LOS ANGELES--(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.)--Citing another failed clinical trial in women of the use of
“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”
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.