Press Release

Discontinuation of the FEM-PrEP Trial Disappointing, AVAC Says; Calls for continued research to find new ways to end the HIV epidemic

New York, 18 April 2011 – At a scheduled, interim data review, the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP study of oral pre-exposure prophylaxis (PrEP) using daily TDF/FTC (brand-name Truvada) determined that the trial would not be able to answer the question of whether the study drug decreased risk of HIV infection among HIV-negative women at risk via sexual transmission. The IDMC has, therefore, recommended that the study be discontinued.

“Today’s announcement about the FEM-PrEP study is disappointing,” said Mitchell Warren, AVAC executive director. “However, it must be seen as what it is – the closure of a single trial in a field that has generated exciting results in the recent past. Even with this finding, there is still a strong rationale for continuing other trials, including those in women, in hopes of obtaining better results in the future.”

The FEM-PrEP trial tested the same drug and daily dosage of TDF/FTC (also known as Truvada) as the landmark iPrEx PrEP trial among gay and bisexual men and transgender women. Last November, results of the iPrEx trial showed a 44 percent reduction in HIV risk overall in participants who received TDF/FTC compared to those who received the placebo. In July 2010, results of the CAPRISA 004 study showed a 39 percent reduction in HIV risk among women who used a 1% tenofovir gel microbicide compared to those who received a placebo gel. In both trials, there was evidence that adherence matters – that participants who used the intervention most consistently had the highest levels of protection.

Two other ongoing trials in sub-Saharan Africa are evaluating oral TDF/FTC and/or TDF alone among heterosexuals. The VOICE trial is evaluating oral TDF and TDF/FTC as well as 1% tenofovir gel in 5,000 women in sub-Saharan Africa. Partners PrEP is evaluating oral TDF and TDF/FTC in the HIV-negative member of couples in which one partner is HIV-infected.

“The premature closing from FEM-PrEP does not predict the findings from either VOICE or Partners PrEP,” Warren said. “It is too soon to tell whether the differences observed between iPrEx and FEM-PrEP are due to the route of exposure, pill-taking behavior, biological differences in drug activity, or some other factor. Along with further analysis of FEM-PrEP data, VOICE, Partners PrEP and other ongoing trials will add critical pieces to the puzzle of if and how to deploy PrEP as an effective prevention tool.”

“We commend the FEM-PrEP trial team, the members of the IDMC and especially the nearly 2,000 women who participated in the trial. Despite the inability of the trial to answer the question of whether TDF/FTC reduces women’s risk of HIV infection, FEM-PrEP has provided and will continue to provide key information that will help move the PrEP research agenda forward,” Warren said.

Further analysis of the FEM-PrEP data will provide a better of understanding of the observation that there was a higher pregnancy rate among women in the active drug arm of the trial, compared to those in placebo arm.

In addition to VOICE and Partners PrEP, there is an ongoing PrEP efficacy trial among injection drug users and a soon-to-be-launched follow-on to iPrEx known as the iPrEx Open Label Extension study, or iPrEx OLE. There are still close to 20,000 participants involved in PrEP trials around the world.

“Medical research is often complicated, and we must expect setbacks along the way. But with 2.6 million new HIV infections every year, it is imperative that we continue to look for new ways to curb the epidemic,” Warren added. “The success of the iPrEx and the CAPRISA 004 trials have shown the promise of ARV- based prevention options as part of a comprehensive prevention package that includes condoms behavioral counseling and treatment of other sexually transmitted diseases. There will never be a silver bullet for HIV prevention, so we must continue to seek a variety of new options to protect those at risk through different routes of transmission and throughout their lives.”

More information about ongoing PrEP research is available at avac.org/prep.

 

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

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About AVAC: Founded in 1995, AVAC is an international non-profit organization that uses education, policy analysis, advocacy, and community mobilization to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

New report provides women’s perspectives on medical male circumcision for HIV prevention: Findings from community-led research in five African countries

New York, NY—A new report from the Women’s HIV Prevention Tracking Project (WHiPT), a collaborative initiative of AVAC and the ATHENA Network, features an unprecedented collection of voices from Kenya, Namibia, South Africa, Swaziland and Uganda reflecting on what male circumcision for HIV prevention means for women. It highlights women’s perspectives, advocacy priorities and recommendations on this new prevention strategy.

Making Medical Male Circumcision Work for Women is the first report from WHiPT, which was launched in 2009 to bring community perspectives, particularly women’s voices, to the forefront of biomedical prevention research and the broader response to HIV.

The report highlights community-level support as well as concerns and misperceptions that can hinder effective implementation.

“Women are excited for medical male circumcision because they’re desperate for new prevention options, but they lack detailed factual knowledge of its benefits and risks,” says Cebile Dlamini of Swaziland for Positive Living. “For example, the fact that it only provides partial protection can be overlooked and some women and men believe once a man is circumcised, he is by definition HIV-negative.”

