Cape Town, South Africa, December 9, 2013 – In a report released today, AVAC calls on funders and researchers to capitalize on lessons learned from a range of recent HIV prevention trials with better problem solving, more critical thinking and coordinated action around large-scale human trials, faster roll out of proven options and ongoing research for new advances that women and men will want to use.

This year’s AVAC Report, entitled Research and Reality, pays particular attention to the needs of women and girls. Citing recent trials that failed to provide conclusive answers due to low use of products in the studies, the report lays out a broad and ambitious development agenda for female-initiated prevention options including vaginal gels, rings and other emerging biomedical strategies.

The new report also urges researchers, donors and implementers to step up plans for large-scale delivery of recently proven methods for women and men, including pre-exposure prophylaxis (PrEP) and non-surgical male circumcision devices. While pilot studies of these options are in progress, a lack of longer-range plans for program scale-up and roll out means that valuable time, and lives, could be lost.

“Prevention research has had both rough times and revolutionary breakthroughs in the past few years. It’s time to apply lessons from these experiences to work faster and smarter going forward,” said Mitchell Warren, AVAC executive director. “As advocates, we’re looking to make sure that new HIV prevention developments are turned into action—whether that’s delivering new options that work to the people who need them, or revising past assumptions based on trials that didn’t go as planned.”

“We need to keep focused on HIV prevention that’s effective, available and meets the needs of men and women throughout their lives,” Warren said.

Refocusing the Search for New Methods for Women

Research and Reality, released at the 17th International Conference on AIDS and STIs in Africa (ICASA), takes an in-depth, critical look at prevention research for women. There has been a positive, proof of concept finding that a vaginal gel can reduce women’s risk of HIV, as well as positive data on daily oral tenofovir-based PrEP in women. However, there have also been two trials in which participants did not actually use the options being tested regularly enough to answer the study questions.

In the report, AVAC offers recommendations and analysis to move beyond competing interpretations of these data. This is the first advocacy document to provide a full picture of what the trials do and do not reveal about the future of female-initiated prevention. It identifies clear steps to take to address issues from past trials and a core set of questions that need to be answered through strategic research going forward.

“It would be completely unacceptable to throw up our hands and say we don’t know what women want,” said Warren. “With women representing half of the global HIV epidemic, it’s both a practical and a moral imperative to keep up the search for new methods that women can control and want to use.”

“Recent trial results may be puzzling, but one thing we know for sure is that many women at risk want and need new ways to protect themselves from HIV,” said Nono Eland, chairperson of the Women’s Sector of the South African National AIDS Council (SANAC). “The prevention revolution continues. Earlier this year, participants at the SANAC Women’s Sector biennial summit called for better investment in prevention for women. We called for women to be meaningfully involved at all stages—from planning to distribution of HIV prevention products that are developed for us and reiterated the need for prevention research literacy for communities.”

To help resolve questions and challenges about women’s prevention options, Research and Reality recommends that researchers and trial sponsors:

• Continue to explore and measure methods to improve adherence.
• Conduct additional qualitative research to better understand women’s reasons for enrolling in a trial and using (or not using) a study product.
• Use innovative trial designs that would select trial participants who are most likely to adhere to a product regimen so efficacy can be determined – if the trial shows efficacy, bridging studies should be designed to examine how the strategy might work among more diverse populations

“When conventional approaches to science are not working, it’s time to break with convention,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute in South Africa and a member of AVAC’s board of directors. “We urgently need to identify a range of prevention options that can work for women – and then we need to know which options will work best for which women.”

Research and Reality also provides four overarching recommendations on issues that lie at the intersection of research goals and real-world conditions.

• Launch complex trials to answer complex questions – Clinical trials remain the only way to answer the most important scientific questions in HIV prevention. Researchers and funders must continue to launch new trials despite the challenges, complexities and costs. This is especially true for AIDS vaccines, as well as to clarify the effect of hormonal contraception on HIV risk, where research is critical and must proceed.
• Plan for roll out beyond pilot projects – Pilot projects are an important first step toward ensuring that promising research results translate into real impact on people’s lives, but pilot projects alone will not end the AIDS epidemic. To realize their full potential, interventions such as daily oral PrEP and non-surgical devices for voluntary medical male circumcision need to be adequately resourced, ramped up, and included in national HIV/AIDS implementation plans.
• Invest and innovate in virologic suppression – In addition to the life-saving benefits of antiretroviral therapy as treatment for people living with HIV, research shows that ARV treatment can dramatically reduce the risk of HIV transmission to others. But treatment works in this way only when it effectively suppresses virus in the body to very low levels. To achieve and sustain HIV suppression and realize the full preventive potential of treatment, it is critical to invest in treatment adherence programs, new antiretroviral therapies, therapeutic vaccines and a cure.
• Align programs, models and funding to stay on track to end AIDS – Countries are developing HIV prevention plans and targets based on modeling that does not fully account for realities on the ground. Models are essential, but they need to be designed with built-in feedback loops – pulling in surveillance data and other information about the impact of prevention programs, so that results can be improved quickly over time.

The new Research and Reality recommendations build on the AVAC Playbook, a long-term agenda for global HIV prevention efforts first issued in 2011. AVAC assesses and reports on the most critical next steps for the development and delivery of new prevention options each year.

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

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic. The full report, AVAC Report 2013: Research and Reality, is available at www.avac.org/report2013.

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, [email protected], +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.

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:

1. 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.

2. 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.

3. 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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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.

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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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.