Brief Report: Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis
Journal
Journal of acquired immune deficiency syndromes (1999)
Journal Volume
84
Journal Issue
1
Pages
60-65
Date Issued
2020
Author(s)
Eron J.
Baril 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.
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 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
Other Subjects
anti 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 Adult
Publisher
NLM (Medline)
Type
journal article