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Pre-exposure prophylaxis of HIV in adults at high risk: Truvada (emtricitabine/tenofovir disoproxil)

Thursday 6 October 2016


This evidence summary reviewed 4 randomised trials of Truvada (emtricitabine/tenofovir disoproxil 200 mg/245 mg) for pre-exposure prophylaxis (PrEP) of HIV in either HIV-negative men or transgender women who have sex with men, or HIV-negative individuals in a heterosexual partnership with a person already infected with HIV. In these trials, Truvada reduced the relative risk of acquiring HIV infection by between 44% and 86% compared with placebo or no prophylaxis, which is equivalent to approximate numbers needed to treat of between 13 and 68 per year. In all trials, Truvada was given in addition to a comprehensive package of prevention services including HIV testing, risk-reduction counselling, condoms and sexually transmitted infection management. In addition to efficacy, issues relating to uptake, adherence, sexual behaviour, drug resistance, safety, prioritisation for prophylaxis and cost-effectiveness are also important to consider, especially at a population level.

Regulatory status: A licence extension for the use of once-daily Truvada for PrEP was approved by the European Medicines Agency in August 2016. The aim of this evidence summary is to inform forward planning around the use of Truvada for PrEP within local health systems.

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