PrEP Watch

In the United States, over 50,000 HIV infections occur every year despite our best efforts to prevent them. Globally, millions of men and women continue to be infected. The world needs new HIV prevention options. On May 10, the FDA Antiviral Drug Advisory Committee recommended 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. Advocates’ call: Please join us for a call on May 15 at 10am to discuss the FDA process and next steps for advocates. Register here.  Continue reading below for updates, background information on PrEP and the FDA review process, and commentary from this broad coalition of AIDS organizations.

In the United States, over 50,000 HIV infections occur every year despite our best efforts to prevent them. Globally, millions of men and women continue to be infected. The world needs new HIV prevention options.

On May 10, the FDA Antiviral Drug Advisory Committee recommended 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.

Advocates’ call: Please join us for a call on May 15 at 10am to discuss the FDA process and next steps for advocates. Register here. 

Continue reading below for updates, background information on PrEP and the FDA review process, and commentary from this broad coalition of AIDS organizations.

05/4/12

—> REACTIONS TO THE COMMITTEE’S RECOMMENDATION
—> THE FDA REVIEW PROCESS
—> WHAT THE SCIENCE TELLS US
—> CIVIL SOCIETY VOICES
—> MEDIA CONTACTS


REACTIONS TO THE COMMITTEE’S RECOMMENDATION


ADVOCACY IN THE FDA REVIEW OF TRUVADA AS PREP

An FDA advisory committee meeting to consider Truvada as PrEP took place on May 10. This is just one part of the FDA review process of Gilead’s submission for an HIV prevention indication for its AIDS treatment drug Truvada. See below for more information on the process and how advocates can get involved.


EVIDENCE FOR PREP: WHAT THE SCIENCE TELLS US

At the May hearing, an FDA Advisory Committee considered 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 regimen.
  • 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.

For more information about PrEP, please visit www.avac.org/prep.


CIVIL SOCIETY VOICES IN SUPPORT OF PREP
Organizations and individuals from around the US have made their voices heard in support of an FDA approval of TDF/FTC as PrEP for HIV prevention. Below you will find public comments from a range of groups and media commentators.


MEDIA CONTACTS

AIDS Foundation Chicago
Jim Pickett, AFC Director of Prevention Advocacy and Gay Men’s Health and Chair, IRMA
jpickett@aidschicago.org, (773) 600-6407

AIDS United
Ronald Johnson, Vice President of Policy & Advocacy
rjohnson@aidsunited.org  (202) 657-9320 
Victor Barnes, Interim President & CEO
vbarnes@aidsunited.org  

amFAR
Chris Collins, Vice President and Director, public policy
chris.collins@amfar.org, (202) 492-5807

AVAC
Mitchell Warren, Executive director
mitchell@avac.org, (914) 661-1536
Kay Marshall, Communications consultant
kay@avac.org,  (347) 249-6375

Bay Area Perinatal AIDS Center
Deborah Cohan
cohand@obgyn.ucsf.edu, (415) 336-1236

Drexel University College of Medicine, Division of Infectious Diseases and HIV Medicine
Erika Aaron, CRNP
Erika.Aaron@DrexelMed.edu, (215) 696-0640

Fenway Health
Sean Cahill, Director, Health Policy Research  
scahill@fenwayhealth.org  (646) 761-6639

Project Inform
Dana Van Gorder, Executive Director  
dvangorder@projectinform.org, (415) 987-7061  
David Evans, Director of Research Advocacy
devans@projectinform.org, (626) 241-8267 

San Francisco AIDS Foundation  
Ernest Hopkins, Director, Federal Legislative Affairs
ehopkins@sfaf.org  (415) 987-8855
James Loduca, Vice President, Public Affairs
jloduca@sfaf.org, (415) 786-2396

SisterLove
Dazon Dixon Diallo, MPH, President
ddiallo@sisterlove.org, (404) 932-7661







05/3/12

Accent theme by Handsome Code

PrEP won't end AIDS by itself. But we won't end the epidemic without it.

We are part of the AIDS community. We represent HIV/AIDS and health organizations across the United States.

We support FDA approval of PrEP, a promising new HIV prevention method for men and women.