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 favourable safety in both antiretroviral therapy-naïve and -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 (PLWH) who were naive to antiretroviral therapy, had baseline HIV-1 RNA ranging from 100000 to 500000 copies/mL, and initated DOL/3TC. Virological efficacy and changes in immunological parameters after 12 months of treatment were evaluated and compared with highly viremic PLWH 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 log10 and mean CD4 T lymphocyte count was 488 cells/mm3. HIV RNA <50 copies/mL was obtained in 45 patients (77.6% in the intention-to-treat analysis) after 6 months and in 53 (91.4%) after 12 months. Reasons for treatment failure were virological failure in two cases and adverse events in three. No significant changes in median value of lipids were reported, while there was a not significant increase in body weight (+1.18 Kg). Virological and immunological response at month 12 in patients on DOL/3TC was comparable to that observed in 50 naive patients with high-level viremia and starting a triple antiretroviral therapy.

Conclusion: In this real-life cohort of naive patients with high-level viremia, DOL/3TC was associated with high virological efficacy and good tolerability after 12 months, supporting use of this dual regimen also in persons with high initial viremia.