Press Release

Report on HIV Prevention Research Funding Says New Investment Critical to Capitalize on HIV Prevention Research Breakthroughs

Rome – In the last year, promising trial results and critical scientific breakthroughs have changed the HIV prevention landscape, providing new opportunities for both a broader response to the epidemic with new prevention options and broader clinical and laboratory agendas with new research targets. At the same time, investment in biomedical HIV prevention research remained stable despite the effects of the recent global economic downturn, according to a new report released today in Rome at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. 

Capitalizing on Scientific Progress: Investment in HIV Prevention R&D in 2010 is the seventh annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group documenting investments in biomedical HIV prevention research from public, philanthropic and commercial sectors. This year’s report argues that capitalizing on recent promising scientific breakthroughs will require substantial additional and sustained investment from a broader set of donors.

The major, and surprising finding of the report, given the global funding environment, is that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision. Even in the aftermath of a global recession, this investment approached the previous historical high of US$1.23 billion reached in 2007 for these four prevention technologies.

Yet to capitalize on the recent exciting prevention breakthroughs being discussed at the IAS conference, more investment will be needed across prevention technologies and from bench research to operational and implementation research.

“Certainly in this era of economic restraint it is good news that donors continue to see the value of investing in prevention research,” said Paul DeLay, Deputy Executive Director, Programme, UNAIDS, the Joint United Nations Programme on HIV/AIDS. “But as we capitalize on the recent breakthroughs and move quickly to make new forms of prevention available to those who need them most, we need donors to also move quickly to ensure that funding shortfalls do not become roadblocks.”

There is an urgent need to direct resources to accelerate promise into progress. Yet the report recognized that funders continue to confront budgetary constraints, with some having reduced or eliminated their HIV prevention research programs altogether. Funding for HIV prevention research also remains highly concentrated among relatively few funders, and the Working Group warns that this narrow base of funding will threaten the sustainable research effort required at this critical time and highlights the need for broadening that base, importantly including emerging economies.

“The recent promising results of PrEP and treatment as prevention trials tell us that thirty years into the epidemic we may finally be on the path to ending AIDS,” said Mitchell Warren, AVAC executive director. “New prevention options—medical male circumcision, PrEP, microbicides and eventually vaccines—will play a critical role in reducing the cycle of new infections. As we look toward the next 30 years of AIDS, investment in prevention research has never been more important. Going forward we need funding structures that are flexible, agile, and generous enough to adapt rapidly to new opportunities.”

“We have seen tremendous progress in HIV prevention research over the last two years,” said Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative (IAVI). “Sustaining the momentum built through these advances depends on access to stable funding that can be flexibly applied to the most promising areas of research. This will allow us to build upon the field’s successes and to move promising concepts from the pipeline into clinical trials as swiftly as possible.”

“The recent exciting results in the PrEP and microbicide fields are proof that investment in HIV prevention research is bringing women and men around the world much closer to having a broad range of effective HIV prevention options,” said Zeda Rosenberg, CEO of the International Partnership for Microbicides (IPM). “Wise investments now in laboratory and clinical research, and in efforts to roll out new interventions will pay off as HIV infections decline significantly in the coming decades.”

The report is available online at: www.hivresourcetracking.org. 

Kay Marshall (AVAC), [email protected], +1-347-249-6375
Sophie Barton-Knott (UNAIDS), [email protected], +41 79 514 6896/
+41 22 791 1697
Lauren Wesolowski (IAVI), [email protected], +1-212-328-7420

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The Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI), the International Partnership for Microbicides (IPM), and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

Press Release

AVAC says results of new PrEP trials provide clear evidence that antiretroviral drugs for prevention can help end the AIDS epidemic; calls for quick action on results

New York, NY – Results from two African studies of pre-exposure prophylaxis, or PrEP, released today provide clear evidence that the antiretroviral drugs used to treat HIV can also be used to prevent HIV among heterosexual men and women at risk of HIV infection.

“These results are tremendously exciting and confirm that we are at pivotal period in the AIDS epidemic,” said Mitchell Warren, AVAC executive director. “Antiretroviral (ARV) drugs for HIV treatment began to turn the tide of the epidemic 15 years ago, and it is clear that also using ARVs for HIV prevention will strengthen our response to AIDS. PrEP, ARV-based microbicides and treatment as prevention are powerful tools to help end the cycle of new infections and end the epidemic.”

