration projects run by various organisations.

Prof Bekker said that, while PrEP is not yet widely available, “there is advocacy going on to make sure that the government rolls out PrEP to everyone who needs it.”

The high cost of PrEP is what stops the government from rolling it out to everyone who needs it. Currently, there are only two ways to access PrEP – “People can buy it at a chemist or they can join the demonstration projects that are taking place in the country,” added Bekker.

Bekker said that educating people in the communities about PrEP is important because that will give them knowledge of what the intervention is so that they can make decisions about protecting themselves from HIV and preventing the spread of the disease.

According to World Health Organisation guidelines, PrEP is rolled out to people at substantial risk of contracting HIV. Deborah Baron of Wits Reproductive Health and HIV Institute (WRHI), believes that in South Africa, PrEP should also be rolled out to young women because 7,000 young women become newly infected with HIV every week in Eastern and Southern Africa. “And a third of those women are right here in South Africa,” said Baron.

Baron said that in order to make PrEP interesting for young women there is a need for youth-friendly PrEP delivery models and tools. “We need to be responsive to realities of young women’s lives.”

In late 2015, the South African Department of Health developed policy and guidelines for oral PrEP as well as test-and-treat implementation to protect groups at high risk in line with World Health Organisation guidance. The ARV drug, TDF/FTC, was approved for use as PrEP by the Medicines Control Council.

The National Department of Health, together with the implementing partners, like Baron’s organization, continue to work together to move PrEP forward and get it to the people who most need it. Individuals like Chiliza who take PrEP and talk about it their peers are helping to expand an important HIV prevention option for South Africans.

What’s New on AVAC.org

AVAC.org has a host of new resources providing concise updates, informed perspective and handy tools. Take a look at the highlights below and get up to speed on a range of strategic issues.

New Resources

  • AVAC, in partnership with the Clinton Health Access Initiative (CHAI), is taking on new work focused on supporting innovation in the prevention “market”—including the programs that deliver new products and the pipeline of products in trials. This two-page intro to the “HIV Prevention Market Manager” gives an overview of this new body of work.
  • To get a flavor of the work the Prevention Market Manager team is focused on, check out this new resource: End-User Research Landscape Mapping and Findings. The term “end user” is used by people who work on developing and marketing products. It refers to the individual who’s ultimately going to make the decision to seek out and use a given product or intervention. This resource gives a sense of the range of efforts trying to understand what is and isn’t known about one key set of “end users” for new prevention options—adolescent girls and young women in sub-Saharan Africa.

From the Infographics Gallery

  • Introduction to Long-Acting Injectables is an updated graphic to guide you through the basics of antiretrovirals that are being developed as long-acting injectables for both treatment and prevention.

Strong Voices in P-Values

  • Progress and justice for women and girls has come under attack by the new US administration via the reinstatement and proposed expansion of the Global Gag Rule. In Standing Together Against the Global Gag Rule the AVAC team reaffirms its commitment to the fight for bodily autonomy, for justice, for choice and voice for women and girls.
  • In New and Touted HIV bNAb: Big deal or news blip?, veteran science writer and HIV journalist Mark Mascolini delves into the nuances of vaccine research using broadly neutralizing antibodies. You will learn more than just what these are; Mascolini looks at the big promises and the small print.
  • Lindsay Roth, a long-time organizer and advocate for sex workers’ rights, gives any lay reader on the subject of sex work an opportunity to gain a deeper understanding of the issues at stake in Getting Set to Defend and Advance Sex Workers’ Rights in 2017 and Beyond. Roth’s reporting shows how HIV prevention, human rights and economic justice can only succeed together.

What’s New and What’s Needed: Updates in research results and advocacy

Welcome to our first post-US election update! Many of us, in the US and around the globe, continue to be moved, activated and concerned by the recent US election. We have been grateful for forums exploring how our work may be affected by various political scenarios, including this call on the future of Global AIDS Funding, hosted by GNP+. At the same time, we want to restate our long-standing and vigorous commitment to our ongoing work, which will continue with the same rigor as ever, in pursuit of our mission.

