Press Release

African leaders at International AIDS Conference call for scaling up services in east and southern Africa for male circumcision, an evidence-based HIV prevention intervention

Washington, DC — This evening the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Joint United Nations Programme on HIV/AIDS (UNAIDS), the World Health Organization (WHO), AVAC and Champions for an HIV-Free Generation brought together African political and traditional leaders, as well as key figures in the international HIV response, for a satellite event at the 19th International AIDS Conference 2012. This unique group of leaders shared their views on the challenges and solutions to Voluntary Medical Male Circumcision (VMMC) for HIV prevention in East and Southern Africa.

Three clinical trials have proven that VMMC can reduce female to male transmission of HIV by approximately 60%. If scaled up to reach 80% of adolescents and adult men within five years, and coverage is thereafter maintained, VMMC has the potential to avert more than 3.4 million new HIV infections and save an estimated US $16.5 billion in care and treatment costs over the next 15 years. This cost savings could free up fiscal space for other lifesaving prevention, care and treatment interventions. In 2007, WHO and UNAIDS first recommended that countries and regions with high HIV prevalence, but low rates of male circumcision, add VMMC as part of their comprehensive IV prevention portfolio. Progress has been uneven with some countries making significant gains while others have been slow to bring the program to scale. By the end of 2011, at least 1.3 million men had been circumcised. As of March 2012, five years after WHO-UNAIDS recommendations, PEPFAR estimates that about 1.7 million men have been circumcised. This represents more than 8% of the 20.3 million men that need to be circumcised in order to reach 80% coverage of adolescent and adult men in East and Southern Africa.

“Over the next five years, enough men can be circumcised through voluntary medical male circumcision to prevent 3.4 million new HIV infections and save billions in care and treatment costs,” said His Excellency Mr. Benjamin Mkapa, former President of Tanzania and Champion for an HIV-Free Generation. “Scaling up this intervention is an urgent priority. Although it means an upfront investment, the results are significant long-term cost savings.”

In December 2011, UNAIDS, WHO, PEPFAR, the Bill and Melinda Gates Foundation, the World Bank and the Ministries of Health from 14 priority countries (Botswana, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Uganda, the United Republic of Tanzania, Zambia and Zimbabwe) committed to a five-year action framework to accelerate scale up of VMMC, and in turn reduce new HIV infections and free-up resources for other crucial interventions. The framework’s immediate “catch-up” phase is designed to quickly achieve coverage of adolescents and adult men who are most likely sexually active. The second phase—“sustainability”—will expand the framework’s reach to finally integrate VMMC into infant health programs.

Her Excellency Dr. Speciosa Wandira, former Vice President of Uganda and Champion for an HIV-Free Generation, emphasized that men need not be the missing link in HIV prevention. She added that political, traditional and community leaders must lead the charge in changing men’s attitudes about their role in HIV prevention.

“I’m proud of the men of Uganda for accepting the good science behind VMMC and stepping up for male circumcision,” said Dr. Wandira. “Women, in their role as sisters, mothers, wives and partners also play a pivotal role in supporting men to make this decision. VMMC is consistent with our values and shows how we, as men and women and as nations, are able and willing to do all we can to protect our health.”

A PDF version of this press release is available.

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The United States President’s Emergency Plan for AIDS Relief (PEPFAR)
PEPFAR is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally, and PEPFAR investments also help alleviate suffering from other diseases across the global health spectrum. PEPFAR is driven by a shared responsibility among donor and partner nations and others to make smart investments to save lives.

Anjana Padmanabhan
Email: AIDS2012@state.gov
Phone (Office): +1 (202) 663-3419
Phone (Mobile): +1 (240) 505-3531

AVAC
Founded in 1995, AVAC is a nonprofit 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.

Kay Marshall
Email: kay@avac.org
Phone: +1 (347) 249-6375

Champions for an HIV-Free Generation
Champions for an HIV-Free Generation is a group of former African presidents and other influential personalities with an aim to mobilize high-level leadership in renewed and revitalized responses to HIV and AIDS in Sub Saharan Africa. The Champions transcend political partisanship to speak freely and independently about the issues that need to be discussed, both publicly and behind the scenes.

Rebecca Aaku
Email: aakur@hivfreechampions.org
Phone: +1 (267) 369-7292
Phone: +1 (267) 7476-1663 / +1 (267) 7233-1488

Press Release

amfAR and AVAC launch Global Action Agenda for Ending AIDS; report lays out policy priorities and milestones through 2015 to hasten a “tipping point” in drive to end AIDS

Washington, DC — Two of the world’s leading AIDS advocacy organizations today released a global action agenda aimed at accelerating progress towards the end of the AIDS epidemic. Announced ahead of the XIX International AIDS Conference in Washington, D.C., the agenda identifies five major short-term priorities for global AIDS programs together with realistic, annual targets that must be achieved through 2015. The recommended actions, if taken together, could accelerate achievement of a “tipping point” in the global AIDS epidemic, at which — for the first time ever — the number of people gaining access to HIV therapy will outpace the number of people becoming newly infected.

The report, An Action Agenda to End AIDS, was developed by AVAC and amfAR, The Foundation for AIDS Research, and was informed by an analysis of modeling research and consultations with top HIV prevention experts. The Action Agenda, available online at www.EndingAIDS.org, will be the focus of a satellite session at the International AIDS Conference on Monday, July 23 at 6:30pm ET, as well as a press conference on Tuesday, July 24 at 2:00pm ET.

“It’s time for talk about ending AIDS to make way for action,” said Mitchell Warren, executive director of AVAC. “When we look back a decade from now, we’ll judge ourselves on whether we made the kinds of hard choices outlined in this plan. If we do, we’ll soon begin to bring the epidemic under control, creating a world defined by declining HIV infections and a growing capacity to treat people in need. If we don’t, we will instead witness millions more preventable HIV infections and needless deaths.”

