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Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial

2018; Oxford University Press; Volume: 69; Issue: 9 Linguagem: Inglês

10.1093/cid/ciy1132

1537-6591

Laurent Hocqueloux, François Raffi, Thiérry Prazuck, Louis Bernard, Simon Sunder, Jean-Luc Esnault, David Rey, G. Le Moal, Mariam Roncato-Sabéran, Marie André, Éric Billaud, Antoine Valéry, Véronique Avettand-Fènoël, Jean‐Jacques Parienti, Clotilde Allavena, Olivier Bollengier-Stragier, Jean-Luc Esnault, Thomas Guimard, S Léautez, Philippe Van de Perre, Romain Lemarié, Xavier Pouget-Abadie, Mariam Roncato-Sabéran, Marie André, Thierry May, Évelyne Schvoerer, Clotilde Allavena, Elisabeth André‐Garnier, C. Bernaud, Éric Billaud, Sabelline Bouchez, Nolwenn Hall, François Raffi, Véronique Reliquet, Florian Vivrel, P Deleplanque, Anabele Dos-Santos, Simon Sunder, Cendrine Boulard, Aurélie Despujols, Jérôme Guinard, Laurent Hocqueloux, Sandrine Lefeuvre, Catherine Mille, Mohamadou Niang, Montasser Ouezzani, Thiérry Prazuck, Gaëlle Thomas, Antoine Valéry, Véronique Avettand-Fènoël, G. Giraudeau, G. Le Moal, Marie-Laure Batard, Samira Fafi‐Kremer, David Rey, Francis Barin, Frédéric Bastides, Louis Bernard, Guillaume Gras, Marie Charlotte Hallouin-Bernard, Adrien Lemaignen, Pascal Le Bret, Karl Stéfic,

HIV Research and Treatment

We investigated whether dolutegravir (DTG) monotherapy could be used to maintain virological suppression in people living with human immunodeficiency virus (HIV) on a successful dolutegravir-based triple therapy.MONCAY (MONotherapy of TiviCAY) was a 48-week, multicentric, randomized, open-label, 12% noninferiority margin trial. Patients with CD4 nadir >100/μL, plasma HIV-1 RNA <50 copies/mL for ≥12 months, and stable regimen with DTG/abacavir (ABC)/lamivudine (3TC) were 1:1 randomized to continue their regimen or to DTG monotherapy. The primary endpoint was the proportion of patients with HIV RNA 50 copies/mL within 2 weeks apart.Seventy-eight patients were assigned to DTG monotherapy and 80 to continue DTG/ABC/3TC. By week 24, 2 patients in the DTG group experienced VF without resistance to the integrase strand transfer inhibitor (INSTI) class; 1 patient discontinued DTG/ABC/3TC due to an adverse event. The success rate at week 24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm (difference, 2.7%; 95% confidence interval [CI], -5.0 to 10.8). During subsequent follow-up, 5 additional VFs occurred in the DTG arm (2 of which harbored emerging resistance mutation to INSTI). The cumulative incidence of VF at week 48 was 9.7% (95% CI, 2.8 to 16.6) in the DTG arm compared with 0% in the DTG/ABC/3TC arm (P = .005 by the log-rank test). The Data Safety Monitoring Board recommended to reintensify the DTG arm with standardized triple therapy.Because the risk of VF with resistance increases over time, we recommend avoiding DTG monotherapy as a maintenance strategy among people living with chronic HIV infection.NCT02596334 and EudraCT 2015-002853-36.