Eron J.CHIEN-CHING HUNGBaril J.-G.Slim J.Falcó V.Bogner J.Maggiolo F.Mills A.Sievers J.Man C.Y.Urbaityte R.Underwood M.Tenorio A.R.Pappa K.A.Wynne B.Koteff J.Gartland M.Smith K.Y.Aboud M.2021-12-012021-12-0120201944-7884https://www.scopus.com/inward/record.uri?eid=2-s2.0-85083042256&doi=10.1097%2fQAI.0000000000002302&partnerID=40&md5=6fcf36542665f34750ff5d0aab252955https://scholars.lib.ntu.edu.tw/handle/123456789/588719BACKGROUND: 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.[SDGs]SDG3anti human immunodeficiency virus agent; dolutegravir; emtricitabine; fused heterocyclic rings; lamivudine; tenofovir; adolescent; adult; aged; CD4 lymphocyte count; clinical trial; combination drug therapy; controlled study; double blind procedure; female; human; Human immunodeficiency virus 1; Human immunodeficiency virus infection; isolation and purification; male; middle aged; phase 3 clinical trial; randomized controlled trial; virology; virus load; young adult; Adolescent; Adult; Aged; Anti-HIV Agents; CD4 Lymphocyte Count; Double-Blind Method; Drug Therapy, Combination; Emtricitabine; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Humans; Lamivudine; Male; Middle Aged; Tenofovir; Viral Load; Young Adultjournal article10.1097/QAI.0000000000002302319775952-s2.0-85083042256