1. Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial
- Author
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Simon Sunder, Louis Bernard, Mohamadou Niang, Romain Lemarie, Cendrine Boulard, Jean-Luc Esnault, Sabelline Bouchez, Philippe Van de Perre, Aurélie Despujols, Guillaume Gras, David Rey, Eric Billaud, Thomas Guimard, Marie André, Francis Barin, Olivier Bollengier-Stragier, Antoine Valery, Samira Fafi-Kremer, Florian Vivrel, Elisabeth André-Garnier, François Raffi, Gaëlle Thomas, Gwenael Le Moal, Clotilde Allavena, Catherine Mille, Camille Bernaud, Anabele Dos-Santos, Thierry Prazuck, Sandrine Lefeuvre, Marie-Laure Batard, Pascal Le Bret, Pascale Deleplanque, Thierry May, Montasser Ouezzani, Xavier Pouget-Abadie, Adrien Lemaignen, Véronique Reliquet, Mariam Roncato-Saberan, Jean-Jacques Parienti, Evelyne Schvoerer, G. Giraudeau, Sophie Leautez, Nolwenn Hall, Marie Charlotte Hallouin-Bernard, Jérôme Guinard, Laurent Hocqueloux, Véronique Avettand-Fenoel, Karl Stefic, and Frédéric Bastides
- Subjects
Adult ,Male ,0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Anti-HIV Agents ,Pyridones ,030106 microbiology ,Integrase inhibitor ,HIV Infections ,Piperazines ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Abacavir ,Internal medicine ,Drug Resistance, Viral ,Oxazines ,Confidence Intervals ,medicine ,Humans ,Cumulative incidence ,030212 general & internal medicine ,Adverse effect ,business.industry ,Lamivudine ,Abacavir/Lamivudine ,Middle Aged ,Resistance mutation ,Dideoxynucleosides ,Infectious Diseases ,chemistry ,Mutation ,Dolutegravir ,Female ,business ,Heterocyclic Compounds, 3-Ring ,medicine.drug - Abstract
Background 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. Methods 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 within 2 weeks apart. Results 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. Conclusions 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. Clinical Trials Registration NCT02596334 and EudraCT 2015-002853-36.
- Published
- 2019