Gilead Sciences' fixed-dose antiretroviral drug combination of emtricitabine and tenofovir alafenamide (Descovy) for treatment of HIV infection got a thumbs-up today from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommended marketing authorization for two doses of the emtricitabine/tenofovir alafenamide combination (200 mg/10 mg and 200 mg/25 mg) for treatment of HIV-1 infection in adults and adolescents 12 and older weighing at least 35 kg, in combination with other HIV medications.
Descovy is an alternative treatment option to Gilead's tenofovir disoproxil fumarate (TDF, Viread) and is expected to have similar efficacy, the EMA notes in a news release.
The CHMP positive opinion on Descovy is based on data from three phase 3 studies as well as bioequivalence studies, Gilead notes in a news release.
Tenofovir alafenamide (TAF) is a novel targeted prodrug of TDF that has demonstrated high antiviral efficacy similar to that of TDF, and at a dose less than one tenth that of TDF, they explain.
TAF also has demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared with TDF in clinical trials in combination with other antiretroviral agents, the company said.
Because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose, and there is 90% less tenofovir in the bloodstream, they point out.
The most common adverse effect is nausea. The CHMP recommends that Descovy be prescribed by physicians experienced in managing patients with HIV infection.
Detailed recommendations for the use of Descovy will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.
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Cite this: CHMP Backs Emtricitabine/Tenofovir Alafenamide for HIV - Medscape - Feb 26, 2016.