Efficacy and Safety of Dolutegravir/Lamivudine in Antiretroviral Therapy-Naive People Living With HIV-1 and With High-Level Viremia.

Background: Dual regimen dolutegravir/lamivudine (DOL/3TC) showed potent efficacy and favorable safety in both antiretroviral therapy-naive and therapy-experienced patients, but data from real life about naive people with high-level viremia are still lacking. Methods: We performed a retrospective cohort study of people living with HIV who were naive to antiretroviral therapy, had baseline HIV-1 RNA ranging from 100,000 to 500,000 copies/mL, and initiated DOL/3TC. Virologic efficacy and changes in immunologic parameters after 12 months of treatment were evaluated and compared with highly viremic people living with HIV who started a triple antiretroviral combination. Results: Inclusion criteria were met by 58 patients with median age of 43.4 years. At baseline, mean HIV RNA was 5.4 log 10 and mean CD4 T lymphocyte count was 488 cells/mm 3 . HIV RNA <50 copies/mL was obtained in 45 patients (77.6% in the intention-to-treat analysis) after 6 months and in 53 patients (91.4%) after 12 months. Reasons for treatment failure were virologic failure in 2 cases and adverse events in 3 cases. No significant changes in median value of lipids were reported, while there was a not significant increase in body weight (+1.18 kg). Virologic and immunologic response at month 12 in patients on DOL/3TC was comparable with that observed in 50 naive patients with high-level viremia and starting a triple antiretroviral therapy. Conclusions: In this real-life cohort of naive patients with high-level viremia, DOL/3TC was associated with high virologic efficacy and good tolerability after 12 months, supporting use of this dual regimen also in persons with high initial viremia.