NIH-Funded HIV Trial Networks: A family tree

This graphic provides a visual history of the DAIDS Networks and a look at what’s proposed for the next funding cycle. It appears in AVAC Report 2017: Mixed messages and how to untangle them.

Total Global HIV Prevention R&D Investment by Prevention Option, 2015–2016

This graphic shows the percentage of total global investment in HIV prevention spent on different interventions in 2015 and 2016. For much more on HIV prevention research & development funding, visit www.hivresourcetracking.org.

US HIV Research: A family tree

This graphics shows a family tree representing HIV research in the United States. It appears in AVAC Report 2017: Mixed messages and how to untangle them.

Timeline for DAIDS HIV Trials Network Recompetition

This graphic looks ahead from 2017 through 2027 at the DAIDS HIV Trials Network Recompetition process. It appears in AVAC Report 2017: Mixed messages and how to untangle them.

New HIV Prevention Trials Hold Promise for New Prevention Options for Women

Just ahead of another World AIDS Day, two new efficacy trials officially launched in Africa today with the potential of additional HIV prevention methods in the future.

The two trials – one studying a new vaccine strategy from Janssen/Johnson & Johnson that could protect against multiple strains of HIV and the other with an injectable antiretroviral PrEP strategy every two months from ViiV/GSK – join five other efficacy trials that are hoped to expand the options available to meet the varied needs women and men have for HIV prevention over the course of their lives.

“It is unprecedented to have so much diverse activity in the field, with nearly 25,000 trial participants to be enrolled across all of these trials around the world. As we commemorate World AIDS Day, it’s important to pause and be thankful for the many thousands of women and men around the world who have stepped up to volunteer for clinical trials that have given us the means to respond to this epidemic, in whose footsteps the 6,000 African women who will take part in these two new trials now follow,” said Mitchell Warren, executive director of AVAC, a global HIV prevention organization.

“Equally unprecedented is the level of pharmaceutical engagement within these trial partnerships. While both of these new trials are jointly funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation, the two product developers are active financial partners,” said Warren. “We hope that the examples of ViiV and Janssen will prompt additional and sustainable industrial partnerships in HIV prevention research.”

“These new trials come at one of the most dynamic times for HIV prevention. There are more trials of new concepts; more programs beginning to deliver daily oral PrEP; a vaginal ring going through regulatory review; record numbers of people on HIV treatment; new guidelines reflecting the scientific evidence behind undetectable = untransmittable; and real-world evidence from Uganda that scaling up treatment and voluntary medical male circumcision can reduce new HIV infection at a population level,” said Warren.

This dynamism also makes the field far more complex than ever before, as these multiple signs of progress co-exist and compete for resources. Later today, AVAC will be releasing its annual “state of the field” report—Mixed Messages and How to Untangle Them—which addresses these realities. The report will be available online at www.avac.org/report2017.

“Both new trials could pave the way for valuable new long-acting prevention options—in addition to, not instead of, the interventions we have today. As the AVAC Report describes, now is the time to structure research agendas and networks, oral PrEP programs and comprehensive approaches to HIV prevention in such a way that they lay the groundwork for strategies like those being tested in these trials,” Warren said.

Press Release

New HIV Prevention Trials Hold Promise for New Prevention Options for Women

Contacts

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

New York — Just ahead of another World AIDS Day, two new efficacy trials officially launched in Africa today with the potential of additional HIV prevention methods in the future.

The two trials – one studying a new vaccine strategy from Janssen/Johnson & Johnson that could protect against multiple strains of HIV and the other with an injectable antiretroviral PrEP strategy every two months from ViiV/GSK – join five other efficacy trials that are hoped to expand the options available to meet the varied needs women and men have for HIV prevention over the course of their lives.

“It is unprecedented to have so much diverse activity in the field, with nearly 25,000 trial participants to be enrolled across all of these trials around the world. As we commemorate World AIDS Day, it’s important to pause and be thankful for the many thousands of women and men around the world who have stepped up to volunteer for clinical trials that have given us the means to respond to this epidemic, in whose footsteps the 6,000 African women who will take part in these two new trials now follow,” said Mitchell Warren, executive director of AVAC, a global HIV prevention organization.

“Equally unprecedented is the level of pharmaceutical engagement within these trial partnerships. While both of these new trials are jointly funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation, the two product developers are active financial partners,” said Warren. “We hope that the examples of ViiV and Janssen will prompt additional and sustainable industrial partnerships in HIV prevention research.”

