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

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

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Press Release

AVAC Report Defines Agenda for Ending the Global AIDS Epidemic

New York, NY — AVAC today issued a three-part, science-based agenda for ending the AIDS epidemic within our lifetimes. The new report, titled The End?, is a unique strategic vision encompassing key steps to accelerate impact with existing HIV prevention tools, emerging strategies and longer term research. It identifies critical priorities in each of these areas and advances specific recommendations for both 2012 and for the next decade.

“The past year has seen building excitement about the possibility of ending AIDS in our lifetime. It is an ambitious goal, but a realistic one, provided we have a clear path forward and the will to do what’s needed,” said Mitchell Warren, AVAC executive director. “The science-based agenda in this year’s AVAC Report fills a gap at a critical moment: it describes the full spectrum of actions needed to realize the potential of existing, emerging and long-term biomedical HIV prevention options and change the AIDS response forever.”

The report comes at a pivotal moment for the AIDS response. Just weeks ago, US Secretary of State Hillary Clinton committed the US government to realizing an “AIDS-free generation.” A recent report from UNAIDS mapped a new framework for AIDS investments which are focused on high-impact, evidence-based strategies. Yet at the same time, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced that it has insufficient funds for its next round of grants, effectively delaying any new funding commitments until 2014. Ensuring that the Fund is replenished and continues to support countries worldwide is a top priority for ending AIDS.

“Secretary Clinton and other leaders have put a spotlight on what’s possible. Now, it’s time to agree on a coherent, long-term plan to make it happen,” said Warren. “While our success at ending AIDS is far from assured, the scientific data are speaking loud and clear and expectations are running high. It is essential that funding, implementation and research commitments align. The future of the epidemic hangs in the balance.”

Game-changing research advances fuel optimism
Recent studies have demonstrated that antiretroviral (ARV) medications and other tools can prevent HIV transmission, creating new opportunities to accelerate the global decline in new HIV infections:

In 2006, trials showed that voluntary medical male circumcision can reduce a man’s risk of infection from a female partner by about 60 percent.
In 2011, a large US-funded trial released data showing that starting effective HIV treatment earlier reduced individuals’ risk of transmitting HIV by 96 percent.
In 2009 and 2010, trials of oral and topical pre-exposure prophylaxis (PrEP) using ARV medications in specific populations of HIV-negative people provided proof of concept that PrEP is an effective prevention tool.
In 2011, scientists identified vaccine-induced immune correlates of risk that help explain the positive finding from the RV144 AIDS vaccine trial—the first to demonstrate that a vaccine can have an impact on HIV transmission—and point the way to discovery of an effective AIDS vaccine.

AVAC Report 2011 outlines priorities for success
The agenda for action in the AVAC Report covers three major priority areas. Each area demands action today, while the dividends in terms of impact on the epidemic will be seen in the short, medium and long term:

Deliver today’s proven strategies at scale, for immediate impact on the epidemic.Scale up innovative HIV testing programs to identify people who can benefit from prevention and treatment; expand access to treatment to preserve health and prevent transmission; and realize the full potential of voluntary medical male circumcision, a so-far underutilized tool.
For 2012, specific global goals include achieving universal access to ARVs at CD4 counts of 350 or below; and ensuring that relevant countries have long-term plans in place to roll out voluntary medical male circumcision with the goal of achieving 80 percent voluntary circumcision rates.
Demonstrate and roll out emerging tools, including PrEP and microbicides, for even greater impact in five to 10 years.Quickly establish clear plans to understand how and for whom these promising tools might work; launch pilot projects to determine their best uses in different populations; and then prioritize their use in the populations, and in combinations, where their potential impact is greatest.
For 2012, global goals include swift implementation of pilot projects, establishing a clear pathway for confirmatory research on the tenofovir-based microbicide gel, and building and maintaining a pipeline of longer-acting options.
Develop long-term solutions, including an effective vaccine and a cure.Sustain funding to capitalize on recent scientific advances that have energized the research field.
A key 2012 goal is to close funding gaps for trials that are needed to pursue leads from the RV144 vaccine trial. Such trials are increasingly threatened by potential research budget cuts in the U.S. and other nations. In addition, it is increasingly important to define how a vaccine could impact combination prevention.

Success hinges on sustained financing, used wisely
The report urges that resources for HIV prevention be allocated for greatest possible impact. Where necessary, funding that supports low-impact activities should be reprogramed, based on evidence, to further reduce infections and save more lives. Moreover, AVAC argues that to end the AIDS epidemic, the field needs to define, evaluate and implement combination prevention in every community affected by HIV.

