Suppressed switch to Bictegravir/emtricitabine/tenofovir alafenamide compared with dolutegravir/lamivudine: Real-world evidence from the OPERA cohort

Abstract

Objectives: To compare the virologic effectiveness and discontinuation of the commonly prescribed fixed-dose combination 3-drug and 2-drug regimens, bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir/lamivudine (DTG/3TC), in virologically suppressed individuals in routine clinical care in the US. Methods: From the OPERA cohort, ART-experienced, virologically suppressed (viral load <200 copies/mL) adults with HIV who switched to B/F/TAF or DTG/3TC (01AUG2020-30JUN2022) were followed through 31DEC2022, death, loss to follow-up or discontinuation. Cox proportional hazard models with stabilized inverse probability of treatment weights were used to assess the association between regimen and time to confirmed virologic failure (cVF200; 2 viral loads ≥200 copies/mL or 1 viral load ≥200 copies/mL + discontinuation) or time to discontinuation. Results: A total of 3512 B/F/TAF users were followed for a median of 16 months (IQR: 11, 22); 2327 DTG/3TC users were followed for a median of 15 months (IQR: 10, 21). cVF200 was observed among 2% of B/F/TAF and 3% of DTG/FTC users, for an adjusted hazard ratio of 0.84 (95% CI: 0.59, 1.18) for B/F/TAF compared with DTG/3TC. Regimen discontinuation was observed among 17% of B/F/TAF and 19% of DTG/3TC users, for an adjusted hazard ratio of 0.83 (95% CI: 0.73, 0.94) for B/F/TAF compared with DTG/3TC. Treatment-related reasons for discontinuation represented 6% of B/F/TAF and 9% of DTG/3TC discontinuations. Conclusions: In this large US cohort, both B/F/TAF and DTG/3TC were well tolerated and effective treatment options among virologically suppressed individuals in routine clinical care, although DTG/3TC tended to be discontinued faster than B/F/TAF.