FDA approves first drug for HIV prophylaxis: Is it right for your patient?

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The US Food and Drug Administration (FDA) has approved a medication to reduce the risk of sexually acquired human immunodeficiency virus (HIV) infection. Truvada PrEP (emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis) “marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret A. Hamburg, MD.

Truvada PrEP, a tablet taken once daily with or without food, is approved for use in patients ages 12 years and older who are HIV negative—a status to be confirmed by testing before the medication is prescribed and retested every 3 months for the duration of treatment. In addition, it is intended only for individuals at high risk for HIV infection (eg, those whose partners are infected or who have multiple sex partners), as part of a strategy that also includes safer sex practices.

Previously approved for use in combination with other antivirals as a treatment for HIV-positive patients, Truvada’s safety and efficacy in uninfected individuals was demonstrated in 2 large randomized double-blind trials. One study focused primarily on men who have sex with men; the other involved heterosexual men and women with HIV-infected partners. Compared with placebo, Truveda PrEP reduced the risk of HIV infection by 42% among the men who had sex with men, and by 75% among individuals who had infected partners.

The FDA is strengthening Truvada’s black-box warning to help ensure that the PrEP is used as intended. In addition, Gilead Science, which manufactures Truvada, is required to develop a Risk Evaluation and Mitigation Strategy (REMS) for the newly approved prophylaxis. Clinician education is the key component of the REMS, with emphasis on the importance of strict adherence to the once-daily dosing regimen and regular testing intervals to minimize the risk that patients on Truvada PrEP will become infected and that resistant strains of HIV will develop.

Estimates of the cost for Truvada PrEP range from $6,154 to $14,000 per year.1 Gilead has offered to help eligible adults who lack health insurance to obtain Truvada PrEP through its medication assistance program.2

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