Effectiveness and tolerability of dolutegravir/lamivudine in virologically suppressed people with HIV at 96 weeks in a multicentre cohort.

To evaluate the effectiveness and tolerability of dolutegravir/lamivudine (DTG/3TC) at 96 weeks in virologically suppressed persons with HIV, both overall and across subgroups, within CoRIS, a large multicenter cohort in Spain, in 2018-2023 METHODS: We included treatment-experienced adults with HIV who were virologically suppressed (viral load <50 copies/mL) when switching to DTG/3TC. We calculated the proportion maintaining viral suppression (VS), change in CD4 cell counts, virological failure (VF; two consecutive viral load (VL) ≥50 copies/mL or one ≥1000 copies/mL), and discontinuations due to adverse events (AEs) up to 96 weeks post-switch. Outcomes were stratified by sex, age, region of origin, antiretroviral regimen at switch, and previous VF RESULTS: Among 2058 participants (22.5% women), 95.9% maintained VS, 2.2% experienced VF, and 2.2% discontinued due to AEs. In multivariable analysis, no significant differences in VS, VF or CD4 change were observed across most subgroups. Participants aged ≥50 years were more likely to maintain VS, had lower VF risk, and a smaller CD4 increase compared with <50 years. Prior VF was associated with lower likelihood of maintaining VS and higher VF risk. Switching from 2NRTIs + PI or 2NRTIs + INSTI increased risk of VF compared with NRTIs+NNRTI CONCLUSIONS: DTG/3TC showed high effectiveness and tolerability at 96 weeks, with consistent outcomes across most subgroups. Previous VF reduced the likelihood of sustained VS.