Leading AIDS Advocates Support FDA Approval of Pre-Exposure Prophylaxis (PrEP), a Promising New HIV Prevention Method, for Men and Women
May 1, 2012 - 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
- 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
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. Please
Mitchell Warren, firstname.lastname@example.org , +1-914-661-1536
Kay Marshall, email@example.com , +1-347-249-6375
Source: AVAC Global Advocacy for HIV Prevention
"Reproduced with permission - AVAC Global Advocacy for HIV Prevention"
AVAC Global Advocacy for HIV Prevention