“We now have data that earlier treatment initiation in HIV-positive people can reduce risk of HIV transmission—and that use of ARVs in HIV-negative people can reduce risk of infection. There is a global imperative to act on these results without delay,” Warred added. “Now is the time to include ARV-based prevention in national plans, applications to the Global Fund to Fight AIDS, Tuberculosis and Malaria and donor priorities. We need ambitious pilot and demonstration projects to guide programmatic design, along with national and international guidance on how best to use ARVs as lifesaving prevention tools. The next steps will not be simple but they will be essential. Scientific data do not change the world—programs and policies backed by civil society, donors, implementers and governments do. The countries where PrEP trials took place should lead the way in these critical efforts.”

“We congratulate the trial sponsors, scientific collaborators and partners who conducted these trials. We especially want to thank the more than 10,000 men and women whose altruism and commitment as trial volunteers made this effort possible,” Warren said. “These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for men and women to protect themselves from HIV.”

The Partners PrEP study in Kenya and Uganda enrolled 4,758 heterosexual couples in which one partner was HIV-positive and the other HIV-negative. The trial showed that both tenofovir (TDF, marketed as Viread) and tenofovir plus emtricitabine (TDF/FTC, marketed as Truvada) taken daily can reduce the risk of HIV transmission among both men and women. In the trial, daily oral TDF reduced HIV risk by an estimated 62 percent infections (95% CI 34 to 78, p=0.0003) and daily oral TDF/FTC reduced HIV risk by an estimated 73 percent (95% CI 49 to 85, p<0.0001) when compared to a placebo. Both drugs were effective in both men and women, and there were no significant safety events in the trial.

Separately, the TDF2 study in Botswana enrolled just over 1,200 sexually active men and women. At the time of its completion, TDF2 was an expanded safety trial that was not designed to provide information on effectiveness. However, analysis of final data on numbers of infections in the active and placebo arms indicated that daily oral TDF/FTC reduced the risk of HIV infection in both men and women participants by an estimated 62.6 percent (95% CI 21.5 to 83.4, p=0.0133) compared to those who received the placebo.

AVAC looks forward to continued discussion of the meaning of these findings for men and women in different contexts. Additional data from these studies not released today, but expected over the coming months, will help guide these discussions. These include data on drug resistance from Partners PrEP, data on drug levels in blood plasma, cells and tissue samples, viral genotyping of infecting strains within Partners PrEP couples to identify linked and unlinked transmissions, and other information.

These results add to a growing body of evidence confirming the powerful potential of antiretroviral drugs for HIV prevention. This includes the positive results of the iPrEx trial, a study of daily oral TDF/FTC in gay men, other men who have sex with men, and transgender women, which showed a 44 percent reduction in HIV risk compared to placebo; CAPRISA 004, a trial of 1% tenofovir gel in heterosexual women, which showed that women who received the gel had an estimated 39 percent lower risk of infection compared to those who received an inactive placebo gel; and HPTN 052, which demonstrated a 96 percent reduction in HIV transmission among HIV serodiscordant couples when the HIV-positive partner received early antiretroviral treatment.

“At this critical juncture in biomedical prevention research, it is essential that governments, program implementers and donors move with speed to identify and enact the next steps suggested by the findings from these two trials of pre-exposure prophylaxis and from other recent successful trials,” Warren said.

Today’s findings make even more critical that stakeholders act on recommendations put forward in a statement, “We CAN End the AIDS Epidemic,” which has been endorsed by more than 30 organizations and close to 400 individuals around the world to date. Next steps should include:

  • Trial teams and Gilead, which donated the study drug, should ensure continued access to study drug for all participants in the Partners and TDF2 studies, including those in the placebo arms.
  • National governments should work with donors and program implementers to identify the implementation research needed to address unanswered questions and evaluate the potential impact of PrEP in key populations and contexts and to evaluate treatment as prevention, building on the result from HPTN 052.
  • At national and international levels, new findings from Partners and TDF2 as well as data from iPrEx and HPTN 052, should be integrated into ongoing strategic planning, funding proposals for the Global Fund to fight AIDS, Tuberculosis and Malaria and other processes.
  • National AIDS programs along with civil society and other key partners must swiftly develop clear messages for a range of audiences, including at-risk individuals and communities, program implementers, policy makers, regulators and others, about what these data mean—and what questions remain to be answered.
  • Funders, trial sponsors and researchers should prioritize additional research for PrEP and microbicides using different agents and mechanisms of delivery.

