May 30, 2012

HIV Medications: Not Just for Treatment Anymore?

Washington, D.C.In a first step to approval of the use of HIV drugs as prophylaxis and not just treatment, the Antiviral Drugs Advisory Committee of the FDA has voted to support approval of once-daily oral Truvada. The combination of emtricitabine and tenofovir disoproxil fumarate is designed to reduce the risk of HIV-1 infection among uninfected adults when used as pre-exposure prophylaxis (PrEP).

Committee members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with two abstaining) in other individuals at risk for acquiring HIV through sexual activity. The drug is marketed by Foster City, California-based Gilead Sciences Inc.

The issue of using HIV treatment as prophylaxis is controversial, and recommendations of the Advisory Committee are not binding. Those recommendations will be considered, however, during the FDA’s 6-month priority review of Gilead’s application to also use Truvada for PrEP. FDA has established a target review date of June 15, 2012.

Truvada, which was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States, is not currently indicated for HIV prevention.

A recent study funded by the National Institutes of Health found that prophylaxis for HIV can be effective in preventing spread of the disease but is economically feasible only if used in very select, high-risk groups. That research, published in the Annals of Internal Medicine, used an economic model focused on men who have sex with other men (MSM) to measure the cost-effectiveness of once-a-day administration of the combination drug tenofovir-emtricitabine. It suggested that if PrEP were only used by 20% of high-risk individuals, defined as those who have five or more sexual partners in a year, that 41,000 new infections would be prevented at a cost of about $16.6 billion over 20 years.

A 2010 trial found that the drug combination reduces risk of HIV infection by 44% in a daily dose, with patients who strictly followed the regimen reducing their risk as much as 73%.

The FDA’s Antiviral Drugs Advisory Committee also voted 13 to 1 in support of approval of another Gilead drug, the Quad, a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-na├»ve adults.

U.S. Pharmacist Social Connect