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Medicines licensing

First drug licenced in Europe for pre-exposure prophylaxis against HIV

The European Commission has approved the first drug for pre-exposure prophylaxis (PrEP) against HIV for use in Europe following a positive recommendation by the European Medicines Agency (EMA) in July 2016.

Gilead Sciences has been granted a licence to market emtricitabine/tenofovir disoproxil (Truvada) to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk of infection who are following safer sex practices. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine and tenofovir both block the activity of viral reverse transcriptase, which is necessary for the virus to multiply.

The marketing authorisation for PrEP is based on the results of two large placebo-controlled trials that found ‘substantial’ reductions in HIV-1 infection when the product was used as PrEP. In the iPrEx study, the drug reduced the risk of HIV infection by 42% in HIV-negative men or transgender women who have sex with men and who were considered at high risk of HIV infection, while in the Partners PrEP trial, Truvada reduced the risk of becoming infected by 75% in the heterosexual partners of HIV-positive men and women.

The incidence and types of side effects in these two studies were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen, and the most commonly reported side effects were headache, stomach discomfort and weight loss.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201634

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