HIV treatment with coformulated bictegravir, emtricitabine, and tenofovir alafenamide was noninferior and had better gastrointestinal tolerability compared with another standard fixed-dose coformulation, according to a recent study published in the Lancet.
In this randomized controlled trial, researchers evaluated 631 untreated adults with HIV-1 infections. Participants had HIV-1 RNA ≥500 copies per mL, were HLA-B*5701-negative, and had no hepatitis B infection. Participants received coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (n = 316) or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (n = 315) once daily for 144 weeks.
After 48 weeks of treatment, the primary endpoint of HIV-1 RNA <50 copies/mL was reached in 92.4% of patients in the bictegravir, emtricitabine, and tenofovir alafenamide group and 93.0% of patients in the dolutegravir, abacavir, and lamivudine group, reaching the predetermined noninferiority mark. No treatment-emergent resistance was noted in either group.
Most adverse events were similar in incidence and severity between the 2 groups, including diarrhea, headache, and upper respiratory tract infection. Nausea was less common in the bictegravir, emtricitabine, and tenofovir alafenamide group compared with the dolutegravir, abacavir, and lamivudine group (10% vs 23%; P <.001).
Fewer adverse events related to treatment were seen with bictegravir, emtricitabine, and tenofovir alafenamide than with dolutegravir, abacavir, and lamivudine (26% vs 40%), which was primarily related to the difference in treatment-related nausea (5% vs 17%; P <.001).
They study authors concluded that “[b]ictegravir, emtricitabine, and tenofovir alafenamide was safe and well tolerated with better gastrointestinal tolerability than dolutegravir, abacavir, and lamivudine.”
The researchers further explained that the coformulated bictegravir, emtricitabine, and tenofovir alafenamide may be preferable to other treatments, as it “does not require HLA B*5701 testing and provides guideline-recommended treatment for individuals co-infected with HIV and hepatitis B, [lending] itself to rapid or same-day initiation of therapy in the clinical setting.”
Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial [published online August 31, 2017]. Lancet. doi: 10.1016/S0140-6736(17)32299-7