“Because the drugs evaluated in the Partners and TDF2 PrEP trials are licensed and available as treatment for HIV-positive people, men and women at risk of HIV infection need immediate information about what these data tell us and what questions remain. The US Centers for Disease Control and Prevention (CDC) moved quickly to provide interim guidance for PrEP use among men who have sex with men in the United States following the data from the iPrEx trial. Now CDC should move quickly to issue updated guidance for all populations in which PrEP has been shown to be effective.

At the same time, the World Health Organization (WHO) must move quickly to develop guidance for all populations for whom PrEP has now been shown to be effective,” Warren said. “And African countries, especially those where these trials took place, must also move quickly to determine the place of both PrEP using TDF/FTC or TDF, as well as earlier initiation of ARVs, in national prevention programs.”

In addition, the VOICE trial, which is looking at the use of oral PrEP and vaginal microbicides among women in several African countries, is expected to provide additional data that may help guide both PrEP and microbicide programs. “We know that the VOICE team and its independent Data and Safety Monitoring Board will be carefully reviewing the data from both of these trials and evaluating the potential impact on VOICE, and that the trial will provide critical additional information about both PrEP and tenofovir gel microbicides.” Warren said. Results from the VOICE trial are expected in 2012. Forthcoming data from the FEM-PrEP trial, which was stopped earlier this year after it was determined that the trial would not be able to provide an efficacy result, will also provide additional information about PrEP use among women.

More information is needed about issues such as adherence and possible drug resistance as well as optimal program design, integration of PrEP and earlier ART initiation into comprehensive prevention programs, and cost. Gilead announced earlier this month that it would make both drugs studied in these trials available to the UNITAID patent pool, which seeks to make generic versions of ARVs more affordable in developing countries, and which may help make PrEP more affordable.

Adherence—the ability to take PrEP as prescribed by the trial protocol—is a critical component of efficacy. Initial findings from the Partners PrEP study showed high reported adherence for the once-daily regimen. It will be important to learn why and how adherence was high in this study and what lessons can be learned for eventual rollout of PrEP. At the same time, research into intermittent dosing (e.g., weekly, semi-weekly or around the time of sex), which may be easier from some people to adhere to, is needed. Moreover, additional research is still urgently needed for other methods where adherence is less important, such as vaginal rings with monthly release, periodic injectable forms of ARVs and vaccines.

As with other HIV prevention trials, Partners and TDF2 provided a comprehensive HIV prevention package. All trial participants received condoms, safer sex counseling and treatment of sexually transmitted infections. Female participants were also provided with effective contraception. Participants were frequently tested for HIV and were intensely counseled on the importance of adhering to the daily regimen and using condoms and other prevention options—a level of counseling and testing not easily achieved outside of a clinical trial.

Demonstration projects and additional research can provide important information about how PrEP programs should be structured to account for these “real world” issues. Such projects should be prioritized and fully funded to provide answers as quickly as possible.

“As we move towards PrEP implementation, it is critical to remember that millions of HIV-positive people around the world lack access to the HIV treatment they need, which is often the same drug used in these trials,” 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, including universal access to treatment and care, PrEP, treatment as prevention and medical male circumcision; ensuring continued research to find and refine effective new options, including microbicides, vaccines, new and improved treatment options and a cure; and planning for integrating these new interventions into fully funded combination programs.”

More information on these and other PrEP trials can be found online at www.avac.org/prep. The sign on statement is available at endtheepidemic.org.

A PDF version of this press release is available here.

 

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 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

Activists and Researchers: Evidence Shows We Can End the AIDS Epidemic; International coalition calls for clear actions from world leaders

New York, NY – An international coalition of scientists and activists today launched a common platform for ending the AIDS epidemic. Thirty years into the epidemic, as world leaders come together at the United Nations to recommit to a global AIDS response, the broad-based international coalition issued a statement calling for world leaders to support a rational, evidence-based approach to responding to AIDS. The group also calls for additional signatories to the declaration.