Recent breakthroughs have expanded the range of effective HIV prevention methods and led to new optimism in the AIDS field. After clinical trials demonstrated that antiretroviral treatment (ART) in HIV-positive people can reduce the risk of HIV transmission, and that voluntary medical male circumcision (VMMC) and other new tools can significantly reduce the risk of HIV infection in HIV-negative people, leaders including U.S. President Barack Obama and Secretary of State Hillary Clinton publicly embraced the possibility of creating an “AIDS-free generation.” Despite these encouraging statements, however, global AIDS efforts continue to lack coherent priorities and are threatened by cuts in funding.

“At this moment of great opportunity, we need to be clear about the critical choices ahead,” said Chris Collins, Vice President and Director of Public Policy at amfAR. “The world can begin to turn the epidemic around within the next three years — but only if we agree on the major priorities, commit to realistic milestones and hold ourselves accountable. This new agenda outlines the critical decisions we need to make in the coming years to put us on a path to beginning to end the AIDS epidemic.”

Year-by-year action steps for all stakeholders

The agenda lays out essential steps that must be taken — year by year through 2015 — by national governments; international organizations, donors and stakeholders; civil society; researchers; and technical agencies. These action steps fall within five overarching priorities:

  • Make hard choices by emphasizing, above all other efforts, the rapid scale-up of core interventions that can have the greatest impact. These include HIV testing and treatment, VMMC, prevention of mother-to-child (vertical) transmission, and evidence-based, human rights-based interventions for gay men, sex workers, injection drug users and others at greatest risk.
  • Mobilize sufficient, sustainable resources to ensure the rapid scale-up of these core interventions.
  • Agree on clear roles and responsibilities and hold one another accountable for results, through agreed timelines, target outcomes, transparent reporting, and real-time assessment of results.
  • Build the evidence base to end AIDS, by prioritizing research on the most effective ways to implement new prevention strategies, as well as the continued search for a preventive vaccine and a cure.
  • Use every dollar of funding as effectively as possible by lowering the unit costs of core interventions, improving program management, and strategically targeting services.

Tracking critical milestones through 2015

In addition, the report lists a series of key results that must be achieved each year from 2012 through 2015 to fully capitalize on recent research advances. These include cutting the numbers of new HIV infections and deaths, as well as more specific epidemiological and policy-based milestones tied to the global scale-up of critical interventions.

By steadily reducing annual new HIV infections and simultaneously continuing to expand access to HIV treatment, the report authors project that a global “tipping point” can be achieved within two to three years. At that time, roughly 1.75 million people would gain access to HIV therapy yearly, exceeding — for the first time ever — the number of annual HIV infections, which would fall close to 1.5 million. This shift would mark a critical step in controlling the global epidemic.

The targets reflect best-case scenario calculations based on published modeling and epidemiological data, as well as analysis provided by experts in the field. A bibliography and explanation of methodology can be found at www.EndingAids.org.

The feasibility of the report’s targets was also reinforced by encouraging new data released by UNAIDS on July 18. The agency reported that more than 8 million people in low- and middle-income countries were receiving HIV therapy in 2011, a 20 percent increase from the year before. Annual HIV infections declined to 2.5 million in 2011, from 2.7 million the year before.

“The past decade has taught us that when global AIDS efforts have clear priorities and realistic targets, they can have a huge impact,” said Nelson Otwoma, National Coordinator of the National Empowerment Network of People Living with HIV/AIDS in Kenya (NEPHAK). “We’ve already accomplished so much, and now the opportunities are greater than ever. If we can agree on a plan and act decisively to make it happen, then countries around the world will have much to celebrate in the years ahead.”

AVAC and amfAR will continue to track global progress against the recommendations and targets in the Action Agenda over the coming years. Status updates, analysis and other information will be released periodically and made available on www.EndingAIDs.org.

Top AIDS leaders to discuss Action Agenda at IAC satellite, July 23

On Monday, July 23 at 6:30pm, a panel of top experts will discuss the new Action Agenda and provide their assessments of what advocates, policymakers, and scientific and government leaders must do to ensure that the rhetoric of the International AIDS Conference becomes the foundation for an urgent, systematic plan to end AIDS.

The event will be moderated by celebrated journalist Charlayne Hunter-Gault, and will feature Dr. Antony Fauci (National Institute of Allergy and Infectious Diseases), Dr. Agnes Binagwaho (Minister of Health, Rwanda), Dr. Deborah Birx (CDC Center for Global Health), Dr. Helen Rees (Wits Reproductive Health and HIV Institute, South Africa) and other prominent global AIDS leaders.

Details of the event are available online.

This press release is also available as a PDF.

Contact:
Kay Marshall, kay@avac.org, +1-347-249-6375
Cub Barrett, cub.barrett@amfar.org, +1-212-806-1602

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About amfAR: amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and the advocacy of sound AIDS-related public policy. Since 1985, amfAR has invested more than $340 million in its programs and has awarded grants to more than 2,000 research teams worldwide.

About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

AVAC welcomes landmark FDA approval of (truvada) TDF/FTC as PrEP for HIV – urges immediate steps to make important new HIV prevention option available for the men and women who need it

New York, NY — AVAC today hailed the decision by the US Food and Drug Administration (FDA) to approve the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) for use as pre-exposure prophylaxis (PrEP) among sexually active HIV-negative adult men and women.

“This is a watershed moment for both US and global HIV prevention efforts,” said Mitchell Warren, executive director of AVAC. “This is the first completely new biomedical HIV prevention tool to receive FDA approval in 19 years. Importantly, PrEP is a user-controlled method that greatly reduces HIV risk and does not need to be used immediately before or during sex. It has the potential to be a powerful tool for many individuals and couples struggling to remain HIV-free.

“Daily oral PrEP using TDF/FTC is absolutely not a silver bullet. It provides partial protection and is not a replacement for other prevention strategies like the male and female condom. It will not be right for everyone. It requires adherence, a confirmed HIV-negative diagnosis and ongoing monitoring.

