{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T06:44:34Z","timestamp":1790232274485,"version":"4.1.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2019,1,2]],"date-time":"2019-01-02T00:00:00Z","timestamp":1546387200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Centre Hospitalier R\u00e9gional d\u2019Orl\u00e9ans\u2013"},{"name":"La Source"},{"name":"COREVIH"},{"name":"Centre-Poitou Charentes"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>MONCAY (MONotherapy of TiviCAY) was a 48-week, multicentric, randomized, open-label, 12% noninferiority margin trial. Patients with CD4 nadir &gt;100\/\u03bcL, plasma HIV-1 RNA &lt;50 copies\/mL for \u226512 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 &lt;50 copies\/mL at week 24 in intention-to-treat snapshot analysis. Virologic failure (VF) was defined as 2 consecutive HIV RNA &gt;50 copies\/mL within 2 weeks apart.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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], \u20135.0 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT02596334 and EudraCT 2015-002853-36.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciy1132","type":"journal-article","created":{"date-parts":[[2018,12,29]],"date-time":"2018-12-29T20:08:33Z","timestamp":1546114113000},"page":"1498-1505","source":"Crossref","is-referenced-by-count":58,"title":["Dolutegravir Monotherapy Versus Dolutegravir\/Abacavir\/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial"],"prefix":"10.1093","volume":"69","author":[{"given":"Laurent","family":"Hocqueloux","sequence":"first","affiliation":[{"name":"Service des Maladies Infectieuses et Tropicales, CHR d\u2019Orl\u00e9ans\u2013La Source, Tours"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Raffi","sequence":"additional","affiliation":[{"name":"Service des Maladies Infectieuses, CHU H\u00f4tel Dieu and INSERM UIC 1413 Nantes University, Tours"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Prazuck","sequence":"additional","affiliation":[{"name":"Service des Maladies Infectieuses et Tropicales, CHR d\u2019Orl\u00e9ans\u2013La Source, Tours"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis","family":"Bernard","sequence":"additional","affiliation":[{"name":"Service des 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