A Miracle Pill For HIV Prevention? Not So

Concerns about FDA approval for preventative HIV pill Truvada

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) The first pill approved by the FDA for preventing HIV in healthy patients doesn't come without concern. Experts worry that the drug does more harm than good.

Recently, a U.S. Food and Drug Administration panel recommended that the federal agency approve Truvada to prevent HIV.

While the drug hasn't been given the official green light, outside experts are concerned that the pill may be misunderstood and misused by patients.

"Use of a preventative pill must be paired with other strategies to protect against HIV."

Truvada is already on the market as part of a cocktail of drugs that keep the virus under control in HIV-positive patients. It contains a combination of two antiviral medications.

A few years ago, it was discovered through clinical trials that Truvada was effective in protecting healthy people against contracting HIV. It's a daily pill that must be taken every day to provide resistance.

The basic concern is that patients who receive Truvada to prevent HIV will consider it a “miracle pill” and discontinue other protective measures. The risk is highest among those who have an HIV-positive partner.

The American Psychological Association (APA) issued a statement that warned against relying on the drug alone to provide a defense against HIV.

"Exclusive reliance on a drug to prevent HIV or any sexually transmitted disease could actually result in a worse outcome if those at risk don't understand how their own behavior affects treatment," said Perry N. Halkitis, PhD, chair of APA's Committee on Psychology and AIDS, in a press release.

"We know that medical intervention depends on human behavior. The fact that only 28 percent of HIV-positive Americans in care achieve full viral suppression suggests very clearly that any medical intervention depends fully on behavioral as well as social and political factors."

In other words, people taking Truvada to prevent HIV need to remain vigilant about their own behavior, and not view the pill as a substitute for all preventative measures.

Strict adherence to the pill is necessary, and the APA and other public health experts worry that in itself may create problems. You can still get HIV if you skip doses or take the drug only occasionally.

If you contract HIV while taking Truvada, the virus may become resistant to treatment. In one study, only 10 percent of study participants used the drug as directed.

One of the biggest concerns is that people who are prescribed the drug will think that they no longer need to use condoms. This may put them at even greater risk, because they might be likely to have unprotected sex without taking Truvada correctly.

The APA recommends a combination of medical and behavioral approaches to preventing HIV.

The FDA doesn't have to follow the recommendations of reviewers, but they typically do. The agency is expected to vote on Truvada by June 15.

Reviewed by: 
Review Date: 
May 14, 2012
Last Updated:
July 12, 2012