“As at so many other critical points in the epidemic, we have the opportunity now to use the fruits of science and research to show the way forward. Putting more people on AIDS treatment will save lives and prevent new infections, and will also help build and strengthen platforms for delivering comprehensive health services in resource-poor settings,” said Paul Farmer, Harvard University Professor and co-founder of Partners In Health. “We have the knowledge and the tools to reverse the epidemic—and we must not fail to use them.”

The declaration, “We Can End the AIDS Epidemic,” argues that highly-active antiretroviral treatment (ART) for HIV positive people is a preventive strategy that is a cornerstone to ending the epidemic.

The founding group of signatories includes African Services Committee, AIDS Foundation of Chicago, AIDS United, amfAR, AVAC, ATHENA Network, Black AIDS Institute, Canadian HIV/AIDS Legal Network, Fenway Health/The Fenway Institute, GIV, Health GAP, HIV Prevention Justice Alliance, International Community of Women Living with HIV, International Rectal Microbicide Advocates, International Treatment Preparedness Coalition, New HIV Vaccine and Microbicide Advocacy Society, Open Society Public Health Program, Partners In Health, Project Inform, Treatment Action Campaign, Treatment Action Group, and the Wits Institute for Reproductive Health and HIV, and more than two dozen leading the global AIDS researchers and advocates.

“This statement represents the common vision of scientists and activists to halt the epidemic. For the first time in three decades, we now have the real potential to end the AIDS epidemic. The question now is will we?” said Mitchell Warren, AVAC executive director. “Recent breakthroughs in AIDS vaccine, PrEP and microbicide research suggest powerful, additional tools for the future. Right now, the scientific evidence that treatment is prevention must serve as a clarion call to funders, policy makers and program implementers to move forward boldly and quickly to capitalize on the conclusive evidence provided by the clinical trial HPTN 052.”

HPTN 052 found that earlier initiation of antiretroviral treatment provides a health benefit to HIV-positive people, and is a highly powerful tool for preventing transmission to sexual partners.

The statement calls for:

  • World leaders to adopt ambitious treatment and prevention targets.
  • Donors, including PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria, to evaluate existing and new funds with core activities including antiretroviral treatment for individuals with CD4 cell counts at 350 or above
  • All working on the AIDS response to end non-integrated, artificially-separated approaches to funding and delivering treatment and prevention services.
  • Donors, communities, implementers, industry and researchers to map and execute an implementation research agenda for ART as part of combination prevention strategies.

“The most expensive, least effective strategy is to continue spending on AIDS the way that we are today,” said Nono Eland of South Africa’s Treatment Action Campaign. “We need more resources and better strategy. Funds need to be aligned with what is known to work—and reprogrammed where needed. We have no time to waste. World leaders at the UN this week should make clear commitments to the platform outlined in this statement.”

According to the declaration, and consistent with a new investment framework from UNAIDS published last week in the Lancet, funding needs to be directed to evidence-based strategies with combination ART as a cornerstone of a set of proven strategies to prevent and treat HIV, including male and female condoms, male circumcision, prevention of vertical transmission, behavior change programs that target social norms as well as individual risk, and activities addressing key populations including sex workers, men who have sex with men and harm reduction programs for injecting drug users. Funds that are not aligned with these core activities need to be justified and, where applicable, reprogrammed.

“The scientific evidence is clear. We know that early treatment has health benefits for HIV-positive people, and we now know that treatment also provides clear benefit for prevention,” said Kenneth H. Mayer, M.D. of Fenway Health. “As we work to scale up HIV treatment programs, we must also scale up and sustain research that builds on important proof of concept for biomedical prevention options, including pre-exposure prophylaxis, or PrEP, microbicides and vaccines to prevent HIV. Widespread treatment access coupled with new prevention options will be essential as we move to end this epidemic.”

The declaration grew out of a think tank on optimizing the potential of ARV-based prevention convened by AVAC with support from the John M. Lloyd Foundation. The meeting brought together 25 HIV experts to discuss the way forward capitalizing on mounting evidence of the broad benefit of widespread access to antiretroviral treatment.

