The European Medicines Agency (EMA) has recommended authorising Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) for the treatment of HIV-1 infection.
Bictegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration that is essential for the HIV replication cycle. Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination.
Biktarvy has been shown to achieve a potent antiretroviral response in a once daily, single pill regimen. The most common side effects are diarrhoea, headache, nausea, fatigue, dizziness and abnormal dreams.
If the recommendation is accepted by the European Commission (EC), the full indication will be the treatment of adults infected with HIV-1 without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. It is proposed that prescribing will be limited to physicians experienced in the management of HIV.
Detailed recommendations for the use of Biktarvy will be described in the summary of product characteristics (SmPC), which will be published in all official European Union languages after marketing authorisation has been granted by the EC.