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, [email protected], +1-347-249-6375
IAVI: Rose Catlos, [email protected], +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.

Press Release

Trump Administration’s proposed budget cuts will reverse more than a decade of life-saving HIV treatment and prevention rollout and halt promising research

New York, NY; May 24, 2017 — AVAC’s Executive director Mitchell Warren today released the following statement on the proposed 2018 budget from the Trump Administration:

President Trump’s 2018 budget request delivered to Congress yesterday would be a disaster for people living with HIV and for those at risk of HIV infection here in the US and around the world.

The budget, entitled “A New Foundation for American Greatness,” would, in fact, devastate health, development and research programs that are hallmarks of America’s profound commitment to advancing knowledge and saving lives at home and abroad. AVAC stands in solidarity with many partner organizations in calling on Members of Congress to restate the long-standing bipartisan support for a comprehensive domestic and global AIDS response.

No HIV treatment, prevention or research program supported by the US government is left untouched in the proposed budget. Critical global and domestic health, development and poverty programs also face devastating cuts. Evidence has shown us that the HIV pandemic is driven by poverty, gender inequality and violence, as are virtually all disease outbreaks. The spectrum of proposed cuts in this budget create conditions where HIV and other health threats will thrive, as America’s superb research and implementation capacities are hobbled and unable to respond.

  • The US PEPFAR program and the Global Fund to Fight AIDS, Tuberculosis and Malaria—to which the US is a major contributor—together provide the bulk of funding for HIV prevention, treatment and care programs in sub-Saharan Africa and other parts of the developing world. Both would receive significant cuts of approximately 15 percent in this proposed budget. These proposed reductions would have a disastrous and deadly impact on the fight to bring the AIDS epidemic to a conclusive end, as would cuts in related areas including family planning, reproductive health, and scientific research.
  • The proposed budget cuts USAID’s global health programs by a devastating 50 percent, and eliminates long-term investments in critical vaccine and microbicide research.
  • A $7 billion cut to the NIH includes a $1.1 billion cut to NIAID–almost a quarter of that Institute’s budget – which would likely have a devastating impact on HIV research overall, research and development of vaccines and other new prevention options, and scientific innovation.
  • Cuts to the CDC, the elimination of NIH’s Fogarty International Center, cuts to Medicaid and the Ryan White Program and other devastating and irrational cuts to the budget make it clear that this is nothing less than an assault on the health of citizens everywhere—in the US and abroad.

The budget proposal asserts the US government will continue treatment for “all current HIV/AIDS patients” under PEPFAR. PEPFAR has succeeded by increasing the number of people on treatment every year and providing critical funding for primary prevention programs. Increasing the number of people on treatment every year has contributed to the ambitious global goal of curbing the epidemic and of moving toward universal access to HIV treatment, a fundamental human right. Simply maintaining current treatment rolls is poor science and a poor investment of US resources. We know an increase in antiretroviral treatment (ART) programs with a parallel unstinting investment in additional HIV prevention programs, including voluntary medical male circumcision, condom programs and oral PrEP, will have significant impact on the pandemic. The proposed budget approach, which threatens prevention as well as treatment, will not.

The US government is the largest funder of HIV and global health programs and research. After years of prudent investment, we have seen amazing dividends in lives saved, families kept together, communities revitalized and economies boosted. Global health and HIV programs have enjoyed bipartisan support throughout the previous Bush and Obama Administrations. We call on the Congress to remember why these programs have been consistently supported and ensure they are reinstated in the 2018 budget.

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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.

Press Release

AVAC Statement on the Expanded Global Gag Rule

Today the Trump Administration took steps to implement a policy change that will endanger the lives of millions of adolescent girls and young women living in countries supported by US global health development aid. The State Department released a communication on the expansion of the “Global Gag Rule” — also known as the Mexico City Policy. The updated policy applies not only to US global health assistance for family planning—as have previous iterations of the Global Gag Rule—but to all US global health assistance.

The expansion has been erroneously rebranded as “Protecting Life in Global Health Assistance.” This policy is not life-saving; it is the opposite. This expanded rule will force clinics to close and women to lose access to contraception, HIV prevention and maternal health care, resulting in more unintended pregnancies and more unsafe abortions. It will prevent advocates, community health workers and others from sharing important information with women and girls most at risk.

