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

Title
Efficacy and safety of dolutegravir plusemtricitabinevs combined antiretroviral therapy for the maintenance of viral suppression: 144-week results of the SIMPL'HIV trial
Presenter
Annalisa Marinosci
Authors
A. Marinosci * (1), D. Sculier (2), G. Wandeler (3), S. Yerly (4), M. Stoeckle (5), E. Bernasconi (6), D.L. Braun (7), P. Vernazza (8), M. Cavassini (9), M. Buzzi (10), L. Decosterd (9), P. Schmid (8), M. Branca (11), A. Limacher (11), M. Egger (12), H.F. Günthard (13), K.J. Metzner (14), A. Calmy (4)
Institutions
(1) Hôpitaux Universitaires de Genève, Infectious Diseases, Geneva, Switzerland, (2) Private office, Geneva, Switzerland, (3) Inselspital, Bern, Switzerland, (4) Hôpitaux Universitaires de Genève, Geneva, Switzerland, (5) University Hospital Basel, Basel, Switzerland, (6) Ospedale Regionale Lugano, Lugano, Switzerland, (7) University Hospital Zurich, Zurich, Switzerland, (8) Kantonsspital St. Gallen, St. Gallen, Switzerland, (9) Centre hospitalier universitaire vaudois, Lausanne, Switzerland, (10) Private Office, Geneva, Switzerland, (11) CTU, Bern, Switzerland, (12) University of Bern, Bern, Switzerland, (13) University Hospital of Zurich, Zurich, Switzerland, (14) University Hospital of Zuirch, Zurich, Switzerland

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.