AVAC Urges FDA Approval of PrEP Following Positive Advisory Committee Recommendation; Lays out Priorities to Ensure Access

NEW YORK, May 10, 2012 /PRNewswire-USNewswire/ -- 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 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.

SOURCE AVAC