Momentum for PrEP and Other News from USCA

In October, AVAC’s Kevin Fisher and Deirdre Grant and a number of PxROAR program members descended on Las Vegas for the United States Conference on AIDS (USCA). USCA is a US-focused conference that largely attracts front-line providers from AIDS service organizations.

This was AVAC’s fourth year presenting on PrEP at USCA, but importantly the first time since the United States FDA approved an indication for daily oral TDF/FTC (Truvada) as PrEP in July. Kevin and Deirdre led a seminar session PrEP can protect women and men against HIV! What do we need to know and do so we can translate results into public health impact? Over 75 people engaged in discussions on the state of PrEP research/implementation—the largest audience AVAC has had for this type of session at USCA—highlighting the growing need for information about PrEP, especially in translating research to rollout.

The audience participated in an energetic debate about whether at next year’s USCA, they thought they would be talking about how their communities had integrated PrEP into local HIV prevention efforts. In a reversal from previous years, almost everyone in the room was supportive of the idea that PrEP would be a part of their local prevention efforts. Previous questions surrounding PrEP have begun to be answered and its potential as a new—and needed—HIV prevention option is seen.

PxROAR members were also busy at USCA. Nichole Little led a roundtable discussion on PrEP and women based largely on her ROAR work—Sex, Biomedical HIV Prevention & The New Millennium Woman: Is PrEP The Answer For Me? Kieta Mutepfa helped facilitate a session on Strategies for HIV Prevention Message Development in Specialized Populations: A Case Study of Empowering Young MSM of Color in Los Angeles as Advocates for PrEP. Ebony Johnson was a speaker at the Opening Plenary Breakfast addressing what can be done to turn the tide of the epidemic among women and ensure social and health equity for all women in the United States.

The Change We Need to End AIDS in Uganda

2012 AVAC Fellow Alice Kayongo played a leading role in developing a civil society report, “The Change We Need to End AIDS in Uganda”, which details concerns and recommendations for shaping the national AIDS response in Uganda. This report was presented at the Joint Annual Review (JAR) of the country’s five-year National Strategic Plan (NSP) for responding to HIV/AIDS, which was first launched about a year ago. The mid-October JAR meeting was an opportunity to review progress and gaps. In the weeks leading up to the JAR, civil society participated in reviews of draft assessments of progress on the various elements of the NSP, including prevention, treatment and care, and health systems strengthening.

Kayongo was joined in this coalition effort by Sylvia Nakasi and Bharam Namanya of UNASO (2011 Fellow and Host Supervisor, respectively), and Leonard Okello, Alice’s Fellowship supervisor and Lillian Mworeko of ICW-EA (2012 Host)—as well as a broad range of other advocates.

The report, presented at the JAR, included a 10-point plan to halt new infections, save lives and ensure leadership, and provided a detailed critique of the national AIDS response to date.

This advocacy comes on the heels of a dynamic and successful campaign to increase funding for and recruitment of more than 6,000 health care workers throughout Uganda.

For a copy of the report, reach out to fellows@avac.org.

Press Release

AVAC statement on PEPFAR Blueprint

New York, NY – PEPFAR’s blueprint has enormous potential to accelerate global HIV prevention efforts. It rightly emphasizes that we need to ‘follow the science’ if we intend to deliver life-saving HIV prevention and treatment breakthroughs to millions of people worldwide. The blueprint underscores that success depends on scaling up combinations of effective strategies. It also places much-needed emphasis on voluntary medical male circumcision, which could prevent millions of HIV infections and do so more affordably than almost any other method today.

It’s particularly encouraging that the blueprint focuses on translating scientific breakthroughs into lives saved. Powerful new HIV prevention options could together lead to dramatic reductions in HIV infections, but we don’t have all the information we need to scale them up in the right combinations for various communities. Urgent questions about the real-world use of new prevention tools in combination have been clear for months or even years, yet the work to answer them is barely under way. That’s as unconscionable as it is unnecessary.

The blueprint also recognizes that ending AIDS will not be easy or quick. While current options can have a tremendous impact, continued science and innovation are essential to ultimately halt new HIV infections and deaths from AIDS.

The US has shown great leadership, and now it’s time for the rest of the global community to step up. Frankly, we are not on pace to end AIDS – but we could be. Global agencies, governments, donors and advocates need to work with PEPFAR now to agree on the most urgent priorities, set specific goals and demonstrate real progress within the next year.