Today’s announcement makes it crystal clear that the new administration does not value the lives of women and girls. US government funding and support for service provision and research and development under long-standing bipartisan leadership from both the legislative and executive branches has saved millions of lives and helped advance human rights for girls and women in Africa. It is infuriating to see Donald Trump roll back advances in health and human rights for women and girls with the stroke of a pen.

We know that because of the George W. Bush administration’s use of the Global Gag Rule many women and girls in developing countries were unable to access family planning and health services and some of them died because of that. With the present “youth bulge” in Africa, there are, in some countries, double the number of young people than there were when the epidemic began. Many of these young people are more concerned about pregnancy prevention than they are about HIV prevention; they need comprehensive services for both HIV and family planning. Today there are millions of girls and young women seeking access to contraception, HIV prevention and treatment and other health services. The Trump administration has just closed the doors to clinics offering comprehensive services that will save their lives and the lives of their children.

AVAC and our partners in Africa will do all that we can to help ensure that lifesaving programs and information for women and girls continue. And we will continue to speak out against the immoral and anti-public health decisions made by this administration.

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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.

Press Release

2016 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy Celebrates the Prevention Research Advocacy Movement

85 Leaders in HIV Prevention Advocacy from 19 Countries Honored

Chicago – The fourth Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was presented today at the second HIV Research for Prevention (HIVR4P) Conference in Chicago. The award is given in memory of Nigerian activist Omololu Falobi, who is remembered by friends and fellow advocates as a talented journalist, an activist for social justice, an advocate for prevention research and a son of Africa who worked tirelessly to ensure Africans were taking ownership of their own HIV care and prevention.

Since 2008, the award has been presented in Falobi’s memory as ongoing legacy that recognizes his commitment and lasting contributions to HIV prevention research advocacy and honors those who follow in his footsteps.

In a break with tradition, the selection committee decided on this 10th anniversary of Falobi’s passing that it was fitting to honor his legacy by celebrating not an individual, but the prevention advocacy movement. The 2016 award celebrates 85 advocates from 19 countries, all nominated by their peers in the field. The honorees include community and global advocates, researchers, funders, policy makers and others who have helped bring the HIV prevention field to where it is today.

The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was established in 2008 by the African Microbicides Advocacy Group (AMAG) and partner organizations to recognize advocates’ contribution to the HIV prevention research field through advocacy. Today the award is presented by AMAG, AVAC, International Rectal Microbicides Advocates (IRMA), Journalists Against AIDS Nigeria (JAAIDS), New HIV Vaccine and Microbicides Advocacy Society (NHVMAS) and Treatment Access Movement (TAM) Nigeria.

Manju Chatani-Gada of AVAC, who directs the AVAC Advocacy Fellows Program profiled this year’s 85 recipients at the closing ceremony of HIVR4P.

“These 85 honorees are a fraction of the thousands of people who have worked to push the HIV prevention field forward in the decade since we lost Omololu,” Chatani-Gada said. “Together we have helped shape a revitalized HIV prevention field. Omololu was devoted to building a movement and he would have been so proud that advocates have been key partners in building the field.”

The Falobi Award includes a cash prize and this year’s prize is being given to Falobi’s children through the Omololu Falobi Foundation.

Nigerian advocate Morenike Folayan accepted the award on their behalf. “Omololu was a visionary leader and activist, who accomplished much in his too-short life. He dedicated himself to powerful advocacy for HIV and HIV prevention research in Nigeria, Africa and worldwide, Folayan said. I know he would be proud of every one of the honorees.”

Profiles of all 85 honorees and more information about the award, Falobi, and previous recipients are online at www.avac.org/falobi.

Press Release

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

Contacts

AVAC: Kay Marshall, [email protected], +1-347-249-6375
IAVI: Arne Naeveke, [email protected], +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.

Press Release

Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Contacts

The fundamentals of HIV treatment provision: eight global HIV advocacy groups release consensus statement at the International AIDS Conference

Durban, South Africa—The HIV epidemic could become a thing of the past, as long as everyone involved in providing HIV drugs as treatment and as prevention sticks to a few basic principles respecting the rights of people with or at high risk of HIV, eight global HIV treatment advocacy organisations announced today on the eve of the 2016 International AIDS Conference.

