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Medicines licensing

EMA recommends approval of Truvada as HIV pre-exposure prophylaxis

The first drug for HIV pre-exposure prophylaxis (PrEP) has been recommended for approval across the EU.

The European Medicines Agency (EMA) says the combination drug emtricitabine/tenofovir disoproxil (marketed as Truvada) should be given a marketing authorisation and should be offered as part of a wider safer sex education programme that includes the use of condoms. The combination product is already licensed for the treatment of adults with HIV-1 infection.

The EMA’s latest recommendation was based mainly on the results of two studies that found ‘substantial’ reductions in HIV-1 infection when the product was used as PrEP.

In the first study, known as 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.

In the second study, known as 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 found that better adherence to daily treatment with emtricitabine/tenofovir disoproxil meant better protection against HIV-1 infection.

Emtricitabine and tenofovir both block the activity of viral reverse transcriptase, which is necessary for the virus to multiply.

The recommendation from the EMA’s Committee for Medicinal Products for Human Use now goes to the European Commission for approval. It will then be up to individual EU states to decide whether to make the drug available.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201496

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