In total, nearly 500 women in HIV-affected communities completed a questionnaire, developed and administered by the women-led WHiPT teams in five countries. Almost 40 focus groups provided additional information about women’s attitudes about medical male circumcision. In each country, research took place in different locales, selected to reflect a diversity of circumcision practices, including communities that practice traditional male circumcision and those that do not circumcise, as well as those practicing female genital mutilation.

The majority of teams conducted their research in settings where male circumcision for HIV prevention had not yet been introduced as part of a national HIV strategy. Therefore many reported perceptions and concerns can be integrated into emerging programs—making this report both timely and urgent.

The Kenyan WHiPT team surveyed women in settings where male circumcision was evaluated in a clinical trial and subsequently introduced. Reports from women reached by the Kenyan WHiPT team underscore women’s fears that male circumcision may lead to changes in men’s behaviors and perception of risk.

“The women reported their partners either adapting or continuing risky behavior after ‘the cut’”, says Carol Odada, from Women Fighting AIDS in Kenya.

The report documents women’s concerns that medical male circumcision might lead to an increase in heightened stigma for women living with HIV. This would be a result of circumcised men’s misperceptions that they could not be HIV positive and/or could not transmit the virus. Thus sex and or safer sex would be less negotiable than before circumcision, putting women at greater risk for gender-based violence and HIV.

The report also highlights perceptions of male circumcision for HIV prevention in the context of traditional practices. Specifically, it underscores the need for communications campaigns that directly address the distinctions between medical male circumcision, traditional circumcision and female genital mutilation.

“Some women report the concern that the promotion of circumcision for men would increase the promotion of female genital mutilation,” says Allen Kuteesa from Health Rights Action Group in Uganda.

The myths and misunderstandings identified by WHiPT teams – such as the perception that medical male circumcision is directly protective for women – underscore the urgent need for adequate education campaigns directed at women. Further, for women to access and act on information related to medical male circumcision and HIV, the information needs to be specifically tailored to women, and the socio-cultural context and realities of women’s lived experience need to be taken into account.

The report summarizes advocacy activities that WHiPT teams will undertake over the coming year to ensure that male circumcision implementation addresses women’s concerns.

To download the report and/or a recording of the global report launch teleforum with the report authors, go to www.avac.org/WHiPT.

About WHiPT: The Women’s HIV Prevention Tracking Project (WHiPT) is a collaborative initiative of AVAC and the ATHENA Network launched in 2009 to bring community perspectives, particularly women’s voices, to the forefront of the HIV and AIDS response. The specific purpose of WHiPT is to advance and facilitate the monitoring of HIV prevention research, advocacy and implementation by women who are the most affected by the epidemic. The WHiPT Report was produced by teams led by the AIDS Legal Network, South Africa; the ATHENA Network; AVAC; Health Rights Action Group, Uganda; Mama’s Club, Uganda; Namibia Women’s Health Network, Namibia; Swaziland for Positive Living, Swaziland; and Women Fighting AIDS in Kenya, Kenya.

Contacts: Cindra Feuer, +1 917 685 4942, [email protected]
Tyler Crone, +1 206 697 4789, [email protected]
Allen Kateesa, + 256 772 429 820, [email protected]

Press Release

Evidence that daily antiretroviral pill reduces HIV risk in gay men is a major breakthrough says AVAC: Public health agencies and communities must move quickly to translate trial results into impact

New York, 23 November 2010 – “This is a great day in the fight against AIDS. The positive results of the iPrEx oral PrEP study are a major milestone in HIV prevention research and provide important information about how antiretroviral drugs might be used for prevention by HIV-negative people at high risk for HIV infection,” said AVAC Executive Director Mitchell Warren.

“It’s a result that requires immediate action. Because the pill evaluated in iPrEx is licensed and available as treatment for HIV-positive people, gay men and others at risk of HIV need immediate information about what these data tell us and what questions remain. Moreover, gay men and others at risk of HIV need to give crucial input and have influence on what the next steps for this new intervention might be,” Warren said.    

“There is a global imperative to act on the results with ambitious, carefully prioritized research and implementation agendas, including strategic demonstration projects,” Warren continued.

The iPrEx pre-exposure prophylaxis, or PrEP, trial evaluated the safety and effectiveness of a once-daily dose of the antiretroviral drug TDF/FTC (brand name Truvada) for HIV prevention among 2,499 HIV-negative gay men and transgender women who have sex with men. At the end of the three-year trial, there were 36 infections in participants who received TDF/FTC and 64 in placebo recipients. This translates into an average 43.8% reduction in HIV risk overall in participants who received TDF/FTC compared to those who received the placebo.

“We congratulate the trial sponsors, scientific collaborators and partners who conducted this landmark global trial. We especially want to thank the nearly 2,500 gay men and transgender women from four continents whose altruism and commitment as trial volunteers made this effort possible,” Warren added. “The commitment of the iPrEx volunteers is especially important in light of the current human rights struggles in many countries and communities of gay men and other men who have sex with men. These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for both men and women to protect themselves from HIV. The world owes them and their communities an enormous debt of gratitude.”