AVAC, the European AIDS Treatment Group (EATG), the Global Forum on MSM & HIV (MSMGF), the Global Network of People living with HIV (GNP+), HIV i-Base, the International HIV/AIDS Alliance, the International Treatment Preparedness Coalition (ITPC) and NAM/aidsmap have released the Community Consensus Statement on Access to HIV Treatment and its Use for Prevention as a sign-on statement at www.hivt4p.org for endorsement by as many people working with and affected by HIV as possible.

Simon Collins, advocate at HIV i-Base says, “This clear community demand for the right for universal access to ART is an essential step to achieving our common goal to end AIDS.”

Sixteen years ago, the International AIDS Conference was also held in Durban. That ground-breaking conference woke the world to the fact that providing HIV treatment to people in under-resourced countries was not only lifesaving and a matter of global justice, it was, even more importantly, feasible.

Since then, in what is one of the most remarkable medical initiatives of all time, HIV treatment has expanded to the point where 2016 will be the year that more than half of the people in the world who need HIV treatment get it.

But that still leaves nearly half the world in danger of dying from AIDS, and that need is concentrated among certain regions such as the Middle East and eastern Europe and among certain groups such as people who inject drugs.

In addition, although people on treatment are less infectious, the number of HIV cases continues to rise among some groups, most notably men who have sex with men.

Why? Partly it is due to the number of people still in need of treatment; equally, however, it is because those unreached by treatment or appropriate prevention belong to already-stigmatised groups likely to be stigmatised further if it is known they have HIV.

“While in practice, getting HIV treatment to those who need it may involve considerable expense, logistical challenges and a re-modelling in healthcare services,” says NAM/aidsmap’s Gus Cairns, who helped write the statement, “in principle, it’s not complicated”.

“At heart, the statement says two things: Don’t withhold HIV treatment; equally, don’t enforce it. People have the right to treatment, but also the right to the information and freedom they need to take it as a choice.”

The statement is written as 40 short sentences in deliberately simplified English, spelling out basic principles to be observed in extending HIV testing, treatment and drug-based prevention to all.

The statement emphasises that treatment should be free and offered to everyone with HIV without coercion. Information about treatment and support to take it should be available for everyone. Income, gender, sexuality, age, drug use or social status should not prevent people from getting antiretroviral treatment (ART).

The statement also covers the use of antiretroviral drugs by people who are HIV-negative to prevent HIV infection, known as pre-exposure prophylaxis or PrEP. The option to use PrEP should be available for all people who need it and information about PrEP should be available to all people at risk of HIV infection. PrEP should be offered now to those at high risk of HIV infection, the statement recommends.

“We wanted to hold people’s feet to the fire in the world of HIV,” Cairns continues, “and say essentially, ‘If you can’t agree to this, why not?’ We’d like to see it adopted by the organisations that write treatment guidelines and run programmes as a sort of DNA for what they are doing, the basic principles underlying and directing their actions.”

The following organisations have been involved in writing this statement:

Background

Two years ago, NAM and EATG, with the support of a number of other organisations, released the Community consensus statement on the use of antiretroviral therapy in preventing transmission. This went through a year’s worth of development and was released as a sign-on statement. This new statement is a simpler, more fundamental and more widely co-authored development of that.

Why a new statement?

The science surrounding the use of antiretrovirals to prevent HIV, as well as policy and activism, have moved rapidly over the last two years. In particular, there is now broad consensus for the first time that antiretroviral therapy is both of general medical benefit to people with HIV and, if provided globally, could drastically reduce the HIV infection rate worldwide. In addition, there is increasing awareness of and debate about the use of antiretroviral drugs as PrEP, to prevent infection in HIV-negative people at the highest risk of HIV infection.

Press Release

Data gaps hinder global efforts to reduce HIV infections, AVAC report warns; improved data collection and reporting needed to meet looming global AIDS targets

Contacts

Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

In a report issued today, AVAC warned that major gaps in global HIV/AIDS data stand in the way of delivering HIV prevention advances to millions of people who need them most. The report identifies several critical weaknesses of today’s HIV prevention data collection and monitoring systems and offers a concrete roadmap for closing these gaps. The report, Big Data, Real People, was issued ahead of next week’s International AIDS Conference in Durban, South Africa (July 18-22), where advocates will demand action to speed HIV prevention research and delivery.