In that spirit, this update highlights recent developments in biomedical prevention research. Together they serve as a great example for why a pro-science, pro-research, pro-stakeholder engagement agenda is a non-negotiable necessity, irrespective of politics and political parties.

New basic science provides clues on cure and vaccines. Earlier in the month, two papers were published regarding new innovations in HIV prevention and cure.

A paper authored by Katharine Bar at UPenn and colleagues reported on the effect of the antibody VCR01 in people living with HIV. In these trials, people living with HIV stopped their antiretroviral treatment (ART) while receiving infusions of VRC01, a broadly neutralizing antibody that blocks the activity of many strains of HIV. The study measured the safety of VRC01 and sought to determine if it helped people control their virus while off treatment. Researchers compared viral “rebound” (the reappearance of virus in the body after ART is stopped) between people who received VRC01 and people who did not. Findings show VRC01 only slightly delayed viral rebound. This shows the value of the scientific research field in action, testing and narrowing the field of solutions until we hit the bullseye. VRC01 is also under study as a tool for HIV prevention in the ongoing AMP trials (HVTN 703/HPTN 081 and HVTN 704/HPTN 085), and a number of other antibodies are in various stages of both prevention and therapeutic research.

A paper authored by Dan Barouch of the Ragon Institute and colleagues looked at a strategy for a cure that combines a therapeutic vaccine with a TLR7-agonist. TLR7 is a protein that controls and activates human immune responses. This study looked at non-human primates (NHP) with SIV (the simian version of HIV). The study used the vaccine vector Ad26/MVA from Janssen Pharmaceuticals to instruct immune cells to recognize SIV, and the TLR7-agonist to activate those immune cells. This strategy tested whether the Ad26/MVA/TLR-7 combination would be able to marshal immune cells to eradicate SIV. In the study, non-human primates were put on ART immediately after infection. One group of NHPs received the vaccine alone, another received only TLR7, a third received a placebo and the last received a combination of Ad26/MVA and TLR7. All were then taken off of ART. Those that received the combination had the largest drop in SIV and the longest delay in viral rebound. There are a lot of caveats with animal models, but this finding could add to optimism for the scientific pursuit of an HIV cure. The Ad26/MVA vaccine vector is also being tested as a preventative vaccine, and a large-scale efficacy study of the regimen could begin in 2017.

Community mobilization on the DISCOVER trial of Gilead’s F/TAF as oral PrEP.

An article published on TheBody.com by long-time advocates Anna Forbes and Marc-André LeBlanc outlined the latest developments related to Gilead’s Phase III trial of the drug F/TAF for oral PrEP. The trial, known as DISCOVER, has raised concerns among advocates that stakeholder engagement has been insufficient. The study plans to enroll 5,000 participants from 92 sites across the US and Europe. Participants will be randomized to receive either daily TDF/FTC (Truvada), which is a proven prevention option approved by the US FDA for PrEP in 2012, or daily F/TAF, which is a different version of the drug combination that has been approved for treatment but the efficacy for prevention is unproven. Given the complex messaging of this trial—one that compares an approved option with an experimental one—community engagement over the course of trial planning and execution is imperative. The standards for stakeholder engagement, outlined in the Good Participatory Practice Guidelines, are designed to address this type of trial and should be met. While Gilead has engaged a limited subset of community stakeholders, a group of advocates, representing a range of organizations, submitted a public letter to Gilead on November 16 demanding substantial and meaningful improvements to the process of community engagement. This is the right thing to do and history has shown this process improves the chances for the trial’s success.

Decades of testing and research reflected in studies like these are doing the painstaking, instrumental work it takes to move us toward our goal, the end of AIDS. Let’s keep our eyes on the prize.

HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape

This annual accounting of funding for biomedical HIV prevention research tracks trends and identifies gaps in investment. In 2015, reported funding for HIV prevention R&D decreased from US$ 1.25 billion in 2014 to US$1.20 billion. However, overall funding has remained essentially flat for over a decade. While investments towards research for preventive vaccines and female condoms increased from 2014 levels, investments towards microbicides, PrEP, TasP, VMMC and PMTCT declined.

HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape (1-pager)

This annual accounting of funding for biomedical HIV prevention research tracks trends and identifies gaps in investment. In 2015, reported funding for HIV prevention R&D decreased from US$ 1.25 billion in 2014 to US$1.20 billion. However, overall funding has remained essentially flat for over a decade. While investments towards research for preventive vaccines and female condoms increased from 2014 levels, investments towards microbicides, PrEP, TasP, VMMC and PMTCT declined.

Not To Be Missed: New report on funding for prevention research

The span of a decade—that interval that’s neither too long nor too short to bring innovation—is one that’s often used in the HIV prevention research space, usually to convey optimism. Back in 1997, then President Bill Clinton called for a national commitment to develop an AIDS vaccine within ten years. Just this week, Bill Gates said, “With the right leadership and investments over the next decade, we can discover and deliver a vaccine for HIV.”

The success of these forward-looking claims has always depended on sustained funding. Note, in both cases, the emphasis on commitment and leadership. No one is promising a vaccine with anything less. A look back at the last ten years provides a warning on this front. Released today, the Resource Tracking for HIV prevention R&D Working Group’s latest annual report on global investment into biomedical HIV prevention reports that overall funding for HIV prevention research and development (R&D) has remained essentially flat for over a decade.

Close followers of the annual “RT” report take note—a preliminary version was released at AIDS 2016 in Durban in July. The final version contains slightly updated data and the same overall messages: with a slight fall from US$1.25 billion in 2014 to US$1.20 billion in 2015, overall funding for HIV prevention research and development (R&D) has been more or less level for the past ten years.

And what a decade it’s been! Consider the developments in PrEP, the pipeline of injectable ARVs for prevention and treatment, the continued advance of the ARV-containing vaginal dapivirine ring, and the insights and advances that have come from sustained scientific inquiry related to the search for an HIV vaccine. These are exciting times. And the fact that all of this happened in the context of flat funding for research doesn’t mean that flat funding will get us where we need to go next. As Tom Hope, PhD (Northwestern University) stressed at an opening plenary of the HIV R4P conference where the report was launched, the fact that funding is declining concurrent with new discoveries is a major challenge for the field.

The report notes that preventive vaccine research funding constituted the bulk of all investments, followed by investments in microbicides, TasP, PMTCT, PrEP, VMMC and female condoms. With the exception of vaccines and female condoms, every other HIV prevention option tracked by the working group experienced a decline. These trends are somewhat reflective of the cyclical nature of large-scale clinical trials—when trials end, funding drops off. Likewise, as some interventions enter full scale rollout, like VMMC and TasP, research in this arena can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues.

The right products need to be tested in the populations who need them most. The report is also a powerful reminder that this isn’t necessarily how research works. It provides information on the demographic breakdown of almost 900,000 participants in ongoing HIV prevention trials in 2015, with the majority of these volunteers residing in sub-Saharan Africa, most notably Uganda, Kenya, and South Africa. Only one in eight trial participants in 2015 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users, and cisgender women.

These sobering facts come in the context of a vigorous period in research and development. It’s a time of growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Taking stock of all that’s been accomplished with ten years of flat funding, now is the time to support continued progress with additional, well-targeted resources.

The Resource Tracking Working Group hopes that this tool provides strong facts for advocacy and supports efforts to assess public policy and its role in accelerating scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

Check out the report, share it with your fellow advocates, and be sure to let us know if your organization is either a funder or recipient of HIV prevention grants or if you have further questions or information about resource tracking at all!

Press Release

A Decade of Flat Funding Could Imperil Progress of the HIV Prevention Research Pipeline

Contacts

AVAC: Kay Marshall, kay@avac.org, +1-347-249-6375
IAVI: Arne Naeveke, anaeveke@iavi.org, +1-212-847-1055

A PDF version of this press release is also available.

Report released at HIV Research for Prevention Conference highlights funding trends, opportunities and challenges for HIV prevention R&D

Chicago – A new report released today at the second HIV Research for Prevention Conference in Chicago documents 2015 funding, highlighting a decade of flat funding and its potential impact on continued innovation in the HIV prevention research and development (R&D) field.