“The identification of any new HIV prevention strategy is a landmark moment for the global AIDS response. iPrEx tells us that we have a new tool for gay men and transgender women. At the same time, the adherence and resistance data reported in today’s New England Journal of Medicine article tell us that there’s a lot of work to be done on identifying the best possible ways to deliver PrEP to these communities in ways that are safe, effective and grounded in a rights-based response. It’s also important to remember that even more data will emerge as follow up and analysis continue over the coming months,” Warren said.

One important source of additional information will be a follow-up trial, which will begin in early 2011 and be open to all participants from the original iPrEx trial. All HIV-negative participants who choose to join this open-label trial will receive the active TDF/FTC pill along with an HIV prevention package and will be counseled on daily use of the drug. However, monitoring and HIV testing will be less frequent, with the goal of learning about PrEP safety and effectiveness in a “real world” context.

“As this information is gathered, public health officials, regulatory bodies and policy makers must quickly provide clear statements on what we know and what we don’t, stressing that PrEP reduced risk in gay men and transgender women in the context of intensive counseling around safer sex, condom use and daily pill-taking, as well as regular monitoring including HIV testing.” Warren said.

The trial underscores the importance of providing a comprehensive prevention package. All of the iPrEx participants received a full prevention package, including condoms, safer sex counseling and treatment of sexually transmitted infections. At each monthly clinic visit, participants were tested for HIV and counseled about daily use of the trial drug, a level of counseling and testing not easily achieved outside of a clinical trial.

The trial also demonstrates that PrEP is only safe in people with confirmed HIV-negative diagnoses. Two cases of drug resistance documented in iPrEx occurred among two men who started PrEP while in the earliest phases of HIV infection, and therefore did not test positive for HIV using the trial’s diagnostics.

iPrEx shows that adherence to the drug regimen is essential. Participants who received TDF/FTC and had detectable levels of drug in their blood were at much lower risk of HIV compared to participants who received TDF/FTC and had no drug in their blood. The trial also analyzed risk of infection as it related to reported rates of pill taking. Participants who reported taking their pills correctly and consistently the majority of the time had significantly lower risk of HIV infection compared to those who reported taking the pills less frequently.

These data can’t be extrapolated to people at risk of HIV via heterosexual sex or injection drug use.  Differences in biology of the vagina and rectum, and between HIV risk in sexual versus injection exposure make it essential that ongoing trials looking at PrEP in these contexts must continue.

“iPrEx is the first of several PrEP trials to provide results. There are more than 20,000 participants enrolled in additional PrEP trials worldwide that must continue,” said Warren.

The iPrEx findings add to a growing body of evidence confirming the powerful potential of antiretroviral drugs for HIV prevention. This includes findings from CAPRISA 004, a trial of 1% tenofovir gel as an HIV prevention tool for heterosexual women, which found that women who received the gel had an estimated 39 percent lower risk of infection compared to those who received an inactive placebo gel.

After many years of disappointing results from biomedical prevention trials, iPrEx and CAPRISA 004—along with the RV144 AIDS vaccine trial—mark the beginning of a new era of HIV prevention.

“New strategies come with new costs. We must ensure that any new strategy is well-validated before it is widely introduced, and that this introduction comes with new resources and not at the expense of any proven prevention modality,” said Warren.

“As we move towards potential PrEP implementation, it is critical to remember that millions of HIV-positive people around the world, including thousands in the United States, lack access to the HIV treatment they need, which is often the same drug used in this trial,” Warren said. “We can and must find a way to ensure that PrEP is a part of comprehensive, well-funded response to HIV. That means ensuring access for all who need it to existing HIV prevention and treatment options; ensuring continued research to find and refine effective new options, including PrEP, microbicides, vaccines and the possibility of treatment as prevention; and planning for integrating these new interventions into combination programs.”

Additional information about the trial is available on the official iPrEx trial website at www.iprexnews.com.

More information about key issues around the iPrEx study and the future of PrEP generally is available in AVAC’s PrEP and the iPrEx Trial FAQ that is online at www.avac.org/iprex.

 

Contact:
 Mitchell Warren, +1-914-661-1536, ###

Press Release

AVAC Calls for AIDS Vaccine Field to Implement New Scientific Strategic Plan Released by Global HIV Vaccine Enterprise

New York, NY,  – AVAC welcomes the new Global HIV Vaccine Enterprise Scientific Strategic Plan, released today, as a critical document that the field must implement as part of ongoing efforts to improve coordination, efficiency and transparency to quickly capitalize on recent advances in AIDS vaccine research.

The Plan comes at a crucial time in the field. In the last year, the RV144 Thai vaccine trial proved that an AIDS vaccine is possible, which along with the identification of new potent, HIV-specific neutralizing antibodies have re-energized AIDS vaccine researchers, advocates and funders.

“This is the most exciting period in HIV vaccine research in the last three decades. As we enter this new era in vaccine and HIV prevention research, scientists, funders and advocates are grappling with both the excitement of scientific breakthroughs and the realities of funding shortfalls. This plan has the potential to help meet the current challenges in the field,” said Mitchell Warren, AVAC executive director. “But a plan is only as good as its execution, and AVAC will be watching and reporting on how the field comes together to capitalize both on the consensus of the plan and the promise of the science.”