“In an era in which big data are expected to improve essentially every part of our lives, there’s no excuse for HIV prevention data systems to be so uneven, incomplete and inefficient,” said Mitchell Warren, AVAC’s executive director. “To have any chance of ending the epidemic by 2030, we need to be collecting and accounting for every bit of useful information from every person living with or at risk for HIV.”

The need for improved HIV prevention data systems is particularly pressing given the UNAIDS “fast-track” goal to reduce new annual diagnoses to no more than 500,000 by 2020. Earlier this month, UNAIDS reported that the number of new HIV infections has remained near 2 million per year for the past decade.

Report identifies specific HIV data gaps, recommends solutions

AVAC’s report focuses on four critical data gaps that must be addressed to effectively prioritize, target and measure the impact of efforts to develop and deliver HIV prevention advances.

Specifically, today’s HIV prevention data are:

  • Not sufficiently broken down by age, gender, income status, key population status and other vital categories
  • Missing or incomplete for key populations most in need of prevention, including adolescent girls and young women, men who have sex with men, transgender women, and others
  • Not tied to useful HIV prevention metrics and indicators, so that it is impossible to know whether prevention programs are actually averting infections and improving health
  • Not effectively informing the HIV prevention research agenda

To overcome these weaknesses, the report outlines three critical strategies that should be pursued most urgently:

1. Standardize and systemize data collection and reporting for HIV prevention

Understand, measure and report on the risk level of people testing HIV-negative; create and measure linkages to evidence-based prevention for people at substantial risk; and use a standardized “Prevention Data Dashboard” to continually evaluate progress. Such dashboards would consolidate and arrange available data to illuminate critical prevention gaps and help the global community, governments and funders better conceptualize their HIV prevention programming and evaluation. AVAC’s report provides a model dashboard for decision-makers to adopt.

2. Improve use of data for adolescent girls and young women

Ensure that a growing volume of available data can be applied in a meaningful way. As a first step, funders, implementers and governments need to do a better job of defining and segmenting this population; map who is investing in what and where; put adolescent girls and young women in control of core aspects of the data-collection enterprise; and adopt gender-specific indicators tailored to girls and women.

3. Put research on the “fast-track” and countries at the center

Fit biomedical HIV prevention research into comprehensive prevention plans tied to national targets for incidence reduction. Countries and research institutions must invest time and resources in stakeholder engagement; ensure that research priorities are informed by epidemiological and other quality HIV data; and develop national research plans for meeting the prevention needs of specific, affected populations.

The new report and related resources, including downloadable graphics, are available now at www.avac.org/report2016.

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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.

Press Release

Two clinical trials offer first evidence that vaginal ring may be important HIV prevention option for women

Contacts

Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

AVAC says donors, researchers, regulators and communities must act swiftly to determine future of this approach

Boston, Massachusetts — Results of two large-scale clinical trials in Africa show promise for a potential new HIV prevention option for women but more work is needed before the vaginal ring containing the antiretroviral (ARV) drug dapivirine can be added to the very short list of HIV prevention options controlled or initiated by women.

“It’s clear that the dapivirine vaginal ring can be a viable option for women to protect themselves from HIV,” said Mitchell Warren, AVAC executive director. “These well conducted studies provide clear evidence that some women can reduce their risk of acquiring HIV by using the ring consistently, and they also raise critical questions about the level of use, benefit and future role in prevention that need to be answered. Researchers, donors, regulators and advocates now need to determine the best way forward to determine if and how the dapivirine ring could be used by women at risk of HIV infection.”

“Many women in sub-Saharan Africa – and notably younger women – remain at substantial risk of contracting HIV, and they need and deserve a range of options that they can control and comfortably use to protect themselves every time they have sex. Today, daily oral PrEP is the only truly discrete prevention option they can control. The dapivirine vaginal ring might become an additional option, as additional questions are answered and regulatory agencies consider these results. In the meantime, the incredibly high HIV infection rates among women in these trials tell us that we need to make oral PrEP more widely accessible and available with urgency.”