The full text of the declaration, along with a list of signers, is available at www.avac.org/endtheepidemic, where additional individuals and organizations can also sign on.

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 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

HPTN 052 trial confirms ARV treatment is a powerful prevention tool: “Early initiation of treatment will be fundamental to turning the tide of the epidemic,” AVAC says

New York, May 12, 2011 – Today the sponsors of a randomized clinical trial known as HPTN 052, which is evaluating combination antiretroviral therapy for HIV prevention, announced that randomization would halt due to overwhelming evidence of benefit.

“We now have evidence from a randomized trial confirming what has been seen in observational settings: ARV treatment is prevention,” said AVAC Executive Director Mitchell Warren. “These data must serve as a clarion call to funders, policy makers, civil society and implementers. HPTN 052 shows a prevention benefit that must be translated into programmatic reality. If deployed effectively, efficiently and ethically, early initiation of treatment will be fundamental to turning the tide of the epidemic.”

HPTN 052 is a large, multi-site, randomized trial designed to determine whether antiretrovirals, medicines currently licensed to treat HIV infection, can prevent the sexual transmission of HIV among couples in which one partner is HIV-infected and the other is not (serodiscordant couples). Nearly 1,800 of these HIV-serodiscordant couples from four continents are participating in the trial. At the time of enrollment, the HIV-positive partners had CD4 cell counts between 350 and 550 cells/cubic millimeter and so were not eligible for ARVs based on most national guidelines. Couples who enrolled were randomly assigned to one of two groups. In one group, HIV-positive partners received antiretroviral therapy immediately. In the other group, HIV-positive partners deferred initiation of ARV treatment until they had the clinical or laboratory findings indicating ARV eligibility based on national guidelines.

In a scheduled review of interim data, the trial’s independent Data Safety and Monitoring Board (DSMB) found clear evidence that providing immediate antiretroviral therapy to the HIV-positive partner significantly reduced the risk of transmitting HIV to their HIV-negative partner. The trial team has used viral genetic analysis to establish which new infections were linked to the HIV-positive partner. They reported that there was one such linked HIV infection in the immediate treatment group versus 27 infections in the group that began treatment according to national guidelines.

Based on this indication of a clear benefit, the DSMB recommended that the trial halt randomization. The trial team announced today that it would do so, and begin offering immediate treatment to all HIV-positive partners. All couples will continue to be followed until the protocol-defined end of the trial.

“We congratulate the trial sponsors, scientific collaborators and partners who conducted this landmark global trial. We especially want to thank the nearly 1,800 HIV-serodiscordant couples from four continents whose commitment as trial volunteers made this effort possible,” Warren said. “As the global community reflects on the prevention and treatment implications of this trial, we must also consider current and future trials working with serodiscordant couples, and civil society voices must contribute to the way forward.”

“Today’s result should be viewed in light of other recent findings from trials using ARVs for prevention,” said Warren. “The recent results from the iPrEx trial showed that PrEP is effective in gay men and transgender women, while the CAPRISA 004 microbicide trial showed that 1% tenofovir gel is effective at reducing HIV risk for women.”

“Together, these results allow us to imagine a world in which men and women seek HIV testing with the knowledge and confidence that they will receive a range of highly effective options for staying healthy and protecting themselves and their partners—whatever the test result,“ Warren added. “The results of the study require us to rethink how we structure the delivery and funding of HIV services overall.”

“The financial, human and technical resources needed to translate the HPTN 052 trial finding into a public health breakthrough on a national or global level will not come overnight. And ARVs alone will not solve the epidemic,” said Warren. “Existing prevention tools including male and female condoms, syringe exchange, male circumcision, behavior change programming, prevention of vertical transmission, and HIV testing, remain critical as do structural interventions, stigma reduction initiatives and comprehensive care and treatment programs. We also still need to maintain and build on the momentum of other recent positive results from vaccine, microbicide and PrEP research.”

“Realizing this vision will require substantial resources,” said Warren. “The upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account,” Warren said. “We need to start critical discussions and come to quick decisions about where and how to deploy treatment as prevention in the short-term. Government and international normative agencies now have a critical mass of data to publish guidelines for appropriate implementation of treatment as prevention in concert with other prevention methods.”

“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,” Warren added.

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

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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

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]