A PDF version of this is available for download.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536

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

Press Release

AVAC report finds that world is already falling behind pace to end AIDS epidemic; five essential actions needed in 2013 to avoid historic missed opportunity

New York, NY – AVAC today issued a “top five” list of global actions needed in 2013 to accelerate HIV prevention efforts and preserve the opportunity to end the AIDS epidemic. The recommendations address urgent, unresolved challenges that threaten the delivery of powerful new HIV prevention methods that could help dramatically reduce the 2.5 million new HIV infections that occur worldwide every year. They include critical actions to speed access to HIV treatment, voluntary medical male circumcision (VMMC) and pre-exposure prophylaxis (PrEP), and to safeguard vital new research on vaccines, microbicides, other HIV prevention options and a cure.

“Recent scientific breakthroughs give us reason to be optimistic like never before, but our chances of success are already imperiled,” said Mitchell Warren, AVAC executive director. “Right now, the world isn’t moving as fast as it should be to begin ending the epidemic. There is still time to get back on a winning pace but only with focused, aggressive action now. This can be the year that HIV prevention begins to achieve its potential – in fact, it has to be.”

The priorities are featured in a new report, Achieving the End: One Year and Counting, which offers AVAC’s critical assessment of progress achieved since global leaders began to discuss the opportunity to “begin to end AIDS” in late 2011. The report reflects input from HIV prevention leaders across a broad spectrum.

“We have a narrow window to translate the past year’s excitement into life-saving changes on the ground,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute (WRHI) in South Africa and a member of AVAC’s board of directors. “The possibility of ending AIDS is very much alive but depends on much bolder leadership, increased coordination and agreement on a clear set of short-term priorities.”

“The world needs immediate answers to the question, ‘What now?’, and then it needs to act on them,” said Warren. “We’ve identified what we believe are the five HIV prevention priorities that can make the greatest possible difference in the coming year. Whether we’re on pace to end AIDS in a year’s time will depend in large part on our success in these areas.”

AVAC’s priority recommendations for 2013 are as follows:

End confusion about “combination prevention” – In 2012, there was long-overdue recognition that different countries will need to implement different combinations of HIV prevention interventions for different populations at risk. But the hard work of defining those combinations and establishing priorities has not been done. In 2013, donors, policy makers and civil society need to be held accountable for choosing, implementing and evaluating the right packages of interventions for specific circumstances.
Close the gaps in the HIV “treatment cascade” – Antiretroviral treatment not only improves and prolongs the lives of those infected, it is among the most powerful HIV prevention strategies available, reducing the risk that an infected person will pass on HIV by up to 96 percent. But only a small proportion of people diagnosed with HIV are linked to antiretroviral treatment and an even smaller share stay on treatment and have their HIV infection suppressed to levels low enough to prevent transmission to others. A range of studies is looking at ways to narrow this gap, but these efforts are uncoordinated and incomplete. In 2013, researchers and funders need to convene and establish a clear research and implementation agenda to close the gaps in the treatment cascade.
Prepare for new non-surgical male circumcision devices – In 2013, the World Health Organization (WHO) is expected to approve new male circumcision devices that could eliminate the need for surgery, speed recovery and lower costs in many of the 14 priority African countries where VMMC could reduce HIV infections by 20 percent. While the new devices may not be right for every country or setting, there could be months or years of lost opportunities unless national health leaders immediately take action to evaluate their benefits, costs and optimal uses.
Define and roll out needed PrEP demonstration projects – Global health agencies including WHO and UNAIDS have said they are awaiting the results of real-world demonstration projects before they can provide guidance on the use of PrEP – yet there is no clarity on what range of studies is needed, and few are under way. By the end of 2013, a core set of studies must be defined and moving ahead.
Safeguard HIV prevention research funding – New momentum on research into HIV vaccines, microbicides and other new tools is threatened due to the possibility of federal budget sequestration in the US and similar pressures in other countries. The potential cuts could slow or halt progress on some of the most promising HIV prevention research in many years. Policy makers must have the courage to preserve this vital research in 2013.

“The most urgent questions about new prevention tools have been clear for months or even years, and yet the work to answer them is barely under way,” said Warren. “That’s as unconscionable as it is unnecessary. Millions of lives depend on our ability to pick up the pace.”

The new recommendations build on AVAC’s long-term agenda for global HIV prevention efforts, issued in late 2011. That report, titled simply The End?, established near-, medium- and long-term goals for delivering available prevention interventions, demonstrating potential impact of emerging tools such as PrEP and microbicides, and developing essential new tools, including AIDS vaccines. In addition to the five key priorities for 2013, AVAC’s new report includes key updates to the long-term agenda for global HIV prevention.

A PDF version of this press release is available.

Contact:

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

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PrEP for Women — What’s the Plan?

