FDA

Letter to FDA: Request for Priority Review of Truvada® for PrEP HIV Prevention Use

A coalition of 25 leading HIV/AIDS and health organizations, including HIV PJA, drafted and endorsed the following letter to the FDA asking for priority review of Truvada® for PrEP.  The potential of PrEP as part of a comprehensive approach, including condom use of risk counseling, is an important step in increasing the effectiveness of HIV/AIDS prevention.  Take a look:

January 25, 2012
Margaret A. Hamburg, M.D.
Commissioner
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852 Read more »

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4/20 HIV PJA Webinar - Materials Available

Materials are now available from the 4/20 HIV PJA Strategy Webinar: "Practical PrEP Priorities, or Profound Problems: U.S. Pricing and Access Issues in the wake of iPrEx." 

The agenda covered PrEP pricing options for the U.S. market and the landscape for FDA review of oral PrEP, as well as updates on the FEM-PrEP trial closure and the upcoming UN high-level meeting on AIDS.  Read more »

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4/20 HIV PJA Strategy Webinar Recap: FEM-PrEP Trial Closure, U.S. Pricing & Access Issues after iPrEx, & UN Update

HIV PJA convened a full slate of policy and research experts for our April 20th strategy call to explore current issues relating to PrEP research and rollout in the United States.  Check back soon for a video recording; you can also view the presentation slides here.  If you'd prefer to download this blog post as a PDF, click here

Keith Green, Director of Federal Affairs at the AIDS Foundation of Chicago, opened the discussion by framing the evidence coming out of pre-exposure prophylaxis (PrEP) trials in terms of ultimate implications for a U.S. rollout.  A key question is who is PrEP for?  Risk relates to identity, community, and behavior; and multiple populations are categorized as high-risk for HIV: gay men and other men who have sex with men (MSM), HIV negative partners, African Americans, sex workers, injection drug users.  Will PrEP be another means of division between groups affected by HIV or is there a way it can pull us all together? He also recognized that PrEP is a controversial topic that can bring up strong feelings, and urged us to hear each other out, and to base our discussions in facts whenever possible.

FEM-PrEP Trial Closure – Dr. Tim Mastro, Senior Director of Research, Family Health International
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ACT NOW: Choice in HIV Prevention: Let FDA Look at the PrEP Data

Do you believe that we need new tools in our HIV prevention toolbox? At the HIV Prevention Justice Alliance, we support broad and strategic research to explore new methods and interventions for HIV prevention.

Like many of you, we were intrigued by the results of the iPrex trial of pre-exposure prophylaxis (PrEP) that came out late last year.  The U.S. Food and Drug Administration (FDA) should review those results and determine if PrEP is safe and effective enough to be approved for widespread use.

Unfortunately, a key HIV health care provider is asking the FDA to deny this choice to gay men and transgender people across the United States.  Sign this letter as individuals and/or organizations to support immediate FDA review of PrEP.

The iPrEx trial showed that daily use of the treatment pill TDF/FTC (brand name Truvada) as part of a comprehensive prevention package reduced the risk of HIV infection by 44 percent across the whole group of gay men, other men who have sex with men (MSM) and transgender women who have sex with men (TSM) who volunteered in the study. Half of that group received Truvada and half did not in order to compare whether its use made a difference.

44% may not seem like a home run, but it can have a powerful impact for the people who need it. It's well within the accepted range for many widely used prevention interventions and medical treatments – and could be the first step towards a true advance in HIV prevention. And it's much better than 0% protection for folks who are unable to use condoms, for whatver reason.
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