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We report virologic and resistance outcomes for patients initiating or switching to TLD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A prospective observational study was performed at 13 AIDS Clinical Trials Group sites in 6 President's Emergency Plan for AIDS Relief-supported countries coincident with TLD rollout. This report includes results from 2 groups: group 1 (Gp1) were virally suppressed on nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy (ART) and group 2 (Gp2) were ART-na\u00efve at TLD initiation. The primary objective was to estimate the proportions of participants with HIV-1 RNA \u22641000\u2005copies\/mL and frequency of dolutegravir resistance mutations 6 months after TLD initiation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From October 2019 through July 2022, we enrolled 425 participants in Gp1 and 179 in Gp2. Two in Gp1 (0.5%) and 3 in Gp2 (1.7%) discontinued TLD by 6 months due to adverse events considered related to TLD (n = 4) and participant decision (n = 1). Ninety-three percent of participants in Gp1 and 92% in Gp2 who were still on TLD had a 6-month plasma HIV-1 RNA. Plasma HIV-1 RNA \u22641000, \u2264 200, and &amp;lt;50\u2005copies\/mL was achieved in 99%, 98%, and 96% in Gp1 and in 90%, 87%, and 85% in Gp2, respectively. A new integrase mutation (T97A\/T) was observed in 1 participant in Gp1 and none in Gp2.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>TLD was well tolerated and achieved or maintained viral suppression (\u22641000\u2005copies\/mL) in 90% of ART-na\u00efve and 99% of participants with preswitch viral suppression. An emerging integrase strand transfer inhibitor mutation of uncertain significance was detected in only 1 participant. These data support early tolerability, virologic efficacy, and rare integrase strand transfer inhibitor resistance emergence with TLD transition or initiation in programmatic settings.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofaf270","type":"journal-article","created":{"date-parts":[[2025,5,2]],"date-time":"2025-05-02T18:47:11Z","timestamp":1746211631000},"source":"Crossref","is-referenced-by-count":3,"title":["Virology Outcomes of Tenofovir-lamivudine-dolutegravir in Treatment-na\u00efve and Virologically Suppressed Individuals Switching From an NNRTI-based Regimen: An Observational Analysis at 13 Sites"],"prefix":"10.1093","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9286-7052","authenticated-orcid":false,"given":"Cissy","family":"Kityo","sequence":"first","affiliation":[{"name":"Joint Clinical Research Centre (JCRC)\/Kampala CRS , Kampala ,","place":["Uganda"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-9835-0248","authenticated-orcid":false,"given":"Caitlyn","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T.H. 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