Truvada Recommended as First Drug for HIV PrEP in Europe

Megan Brooks


July 22, 2016

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of emtricitabine/tenofovir disoproxil (Truvada, Gilead Sciences) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk for sexually acquired HIV-1 infection in adults at high risk.

Truvada is the first drug recommended to reduce the risk for HIV infection in the European Union. "It is to be used as part of an overall HIV infection prevention strategy, notably including condom use, that can not only prevent HIV infection but also other sexually transmitted infections," the EMA said in a news release.

The CHMP based its decision on two major studies that found substantial reductions in the risk for HIV-1 infection when Truvada was used as PrEP.

In the iPrEx study, Truvada cut the incidence of HIV infection by 44% during a median follow-up period of 1.2 years in HIV- negative men or transgender women who have sex with men and who were considered at high risk for HIV infection.

In the Partners PrEP trial, Truvada reduced the risk of becoming infected by 75% in the heterosexual partners of HIV-positive men and women.

Both studies linked better adherence to daily Truvada to better protection against HIV-1 infection.

The adverse events reported during the clinical trials of Truvada for PrEP were similar to those seen with Truvada when used for the treatment of HIV-1 infection and included diarrhea, nausea, tiredness, headache, and dizziness. Truvada was approved in the EU in 2005 for the treatment of adults infected with HIV-1 in combination with antiretroviral therapy.

The CHMP opinion on Truvada for PrEP now goes to the European Commission, which will make the final decision on marketing authorization.


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