Efficacy and safety of dolutegravir-based regimens in advanced HIV-infected naïve patients: results from a multicenter cohort study.

The aims were to describe efficacy and tolerability of regimens containing dolutegravir (DTG) in advanced ART-naïve people living with HIV (PLHIV) from the clinical practice. The frequency of Immune Reconstitution Inflammatory Syndrome (IRIS), the estimated time of discontinuation of the first ART regimen and the time to reach virological suppression in a multicenter cohort of AIDS-presenters or late-presenters with CD4 <350/μL were assessed. We included 272 PLHIV: 120 (44%) AIDS-presenters and 152 (56%) late-presenters. The most frequent AIDS-defining event was Pneumocystis jirovecii pneumonia in 41 (34%). One hundred-thirty-two PLHIV (48%) started first-line cART regimens including DTG and 140 PLHIV (52%) were treated with cART regimens without DTG. One-hundred-eighty-two (67%) individuals discontinued their first-line regimen: 109 (60%) for simplification, 32 (18%) for toxicities, 4 (2%) for drug-drug interactions, 37 (20%) for other reasons. DTG was interrupted in 19/132 (14%) PLHIV: 13 (68%) for adverse events (5 intolerance, 4 gastrointestinal disorders and 4 neurological symptoms), 2 (11%) for proactive switch and 4 (21%) for medical/individual choice. IRIS was reported in 13 (5%) AIDS-presenters without differences between arms. During a median observation time of 16 months (IQR 5-24), HIV-1 RNA<50 copies/mL was achieved in 95/132 (72%) individuals on DTG-based regimen and in 92/140 (66%) individuals with other regimens. The 12-month estimated probability of DTG interruption was 14% (95% CI 11-17). The results demonstrated the low risk for IRIS and the high potency, good tolerability and safety of DTG in our population of advanced naïve PLHIV.