The new Scientific Strategic Plan provides important signposts for the way forward, but the field must also be willing to be flexible and adaptable to quickly react to the changing realities of the AIDS epidemic and biomedical research.

“This plan proposes a comprehensive strategy that goes beyond the scientific activities of any single funder or organization,” said Bill Snow, a co-founder of AVAC, who was involved in the planning process. “There is now an urgent need to broaden international participation in the work that is necessary to build on the recent developments that have made HIV vaccine design and development as exciting and essential as it has ever been.”

AVAC recommends the following actions to realize the potential of the Plan:

  • The Enterprise, through the secretariat and its governing Council, develop a comprehensive and ambitious resource mobilization strategy that identifies key gaps, new funding sources and opportunities to make the best use of already committed funds.
  • The Enterprise secretariat, with guidance and input from its scientific working groups, identify priority, time-sensitive issues that could be resolved or refined through immediate, Enterprise-led action.
  • Each Enterprise member articulate how their funding and/or scientific decisions are aligned with the Plan, or articulate why not.

AVAC believes it is crucial that the Global HIV Vaccine Enterprise Council, Director and Secretariat drive execution of the plan. Collectively, they should hold themselves and the full range of stakeholders, including donors, scientists and organizations, accountable for matching
their work to the plan’s priorities with urgency.

“Now more than ever, HIV vaccine research must also be seen in the context of the overall research agenda for HIV prevention,” Warren added. “Even as this plan is executed, the AIDS vaccine field must adapt to emerging results from other biomedical prevention trials, such as microbicides and pre-exposure prophylaxis (PrEP), by preparing for positive data with new ideas for trial design and combination prevention.”

AVAC’s annual state of the field report on vaccines and HIV prevention research, which provides more information about the way forward for prevention research and more detail about our expectations of the Global HIV Vaccine Enterprise, is available online at www.avac.org/avacreport. The Global HIV Vaccine Enterprise Scientific Strategic Plan is being published open access today by Nature Medicine and available at www.vaccineenterprise.org. 

Contact:
 Mitchell Warren, +1-914-661-1536, [email protected]

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

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Press Release

AVAC Calls for Speedy Funding of Critical Microbicide Follow-Up Studies

New York, NY, – AVAC today issues a call to action to donors, policy-makers, researchers and advocates to ensure that critical follow-up studies to the landmark CAPRISA 004 microbicide trial receive the economic and political support needed to move forward as quickly as possible. The call comes as a group of microbicide and public health experts have agreed upon a plan for further studies, which are expected to cost $100 million over three years, of which only $58 million has been committed.

“We have an imperative to learn about the effectiveness of 1 percent tenofovir gel, the product tested in CAPRISA 004. If the results are confirmed, we now have an incredible opportunity to translate a clinical trial result into public health impact — and we should not miss it” said Mitchell Warren, AVAC executive director. 

A group of key decision makers met recently in South Africa to develop a comprehensive research agenda to build on the results of the CAPRISA 004 microbicide gel trial. At that meeting, public health officials, researchers, and regulators moved with remarkable speed to develop a consensus plan that calls for a set of studies aimed at confirming the CAPRISA 004 results and developing implementation strategies.

“A plan is in place to move the research forward, and funders and policy makers must now move quickly ensure that it can be implemented as soon as possible,” Warren added.  “Women in South Africa and around the world are calling for access to this product. We have a moral obligation to quickly and efficiently answer the remaining questions that will tell us if this is an intervention that can be used and how it will need to be implemented.”

“These results could lead to one of most exciting breakthroughs in the history of the AIDS epidemic. This microbicide could be an important tool to help women protect themselves from HIV.” said Warren. “At the same time that researchers work to confirm the results, we must also ensure that plans are in place to ensure swift regulatory approvals and implementation programs. A safe and effective microbicide must not follow the same slow route to full implementation as the female condom.”

The microbicide field has been energized by this result, as has the larger field of biomedical prevention research. We must not lose momentum,” Warren added. “There is funding in place for microbicide research and other trials are ongoing, but there is a real risk that the development of 1 percent tenofovir gel will languish without a new infusion of funding specifically targeted to moving this product and dosing strategy forward.”

“Knowing that AIDS treatment and other global health priorities are starved for resources, we do not make the call for additional funds for this research lightly,” Warren added.  “But a relatively small investment in this research agenda has the potential to reap huge rewards in the number of new infections that can be prevented if 1 percent tenfovir proves to be even a partially effective microbicide.”

It is critical that as the field moves forward with a research agenda for this strategy, a full and robust HIV prevention research agenda continues and the microbicide pipeline is expanded to ensure the development of additional dosing and delivery methods that will work for more women and men. Several key HIV prevention trials are underway, including other microbicide dosing strategies and formulations, PrEP (testing antiretroviral drugs in oral form), and vaccines. A combination of new HIV prevention interventions, along with scaled up treatment and care programs, are needed to end the AIDS epidemic.

