Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500\u2009000 copies/mL: week 48 outcomes from ACTG 5353

Abstract

Background\nThe AIDS Clinical Trials Group study A5353 demonstrated the efficacy and safety of dolutegravir and lamivudine for initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA 1000-500\u2009000 copies/mL. Optimal ART for treatment-naive individuals must be durable.\n\n\nObjectives\nThe aim of this study was to estimate the efficacy and safety of dolutegravir plus lamivudine at week 48 and compare the efficacy in participants with baseline HIV-1 RNA ≤100\u2009000 copies/mL versus >100\xa0000 copies/mL.\n\n\nMethods\nVirological success was defined as HIV-1 RNA <50 copies/mL by FDA Snapshot criteria. Definition of virological failure included confirmed HIV-1 RNA >200 copies/mL at week 24 or later. The proportion of participants with virological success was estimated using two-sided exact Clopper-Pearson 95% CI. Comparison between screening HIV-1 RNA (≤100\u2009000 versus >100\u2009000 copies/mL) strata was carried out by Fisher s exact test. The study was registered with ClinicalTrials.gov, number NCT02582684.\n\n\nResults\nA total of 120 enrolled eligible participants were included in the analysis. At week 48,\xa0102 of the 120 participants (85%; 95% CI 77%-91%) had virological success. Virological success was similar between screening HIV-1 RNA groups. Six (5%) participants had virological non-success and one additional participant experienced virological failure while on study but off study treatment. No new drug resistance mutations were observed. Six (5%) participants had study-related grade 3 or higher adverse events and none discontinued study treatment.\n\n\nConclusions\nThese results add to the evidence that dolutegravir plus lamivudine is a safe and effective option for initial ART in individuals with HIV-1 RNA <500\xa0000 copies/mL.