“However, with its decision, the FDA followed the evidence from multiple trials worldwide. This evidence is clear: If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP using TDF/FTC can dramatically reduce your chances of becoming infected.”

Gilead Sciences and the FDA developed a Risk Evaluation and Management Strategy (REMS) to help guide healthcare providers in prescribing the drug. The REMS is aimed at supporting adherence to the drug and ensuring ongoing HIV testing and other health monitoring for individuals who take PrEP.

“The REMS is a critical part of making sure daily oral TDF/FTC as PrEP is implemented correctly and most beneficially for those who need it. We look forward to reviewing the full REMS and to working with other advocates to ensure that Gilead, the FDA and others implementing PrEP ensure that it meets the needs of patients and providers,” Warren added.

“This approval is one step toward ensuring that TDF/FTC as PrEP is made available to those who need it. Importantly, US approval paves the way for adding this strategy to prevention programs meeting the needs of hard-hit communities throughout the country. It is essential that the strategy be affordable and implemented in innovative, well-designed programs. But there is still much to do to ensure that PrEP is rolled out effectively where it is needed.”

“Access is paramount. We will monitor and advocate that FDA approval is followed by implementation that ensures daily oral PrEP using TDF/FTC is affordable through government assistance programs, Gilead’s patient assistance program and through private health insurance. State of the art HIV prevention is a right and a public health imperative, not a privilege. It is important that we explore all avenues for access and affordability of TDF/FTC as PrEP.”

“We must also work quickly to ensure continued global activity aimed at optimizing the benefit of daily oral PrEP using TDF/FTC. US approval and demonstration projects should be matched by similar action in developing countries, including those where this strategy was evaluated and showed benefit. At the same time, we need to maintain and expand resources for treatment and other HIV prevention options.

“At next week’s International AIDS Conference in Washington, DC, policymakers, advocates and researchers will be talking about beginning to end the AIDS epidemic. We need to be sure that there is clarity and commitment on where daily oral PrEP using TDF/FTC fits into this critical effort.” Warren added.

An action agenda for daily oral PrEP using TDF/FTC
AVAC is calling for immediate actions to ensure that daily oral PrEP using TDF/FTC is introduced through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections.

AVAC’s recommendations include:

  • Address cost and access issues for TDF/FTC as treatment and prevention: TDF/FTC is a well-tolerated drug with a unique resistance profile that is a preferred option for providers and people living with HIV worldwide. Access to affordable, sustainable supplies of TDF/FTC is essential. The agenda for PrEP implementation using daily oral TDF/FTC is inseparable from that of treatment access. Pricing, registration, and supply issues must be addressed.
  • Additional regulatory guidance and consideration: The World Health Organization is expected to issue “rapid advice” on this PrEP strategy in the near future. This should be complemented by swift regulatory review in other countries to reduce delay in determining the appropriateness of PrEP using TDF/FTC for key epidemics.
  • Demonstration projects: Real-world initiatives are urgently needed to answer important questions about how best to implement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, given the evidence to date which includes a trial in African women which did not show benefit–with low levels of pill-taking being one likely explanation. Currently, only a limited number of demonstration projects are planned or underway.
  • Public health guidance: Demonstration projects will provide key information on optimal use of daily oral TDF/FTC as PrEP. However public health entities such as the US Centers for Disease Control and Prevention, the WHO/UNAIDS, South Africa’s Medicines Control Council and others can pave the way for safe and effective use through guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible.
  • Funding: As robust demonstration projects get underway, donors and governments should be quantifying resource needs for daily oral PrEP to be introduced as a sustained public health initiative for key populations. Funding for PrEP should not detract from other essential HIV prevention and treatment efforts. However, funders and governments should start now to quantify and identify resources for public health programming to bring daily oral PrEP using TDF/FTC to those who need it most.
  • Additional research: Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and regulatory agencies should stand ready to act on new data and further expand options for preventing HIV infection.

This press release is available as a PDF.

Contact:
Kay Marshall, kay@avac.org, +1-347-249-6375

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For more information about PrEP and the steps needed to make it available to people in need, visit www.prepwatch.org and www.avac.org/prep.

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

African and US AIDS advocates issue a call to action ahead of the International AIDS Conference urging global leaders to make voluntary medical male circumcision a priority

New York, NY — African and US AIDS advocates today issued A Call to Action on Voluntary Medical Male Circumcision: Implementing a Key Component of Combination Prevention, a new report calling for rapid scale-up of voluntary medical male circumcision (VMMC) and providing detailed recommendations to increase VMMC rates and prevent millions of HIV infections in African countries in the next decade. The report was jointly developed by AVAC, based in the US; the National Empowerment Network of People Living with HIV/AIDS in Kenya (NEPHAK); Sonke Gender Justice Network (Sonke), in South Africa; and the Uganda Network of AIDS Service Organizations (UNASO).

“Voluntary medical male circumcision is one of the most effective HIV prevention tools available today. Countries where VMMC can have an impact should be acting to ensure access—and advocates should be demanding accountability,” said Mitchell Warren, executive director of AVAC. “At this moment in the epidemic, there are few things that could do more to reduce the human and economic toll of HIV. When the AIDS community gathers this month in Washington, we need to refocus on this inexpensive, one-time intervention that offers men life-long partial protection against HIV.”

Research shows that VMMC could help significantly reduce heterosexual transmission of HIV in key African countries. Long-term follow-up from clinical trials conducted in Africa suggests that VMMC reduces a man’s risk of sexually acquiring HIV from an HIV-positive female partner by as much as 75 percent. Modeling research indicates that achieving 80 percent VMMC coverage among men ages 15-49 in 13 key African countries by 2015 would avert up to 3.36 million new HIV infections by 2025. Meeting this target would also avert $16 billion in future direct AIDS prevention and treatment costs.

The authors note that, given slow progress to date, meeting global targets by 2015 may no longer be possible, representing a major missed opportunity.