More information about the CAPRISA 004 result and ARV-based prevention is available in AVAC’s new publication A Cascade of Hope and Questions: Understanding the Results of CAPRISA 004 available at www.avac.org.

A UNAIDS press release about the meeting is available at [email protected]

 

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Press Release

Preliminary Safety and Adherence Data from Oral PrEP Trial Released; Trial Not Designed to Evaluate Effectiveness

New York, NY – Preliminary data were presented today at the International AIDS Conference by the US Centers for Disease Control and Prevention (CDC) from a safety and acceptability trial of daily use of oral tenofovir in HIV-negative gay men and other men who have sex with men (MSM) in the United States. These data, which do not include any evaluation of PrEP effectiveness, add to the body of information about ARV-based prevention available to researchers, policy makers, community and other stakeholders.

This trial, known as CDC 4323, is one of several trials around the world testing the use of antiretroviral drugs to prevent HIV infection, a concept known as PrEP, or pre-exposure prophylaxis.

The findings presented today showed that no serious safety concerns emerged in the initial analyses. CDC also shared early findings about risk-taking among men in the study. The trial was designed so that some men began taking the daily oral tenofovir or a placebo pill immediately, while other participants were delayed by nine months. This design allowed the research team to gather information on how pill-taking affected sexual behavior in participants who were all receiving the same standard prevention package, including counseling about safe sex, condoms and STD testing for the duration of the trial. The preliminary analyses indicate that rates of risk behaviors were comparable between the participants randomized to begin taking tenofovir or placebo pills daily immediately compared to those who began after nine months of trial participation.

Importantly, these results did not provide any information on whether PrEP reduces the risk HIV infection. This trial focused solely on safety and behavior issues and was not designed to explore possible effectiveness of PrEP. Several studies that are studying possible PrEP effectiveness are currently underway.

“The information from this trial provides important pieces of information about the possible use of PrEP if it is proven effective in other ongoing effectiveness trials around the world,” said Mitchell Warren, AVAC executive director. “It is encouraging to hear there were no serious safety concerns and that the men in the study did not appear to increase risk-taking behaviors while taking a pill.”

“But much more safety, adherence and risk data will be needed before PrEP can be implemented if it is proven effective. And, importantly, this trial does not tell us anything about whether or not PrEP will work to reduce the risk of infection,” Warren added.

“Antiretroviral-based prevention research shows great promises, especially in the light of the positive results from the CAPRISA 004 microbicide proof-of-concept study released earlier this week. Although the CDC safety study used oral tenofovir, the same antiretroviral that was formulated as a gel in the CAPRISA 004 microbicide study, it is important not to extrapolate between the two studies. There are a series of ongoing trials that still need to be completed before we know whether PrEP can be added to our list of available HIV prevention options. Each of these trials provides a piece of the puzzle of how antiretrovirals might be used by HIV-negative people to reduce their risk of acquiring HIV,” Warren said.

More information about PrEP research is available in AVAC’s publication A Cascade of Hope and Questions: Anticipating results of ARV-based HIV prevention trials, available at [email protected].

Contacts: 
Mitchell Warren, +1-914-661-1536, [email protected]

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

 

Press Release

New Edition of Guidelines for Communities in HIV Prevention 
Research Released at International AIDS Conference

GPP Plays Critical Role in Moving HIV Prevention Research Agenda Forward

VIENNA – The draft second edition of The Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials were released yesterday at the International AIDS Conference in Vienna by AVAC and UNAIDS. The GPP Guidelines aim to provide trial funders, sponsors, and implementers with systematic guidance on how to effectively work with a range of stakeholders as they design and conduct biomedical HIV prevention trials.

The guidelines were developed by AVAC and UNAIDS in consultation with a broad range of global stakeholders who have provided perspectives since the first edition was published in 2007. AVAC and UNAIDS are now seeking feedback on the draft second edition from those with interest and expertise in HIV prevention research until 31 October, after which the final second edition will be published.

Clinical trials are guided by Good Clinical Practice, Good Laboratory Practice, and other guidelines and regulations that cover scientific and general ethical conduct, but global guidelines had not existed for community engagement before the first publication of GPP.

“Recent breakthroughs, including positive results from the CAPRISA 004 microbicide trial, have reenergized prevention research, and around the world, thousands of research participants and hundreds of researchers and trial site staff are working together find new HIV prevention options. Thousands more will be needed as we work to find new solutions to ending the AIDS epidemic,” said Mitchell Warren, executive director of AVAC.

“The GPP Guidelines were developed to fill an important gap in the conduct of biomedical HIV prevention research and to help research teams, trial sponsors, trial funders, communities, advocates, and other stakeholders plan, implement, and evaluate community engagement in trials, reduce unnecessary conflict and ensure that research is meaningful to both communities and trial implementers,” Warren added.

