Bictegravir combined with emtricitabine and tenofovir alafenamide vs dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: Week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial
The Lancet HIV Jun 02, 2019
Wohl DA, et al. - In this ongoing, randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority trial, researchers compared bictegravir, emtricitabine, and tenofovir alafenamide vs co-formulated dolutegravir, abacavir, and lamivudine at week 96 regarding effectiveness, safety and tolerability. The trial was performed at 122 outpatient centers in nine countries with adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus infection, and had an estimated glomerular filtration rate of at least 50 mL/minute. Screening 739 participants, they excluded 108 patients and randomly assigned 631 to bictegravir, emtricitabine, and tenofovir alafenamide (n=316) or dolutegravir, abacavir, and lamivudine (n=315). Bictegravir, emtricitabine, and tenofovir alafenamide were identified as a safe, well tolerated, and durable for treatment of people living with HIV-1 with no nascent resistance, as per week 96 data. At week 96, bictegravir, emtricitabine, and tenofovir alafenamide was identified as non-inferior to dolutegravir, abacavir, and lamivudine in terms of achieving HIV-1 RNA less than 50 copies per mL. The most common adverse events were nausea, diarrhea, and headache.
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