AHF Demands FDA Reversal on Use of Gilead’s HIV Prevention Pill for Women

  AHF Demands FDA Reversal on Use of Gilead’s HIV Prevention Pill for Women

 Results of latest study of Pre-exposure Prophylaxis (PrEP) in women released
  Monday during the Conference on Retroviruses and Opportunistic Infections
      (CROI) showed ‘no protection’ compared with placebo; AHF says FDA
   irresponsibly approved Gilead’s Truvada for use as PrEP by women without
sufficient data showing drug’s efficacy; urges FDA to take immediate action to
                            remove this indication

Business Wire

LOS ANGELES -- March 5, 2013

Citing another failed clinical trial in women of the use of Gilead Sciences’
AIDS drug Truvada as a form of Pre-exposure Prophylaxis (PrEP) to prevent HIV
infection, AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS
nonprofit medical provider, today urged the Food and Drug Administration (FDA)
to remove this indication for use by women citing insufficient data
demonstrating the drug’s safety and efficacy. Last year, the FDA approved the
use of Truvada as prevention in certain populations despite modest clinical
trial results supporting Gilead’s application for expanded use of its
blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in
non-infected people.

On Monday during the Conference on Retroviruses and Opportunistic Infections
(CROI) in Atlanta, the National Institutes of Health (NIH) released results of
another HIV clinical trial that evaluated two oral antiretroviral prophylaxis
regimens and a vaginal microbicide among sexually active women. Compared with
the subjects taking placebos, those taking the drug also received no
protection.This is the third major study of PrEP in women that
failed—following the FEM-PREP study and the VOICE Study (Vaginal and Oral
Interventions to Control the Epidemic)—each of which were halted mid-trial
after it was determined they were demonstrating no efficacy whatsoever in
women trial subjects.

“On the heels of the release of this latest failed trial of PrEP in women, we
urge the FDA to take immediate action to reverse its earlier action and remove
its indication and guidelines for use of Truvada as a form of HIV prevention
in women,” said Michael Weinstein, AHF’s President. “We believe the FDA
irresponsibly approved Gilead’s Truvada for use as PrEP—particularly its use
by women—without sufficient data demonstrating the drug’s safety and
efficacy.”

Another study last year showed that Truvada (which is a combination containing
two Gilead drugs—tenofovir DF + emtricitabine—in one tablet) is linked to a
significant risk of kidney disease and damage. Most alarmingly, the risk
remains even after people stop taking the drug.

AHF has long been critical that PrEP will not work on a large-scale basis
because, consistent with poor medication adherence rates for most diseases,
people will not be able to take Truvada as directed. Because of this, there
will be little or no preventative effect, and drug resistance and drug
resistant strains of HIV will develop. In addition, people who falsely believe
they are fully protected against HIV very likely may engage in riskier
behavior, thereby increasing their risk of HIV infection.

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization,
currently provides medical care and/or services to nearly 200,000 individuals
in 28 countries worldwide in the US, Africa, Latin America/Caribbean, the
Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit
our website: www.aidshealth.org, find us on Facebook:
www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Contact:

AIDS Healthcare Foundation
Ged Kenslea
Communications Director
Work: 323-308-1833
Cell: 323-791-5526
gedk@aidshealth.org
or
Lori Yeghiayan Friedman
Assoc. Dir. of Communications
Work: 323-308-1834
Cell: 323-377-4312
loriy@aidshealth.org