“AVAC and UNAIDS is pleased to release this new version of the GPP guidelines at the conference at which the groundbreaking results of the CAPRISA tenofovir microbicide gel trial have been presented, recalling that it was the stopping of antiretroviral pre-exposure prophylaxis trials in 2004 that first inspired the development of the GPP guidelines,” said Dr. Catherine Hankins, UNAIDS’ chief scientific adviser.
The GPP guidelines include:

  • Guiding Principles of GPP that serve as the foundation of the relationship between trial funders, sponsors, implementers, and other stakeholders.
  • GPP Standards that trial funders, sponsors, and implementers should follow when designing, preparing for, conducting, and concluding a biomedical HIV prevention trial.

The GPP Guidelines are available online at: www.avac.org/gppdocuments or www.unaids.org.

AVAC Contact: Kay Marshall, +1-347-249-6375, [email protected]
UNAIDS Contact: Saya Oka, +41 22 791 1697, [email protected]

Press Release

Report Warns Flat Funding for HIV Prevention Research May Limit Ability of Researchers to Move Promising Approaches Forward

VIENNA (21 July, 2010) – Following significant advances in vaccine and microbicide research, importantly including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers’ ability to quickly move promising approaches forward.

The report examines investment in HIV prevention research in 2009 and finds that the onset of a global recession did not immediately impact funding levels for biomedical HIV prevention research.  Total funding remained stable at approximately US$1.165 billion for preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) and operations research related to male circumcision.

In the face of an economic crisis that has deeply affected the economies and public-sector budgets of HIV prevention research funders, level funding for HIV prevention is cause for cautious optimism. Yet much of the 2009 funding was likely reflective of resources committed when the global economy was far healthier. As current funding commitments come to an end, the concern will be whether funders will be able to renew commitments at existing funding levels. Furthermore, the report authors argue that flat funding of HIV prevention research could have serious consequences for the field as results from critical prevention trials move the research agenda forward. They warn that researchers could have insufficient resources to advance important opportunities to prevent HIV.

Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, the sixth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group, was released today at the XVIII International AIDS Conference in Vienna, Austria.  It documents investments in biomedical HIV prevention research from public, philanthropic and commercial sectors in 2009. HIV vaccines continued to receive the majority of funding, with a total of US$868 million, which was equal to 2008 funding levels. Investment in microbicides was US$236 million, a decline of 3 percent from 2008 levels. Funding for oral pre-exposure prophylaxis (PrEP) increased by 18 percent over 2008 levels to US$52 million.

The stability in funding is encouraging, given a 10 percent decrease in funding for AIDS vaccine research seen in 2008, but the Working Group identified several areas of concern if funding remains flat, including escalating costs of late-stage clinical research, dependency on a small group of funders and a lack of diversity in funders. In addition, the Working Group stresses that the CAPRISA 004 results, while tremendously exciting, are by no means the definitive answer about antiretroviral-based microbicides and appropriately resourced confirmatory and exploratory research will be needed.

The Working Group has documented an overall trend since 2000 toward increased funding of new funders joining in the effort to support HIV prevention research. Yet in 2009, this funding stability was largely the result of increased or sustained funding by the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together accounted for 79 percent of vaccine funding, 59 percent of microbicide funding and 70 percent of PrEP funding.

“With five new infections, for every two people newly on treatment we cannot give up our quest for new HIV prevention tools,” said Michel Sidibé, Executive Director of UNAIDS. “Investments for HIV prevention must be enhanced and sustained.”

“As we push for expanded funding and political commitments for HIV prevention research and the overall AIDS response, we must also work to find smart and innovative ways to make the best use of available funding to continue to scale up delivery of existing interventions and to look for new ones,” said Mitchell Warren executive director of AVAC. “HIV prevention researchers, advocates and donors must all commit to working together to ensure that we make the best and smartest use of limited resources, while also ensuring that the most promising interventions continue to move forward.”

Recent and upcoming results from several major studies could radically change the trajectory of HIV prevention research and increase the need for funding. These include the results of the RV144 Thai AIDS vaccine trial, which showed modest protection against HIV and scientifically demonstrated for the first time that an AIDS vaccine was possible, results from an important proof of concept microbicide trial CAPRISA 004, released yesterday at the Vienna AIDS conference, and anticipated results from two PrEP trials in the coming year.

“This is a very exciting time in HIV prevention research,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative. “As the prevention research field is primed to exploit scientific advances availability and flexibility of funding will be critically important.  Our ability to move discoveries into and to undertake even the most critical of these large-scale trials is at risk in the current funding environment.”

 “We must work to continuously ensure resources are available to fulfill the promise of new scientific advances that could save millions of lives,” said Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides.  “Microbicides, PrEP, vaccines and treatment-as-prevention are just beginning to show great promise for HIV prevention in large-scale trials.  As we work together to develop these tools and transform our global health goals into reality, our success depends on having sufficient resources to keep pace with research developments in the field.” 

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Press Release

Study of Microbicide Gel Shows Reduced Risk of HIV & Herpes Infections in Women

“This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection,” said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.

“We believe that the most responsible plan of action now is to quickly and efficiently articulate the sequence of steps necessary for confirmation and follow-up of these results, while also aggressively planning for potential roll-out of a licensable product.”