The results of the two studies, ASPIRE and The Ring Study, were previewed today by researchers at the Conference on Retroviruses and Opportunistic Infections (CROI) ahead of a scientific presentation later this week. Results from the ASPIRE study were also published today in the New England Journal of Medicine. The trials evaluated the safety and efficacy of a vaginal ring – which women placed themselves and replaced each month – containing the ARV dapivirine.

Both trials had similar results. Among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent. Both studies found the ring was safe to use.

In both trials, efficacy was substantially higher among the subset of women who were over 21 who appeared to keep the ring in consistently throughout the month. As with previous trials with other prevention methods, adherence to the prescribed use appeared higher among older women, which might explain higher levels of efficacy in these age groups. (For more information on the results see the table at the end of release).

“We congratulate the trial sponsors, scientific collaborators and partners for these well run and scientifically rigorous trials. We especially want to thank the more than 4,500 women whose altruism and commitment as trial participants made this effort possible,” Warren added.

The lack of protection seen among women in the trial between 18 and 21, likely because of lower adherence, is not unique to these two studies. Previous ARV-based prevention efficacy trials with both tenofovir gel and tenofovir-based oral PrEP also saw lower protection among younger male and female participants, likely due to lower adherence. With daily oral PrEP, however, adherence increased for younger participants in subsequent post-trial studies, in which participants knew that PrEP had already been proven effective and that they were receiving the active product.

“It is reasonable to believe that both adherence and efficacy can be increased for dapivirine ring use, just as we’ve seen it increase over time in PrEP studies,” Warren said. “A critical first step is to launch open label extension studies, with no placebo, among former ASPIRE and Ring Study participants. These studies results are needed to help guide decisions about regulatory approval and, perhaps, eventual rollout of a monthly dapivirine ring. In addition, we need to look at streamlining the process of developing a combination ring that would could protect against both HIV and pregnancy.”

As the product developer, IPM, along with the other trial sponsors and researchers, look at the path forward for the dapivirine ring, they can look to learn lessons from oral PrEP programs, female condoms and from the contraceptive field to understand how to better support adherence, improve product use and address special access needs of young women.

“HIV continues to be a public health crisis, especially for young African women who have few options for protecting themselves from HIV infection,” Warren said. “With each new prevention research result over the past six years show partial protection – for oral PrEP, microbicide gel and the RV 144 vaccine – AVAC said there was a global imperative to act on those results,” Warren said. “Today, there is a global imperative to act on these new vaginal ring results with a clear path to regulatory review and a fully funded, carefully prioritized research agenda to help answer the remaining questions about the dapivirine ring and how it might be added to prevention options for women.”

“While we need understand the path forward for rings and deliver existing HIV prevention and treatment options, we also need to press ahead with research and development of additional options. As long as women continue to be infected by HIV at high rates, we have a moral imperative to sustain the search for prevention options that women will want and use, including long-acting ARV-based prevention options, vaccines, antibody-mediated prevention and multipurpose prevention options that may combine HIV prevention with contraceptives,” 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.

Press Release

New WHO guidelines on ART and PrEP can put the world on track to end AIDS – If they are implemented quickly and comprehensively says AVAC

Contacts

Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

New York, NY — Today’s World Health Organization (WHO) “Early Release Guideline” on antiretroviral therapy (ART) for HIV treatment and pre-exposure prophylaxis (PrEP) for HIV prevention has the potential to change the world and help begin to end the AIDS epidemic – if the guidance is swiftly and comprehensively funded and implemented. The new guideline recommends providing ART to all adults living with HIV, regardless of CD4 cell count, and offering oral PrEP as an additional prevention option to all people at substantial risk of acquiring HIV.

“This is a cause for celebration,” said Mitchell Warren, AVAC Executive Director. “WHO is paving the way for a fundamental shift in the world’s response to HIV – abandoning the partial or piecemeal use of antiretroviral medicines in favor of full access for men and women in need. Both science and conscience demand that we put these recommendations into effect as quickly as possible.

“If fully funded and implemented, the recommendations will greatly simplify ART for people living with HIV and revolutionize prevention for people at risk. But there is much work ahead to translate them into practice, from securing resources to revamping HIV guidelines in country after country to implementing comprehensive treatment and prevention programs. These new recommendations will contribute to achieving the #GlobalGoals agreed by the UN last week; now global leaders like PEPFAR and the Global Fund and national governments must begin rallying resources and laying out a vision for action.”

