{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T21:07:14Z","timestamp":1789679234030,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,9,17]],"date-time":"2024-09-17T00:00:00Z","timestamp":1726531200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100022752","name":"MSD Sharp and Dohme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100022752","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Treatment\u2010related weight gain and metabolic complications with antiretroviral integrase\u2010based regimens, especially among Black women, suggest the need for alternative options.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a 48\u2010week, open\u2010label, single\u2010arm, single\u2010centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz\u2010 or dolutegravir\u2010based antiretroviral therapy to doravirine\/lamivudine\/tenofovir disoproxil fumarate in Black women.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 101 participants enrolled (median age 35\u2009years; interquartile range 31\u201340) were on efavirenz (<jats:italic>n<\/jats:italic>\u2009=\u200946; mean duration on therapy 1.7\u2009years) or dolutegravir\u2010based (<jats:italic>n<\/jats:italic>\u2009=\u200955; mean duration 1.5\u2009years) antiretrovirals at screening. Retention at 48\u2009weeks was 92\/101 participants, and viral suppression was &gt;90% throughout the study, with a single case of doravirine resistance (106\u2009M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0\u20136.5; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and the adjusted mean change was 2.7\u2009kg (95% CI 1.50\u20133.98; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9\u20137.1; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and the adjusted weight gain was 3.5\u2009kg (95% CI 1.93\u20135.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8\u20137.3; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and the adjusted weight gain was 2.1\u2009kg (95% CI 0.26\u20133.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol \u22128.4% (95% CI \u221211.3 to \u22125.5; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), triglycerides \u221210.4% (95% CI \u221216.4 to \u22124.4; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) and high\u2010density lipoprotein \u221214.8% (95% CI \u221218.5 to \u221211.2%; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz\/dolutegravir regimens. Adverse events due to doravirine were few and mild.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13711","type":"journal-article","created":{"date-parts":[[2024,9,17]],"date-time":"2024-09-17T20:50:59Z","timestamp":1726606259000},"page":"81-96","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["<scp>DORA<\/scp>: 48\u2010week weight and metabolic changes in Black women with <scp>HIV<\/scp>, in a phase IIIb switch study from dolutegravir\u2010 or efavirenz\u2010 to doravirine\u2010based first\u2010line antiretroviral therapy"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3507-3800","authenticated-orcid":false,"given":"Joana","family":"Woods","sequence":"first","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simiso","family":"Sokhela","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Godspower","family":"Akpomiemie","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bronwyn","family":"Bosch","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karlien","family":"M\u00f6ller","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Bhaskar","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chelsea","family":"Kruger","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ncomeka","family":"Manentsa","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noxolo","family":"Tom","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philadelphia","family":"Macholo","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nomathemba","family":"Chandiwana","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Hill","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics University of Liverpool  Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Moorhouse","sequence":"additional","affiliation":[{"name":"Wits Ezintsha, Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4157-732X","authenticated-orcid":false,"given":"Willem D. 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