“If we’re serious about ending the epidemic, then we all need to make certain that precious resources are put where they’re needed most,” said Warren. “And we need to ensure that adequate resources are available. We cannot meet these ambitious goals if the Global Fund, PEPFAR and other essential programs are not adequately funded.”

In launching the report, AVAC called on the United States, global health donors and developing countries to increase funding for scale-up of interventions including HIV testing, treatment and voluntary medical male circumcision. At the same time, renewed promise in the vaccine research field can only be pursued through sustained support from the US and other research sponsors.

“Today’s exciting science comes at one of the most challenging and frustrating economic times,” said Warren. “But the case for investing in the AIDS fight is the strongest it has ever been. If we spend more today—and spend it more wisely—we can save money over the long term and rid the world of one of the most devastating and prolonged epidemics in history.”

The full AVAC Report 2011: The End?, along with AVAC’s Playbook 2012, podcasts, graphics and other materials about ending the epidemic, are available at www.avac.org/report2011.

A PDF version of this press release is available here.

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

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Press Release

VOICE trial changes are disappointing, says AVAC; Calls for continued research to find new prevention options for women

New York, NY — The announcement today that the 1% tenofovir gel arm of a large-scale HIV prevention trial known as VOICE will stop early is disappointing but is not the end of the road for tenofovir gel or antiretroviral (ARV)-based microbicides.

“This is a blow to the HIV prevention field but is not the definitive answer about whether 1% tenofovir gel is an effective HIV prevention product for women,” said Mitchell Warren, AVAC Executive Director. “New interventions are studied in multiple effectiveness trials for exactly this reason. CAPRISA 004, the first trial of 1% tenofovir gel, found effectiveness in women. VOICE found no effect. The FACTS 001 safety and effectiveness trial of tenofovir gel, which has just begun in South Africa and uses a different dosing strategy from VOICE, will provide additional information and hopefully clarity about the effectiveness of tenofovir gel.”

“One immediate priority is ensuring that communities directly connected to planned and ongoing trials of tenofovir gel are informed and engaged with discussions about the way forward. Finding prevention options that work for women must remain a top priority, and there is still crucial investigation of tenofovir gel as both a rectal and a vaginal microbicide, which must continue,” Warren said.

After a recent, scheduled interim review of trial data, the independent Data Safety and Monitoring Board (DSMB) for VOICE—a five-arm proof-of-concept trial that has enrolled more than 5,000 women in South Africa, Uganda and Zimbabwe—recommended that the 1% tenofovir gel arm of the study be stopped and that the women in that arm exit the trial in a structured process. The DSMB concluded that there was no possibility that daily use of tenofovir gel would show efficacy in preventing HIV in the context of the VOICE trial. Importantly, the DSMB found no safety issues in any arm of the trial. No other data from the trial have been released at this time.

In September, the VOICE trial DSMB met and recommended stopping the oral tenofovir (TDF, brand-name Viread) arm of the trial after it was determined that oral TDF could not be shown effective in the context of this trial.

VOICE will continue to evaluate oral TDF/FTC (a combination of TDF and emtricitabine (FTC), brand-name Truvada) with final results expected in late 2012.

In July 2010, results from the CAPRISA 004 trial showed that 1% tenofovir gel reduced the risk of HIV infection by 39 percent overall among the women in that trial. At this time, it is impossible to know why the results of VOICE and CAPRISA 004 were different. The differences could be related to the dosing schedule—women in CAPRISA 004 were counseled to use the gel before and after sex, while women in VOICE were counseled to use it daily—or it could be related to how frequently women used the gel or other variables. VOICE launched in 2009 with a five-arm trial design to evaluate the safety and effectiveness of oral TDF, oral TDF/FTC and 1% tenofovir gel, each used daily, compared to a placebo gel or placebo pill.

“Based on the limited information available at this time, we simply don’t know whether the lack of effect was due to biology, adherence, both, or something else. This is one reason why the ongoing FACTS 001 trial, which is evaluating a different dosing strategy, with different adherence requirements, should continue,” Warren said. “The concept of ARV-based prevention has been proven, but to meet the prevention needs of different populations we need the right drug at the right time in the right place. We hope that further research with tenofovir- and other ARV-based options will provide a range of new prevention options.”

The FACTS 001 trial of 1% tenofovir gel, which began enrolling in October and will include 2,200 HIV-negative women in South Africa counseled to follow the same dosing schedule as CAPRISA 004, should provide more information about how and if tenofovir gel might reduce risk of HIV infection in women. Results from FACTS 001 are expected in 2014. In addition, follow-on studies among women who participated in the CAPRISA 004 study will provide more critical information about the effectiveness and acceptability of tenofovir gel under different circumstances.

