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Pre-Exposure Chemoprophylaxis for HIV Prevention in Gay Men

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. To study this approach, a study published in the New England Journal of Medicine (23 November 2010), randomly assigned 2,499 HIV-seronegative men or transgender women, who reported to have intimate physical relations with men, to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.

The study subjects were followed for 3,324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001).

In terms of safety, nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

According to the authors, oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects and that detectable blood levels strongly correlated with the prophylactic effect.

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