FDA Approves Truvada for Pre-Exposure HIV Prevention

The Food and Drug Administration has approved the antiretroviral medication Truvada to reduce the risk of HIV infection in uninfected individuals. The HIV prevention strategy is known as pre-exposure prophylaxis or PrEP.

Truvada becomes the first medication ever to be approved for HIV prevention in adults, marking a major milestone in the 30-year global epidemic.

PrEP is the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men. Daily use of the cocktail—a combination of Truvada and/or Viread—has shown up to 75 percent efficacy in preventing HIV transmission. PrEP is a comprehensive HIV prevention strategy that should include other prevention methods, such as safe sex and regular HIV testing. It is NOT a magic "pill", researchers and prevention advocates have warned.

As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.

As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.

There have been some questions about resilience and the impact of powerful antiretrovirals on a healthy immune system. But the major question: Who will pay for the drug? In the United States, Truvada can cost $36 a day or up to $14,000 a year.

The number of new HIV infections in the United States has remained “relatively stable” at approximately 50,000  per year between 2006 and 2009, according to data from the Centers for Disease Control and Prevention (CDC) that was published in August 2011.

But there have been a soaring number of seroconversions among Black men who have sex with men.  The trend has been particularly “alarming” among Black MSM aged 13 to 19, according to the CDC. New infections have increased by 48 percent between 2006 and 2009. New infections rates are much higher in some cities—such as Milwaukee, where an estimated 42 percent of Black gay/bi men could be infected.

See our recent series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2", as well as "What Pre-Exposure Prophylaxis Could Mean for Black Gay and Bi Men" and "Clinical Trials Show PrEP Reduces Heterosexual HIV Transmission" that were syndicated by the Black AIDS Institute across Black print and web properties.

Some Background:
SF First City to Offer PrEP to Gay Men
Leading HIV Groups Call on FDA to Approve PrEP
Preparing for PrEP
"Alarming Increase" in HIV Young Black Gay Men
Daily Drug Reduces HIV Transmission
HIV a Rite of Passage for Young Black Gay Men?
1 in 3 Black Gay Men HIV Positive; 60% Unaware
"Alarming" HIV Rates Young Blk Gay Men in Miss.
CDC: 42% Black Gay Men in Milwaukee are HIV+
HIV "Epidemic" Among Black Gay Chicago Men
CDC: Young Black Gays Hit Hardest by HIV Infections
What PrEP Could Mean for Black Gay Men

Comments

[Osiris]

I'm sorry but I really don't see how anyone could see this as a good thing. The only motivation that I can see behind this is greed from the manufacturers and ignorance from the people who would buy this. Why spend "$36 a day" for a pill with a plethora of unpleasant side effects, when one could just buy condoms for what...$1?

Is the inconvenience of wearing a condom for a few minutes really awful enough for this alternative?

[Trey]

Osiris I am completely with you on this.