“Even if we cannot achieve 80 percent VMMC coverage in all priority countries by 2015, each of these countries should issue a clear timeline for when they will meet their targets,” said Nelson Otwoma, National Coordinator of NEPHAK. “My own country, Kenya, provides a positive example. This essential prevention strategy cannot be allowed to stall as it has for some time in many countries.”

Slow progress punctuated by important successes

The report focuses on VMMC scale-up in 14 African nations (including the addition of Ethiopia, a PEPFAR country) with high HIV prevalence and low coverage of male circumcision. Overall, 1.5 million circumcision procedures have been performed in these countries to date, according to the US-funded PEPFAR program, representing only about 7.7 percent of the estimated 20 million procedures that would achieve 80 percent circumcision coverage among men between ages 15 and 49.

“Circumcision campaigns have barely gotten off the ground in many of the countries where they could help turn the epidemic around,” said Bharam Namanya, Executive Director of UNASO. “That’s unconscionable when we know that voluntary medical male circumcision could prevent so many infections—and do so more affordably than almost any other method.”

The report identifies several major barriers to progress. At the global level, funding for VMMC campaigns remains woefully inadequate. An estimated $1.5 billion over five years will be needed to achieve 80 percent coverage in priority African countries. While this represents a tiny share of current global AIDS funding, current funding commitments for VMMC fall far short.

Insufficient leadership in some African nations is also a significant problem. Relatively few political and community leaders at the national or local levels have become vocal champions for male circumcision, although there have been notable exceptions. Partly as a result, most priority countries still do not have viable VMMC implementation plans in place, and efforts to address stigma, misinformation and logistical challenges have been limited.

“Leadership has always made the difference between winning and losing the battle against AIDS, and it’s no different with voluntary medical male circumcision,” said Desmond Lesejane, Sonke deputy director. “In the few places where leaders have helped make it a national priority and a social norm, we’re seeing impressive increases in male circumcision rates. Where they haven’t, it’s no surprise that we see stigma and inaction.”

The report notes a handful of important success stories, including a large-scale VMMC campaign in Kenya’s Nyanza province. Thanks to close partnerships between health workers and leaders in the region’s Luo community, circumcision rates have climbed from 45 percent in 2008 to above 70 percent today.

Global Call to Action Ahead of the International AIDS Conference

The report includes a comprehensive set of recommendations to address the major barriers to VMMC scale-up. Among these are the following:

  • By the end of 2012, all priority African countries should have detailed national VMMC implementation plans in place.
  • PEPFAR, by far the largest funder of VMMC efforts, should quickly allocate the resources necessary to meet its stated commitment to support 4.7 million circumcisions. At the same time, Europe and middle-income donors must step up their VMMC investments and close the remaining funding gap.
  • Researchers and the World Health Organization should quickly evaluate and approve new devices that may eliminate the need for surgery and reduce the costs and complications of male circumcision in some settings.

The report’s full recommendations, available online, will be the focus of discussions at the International AIDS Conference in Washington, including a forum Call to Action for Voluntary Medical Male Circumcision for HIV Prevention with African leaders and health experts on July 23.

African coalition seeks to advance VMMC campaigns

To help achieve the report’s vision, a growing coalition of more than 300 African scientists, nurses, doctors, counselors, advocates, artists and journalists has begun working to counter stigma and misinformation about VMMC in African countries, and to pressure African leaders to act. The group, known as Africans Telling the Truth about VMMC, was initially established in response to widespread misinformation about the procedure.

“The story of male circumcision and AIDS is an African story: it’s largely thanks to African scientists, nurses, doctors, and men and women at risk that we have this powerful option,” said Richard Hasunira of HEPS Uganda, a member of the coalition. “We’ll certainly need the support of the global community to succeed in scaling up VMMC. But in the end, Africans must continue to lead.”

Members of the coalition will be working to promote the importance of VMMC as part of a comprehensive approach to HIV prevention, and to help establish the procedure as a cultural norm through its website, www.TruthAboutVMMC.org, and Facebook Page, and through media appearances and events in African countries where VMMC scale-up is a priority.

Separately, this week, a coalition of Ugandan advocates including Hasunira and HEPS Uganda released an analysis and strong critique of progress in bringing VMMC to scale in Uganda. The report, Too Little, Too Late, calls on the nation’s government to take greater ownership of VMMC efforts and calls for steps to overcome barriers to progress. The report is available online here. 

A PDF version of this press release is available here.

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Contact:
Kay Marshall, kay@avac.org, +1-347-249-6375

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

Publication of PrEP trial data provides clear evidence that PrEP works for men and women; AVAC lays out priorities to ensure access

New York, NY — Publication of data from three trials of pre-exposure prophylaxis (PrEP) for HIV – including the pivotal Partners PrEP trial – today in the New England Journal of Medicine provides strong evidence that HIV-negative men and women who consistently take a daily antiretroviral (ARV) pill (either TDF/FTC, brand name Truvada, or TDF, brand name Viread) can significantly reduce their risk of HIV infection.

The New England Journal of Medicine articles provide an in-depth review of safety, efficacy, adherence and risk behaviors in three trials whose primary results have been previously presented at scientific conferences and to the US Food and Drug Administration (FDA) as part of its ongoing review of Gilead Sciences’ application for a prevention indication for TDF/FTC for HIV-negative adults. Data from the three studies—including the FEM-PrEP study, which was stopped early for futility—underscore the need for adherence to the prescribed regimen of a once-daily pill to achieve protection from HIV infection.

“The evidence published today is clear: If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP can dramatically reduce your chances of becoming infected,” said Mitchell Warren, AVAC executive director.

“Daily oral PrEP is not a silver bullet or a stand-alone prevention solution. There are many strategies that work, including treatment for HIV-positive people, that will need to be brought to scale if we are to have the needed impact on new infections.”

“However, there will be men and women around the world for whom daily oral PrEP using TDF/FTC can be a life-saving prevention tool. Choice matters. For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope that we will achieve the end of the epidemic.”

