Journal of Antimicrobial Chemotherapy, January 2019
This study is an important subset analysis of the AIDS Clinical Trials Group study A5353, which demonstrated the efficacy and safety of dolutegravir and lamivudine for the initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA levels 1000-500 000 copies/mL for the first time. This study shows the durability of these findings out to 48 weeks and also compares the efficacy of the regimen in participants with baseline HIV-1 RNA ≤100 000 copies/mL versus >100 000 copies/mL. Authors show that – in 120 enrolled eligible participants included in the analysis, 85% (95% CI 77%-91%) had virologic success at 48 weeks. At week 48, 102 of the 120 participants (85%; 95% CI 77%-91%) had virological success. Virological success was similar between those with starting HIV RNA levels below and above 100,000 copies/mL. No new drug resistance mutations were observed in any of the failures and the regimen was well-tolerated. This study, along with the GEMINI study, verifies the durability of DTG/3TC as initial therapy out to 48 weeks for those who are naïve to HIV therapy and have no baseline resistance mutations.