ART “on demand” is a wholly new concept in many parts of the world, where people have long been told to wait until they were sick or approaching low CD4 cell counts to begin treatment. Much work will need to be done to ensure that this guidance is understood and implemented.

The recommendation of PrEP for all people at substantial risk replaces prior WHO guidance focusing on men who have sex with men and on heterosexual couples in which one partner is HIV positive and the other negative. Importantly, it vastly expands the likelihood that oral PrEP will be offered to young women, offering them a long-needed prevention option that they can use discretely, not at the time of sex—a profoundly important development.

AVAC works in coalition with advocates, activists and scientists on advancing an effective AIDS response, and many partners welcome the news and call for immediate action.

“We are hoping that the WHO guidelines push governments in the right direction and finally policy makers will move to making both treatment and PrEP available to those who desperately need it,” said Yvette Raphael, a human rights activist who recently completed a year-long project focused on addressing the HIV prevention, treatment, and sexual and reproductive health needs of young South African women. “In South Africa, many young women have expressed the need for PrEP to be available as an option that will work for them. PrEP can help young women and girls take more control of their sexual and reproductive health rights and be more empowered to control their own sex lives. As a woman who has been living with HIV for 15 years, I know the importance of taking control of all aspects of your life and health.”

“Women living with HIV have been on the frontlines of demanding access,” said Lillian Mworeko, Director of ICW EA. “Now we are on the frontlines of demanding programs that include and prioritize peer support, civil society partners, and a rights-based, treatment-literacy oriented approach to the offer of ART to all.”

“A revolution in HIV prevention is now underway,” said Tom Craig, who participated in the IPERGAY trial, and advocates for improved HIV treatment and prevention. “The concept of combination prevention is now widely accepted, and now PrEP is a part of that revolution. The problem is that few people know about it, especially those in key populations, where the rate of new infections are at an all time high. When will we have access to it? Why is it taking so long? How many more people need to be infected before our governments take action?”

“As a sex worker and prevention advocate from Kenya, I have traveled my country speaking about PrEP,” said Carol Njoroge, a rights activist with the Kenya Sex Worker Alliance and a 2015 AVAC Fellow focused on expanding PrEP access. “I see that most of the people at high risk of HIV who know about PrEP and how effective it is, want it. There is demand from male, female and transgender sex workers and others at high risk for HIV, and we have PrEP demonstration studies looking at how best to provide PrEP in the real world. And in Kenya we have a “Prevention Revolution Roadmap.” But there’s still a lot more needed: clear clinical guidelines, regulatory approval, civil society partnership and funding commitments to make PrEP a reality in Kenya. These recommendations from WHO at this time – can help Kenya move towards PrEP rollout.”

AVAC is committed to working with these and other partners around the world to ensure that the new treatment and PrEP recommendations are put into practice as part of comprehensive programs that address and protect human rights, minimize gender inequities and include tailored packages of proven strategies including harm reduction, male and female condoms and voluntary medical male circumcision—a critical intervention to bring to scale in any epidemic driven by heterosexual transmission.

“We can’t let these groundbreaking guidelines sit on a shelf,” said Warren. “If taken seriously, they can help ensure that millions of people with HIV live long and healthy lives, and that millions more women and men at high risk can remain uninfected.”

At the same time, continued research into additional prevention options is critical. Two efficacy trials of a monthly vaginal ring with a different ARV called dapivirine; phase II trials of two different injectable ARVs, used every two or three months; a phase II daily rectal microbicide gel; ongoing HIV vaccine trials and new passive antibody studies may eventually provide additional options for young people and others at high risk of HIV.

“These guidelines are also an important reminder of the essential work of crafting, funding and implementing a truly comprehensive, integrated and sustained response that links rights-based prevention, treatment and research to end the epidemic,” said Warren.

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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.

