The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies/mL at week 48; this was achieved in 92.4% of patients randomised to bictegravir, emtricitabine and tenofovir alafenamide and 93.0% of those randomised to dolutegravir, abacavir, and lamivudine. The absolute difference between the two groups in rate of virological response was -0.6% (95% CI -4.8 to 3.6, p=0.78), and non-inferiority was demonstrated as the confidence interval was within the pre-specified margin of −12%. Study drug-related adverse events were less common in the bictegravir group (26% v 40%), the difference being driven by a higher incidence of drug-related nausea in the dolutegravir, abacavir, and lamivudine group (5% vs 17%; p<0.0001).
A related Comment discusses the results of this and another study which together compare bictegravir, coformulated with tenofovir alafenamide and emtricitabine with dolutegravir, either coformulated with abacavir and lamivudine or administered with tenofovir alafenamide and emtricitabine. Non-inferiority was demonstrated in both studies and all antiretroviral combinations were well tolerated, with no observed differences between study groups in grade 3 or 4 adverse events or discontinuation rates.