DTG Noninferior to cART in Patients Started on HIV Treatment During Acute Phase

Background: Combination antiretroviral therapy (cART) for HIV infection is complicated by adverse effects. There is interest in minimizing the number of agents needed for viral suppression. Objective: To assess the long-term efficacy of dolutegravir (DTG) monotherapy, as compared to cART, among patients with virologic suppression on cART, initiated during the acute phase of HIV infection. Design: Randomized, open-label, noninferiority study (EARLY-SIMPLIFIED) conducted as part of Zurich and Swiss HIV study cohorts. Methods: Patients who had been started on cART within 6 months of the estimated date of HIV infection, and successfully treated with cART for at least 48 weeks, were included. Patients were excluded if they had a history of antiretroviral therapy failure, treatment interruption, or DTG resistance; patients also had to be negative for hepatitis B surface antigen. The primary end point was noninferiority between DTG monotherapy and standard-of-care cART, as evidenced by the more...