“Much of the momentum to roll out PrEP has focused on gay men in the United States, and PrEP will be an important option for many gay men. But, as these studies suggest, PrEP is also a viable and important option for heterosexual men and women in Africa and other parts of the world. We must ensure global access to this lifesaving intervention,” Warren added.

An action agenda for global PrEP implementation


AVAC is calling for immediate actions to ensure that PrEP can be made available to people at risk of HIV quickly, safely and through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections.

AVAC’s recommendations include:

• Regulatory approval: The US FDA is considering approval of the drug TDF/FTC (marketed as Truvada) for daily PrEP among adults of risk of HIV infection. The FDA should approve Truvada for prevention. Regulatory agencies in other countries should quickly move to evaluate the evidence from these three trials among heterosexuals and the iPrEx trial among gay and bisexual men and transgender women and fast track regulatory decisions.

• Public health guidance: The US Centers for Disease Control and Prevention, the World Health Organization and other public health agencies should issue guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible. Guidance is needed by providers and people at risk, and to help governments and funders set priorities for PrEP implementation.

• Demonstration projects: Real-world studies are urgently needed to answer important questions about how best to implement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, which research has shown to be essential for PrEP to work. Currently, only a limited number of demonstration projects are planned or underway.

• Funding: As robust demonstration projects get underway, donors and governments should be quantifying resource needs for daily oral PrEP to be introduced as a sustained public health initiative for key populations. Funding for PrEP should not detract from other essential HIV prevention and treatment efforts. However, funders and governments should start now to quantify and identify resources for public health programming to bring daily oral PrEP using TDF/FTC to those who need it most.

• Additional research: Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and regulatory agencies should stand ready to act on new data and further expand options for preventing HIV infection.

“PrEP, together with other prevention strategies that we have now and those still to be developed, could help to significantly reduce the global burden of HIV infections and could be a life-saving intervention for some men and women,” Warren added. “Multiple clinical trials have clearly shown that PrEP is safe and effective when used as prescribed. But clinical trials are not the ‘real world’—they are well-controlled environments designed to give clear data. We all must now act on the scientific evidence and translate it into real-world reductions in HIV infections. We simply cannot afford to dismiss any new options in the quest to end AIDS.”

For a PDF version of this press release, click here.

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For more information about PrEP and the steps needed to make it available to people in need, visit www.prepwatch.org and www.avac.org/prep.

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.

Contact: Kay Marshall, kay@avac.org, +1-347-249-6375

Press Release

AVAC urges FDA approval of PrEP following positive advisory committee recommendation; lays out priorities to ensure access

New York, NY AVAC hails the recommendation by an FDA Advisory Committee that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women. Citing the urgent need for new HIV prevention options to stem HIV infections, AVAC urges the FDA to issue an approval for all men and women at risk, and is calling on public health agencies, governments, advocates and funders to take action to ensure access to TDF/FTC as PrEP.

“This brings us closer to a watershed for global HIV prevention efforts,” said Mitchell Warren, executive director of AVAC. “PrEP, while not a panacea, will be an essential additional part to the world’s success in ending AIDS. For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope that we will achieve the end of the epidemic.”

“The evidence from the clinical trials presented today is clear:  If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP can dramatically reduce your chances of becoming infected,” Warren said.

Noting that the FDA typically, but not always, follows its committees’ recommendations, Warren said, “With their support for approval, the FDA’s expert panel and its own scientists have followed the evidence.  We hope and expect that the agency will follow their sound advice.”

“As a young black gay HIV-negative man, I see that the current prevention options are not stemming HIV incidence in my community,” said Matthew Rose, policy chair of the Young Black Gay men’s Leadership Initiative and an AVAC PxROAR partner. “I know that a single drug or prevention strategy will not end this epidemic. But PrEP will give young gay black men tools that will allow them to manage their situation and make their own HIV prevention choices based on knowing all the options that exist.”

An action agenda for PrEP implementation
In anticipation of an FDA approval for TDF/FTC as PrEP, AVAC is calling for immediate actions to ensure that PrEP can be made available to people at risk of HIV quickly, safely and through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections. These actions should take place in the US and in other countries that may take the FDA ruling as a positive signal for national introduction of TDF/FTC as PrEP.

“After decades of research, it’s thrilling that we can begin talking about access to a powerful new HIV prevention option,” Warren said. “Some funders and policymakers have been awaiting a signal from the FDA before launching demonstration projects or developing implementation plans.  The time for waiting is over. We need to get on with the work of setting priorities and rolling out PrEP to people who can benefit the most.”

AVAC’s recommendations include:

  • Public health guidance:  The US Centers for Disease Control and Prevention, the World Health Organization and other public health agencies should issue guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible. Guidance is needed by providers and people at risk, and to help governments and funders set priorities for PrEP implementation.
  • Demonstration projects:  Real-world studies are urgently needed to answer important questions about how best to implement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, which research has shown to be essential for PrEP to work. Currently, only a limited number of demonstration projects are planned or underway.
  • Funding:  In addition to funding robust demonstration projects, donors and governments should be planning for significant investments in well-designed PrEP initiatives. Funding for PrEP should not detract from other essential HIV prevention and treatment efforts. However, funders should explore ways to repurpose funds that currently support lower-impact activities.
  • Additional research:  Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and the FDA should stand ready to act on new data and further expand options for preventing HIV infection.

“PrEP, together with other prevention strategies that we have now and those still to be developed, could help to significantly reduce the global burden of HIV infections and could be a life-saving intervention for some men and women, Warren added. “Multiple clinical trials have clearly shown that PrEP is safe and effective when used as prescribed. We all must now act on the scientific evidence and translate it into practice and impact. We simply cannot afford to dismiss any new options in the quest to end AIDS.”

For a PDF version of this press release, click here.

