The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting marketing authorization for a three-drug HIV-1 combo containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (Biktarvy, Gilead Sciences International Limited).
It is intended for adults with HIV-1 for whom there is no present or past evidence of viral resistance to integrase inhibitors such as emtricitabine or tenofovir.
The drug combination offers patients the potential for a strong antiretroviral response with a single daily pill. Bictegravir inhibits the HIV replication cycle by attaching to the HIV integrase active site and blocking the essential strand transfer step of retroviral DNA integration. Emtricitabine and tenofovir alafenamide — both substrates and competitive HIV reverse transcriptase inhibitors — cause chain termination.
The most frequently seen adverse effects are diarrhea, headache, nausea, fatigue, dizziness, and unusual dreams.
Only physicians with experience in the care of patients with HIV infection should prescribe bictegravir/emtricitabine/tenofovir.
The US Food and Drug Administration approved Biktarvyfor HIV-1 in February.
The summary of product characteristics will contain detailed recommendations for use of the three-drug combination; these will be published in the European public assessment report and will be available in all official European Union languages after the European Commission grants marketing authorization.
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