“It will take time and resources to fully analyze and understand the data, but this proof of concept demands immediate action both in South Africa where there are a range of key, context-specific issues—and on a global level where this new evidence will energize and redirect the microbicide field as well as the broader arena of prevention strategies based on anti-HIV drugs. Simultaneous efforts on many fronts are needed to eventually realize the public health potential suggested by these data.”

“We congratulate the trial sponsors, scientific collaborators, and partners who conducted this trial, and especially want to thank the nearly 900 South African women whose altruism and commitment as trial volunteers made this effort possible. These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for women and men all over the world to protect themselves from HIV. We owe them an enormous debt of gratitude,” Warren said.

“As we move forward in our search for microbicides and other new HIV prevention options, researchers will need the collaboration of tens of thousands more men and women around the world in additional trials. Right now, the VOICE trial is working in four countries, including South Africa, to evaluate both 1% tenofovir gel and oral pre-exposure prophylaxis—this study is more important than ever, as are additional trials that have yet to be planned.”

As the trial team reported in Vienna today, CAPRISA 004 provided the first evidence that the use of the antiretroviral (ARV) drug tenofovir in the form of a vaginal gel can reduce the risk of HIV infection in women. The overall rate of effectiveness reported in the trial was 39 percent. The “test of concept” trial tested the effectiveness of 1% tenofovir gel, used before and after sex, among urban and rural South African women at high risk of HIV via vaginal sex.

“These results move us one step closer to finding much needed new HIV prevention options for women and men,” said Warren. “We look forward to working with the field to further examine the great wealth of data this trial has produced. These data will help guide decisions about further studies needed as well as provide important information to help design implementation programs if additional research indicates that we have a licensable product.”

AVAC calls on the trial sponsors, researchers, funders and others in the field to work quickly, and cooperatively to boldly to translate these findings into development of a scientific action plan to attempt to confirm these results and answer other outstanding questions. Such a plan must be well resourced and swiftly implemented, and it must ensure that additional supplies of tenofovir gel can be quickly manufactured to meet the needs of follow-up studies.

“As exciting as this result is—and as important as it is to follow it up without delay—the reality is that this product will not be available for widespread introduction tomorrow. Its critical to manage expectations while maintaining urgency. This challenging but necessary work falls on the shoulders of all stakeholders involved in AIDS prevention and treatment. At the same time, we must ensure that all stakeholders reaffirm their commitments to work that will lead to eventual access to effective microbicides for everyone who needs them,” Warren said.

Additional relevant information will also come from the ongoing research on other, related antiretroviral-based prevention strategies in HIV negative people. These include trials of pre- exposure prophylaxis, or PrEP, which is evaluating the use of oral ARVs to reduce HIV risk in HIV negative people. There is also one other ongoing effectiveness trial known as MTN 003, or VOICE, that is evaluating daily use of 1% tenofovir gel (a different dosing strategy from CAPRISA 004) along with oral use of tenofovir or tenofovir/emtricitabine. The positive finding from CAPRISA 004 increases hope that there will be benefit in some of these other trials—but it is no guarantee. Ongoing and additional research is needed to clarify the full potential of ARV-based prevention.

“This is an astonishing scientific achievement and a great boost to the microbicide field. At the same time, the results are complicated, and we will need to work hard to make sure that women and their partners understand what these results do and do not mean for the immediate future and in the long-term,” said Warren. “We are committed to working with communities to understand the results and the next steps.”

“The CAPRISA 004 results add immensely to the drive for a comprehensive response to HIV,” Warren added. “That means ensuring access for all who need it to existing HIV prevention and treatment options, including male and female condoms, behavior change counseling, male circumcision, clean needles, harm reduction and antiretroviral drugs; ensuring continued research to find effective new options, including microbicides, PrEP and vaccines; and planning for integrating these new interventions into combination programs.”

CAPRISA 004 was led by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal and FHI and CONRAD in the US, and sponsored by the US Agency for International Development (USAID) and TIA, a biotechnology agency of the South African government’s Department of Science and Technology.

An AVAC report, A Cascade of Hope and Questions: Anticipating the results of upcoming ARV-based prevention trials and additional information about CAPRISA 004 and other upcoming results are available online at center;”>###
 

Press Release

Turning the Page to a New Era in HIV Prevention Research: AVAC Report warns promising developments in biomedical HIV prevention could be undermined by current conditions of the global AIDS response

New York, NY, 14 July 2010 – A new report from AVAC surveys the state of biomedical HIV prevention research, including the first evidence of vaccine-induced protection in humans and the emergence of ARV-based prevention—and provides strategic recommendations for moving forward in a time of constrained resources and faltering commitment to ending AIDS.

Turning the Page, AVAC’s 13th annual report on the state of the HIV prevention research field, offers unique context and a timely critique for issues that will be center stage at the upcoming AIDS 2010 Conference in Vienna. These issues are also central to the AIDS response outlined in the first ever US National HIV/AIDS Strategy, released Tuesday.