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

 
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Press Release

Leading AIDS advocates support FDA approval of Pre-Exposure Prophylaxis (PrEP), a promising new HIV prevention method, for men and women

New York, NY — In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women. Their comments, submitted in advance of a May 10 FDA Advisory Committee meeting, pointed to compelling evidence on the efficacy of TDF/FTC as PrEP and highlighted the unique potential of this intervention to help slow the HIV epidemic in the US.

With PrEP, HIV-negative individuals who are at risk for HIV take anti-HIV medications in order to reduce their chances of becoming infected if exposed to the virus. At the May 10 hearing, the FDA will consider data from clinical trials showing that TDF/FTC reduced the risk of sexual transmission of HIV in populations including men who have sex with men (MSM) and heterosexual women and men.

“The US and international AIDS community overwhelmingly supports FDA’s priority review of this potentially game-changing new tool to prevent HIV,” said Mitchell Warren, executive director of AVAC. “The evidence is increasingly clear that daily PrEP can help reduce HIV risk in women and men who take it consistently as prescribed. While no single tool will be enough to stop the spread of HIV, PrEP could be a vital part of a comprehensive, global strategy to end the AIDS epidemic.”

Despite some progress in reducing HIV incidence using other available methods, approximately 50,000 people become newly infected with HIV every year in the United States, and 2.6 million people were newly infected with HIV worldwide in 2010. Globally, half of all people infected with HIV are women and girls. In the United States, HIV infection continues to take a disproportionate toll on African Americans and Latinos; MSM, including transgender individuals; and the poor. Driving down HIV infection rates is a primary objective of the U.S. National HIV/AIDS Strategy, and is at the core of global efforts to end the AIDS epidemic.

“Today’s HIV prevention tools, including condoms, remain as essential as ever, but it’s clear that they aren’t enough,” said Deborah Cohan of the Bay Area Perinatal AIDS Center. “If approved, PrEP would help address important gaps, including the need for women to have more ways to protect themselves without having to rely on their male partners.”

“Evaluation of new prevention tools is critical to reducing the devastating impact of HIV among Black Americans,” said Douglas Brooks, MSW, Senior Vice President of the Justice Resource Institute. “No single approach will be right for everyone, but PrEP could offer a much needed option for some. The benefits could be especially great for Black gay or bisexual men, who account for nearly one-quarter of new HIV infections in our nation today.”

Modeling studies have shown that widespread access to PrEP could reduce new HIV infections, and thus the scale of the global HIV epidemic, substantially around the world. The FDA’s decision on TDF/FTC as PrEP could help pave the way for global health funders and developing countries to step up their planning for implementation.

Evidence for PrEP: What the Science Tells Us
At the May hearing, an FDA Advisory Committee will consider data from a wide range of safety and efficacy studies, including two pivotal clinical trials of TDF/FTC as PrEP:

  • The Partners PrEP trial, which found that daily TDF/FTC reduced HIV infections by 73 percent among heterosexual couples in Africa in which one partner was HIV infected and the other was not. Efficacy was 90 percent among those who adhered closely to their daily drug regimen.
  • An international study called iPrEx found that daily use of the drugs reduced HIV infections by 42 percent among MSM, and by more than 90 percent among participants who took their medication consistently enough for the drug to be detected in their blood.

These studies demonstrate that PrEP was safe, with minimal side effects and no significant risk of drug resistance. These and other trials also indicate that effectiveness of TDF/FTC as PrEP depends greatly on individuals’ adherence to the PrEP regimen. In each trial, when adherence was low, there was low or no protection, pointing to the central importance of strategies to maximize adherence.

“If FDA approves PrEP, we’ll still have a lot of work to do, just as with any other new drug. We’ll have many questions to answer in order to use PrEP effectively to reduce HIV infections,” said David Munar, President and CEO of the AIDS Foundation of Chicago. “The essential next step will be to launch additional demonstration projects in a wide range of populations and settings. These real-world projects will help us understand how to achieve higher levels of adherence, how to best combine PrEP with other approaches, and which specific populations can benefit the most. While a handful of these real-world studies are now being planned, we need to pick up the pace.”

Summary of the Joint Comments to FDA
Based on the clinical trial results to date, the groups indicated their support for FDA approval of TDF/FTC among both men and women. They also highlighted evidence demonstrating the safety of TDF/FTC when used as PrEP, while urging the FDA to ensure appropriate labeling and post-marketing surveillance to ensure that any future safety concerns will be quickly identified and addressed. In addition, the groups also called for the full participation of communities most likely to benefit from PrEP in any future discussions about FDA-required educational/informational materials and programs to support safe use of TDF/FTC as PrEP.

The full text of the comments is available here. The comments were signed by the following organizations:

  • AIDS Foundation of Chicago
  • AIDS United
  • AVAC: Global Advocacy for HIV Prevention
  • Bay Area Perinatal AIDS Center
  • Black AIDS Institute
  • The Fenway Institute
  • International Rectal Microbicide Advocates
  • Justice Resource Institute
  • National Black Gay Men’s Advocacy Coalition (NBGMAC)
  • National Minority AIDS Council (NMAC)
  • Project Inform
  • San Francisco AIDS Foundation
  • SHERO Empowerment Network
  • SisterLove

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

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Press Release

AVAC praises California’s HIV PrEP demonstration studies: More projects needed to translate science into reduced HIV infections, saved lives

New York, NY — AVAC strongly supports the California HIV/AIDS Research Program (CHRP) in launching new studies to evaluate the “real-world” use of oral pre-exposure prophylaxis (PrEP), a promising HIV prevention strategy recently shown to be effective in clinical trials.

The three CHRP-funded demonstration projects will provide vital information on how to implement recent research results to reduce HIV infections through the use of PrEP among HIV-negative people at high risk. Importantly, these studies will explore PrEP in the context of other new strategies to engage and retain HIV-infected individuals in care and treatment.