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 12th annual report, HIV Prevention Research & Development Investments, 2000-2015 Investment priorities to fund innovation in a challenging global health landscape, finds that funding for R&D of new and emerging prevention options decreased slightly in 2015. This was due in part to decreases from the US public sector and a downswing in global philanthropic funding.

Steady progress in R&D for AIDS vaccines, microbicides, pre-exposure prophylaxis using antiretroviral drugs (PrEP) and treatment as prevention (TasP) confirms science’s critical role in providing solutions to end the HIV/AIDS epidemic. Yet research for these badly-needed solutions is in danger of being slowed or even sidelined by inadequate funding.

“It is critical that investments into HIV prevention innovations, science and technology are scaled up to put us firmly on the Fast-Track to ending AIDS by 2030,” said Luiz Loures, Deputy Executive Director, UNAIDS.

In 2015, funders invested a total of US $1.20 billion across R&D, down from US $1.25 billion in 2014, across eight key areas: preventive AIDS vaccines, microbicides, PrEP using antiretroviral drugs, TasP, HSV-2 vaccines and operations research related to voluntary medical male circumcision, female condoms and prevention of vertical transmission.

The report also finds that investment is being made along all phases of the research pipeline but remains concentrated among a few large investors. A more diverse base of funders would increase the stability of R&D financing and cushion the impact if any of the major funders were to reduce their investments. To improve continuity, RTWG calls for a more balanced funding base, especially through support of new investment by European and low- and middle-income countries. The US public sector (primarily via the National Institutes of Health) remained the largest global contributor at US$850 million, accounting for 70 percent of total funding. Together the US government and the Bill & Melinda Gates Foundation, the largest philanthropic funder, accounted for 81 percent of all funding in 2015.

“There is now very strong momentum in research and development, and we need to expedite the development of vaccine strategies and other new, biomedical prevention options that promise to be safe, accessible and effective for use throughout the world,” said Mark Feinberg, President and CEO of IAVI. “There must be adequate and sustained investment at all stages from early laboratory research and to clinical testing if we are to truly be able to contain the HIV pandemic and approach and end to AIDS.”

This is indeed a time of great optimism for HIV prevention research. Daily oral PrEP is gaining traction as a new prevention option in an increasing number of countries; an antiretroviral-based microbicide ring that showed modest efficacy earlier in 2016 will be further evaluated to determine its viability as a prevention option for women; large-scale efficacy trials of an AIDS vaccine candidate and an injectable form of PrEP are slated to begin soon and a novel proof-of-concept trial of antibody-mediated prevention is underway in several countries. Many more promising candidates in earlier stages are progressing toward pre-clinical and clinical evaluation.

Importantly, 2015 saw increasing investment in the science of delivery – or implementation research – primarily focused on delivery of TasP interventions. Such investments will become even more important to help ensure new prevention options move quickly and efficiently into prevention programs and begin to have an impact on HIV infection rates. There is also an increasing understanding that research must understand and integrate the needs and desires of people who will eventually use new prevention options. Ensuring that the perspective of those for whom new prevention options are being developed is included from the beginning of the research process can help ensure that safe and effective products can be rolled out swiftly and be more fully accepted.

“Innovative science needs innovative funding,” said Mitchell Warren, AVAC Executive Director. “We need an expanded and more diverse global cadre of funders who will be involved in and dedicated to advancing HIV prevention R&D, including product delivery. And these investments need to ensure that new options like daily oral PrEP, and potentially the dapivirine vaginal ring, do not sit on the shelf unused because we don’t know how to effectively deliver them, and that future R&D better meets the needs and wants of those for whom products are developed.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking 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 IAVI, UNAIDS, 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.

Trial Participants by Prevention Research Area, 2015

Given the higher rates of acquisition seen across so-called key populations—members of highly burdened and underserved groups—it is critical to provide access to the research process such that they can participate and reap more immediate benefit of scientific progress. Greater efforts must be made to include key populations in this crucial process for the HIV prevention response to be truly impactful.