Abstract
INTRODUCTION: Integrase strand transfer inhibitor (InSTI)-based antiretroviral regimens have become the recommended antiretroviral therapy for people living with HIV (PLWH) who are antiretroviral-naïve or stably antiretroviral-treated. This meta-analysis aimed to systematically review the efficacy and safety of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among PLWH. METHODS: Randomized controlled trials (RCTs) were included to compare the efficacy and safety between BIC/FTC/TAF and other antiretroviral regimens containing a non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or integrase strand transfer inhibitor plus two nucleos(t)ide reverse transcriptase inhibitors. A Mantel-Haenszel model was used to investigate the combination or interaction of a group of independent studies. I(2) was used to determine whether a fixed-effect model or random-effect model was to be used. RESULTS: A total of seven published randomized clinical trials including 3547 participants were analyzed; three studies were conducted in antiretroviral-naïve PLWH and four in stably antiretroviral-treated PLWH. At week 48, the efficacy with BIC/FTC/TAF was not statistically significantly different from that with control regimens [odds ratio (OR) 1.01 (95% CI 0.79, 1.30)]. BIC/FTC/TAF had comparable safety profiles to control regimens: OR for all adverse effects (AEs) was 0.92 (95% CI 0.78, 1.09); OR for any grade 3 or grade 4 AEs was 0.96 (95% CI 0.66, 1.39); and OR for treatment-related AEs was 1.31 (95% CI 0.68, 2.53). CONCLUSIONS: This meta-analysis of published randomized clinical trials of antiretroviral-naïve and stably antiretroviral-treated PLWH suggests that BIC/FTC/TAF is as safe and efficacious as are its comparators at week 48. The interstudy differences in selected populations and control regimens may lead to the high heterogeneity of the meta-analysis.