Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide vs dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: Week 96 results from a randomized, double-blind, multicentre, phase 3, non-inferiority trial
The Lancet HIV Jun 03, 2019
Stellbrink HJ, et al. - In this ongoing, randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority trial performed at 126 outpatient centers in 10 countries, researchers compared bictegravir, emtricitabine, and tenofovir alafenamide vs dolutegravir plus co-formulated emtricitabine and tenofovir alafenamide regarding longer-term effectiveness, safety, and tolerability at week 96. They included people with chronic hepatitis B or C infection, or both, and those who used antivirals before for prophylaxis and randomized them (1:1) to receive treatment with either co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. On screening 742 individuals, 657 were enrolled; 327 participants were assigned to the bictegravir group and 330 to the dolutegravir group. Week 96 data support that for people living with chronic HIV, bictegravir, emtricitabine, and tenofovir alafenamide is a safe, well tolerated, and durable treatment.
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