Thursday, May 10, 2012
Contact:
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 madeavailable 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 toimplement 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 ofdemonstration 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 fromother
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 itinto
practice and impact. We simply cannot afford to dismiss any new options in the
quest to end AIDS.”
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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 ofAIDS vaccines, male circumcision,
microbicides, PrEP and other emerging HIVprevention options as part of a
comprehensive response to the pandemic.
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