As the report describes, scientific developments in several arenas of biomedical prevention research have re-energized the search for additional strategies. In the vaccine field this includes the first evidence of vaccine-induced protection and strides in identification of new potent, HIV-specific neutralizing antibodies. Antiretroviral-based prevention also shows potential, and the report provides context for the upcoming results of the CAPRISA 004 microbicide trial, the first effectiveness trial of an ARV-based prevention strategy in HIV-negative people.

The biomedical prevention research field must now develop strategies for pursuing new scientific leads and following through on promising developments without the guarantee of expanded financial resources. In addition, the implications of recent breakthroughs need to be explained clearly to diverse audiences. As the report describes, the next phase of human clinical trials will involve complex designs and questions, and their success will depend on the support of all stakeholder groups. It will be difficult to execute this ambitious research agenda in the context of fiscal constraint—and the field needs to address this head on.

“We face yawning gaps in funding for proven prevention and treatment and a crisis in financial and political will,” said Mitchell Warren, AVAC Executive Director. “There is skepticism about whether disease-specific funding for AIDS is cost effective and skepticism about whether limited funds for AIDS should include funding for AIDS prevention research.”

“The recent report from UNAIDS that proven HIV prevention is having a demonstrable impact on the epidemic in many African countries is good news. But to really have an impact on the epidemic we need additional funding and political commitments for AIDS treatment and prevention programs AND more funding for HIV prevention research,” Warren added.

“The AVAC Report makes the critical point that to capitalize on recent breakthroughs in HIV prevention, we must find smart and innovative ways to make the best use of available funding,” said Chris Collins, AVAC Board Member and Vice President and Director, Public Policy at amfAR, The Foundation for AIDS Research.

The HIV prevention research field has been buoyed by major breakthroughs in recent months and Turning the Page calls for researchers, funders and others to prioritize collaboration and nimble and adaptive planning for replenishing the pipeline with new products and designing clinical trials that will yield the most information to move the field forward.

In recent years, the HIV prevention research agenda has broadened beyond vaccines and microbicides to include antiretroviral-based prevention, including pre-exposure prophylaxis, and, more recently, efforts to understand the role of treatment as prevention. At the same time, HIV treatment programs—once thought to be impossible to implement in developing countries—have expanded to reach millions of people around the world.

“The HIV prevention research agenda must take into account the new realities of the fight against AIDS. We believe that new prevention programs cannot be built while current treatment programs are faltering,” Warren said. “To reach the goal of universal access to healthcare—which includes comprehensive AIDS treatment and prevention—advocates, researchers, health care providers, funders and policy makers must speak with one voice.”

Turning the Page lays out the critical components of a response to AIDS that unites treatment and prevention, including: 

  • Sustain and expand current treatment and care programs: Funding restrictions are beginning to take a damaging toll on AIDS treatment programs at the precise moment that data are emerging to show that ARV treatment prevents deaths, lowers health care costs and can reduce the risk of HIV transmission. Donors and policy makers must take the critical steps needed to forestall further damage and put treatment programs back on track.
  • Actively explore treatment as prevention: There is compelling evidence that earlier initiation of antiretrovirals in HIV-positive people can reduce the risk that they will infect sexual partners with HIV. Additional data will come from an ongoing clinical trial, but the world should begin exploring the practical approaches and implications of scaling up HIV treatment as prevention that can help guide policy makers’ decision-making about potential introduction of treatment as prevention when the data become available.
  • Plan for ARV-based prevention: Neither oral PrEP nor topical ARV-based microbicides have yet been proven to have benefit. But, if they do, they will need to be delivered strategically, in programs that provide clear, integrated messages about the risks and benefits of ARVs for prevention in HIV-negative people. Results from CAPRISA 004, the first ARV-based microbicide effectiveness trial, will be delivered next week at AIDS 2010 and results from initial PrEP effectiveness trials are expected in the next 12 months. The field needs to be prepared to address the many questions that will emerge from these results and develop rational plans for ensuring the best use of the potential new options.

“We must also be ready to be surprised. The greatest advances in the fight against AIDS have come about because people and institutions refused to accept conventional wisdom about what was possible,” Warren said. “In 15 years of advocating for AIDS vaccines, we at AVAC have witnessed many moments when an AIDS vaccine was deemed a scientific impossibility. Yet, a trial that had been all but discounted by many provided evidence that a preventive AIDS vaccine is possible. And AIDS treatment programs and their clients have flourished in every possible context around the globe in the face of those who said it was impossible.”

“Now is the best time to invest in an expanded response to the AIDS epidemic. AVAC stands with the global community of advocates for HIV prevention, treatment, research and implementation to expect and demand an extraordinary response to this unprecedented epidemic—our only hope of closing the book on AIDS,” Warren added.

Turning the Page and other AVAC publications, including an upcoming report on anticipating the results of ARV-based prevention trials are available online at www.avac.org.

Contacts: Mitchell Warren, +1 (914) 661-1536, [email protected] / Kay Marshall, +1-347-249-6375, [email protected]

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