Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis.

BACKGROUND: To investigate antiviral potency of the 2-drug regimen (2DR) dolutegravir plus lamivudine vs the 3-drug regimen (3DR) dolutegravir plus tenofovir disoproxil fumarate/emtricitabine, we performed a post-hoc analysis assessing antiviral response rates in the phase III GEMINI-1 and GEMINI-2 studies by baseline viral load (VL). SETTING: One hundred ninety-two centers in 21 countries. METHODS: Treatment-naive HIV-1-infected participants with screening VL ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log10-transformed VL in the overall study population and the subpopulation with baseline VL >100,000 copies/mL. Proportion of participants achieving plasma VL 100,000 copies/mL, median change from baseline at week 4 was -3.38 and -3.40 log10 copies/mL in the 2DR and 3DR groups, respectively; reduction was sustained throughout 48 weeks. Time to VL 100,000 copies/mL than the overall study population (57 [week 8] vs 29 days [week 4]) and similar between the 2DR and 3DR groups. Proportion of participants with VL <50 or <40 copies/mL and target not detected was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks. CONCLUSION: Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive HIV-1-infected individuals across baseline VL strata.