Efficacy and safety of dolutegravir plusemtricitabinevs combined antiretroviral therapy for the maintenance of viral suppression: 144-week results of the SIMPL'HIV trial


BACKGROUND: Simplified treatment is needed to address challenges associated with daily oral HIV treatment in people living with HIV.
METHODS: SIMPL'HIV is a phase 3, randomized, open-label, multicentre, factorial study conducted among HIV-1 infected adults on cART in Switzerland. At baseline, patients with HIV-RNA <50 copies/ml for at least 24 weeks were randomised to switching to dolutegravir (DTG) plus emtricitabine (FTC) or continuing standard combined antiretroviral therapy (cART), and to a reduced biological and medical surveillance vscontinuation of standard 3-monthly monitoring. The main endpoint was the proportion of participants maintaining HIV-1 RNA <100 copies/mL throughout 144 weeks.
RESULTS: 93participants were randomly assigned to DTG+FTC and 94 to cART (mean nadir CD4 count, 259 cells/mm3 [SD=187]; 17%, female). Through 144 weeks, 3 participants in the DTG+FTC group and 6 in the cART group had HIV-RNA levels >100 copies/ml with an adjusted difference of -3.1% (95% CI -9.2-3.1%) in the intention-to-treat population. At week 144 HIV-RNA was >50 copies/ml in one patient in the DTG+FTC group and four patients in the cART group (adjusted difference -3.2%; 95%-CI -7.7-1.5%). Mean CD4 gain between baseline and week 144 was 8.4 (±195.3) and 34.7 (±193.6) cell/mm3 with DTG+FTC and cART, respectively (adjusted difference -19.4; 95% CI -74.2-35.4). Twelve (12.9%) participants in the DTF+FTC group and 15 (18.1%) in the cART group presented with serious AEs through week 144. Adjusted average weight gain between baseline and 144 weeks was 2.4 (±4.7)vs 2.3 (±4.1) kg with DTG+FTC and cART, respectively; participants with 10% or more weight gain were 7.5% and 6.4% in the DTG+FTC and cART groups, respectively.

CONCLUSIONS: DTG+FTC remains safe and non-inferior to standard care in the maintenance of viral suppression in adults with HIV-1 at 144 weeks. No new safety signals were observed and change weight was similar between groups.