FDA approves drug to help prevent spread of HIV infection

• Two-drug combination shown effective for pre-exposure prophylaxis

• Confirmation of HIV-1-negative status necessary prior to prescription to prevent development of resistance

For the first time, we have a drug in our arsenal to help prevent the spread of HIV infection to uninfected individuals.

The United States Food and Drug Administration (FDA) recently approved Truvada (a fixed dose combination of 2 older HIV drugs emtricitabine and tenofovir disoproxil fumarate) (Gilead Sciences, Inc., Foster City, CA) to reduce the risk of HIV infection in uninfected people who are at high risk of contracting the infection through sexual activity with HIV-infected partners. The approval is for pre-exposure prophylaxis (PrEP) only.

FDA previously approved Truvada in 2004 for use in combination with other antiretroviral agents for the treatment of HIV-infected adults and children age 12 years and older.

The current approval is based on results from 2 large trials. The first showed that the drug could reduce risk of HIV transmission by 42% between male partners. The second demonstrated the drug could reduce risk of transmission by up to 75% in opposite-sex pairs.

Both FDA and the drug’s manufacturer, Gilead, emphasize that Truvada taken once daily does not replace safe-sex practices. It is to be used in combination with condoms and regular HIV testing. In fact, to avoid creating HIV-1-resistant variants, physicians can only prescribe the agent to people confirmed to be HIV-negative before beginning treatment who agree to HIV testing every 3 months. A condition of FDA approval is that the manufacturer collect viral isolates from people who acquire HIV while taking the drug so that the isolates can be evaluated for resistance.

No new side effects have been reported with use of Truvada for PrEP; those already known include diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events, although uncommon, include kidney and bone toxicity.

The price tag for the once-daily pill is about $1,200 per month.  

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