Incidence and factors associated with adverse drug reactions in a cohort of individuals starting dolutegravir or efavirenz

Prospective cohort of people living with HIV who started combination antiretroviral therapy (cART) regimens containing efavirenz (EFV) or dolutegravir (DTG) in three specialized HIV/AIDS care services Belo Horizonte, Brazil, the objective analyzing incidence, time to development and factors associated first adverse drug reaction (ADR). Data were collected from September 2015 October 2018 through face-to-face interviews, clinical records, information systems. The ADR-associated evaluated Cox regression ADR Kaplan-Meier survival curves. Among 433 individuals included, 217 (50.1%) had 12 months follow-up. 695 registered ADRs, 604 (86.9%) occurred using EFV-based regimen, gastrointestinal, psychiatric, nervous system disorders most frequent. mean develop was 210.6 days (95% CI: 195.5-225.8). concomitant use other medications a higher risk (HR: 2.00; 95% 1.38-2.89). alcohol 0.64; 0.49-0.85) DTG-based regimen 0.40; 0.28-0.58) lower ADRs. We conclude that better safety profile than at Clinical behavioral characteristics risks should be monitored when managing treatment HIV.