Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

On-Demand Preexposure Prophylaxis

A look at men at high risk for HIV-1 infection

Publish date:: December 15, 2015

Protection against HIV-1 infection in men who have sex with men was provided by the use of tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) before and after sexual activity in a randomized trial of antiretroviral therapy. The 414 participants were randomized to either the TDF-FTC group or the placebo group. Both groups received risk-reduction counseling and condoms, were regularly tested for HIV-1 and HIV-2 and other STIs, and were followed for a median of 9.3 months. Researchers found:

• A total of 16 HIV-1 infections occurred during follow-up; 2 in the TDF-FTC group and 14 in the placebo group (RR=86%).

• Rates of serious adverse events were similar in the 2 study groups.

• There were higher rates of gastrointestinal adverse events (14% vs 5%) and renal adverse events (18% vs 10%) in the TDF-FTC group when compared with the placebo group.

Citation: Molina JM, Capitant C, Spire B, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015;373:2237-2246. doi: 10.1056/NEJMoa1506273.

Commentary: Daily preexposure prophylaxis (PrEP) is effective at decreasing the rate of acquisition of HIV in individuals at high-risk for HIV infection.¹ This study extends the use of PrEP from daily use to as-needed use, to be administered before and after a high-risk sexual episode. It is an area that is receiving a lot of attention in the lay press and is important for those of us in primary care to be aware of the efficacy of PrEP in order to advise patients about its use. —Neil Skolnik, MD

1. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367:399-410. doi: 10.1056/NEJMoa1108524.

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