“These new trials come at one of the most dynamic times for HIV prevention. There are more trials of new concepts; more programs beginning to deliver daily oral PrEP; a vaginal ring going through regulatory review; record numbers of people on HIV treatment; new guidelines reflecting the scientific evidence behind undetectable = untransmittable; and real-world evidence from Uganda that scaling up treatment and voluntary medical male circumcision can reduce new HIV infection at a population level,” said Warren.

This dynamism also makes the field far more complex than ever before, as these multiple signs of progress co-exist and compete for resources. Later today, AVAC will be releasing its annual “state of the field” report—Mixed Messages and How to Untangle Them—which addresses these realities. The report will be available online at www.avac.org/report2017.

“Both new trials could pave the way for valuable new long-acting prevention options—in addition to, not instead of, the interventions we have today. As the AVAC Report describes, now is the time to structure research agendas and networks, oral PrEP programs and comprehensive approaches to HIV prevention in such a way that they lay the groundwork for strategies like those being tested in these trials,” Warren said.

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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 AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Evolving Context for HIV Prevention Research (Map)

A global map showing selected HIV prevention research and oral PrEP status.

Global HIV Prevention R&D Investment by Technology Category, 2000-2016

In 2016, funding for HIV prevention R&D decreased by 3 percent (US$35 million) from the previous year, falling to US$1.17 billion. Funding in 2016 signals the lowest annual investment in HIV prevention R&D in more than a decade.

New Report: Investment trends for HIV prevention and cure R&D

It is said success breeds success. 2016 was a year of encouraging progress, indeed success, on a number of HIV prevention fronts. Two trials of the dapivirine vaginal ring showed efficacy, a spate of new vaccine and antibody trials began, and a trial of long-acting injectable PrEP launched.

Those developments are successes by any measure, and yet this year’s funding report from the Resource Tracking for HIV Prevention Research & Development Working Group (Working Group) shows that prevention funding continues to slowly decline overall. Over the same time, cure research got a big bump from global funders. A separate cure-focused brief from the Working Group, developed in partnership with the International AIDS Society (IAS), showed investment in cure research tripled since 2012.

Global HIV Prevention R&D Investment by Technology Category

Released today, the Working Group’s latest annual report on global investment in biomedical HIV prevention shows that overall funding for HIV prevention research and development (R&D) has fallen to its lowest level in a decade.

The prevention research report notes that funding for preventive vaccine research constituted the bulk of all investments, followed by investments in cure, microbicides, prevention of mother-to child transmission (PMTCT), PrEP, medical male circumcision (VMMC), treatment as prevention (TasP) and female condoms. Over half of the 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 PrEP, VMMC and TasP, research in this area can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues. The progress of this research in the context of flat funding should not be misconstrued. Flat funding will not get us where we need to go next.

Taking stock of all that’s been accomplished with a decade of flat funding, it’s important to note that two million people continue to be infected each year. To achieve control of the epidemic, the field must also take stock of what could be achieved with the right priorities.

The right products need to be tested in the populations who need them most, and research does not always connect well to the people who are most at risk. The report explores the demographic breakdown of almost 700,000 participants in ongoing HIV prevention trials in 2016, with the majority of these volunteers residing in sub-Saharan Africa, most notably in treatment as prevention trials in Botswana, Uganda, Kenya and South Africa. Only one in eight trial participants in 2016 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users and cisgender women.

An intensifying trend towards a small number of large investors is concerning. Together, the US public sector and the Bill & Melinda Gates Foundation (BMGF) represented 88 percent of the total global investment in 2016, compared to 81 percent in 2015. Simply put, for every dollar spent on HIV prevention R&D in 2016, 88 cents came from just two donors.

On a hopeful note, global investment in research toward an HIV cure increased to US$268 million, a 33 percent increase over 2015 levels, with a number of new funders, and an expanded research portfolio at the US National Institutes of Health. The majority of investments (US$253.2 million) came from the public sector with US$13.8 million invested by philanthropies such as Aids Fonds, amfAR, CANFAR, the Bill and Melinda Gates Foundation, Sidaction and Wellcome Trust.

This is a vigorous period in research and development, reflecting a growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Now is the time to support continued progress with additional, well-targeted resources.

The Resource Tracking Working Group hopes these reports will serve as tools for advocacy and be used to develop public policy that accelerates 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

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.