“We commend the VOICE trial team, the members of the DSMB and especially the more than 5,000 women who are participating in the trial,” said Warren. “VOICE has and will continue to provide critical information about both tenofovir-based PrEP and microbicides that will help move the HIV prevention research agenda forward,” Warren said.

The disappointing news from the VOICE trial is the latest development in a complex picture of what ARV-based prevention means for HIV-negative women. The Partners PrEP trial provided evidence of benefit that both daily oral TDF/FTC or daily oral TDF reduced HIV-negative women’s risk of acquiring HIV from an HIV-positive male spouse or stable partner. (The same benefit was observed for HIV-negative men with HIV-positive female partners.) The trial enrolled serodiscordant couples, in which one partner was HIV- negative and one was HIV-positive. The smaller TDF2 expanded safety study, which enrolled young men and women, also showed a reduction in risk for both men and women who took daily TDF/FTC. However, the VOICE oral TDF arm and the FEM-PrEP study of oral TDF/FTC in women found flat results.

“We must, without any delay, accelerate the development of prevention strategies for HIV-negative women that address possible adherence issues. While we do not yet know the role that adherence to the drug regimen might have played in the FEM-PrEP and VOICE trial data to-date, we know that, for some women, strategies that require less-frequent dosing, such as a vaginal ring inserted monthly, and long-acting injectables, will be simpler to use from an adherence stand point,” Warren said.

“Simultaneously, we must make good on the promise made to all trial participants to extract every bit of valuable data that we can from the ongoing trials. We have much to learn from analyses of FEM-PrEP and VOICE as well as from FACTS 001 and the ongoing Partners PrEP trial. The prevention field must be prepared to act on emerging findings from these trials with clear plans and processes for accelerating or shelving approaches.”

“Medical research is often complicated, and we know to expect setbacks along the way. But with 2.7 million new HIV infections every year, it is imperative that we continue to look for new ways to curb the epidemic,” Warren added. “It is especially important that we focus on interventions that will help young women—who so often bear the brunt of the epidemic—protect themselves.”

“There will never be a silver bullet for HIV prevention, so we must continue to rapidly expand testing, treatment and voluntary medical male circumcision, amongst the array of evidence-based interventions, while also accelerating the research and development of additional new options, notably a range of ARV- and non-ARV-based prevention methods and vaccines to protect against HIV.”

A table of ongoing and planned ARV-based microbicide and PrEP trials is below. For more information visit www.avac.org.

A PDF version of this press release is available here.

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

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Press Release

AVAC Applauds Secretary of State Hillary Clinton for Ambitious, Science-Based Vision to End the AIDS Epidemic

New York, NY — AVAC welcomes today’s remarks by U.S. Secretary of State Hillary Rodham Clinton as the first step in an ambitious vision for ending the global AIDS epidemic.

“Secretary Clinton rightly recognized that this is an era of unprecedented opportunity for changing the course of the AIDS epidemic and making an AIDS-free generation a reality. The announcement of an additional US$ 60 million for combination prevention impact evaluation in four countries is a useful first step in terms of realizing the vision. In the coming months, it will be critical for the Obama Administration to build on the plan that she outlined with specific commitments and objectives for the near-, mid- and long-term,” said Mitchell Warren, AVAC executive director.

Secretary Clinton emphasized three core prevention strategies that, if fully implemented, would lead to an AIDS-free generation: prevention of mother-to-child transmission, voluntary medical male circumcision and effective antiretroviral treatment for people who are HIV positive.

“HIV testing and counseling programs are the foundation for each of the interventions Secretary Clinton described, and it will be critical for the Obama Administration to focus on massive scale-up of innovative, ethical testing programs as part of its articulated plan for an AIDS-free generation,” Warren said.

“It is also critical to sustain investments in research and development of additional powerful prevention tools, including pre-exposure prophylaxis (PrEP) using ARVs in HIV-negative people, microbicides, and an AIDS vaccine,” Warren added. “If voluntary medical male circumcision, treatment as prevention and prevention of mother to child transmission are taken to scale, the number of new infections will plummet. Deploying additional tools over the long term,could help realize the greatest achievement of ending the AIDS epidemic in our lifetime.”

“This is truly a new era in the AIDS response, with unprecedented opportunities. Research has brought us a host of new ways to prevent HIV, but we have a long way to go before realizing their full potential. Having identified these key areas, the United States needs to continue to show leadership by articulating a clear plan with milestones for progress. Other developed and developing country governments, communities and donors need to show leadership, ownership and initiative as no single nation can end the epidemic on its own.”

AVAC will release its annual report on the state of global HIV prevention at the end of November, laying out a science-based prescription for the coming decade to realize the end of the AIDS epidemic.

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

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