On-Demand Preexposure Prophylaxis Effective Against HIV

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On-Demand Preexposure Prophylaxis Effective Against HIV


Using a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) before and after sex was 86% more effective than placebo in protecting men having unprotected anal sex with men against HIV-1 infection, according to new results published in the December 3 issue of New England Journal of Medicine.
“While we wait for an effective vaccine against HIV, the use of such preexposure prophylaxis with TDF-FTC among high-risk men could contribute to a reduced incidence of HIV infection,” Jean-Michel Molina, MD, from the Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris in France, and Université de Paris in France, and colleagues write.
The results of the multicenter trial, known as Intervention Preventive de L’Exposition aux Risques Pour Les Gays (IPERGAY), were published online December 1 to coincide with World AIDS day.
Dr Molina and colleagues hypothesized that rate of adherence, and thus efficacy, might be higher among high-risk men with an on-demand pill than a daily regimen, which had shown mixed results in previous studies.
The researchers randomly assigned 400 men who did not have HIV either to the TDF-FTC group (199) or to receive placebo (201) in a double-blinded fashion. A total of 16 HIV-1 infections occurred during the 9-month follow-up: two in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), for a relative reduction in the intervention group of 86% (95% confidence interval, 40% – 98%; P = .002). Participants took a median 15 pills of TDF-FTC or placebo per month.
However, the treatment was associated with increased rates of serious gastrointestinal and renal adverse events compared with placebo: 14% vs 5% (P = .002), and 18% vs 10% (P = .03), respectively.
In a perspective piece, published in the same issue of the journal, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), and Hilary Marston, MD, MPH, Medical Officer and Policy Adviser for Global Health for NIAID, write that the IPERGAY results join other significant achievements that have greatly improved HIV prevention and treatment over the course of the 2 decades since combination antiretroviral therapies were introduced.
As previously reported by Medscape Medical News, major questions have been answered by other landmark trials as to best treatments and when to start antiretroviral therapy.

N Engl J Med. Published online December 1, 2015.

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