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

Abstract

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 oncedaily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log 10 -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 was assessed through week 48 by baseline VL. Time to viral suppression was determined (nonparametric Kaplan-Meier method).Results: For 293 participants with baseline VL .100,000 copies/mL, median change from baseline at week 4 was 23.38 and 23.40 log 10 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 target not detected was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.

Differences in HIV Markers between Infected Individuals Treated with Different ART Regimens: Implications for the Persistence of Viral Reservoirs

“…A number of dual therapies recently appeared in the HIV treatment guidelines. Interestingly, although the possibility of ongoing replication despite ART has been highlighted as a potential concern associated with dual therapy [166], the first data recently presented on RV with the dual treatment with lamivudine + dolutegravir did not show any difference with triple therapy at viral load < 40 copies/mL [167].…”

Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults

“…[9,10] Similar results were reported in studies including some real-world data about 2-drug regimen (2DR) of DTG + 3TC supporting dolutegravir-based 2DRs as good therapeutic options for HIV-1 infection, either ART-naïve or virologically suppressed on previous antiretroviral regimen. [16][17][18][19][20][21][22][23][24][25][26] In China, DTG + 3TC was recently recommended as a first-line regimen for ART-naïve individuals in 2021. [2] Its real-world data for efficacy and safety was limited but have attracted extensive attention.…”

Adherence to and Forgiveness of 3TC/DTG in a Real-World Cohort

“…6 The efficacy of a regimen at producing complete viral suppression, often referred to as 'potency' is another intrinsic drug characteristic that affects forgiveness. 28 To calculate forgiveness an accurate adherence assessment is essential. Existing measures of adherence have conceptual, practical and/or cost limitations.…”

“…6 The efficacy of a regimen at producing complete viral suppression, often referred to as ‘potency’ is another intrinsic drug characteristic that affects forgiveness. 28…”