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
192 centers in 21 countries.
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 <50 copies/mL (Snapshot algorithm) or <40 copies/mL (Abbott RealTime HIV-1 assay) and target not detected (TND) was assessed through Week 48 by baseline VL. Time to viral suppression was determined (non-parametric Kaplan-Meier method).
For 293 participants with baseline 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 <50 copies/mL was longer in participants with baseline 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 TND was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.
Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive
HIV-1–infected individuals across baseline VL strata.