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Glasgow 2018 sees further GEMINI 1 and 2 clinical data presented as the 2-drug era continues to build

25.11.2018

   

Glasgow 2018 — 2-drug regimen of dolutegravir plus lamivudine (DTG+3TC) is non-inferior to dolutegravir plus tenofovir/emtricitabine (DTG+TDF/FTC) at 48 weeks in antiretroviral treatment-naïve adults with HIV-1 infection: subgroup analyses in the GEMINI studies.

Results in GEMINI-1 and GEMINI-2 showed efficacy results generally consistent with the overall study results across demographic and baseline disease characteristics. Overall, rates of adverse events (AEs) were similar between arms, with low rates of withdrawals due to AEs in both arms. GEMINI-1 and GEMINI-2 are 2 identical, global, double-blind, multicentre Phase III studies evaluating efficacy and safety of DTG + 3TC once-daily in treatment-naïve, HIV-1–infected, HBV-negative adults, with screening HIV-1 RNA ≤500,000 copies/mL. Participants were randomised 1:1 to treatment with DTG + 3TC or DTG + TDF/FTC, stratified by screening plasma HIV-1 RNA and CD4+ T-cell count, and the primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (by Snapshot algorithm).

Reference:

  1. Orkin C, et al. Presented at: HIV Drug Therapy Glasgow 2018; October 28-31, 2018; Glasgow, UK.