Press Release

Investment in post-efficacy R&D critical for PrEP, other new HIV prevention options

Contacts

AVAC: Mitchell Warren,[email protected], +1‐914‐661‐1536
Kay Marshall, [email protected], +1-347-249-6375
IAVI: Barbara Rosen, [email protected], + 1.646.206.9331

New funding sources needed to sustain innovative HIV prevention R&D
Vancouver, Canada, 17 July 2015 – The last decade has seen investment in HIV prevention R&D move beyond bench science and clinical trials to include significant funding for implementation research for proven prevention options, such as pre-exposure prophylaxis (PrEP) and voluntary medical male circumcision (VMMC), according to a new report from the HIV Vaccines and Microbicides Resource Tracking Working Group.

Understanding how to ensure a new product reaches those most in need though effective programs is a critical part of HIV prevention research. Positive results from a number of clinical trials of daily oral PrEP led to approval by the US Food and Drug Administration (FDA) and initial guidelines from the World Health Organization (WHO) in 2012. Since then the rallying cry for PrEP researchers and advocates has been “PrEP works, but we must find out how to deliver it effectively.”

In 2014, a number of PrEP demonstration and implementation projects in different settings and populations were underway to help find how to best deliver PrEP. The Working Group found that investment in these projects and several ongoing studies testing long-acting PrEP formulations led to a significant increase in funding for PrEP in 2014 – US $48 million, up from US $36 million in 2013.

“We are at a crucial point in the history of the AIDS response. Sustained investment in research has led to major scientific advances in the past few years,” said Luiz Loures, deputy executive director, Programme, Joint United Nations Programme on HIV/AIDS (UNAIDS). “Now we need to fast-track implementation and ensure that results are made available to people at scale and with urgency.”

HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health And Development Landscape is the 11th annual report by the Working Group, a collaboration among AVAC, UNAIDS, and the International AIDS Vaccine Initiative (IAVI). The report summarizes investment in HIV prevention research across eight prevention options, as well as HSV-2 vaccine and HIV cure and therapeutic vaccine R&D. For the first time this year’s report also tracks investment in R&D for multipurpose prevention technologies (MPTs), an increasing focus of prevention research. The report was released today ahead of the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, Canada. Breakdowns by prevention category are available in the full report at www.hivresourcetracking.org.

A decade of sustained funding, but a decline in number of funders
Overall funding for HIV prevention research was relatively stable over the past decade, peaking at US $1.31 billion in 2012 and remaining essentially flat in 2014 at a total of US $1.25 billion from public-sector, philanthropic and industry investors. In 2014, as in previous years, the US government – primarily through the US National Institutes of Health (NIH) – was by far the largest public sector funder and the Bill & Melinda Gates Foundation remained the largest philanthropic funder. Together they provided 83 percent of total funding. In 2014 there was a decline in the number of individual funders overall, and the number of philanthropic funders has decreased from a high of 30 in 2010 to 16 in 2014.

Calling for an expanded and diversified investment base, the Working Group warned that funding reductions from one or two major donors could imperil the progress of HIV prevention research over the next decade, when several new HIV prevention options – including HIV vaccines, injectable PrEP, new microbicide formulations and multipurpose prevention technologies – now in early stage human trials, may be moving to large scale efficacy trials. These large trials would likely require significant new investment.

“Ending AIDS once and for all will require critical investments in prevention research and development,” said IAVI CEO Margie McGlynn. “This report highlights funders whose commitment should be celebrated, but also underscores the need for public-sector and philanthropic stakeholders to re-engage to the benefit of individuals, communities and economies worldwide. The links between improvements in health and sustainable development are clear.”

The last decade has seen major breakthroughs in HIV prevention R&D, not only in results, but also early stage research and improvements on the way large-scale trials can be conducted, paving the way for innovative new trials and major gains in HIV prevention R&D in the coming decade.

“Innovative science needs innovative funding. We need an expanded and more diverse global cadre of funders who will be involved in and dedicated to advancing HIV prevention R&D and ensuring that new options like PrEP do not sit on the shelf unused because we don’t know how to effectively deliver them,” said Mitchell Warren, AVAC executive director.

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

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The HIV Vaccines and Microbicides Resource Tracking Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). The Working Group has been tracking investment in HIV prevention research since 2004. The Working Group generates estimates of R&D investment that can be compared year to year, across separate technologies and across funding sources, helping assess the impact of public policies aimed at accelerating scientific progress and providing facts for advocacy. This effort provides transparency for funders, policy makers and HIV/AIDS advocates to understand and track investment flows year-to-year.