European CHMP adopts positive opinion on Gilead’s Type II variation application for Truvada

The once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices is intended to lower the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis (PrEP).

The EMA approved Truvada in 2005 to treat HIV-1 infection in adults, in combination with other antiretroviral agents.

Gilead said its type II variation application was based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the US National Institutes of Health and the University of Washington, respectively.

The commonly reported side effects included headache, stomach discomfort and weight loss in studies of Truvada for PrEP.

The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen, Gilead added.

Truvada secured approval for PrEP in Australia, Canada, Kenya, Peru, South Africa and the US. The company is awaiting approval in Brazil, Taiwan and Thailand.

Within the European Union (EU), Truvada is currently available for PrEP in France under a Temporary Recommendation for Use by the French regulatory agency.

Gilead said the use of Truvada for PrEP is investigational in the EU and its safety and efficacy have not been established.

Image: The anti-retroviral drug Truvada, which is a combination of tenofovir and emtricitabine. Photo: courtesy of Jeffrey Beall.