Just days before the start of the International AIDS Conference, the US Food and Drug Administration announced its approval of TDF/FTC for pre-exposure prophylaxis (PrEP). This development has raised hopes, questions and concerns on many fronts. A session in the Global Village at AIDS 2012, “How can ARVs as prevention work for HIV-negative women?”, looked specifically at women’s views on this potential new prevention tool. Over 30 participants, most of whom were women, discussed current and future options for using ARVs for prevention in HIV-negative women. The session was co-facilitated by Lisa Diane White of SisterLove (and a PxROAR member) and Manju Chatani-Gada of AVAC.

The animated dialogue started with a presentation on HPTN 064, also known as ISIS, a US government-funded study designed to estimate the overall new HIV infection rate for women at risk in the US. Through focus groups and in-depth interviews, this research identified a number of barriers to HIV prevention and risk factors affecting these women. The discussion then shifted to one potential new prevention tool for women—daily oral TDF/FTC as PrEP. After a review of the data and current regulatory developments, the audience discussed what PrEP might mean for US women. Participants raised many questions including who would pay, how much PrEP would cost, what types of programs would offer PrEP to HIV-negative women and what kinds of testing would be required.

Similar questions apply internationally. Look out for more opportunities to join the US and international-based conversations led by AVAC and its partners.

Click here for more information.

Press Release

AVAC welcomes CDC guidance on PrEP for heterosexual men and women; calls for more demonstration projects to help guide optimal PrEP use

New York, NY — AVAC today welcomed the US Centers for Disease Control and Prevention (CDC) guidelines on the use of the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) among sexually active heterosexual men and women.

“These guidelines are another essential building block as we look at the ways PrEP can be used as an effective prevention option for men and women,” said Mitchell Warren, executive director of AVAC. “For the US, CDC guidance is a crucial step in a long process of ensuring that TDF/FTC as PrEP is made available to those who need it. Together with CDC’s initial guidance on PrEP use among gay and bisexual men, released in early 2011, these guidelines will help ensure that that individuals and health care providers have the information they need to make informed decisions about PrEP use.”

“We know that daily oral PrEP using TDF/FTC is not a magic 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. As the CDC guidance notes, use of PrEP requires adherence, a confirmed HIV-negative diagnosis and ongoing monitoring. But for some people, some of the time, oral PrEP with TFD/FTC will be a powerful prevention option.”

“We also need real-world projects now to answer important questions about how best to implement PrEP, especially among those most at risk of HIV infection, including many women and young gay men. It is essential that a range of PrEP demonstration projects be fully funded and implemented as quickly as possible.”

PrEP demonstration projects will tell us 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 in the United States and even fewer globally.

“With more than 50,000 new HIV infections in the US each year and millions of new infections globally, we clearly need new ways to prevent HIV infections,” Warren added. “PrEP is an important option for some people here in the US and around the world. We must all work together to ensure that PrEP is integrated into HIV prevention programs in communities where it can prevent infections and save lives.”

This press release is available as a PDF.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
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.

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.

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.

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

Activists Strategize in Peru

In May, AVAC partner Epicentro led a civil society meeting, Activism, Access to Health Services for LGBT and Biomedical HIV Prevention, to develop a plan for engaging with biomedical HIV prevention research occurring in Peru. Local advocates, including MSM sex workers and people living with HIV, participated in the two-day conference. (Download the agenda: English and Spanish.) The objectives were to promote a common understanding of the PrEP and rectal microbicide research taking place in the country and to identify strategies for community mobilization on these issues, HIV treatment and prevention, and LGBT health in general. The resulting advocacy agenda articulated a demand for access to affordable TDF/FTC for treatment of HIV-positive people—an issue that must be addressed before oral PrEP using TDF/FTC in HIV-negative people can be fully explored. It also identified the need for journalist training, sensitization of health workers on LGBT health issues, and general awareness-raising on biomedical HIV prevention.

Communities of gay men, other men who have sex with men, and transgender women have some of the highest rates of HIV in Peru. Yet access to HIV testing, care and treatment is limited—due to many factors including stigma, lack of gay-friendly services, and lack of awareness of health care rights among affected communities. Advocacy also includes continued support for ARV-based prevention research— the iPrEx OLE open-label extension PrEP study; MTN 017, the first phase II rectal microbicide trial; and early phase vaccine studies. For example, in March, Epicentro, AVAC, IRMA, IMPACTA and MTN organized a community consultation for the pending MTN 017 trial. Most meeting attendees were Lima locals, but there was representation from elsewhere in Peru as well as Paraguay and Argentina.

The next steps are to prioritize and operationalize the objectives generated at the meeting. To join the burgeoning network of local and regional Latin American advocates spearheaded by Epicentro, contact Steve Miralles at stevemiralles@hotmail.com or join the group directly at irma-alc@epicentro.org.pe.

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