“PrEP, together with other prevention strategies, could help to significantly reduce HIV infections worldwide and could be a life-saving intervention for some men and women,” said Mitchell Warren, AVAC executive director. “Multiple clinical trials have clearly shown that PrEP is effective when used as prescribed. We now have an obligation to figure out how best to roll it out in the real world for people who need it and are able to use it, without delay.”

PrEP involves the use of daily anti-HIV medications by people who are uninfected but at high risk for HIV. Randomized-controlled trials that were closely overseen by independent ethical and regulatory bodies have shown that daily PrEP with a combination of the drugs tenofovir and emtricitabine (TDF/FTC, or Truvada) can reduce the risk of infection among gay men and other men who have sex with men (MSM), transgender women and heterosexual men and women. While other trials have shown no effect, the overall message is clear: adherence to the PrEP regimen is essential. Among trial participants who consistently took the PrEP pill, the risk of infection was reduced by more than 70 percent, while little or no benefit was seen when participants did not take the pill as prescribed.

“Finding ways to ensure that people who can benefit from PrEP are supported in taking the medication consistently has to be a top priority,” said Warren. “Real-world demonstration projects are the only way to test different approaches and find out what works. A year and a half after the first positive PrEP results, almost none are under way. This kind of delay is of severe concern to anyone interested in expanding the options for preventing HIV in some of the hardest-hit populations here in the US and worldwide.”

In addition to addressing adherence, demonstration projects are needed to answer questions about which populations benefit the most from PrEP and how to deliver it to them safely, effectively and at reasonable cost. They can also help determine the most effective ways to integrate PrEP with existing prevention strategies, such as male and female condoms, which remain essential to reducing HIV infections. AVAC and other advocates have called on governments and AIDS funders to launch an array of PrEP demonstration projects around the world, including the full range of populations that may benefit from the intervention.

“The California studies are smart to focus on gay men and transgender women, who are by far the most affected by HIV in the U.S. Now we need to do the same for other populations, especially the millions of women around the world who remain at risk. PrEP could help address the urgent need for new HIV prevention methods that women can control,” said Warren.

Warren also pointed to the upcoming U.S. Food and Drug Administration review of TDF/FTC as PrEP, saying, “The FDA’s review is a critical step in establishing access to PrEP and ensuring that accurate information is available to providers and potential users.” AVAC expects to be among a number of advocates submitting oral and written comments at a May 10 FDA Advisory Committee hearing.

“Ethics demand that we do everything we can to make proven HIV prevention options available to those who need them, when they need them. AIDS activists have a history of pushing researchers and regulators to make treatment available to people living with HIV as quickly as possible. People at risk of becoming infected deserve no less,” Warren said.

Contact:
Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +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

2012 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy Presented to Longtime Advocate Anna Forbes

Anna Forbes, a long-time microbicide advocate, has received the third Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy. The award was presented during the Microbicides 2012 Conference in Sydney, Australia.

Forbes was honored for her significant contributions to microbicides advocacy over a long career devoted to fostering civil society engagement in HIV care, treatment and prevention and women’s rights. She has been involved in the fight against AIDS for almost three decades and was an early champion for microbicides when the field had few strong advocacy voices.

Forbes’s work for more than a decade as deputy director of the Global Campaign for Microbicides (GCM) helped build awareness of the need for microbicides as a prevention option that could be controlled by women. She was also instrumental in the founding of the International Rectal Microbicide Advocates (IRMA). She continues to advocate for microbicides and other prevention options for women as an independent consultant with multiple organizations working with a special focus on engaging with sex work organizations across the world. Forbes is based in Washington, DC.

“I am honored to receive this award from my peers and proud to be receiving it here at the Microbicides 2012 conference where we have heard good news about the science, policy and advocacy that is moving us closer to new prevention options for women and for men,” Forbes said. “There have been times over the past several years when finding a safe and effective microbicide and other woman-controlled options for HIV prevention seemed like a distant dream, but today we are much closer to making it a reality. As Omololu said, the challenge of our time is HIV/AIDS. Receiving this award his name gives me renewed hope to meet that challenge.”

The Omololu Falobi Award highlights the essential role of community advocacy and leadership in HIV prevention research. It celebrates the life and values of the late Omololu Falobi, a long-time HIV advocate and journalist who founded Journalists Against AIDS in Nigeria, was an instrumental pioneer member of the Nigerian Treatment Access Movement, and co-founded the New HIV Vaccine & Microbicide Advocacy Society. Omololu was killed in Lagos, Nigeria in October 2006. The award was conceived as an ongoing legacy that recognizes his commitment and lasting contributions to HIV prevention research advocacy.

“Omololu was a visionary leader and activist, who accomplished much in his too short a life. He dedicated himself to powerful advocacy for HIV and HIV prevention research in Nigeria, Africa and worldwide,” said Morenike Ukpong of NHVMAS in Nigeria. “It is gratifying to see his ideals and vision live on through this award. I know he would be immensely proud of the work that Anna and the past recipients are doing to simultaneously advance human rights and HIV prevention research.”

Forbes was chosen from among an impressive group of nominees by an independent international panel of HIV prevention research advocates, policy makers, and scientists.

“Anna clearly has created, and continues to create, a fine and necessary inheritance for advocates working for microbicide and other HIV prevention options for women, said Polly Harrison, founder of the Alliance for Microbicide Development and chair of the selection committee. The times and circumstances in which Anna worked and continues to work, have certainly had their challenges. Yet she never seems to despair and she always tells the truth, especially truth to power. What more could one ask? We all look forward to continuing to hear Anna’s voice in this field.”

The 2012 Omololu Falobi Award Recipient was honored during the plenary session today with a plaque and a cash prize. The M2012 Secretariat also provided a full scholarship for the Award recipient to attend the Conference in Sydney.

