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

J Acquir Immune Defic Syndr. 2020 May 1;84(1):60-65. doi: 10.1097/QAI.0000000000002302.


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 <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 -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 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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Double-Blind Method
  • Drug Therapy, Combination
  • Emtricitabine / administration & dosage*
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / isolation & purification
  • Heterocyclic Compounds, 3-Ring / administration & dosage*
  • Humans
  • Lamivudine / administration & dosage*
  • Male
  • Middle Aged
  • Oxazines
  • Piperazines
  • Pyridones
  • Tenofovir / administration & dosage*
  • Viral Load*
  • Young Adult


  • Anti-HIV Agents
  • Heterocyclic Compounds, 3-Ring
  • Oxazines
  • Piperazines
  • Pyridones
  • Lamivudine
  • Tenofovir
  • dolutegravir
  • Emtricitabine