Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a guidelines-recommended single-tablet regimen for people with HIV-1 (PWH). We present 5-year cumulative outcomes of two phase 3 studies of B/F/TAF in treatment-naïve PWH.
We conducted 2 randomized, double-blind, phase 3 studies of B/F/TAF in treatment-naïve adults – Study 1489 (1489): B/F/TAF vs DTG/ABC/3TC and Study 1490 (1490): B/F/TAF vs DTG+F/TAF. After completing 144W of blinded treatment, participants were offered continuation of B/F/TAF for 96W in open-label extensions (OLEs). Efficacy was assessed as proportion with HIV-1 RNA <50 copies/mL at each visit after starting B/F/TAF using missing=excluded analysis; safety by adverse events (AEs) and laboratory results. Bone mineral density (BMD) was measured in those randomized to B/F/TAF in 1489. We present cumulative results for participants treated with B/F/TAF in randomized and/or OLE phases through a maximum of 240W of follow up.
314 participants in 1489 and 320 in 1490 randomized to B/F/TAF with 252 and 254 enrolled in OLE, respectively. 315 randomized to DTG/ABC/3TC in 1489 and 325 randomized to DTG+F/TAF in 1490 and 254 and 265 enrolled in OLE, respectively. Baseline (BL) demographics of B/F/TAF participants in 1489 and 1490 include: median age 31 and 33, 9% and 13% female, 37% and 30% Black/African descent, and 23% and 26% Latino/Hispanic, respectively. Efficacy was >98% after W48 at each study visit through W240 in both studies. No resistance to components of B/F/TAF was detected in the resistance analysis population. During the OLE, 6/504 B/F/TAF participants experienced an AE that led to drug discontinuation, none were renal; ?1.6% had a Grade 3 or 4 drug-related AE. Among B/F/TAF participants through W240, median changes in eGFR: -8.2 mL/min (1489) and -8.5 mL/min (1490), median change in TC:HDL ratio: 0 (1489) and 0.1 (1490). Median change in weight from BL to W240 was 6.1kg in B/F/TAF participants; median weight change for comparators at W144: 3.5kg (1489) and 5.0kg (1490), with 2.4kg and 1.3kg additional gains observed between W144 to W240, respectively. Mean % changes (SD) in hip and spine BMD through W240 in B/F/TAF participants were -0.29% (5.29) and -0.23% (5.16), respectively.
Over 5 years of follow up in treatment-naïve persons living with HIV, B/F/TAF was well tolerated and highly efficacious. These results confirm long term safety and efficacy of B/F/TAF.