The Omololu Falobi Award For Excellence In HIV Prevention Research Community Advocacy was conceptualised and the process coordinated by the African Microbicides Advocacy Group (AMAG) in partnership with AVAC: Global Advocacy for HIV Prevention Research, the Global Campaign for Microbicides (GCM), Journalists Against AIDS in Nigeria (JAAIDS), the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), and the Treatment Action Movement Nigeria (TAM). Joining the coordinating committee this year are the International Rectal Microbicides Advocates (IRMA) and the African AIDS Vaccine Programme (AAVP).

The award honors Omololu Falobi, a visionary leader who continues to inspire many people and projects. He was a leading HIV/AIDS activist, an advocate for prevention research, and an exceptional journalist. Omololu made enormous impact in Nigeria and beyond – he nurtured and/or led campaigns related to prevention, treatment and research; won multiple awards nationally and internationally; and earned a tremendous reputation from all who had the privilege to work with him. He established the Journalists Against AIDS in Nigeria (JAAIDS), co-created the Nigeria-AIDS eForum, co-founded the New HIV Vaccine and Microbicide Advocacy Society of Nigeria (NHVMAS), was an instrumental pioneer member of the Treatment Access Movement (TAM) Nigeria and a key leader of the African Civil Society Coalition on HIV and AIDS.

Financial support for the Award since 2008 comes from AMAG, AVAC, GCM, Family Health International, NHVMAS, the Open Society Institute in South Africa and UNAIDS. The Award also receives support from the M2012 Conference in the scholarship afforded to the Award recipient.

Press Release

AVAC welcomes Gilead’s submission of PrEP Data to FDA; Full review of all available data will help point the way forward for Truvada for PrEP use

New York, NY — An important step to expanding effective HIV prevention strategies has been taken by Gilead Sciences, Inc., says AVAC. Today, Gilead Sciences announced that it has submitted a dossier of research data to the US Food and Drug Administration (FDA) related to the use of the antiretroviral treatment drug TDF/FTC (tenofovir/emtricitabine, brand name Truvada) as a pre-exposure prophylaxis (PrEP) HIV prevention strategy.

PrEP for HIV prevention refers to the use of antiretroviral medications by HIV-negative people to prevent HIV infection. TDF/FTC, or Truvada, is currently used as part of highly effective combination antiretroviral treatment for HIV-positive people. Gilead announced that it was seeking FDA approval for a label change indicating that Truvada can reduce the risk of HIV infection in HIV-negative adults.

“The FDA should place Truvada for PrEP on its accelerated, priority review track. A determination from this regulatory agency on new labeling and other conditions of use would catalyze and clarify decision-making in the US and potentially internationally about where and how to use TDF/FTC as an HIV prevention strategy,” said Mitchell Warren, AVAC executive director. “Approval is not guaranteed as a result of today’s filing. AVAC looks forward to participating in the process that will allow responsible input to any review that promotes safe use to those who may potentially benefit from PrEP. It will also be critical to insure continued and unfettered access to TDF/FTC for HIV-positive people as part of life-saving treatment.”

Every year more than 50,000 people are newly infected with HIV in the United States and rates of infection have remained steady for many years, underscoring the need for new HIV prevention options for gay men and others at high risk of HIV infection in the US. Globally, rates of HIV infection have declined but remain unacceptably high, with women at particularly high risk. More than 2.7 million people were infected with HIV in 2010.

Two major international efficacy trials have found that TDF/FTC is safe and reduces risk of HIV infection among HIV-negative people. The iPrEx study among gay and bisexual men and transgender women, and the Partners PrEP study among stable heterosexual couples in which one partner is HIV-positive and one HIV-negative. In addition, TDF2, a smaller trial, provided additional information about the drug in young heterosexual men and women.

The FEM-PrEP trial among heterosexual African women at high risk of HIV infection recently determined that participants counseled to use oral daily TDF/FTC did not have any reduction in HIV risk compared to those participants counseled to use daily placebo. Additional data from this trial are expected in early 2012. The multi-arm VOICE trial, which is also looking at oral TDF/FTC among African women, is scheduled to report results in 2013. The VOICE trial recently announced that the trial arms testing oral TDF alone and 1% tenofovir gel did not provide any protection. (All participants in all PrEP trials were counseled about and provided with a comprehensive package of proven prevention tools.)

“Even though there have been mixed results on PrEP using TDF/FTC from various clinical trials, both the iPrEx and Partners PrEP data are strong and suggest that, in some contexts, a daily oral pill is a powerful prevention tool that individuals can use to reduce their HIV risk,” Warren said. “More analysis of the full range of trials will tell us why this strategy works in some populations, and not in others, but the need for new options in key groups—including gay men and women in stable partnerships—is so great that proceeding with the FDA review process is an appropriate and important next step.”

Participants in both the iPrEx and Partners trials are continuing to receive TDF/FTC in “open-label” periods of those trials, in which all participants are offered the drug that has been shown to be effective in reducing HIV risk. These open-label studies will generate information on patterns of adherence, impact on HIV risk and other variables outside of a highly controlled clinical trial environment. Visit www.avac.org/prep for more information about ongoing and completed PrEP studies.

“We know that PrEP is not a magic bullet and will not be the right intervention for everyone at risk of HIV infection, but it could be an important prevention option for many people who are unable to use other proven prevention options. An FDA-approved label indication and reasonable conditions of use would make it easier for providers and their clients to consider PrEP as a safe and effective prevention option, and pave the way for appropriate access in the United States,” Warren said. “We also know that TDF/FTC is an important part of treatment regimens for people living with HIV worldwide, and that decisions about when and how to use PrEP based on TDF/FTC can only happen in the context of uncompromised treatment access for people living with HIV.”

“We look forward to the rigorous FDA review process, which will include opportunities for public comment and debate about how Truvada as PrEP might be used,” Warren said. “At the same time, we must continue to rapidly expand testing, treatment and voluntary medical male circumcision, amongst the array of evidence-based interventions, while also accelerating research and development of additional new options, notably a range of ARV- and non-ARV-based prevention methods and vaccines to protect against HIV,” Warren added.

A PDF version of this press release is available here.

 

Contact:
Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +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.