Bictegravir Not Inferior to Dolutegravir for Initial Treatment of HIV Infection

Safety and excellent tolerability make integrase strand transfer inhibitors (INSTIs) in combination with two nucleoside reverse transcriptase inhibitors the most commonly recommended initial therapy for viremic HIV-infected persons in the Department of Health and Human Services and the International Antiviral Society–USA guidelines. Two simultaneous industry-sponsored phase 3 clinical trials have now tested a novel INSTI called bictegravir coformulated with emtricitabine (FTC) and tenofovir alafenamide. Gallant and colleagues compared the new combination to dolutegravir coformulated with abacavir and lamivudine (3TC). Sax and colleagues compared the new drug to dolutegravir coadministered with coformulated FTC plus tenofovir alafenamide. Each study enrolled more than 600 individuals and randomized them 1:1 to the study arms.

In both studies at week 48, an HIV-RNA <50 copies/mL was achieved in 89% to 92% of the patients in the bictegravir arm and 93% in the dolutegravir arm, demonstrating noninferiority of the bictegravir–FTC–tenofovir alafenamide combination. No cases of drug resistance emerged during the studies, and the incidences of severe adverse events were low and similar in all groups. Adverse events related to study drug were slightly higher in the dolutegravir arms mostly related to drug-related nausea.