{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:14:53Z","timestamp":1790702093158,"version":"4.1.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T00:00:00Z","timestamp":1756339200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Dolutegravir (DTG)\/lamivudine dual therapy (DT) has demonstrated noninferiority to triple therapy (TT) in the GEMINI trials. Although the population with \u2264200 CD4\u2005cells\/mm3 had a lower response rate, this was unrelated to virological failure. This trial evaluated the antiviral activity of dolutegravir\/lamivudine among antiretroviral therapy (ART)-naive patients with human immunodeficiency virus (HIV) with a CD4 count \u2264200\u2005cells\/mm3.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>DOLCE is a randomized, hypothesis-based, open-label, multicenter study l, assessing the antiviral efficacy of DTG\/3TC at week 48 in treatment-naive people with HIV (PWH) with CD4 counts \u2264200\u2005cells\/mm3. Participants were randomly assigned in a 2:1 ratio to receive DTG\/3TC as a single tablet regimen or DTG plus Tenofovir disoproxil fumarate (TDF)\/XTC: Emtricitabine or lamivudine (FTC or 3TC). The primary endpoint was the proportion of participants with pVL &amp;lt;50\u2005copies\/mL at week 48 (Food and Drug Administration snapshot analysis intent-to-treat exposed population). This report presents results at week 48.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Baseline characteristics were similar in both arms. In the DT arm, median CD4 cell count was 109\u2005cells\/mm (interquartile range [IQR]: 49\u2013177) and median pVL was 180,000\u2005copies\/mL (IQR: 53 309\u2013468 691); 45.4% had CD4 &amp;lt;100\u2005cells\/mm3, and 61.4% had pVL &amp;gt;100 000\u2005copies\/mL. CDC (Centers for Disease Control and Prevention) stage C: 31.4%. At week 48, virological suppression (pVL &amp;lt;50\u2005copies\/mL) was achieved 82.2% in the DT (125\/152), and the CD4 count increased by +200\u2005cells\/mm3. Per-protocol analysis showed a response rate of 91.9%. Severe adverse events (n = 17) were reported in 15 of 152 participants (11.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Dolutegravir\/3TC demonstrated high efficacy in a population with low CD4 counts and high viral load. This study adds information regarding the efficacy and safety of DTG\/3TC, regardless of baseline CD4 counts and viral load.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT04880395.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf415","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T11:34:59Z","timestamp":1753788899000},"page":"122-131","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and Safety of Dual Therapy With Dolutegravir\/Lamivudine in Treatment-naive Persons With CD4 Counts &amp;lt;200\/mm3: 48-Week Results of the DOLCE Study"],"prefix":"10.1093","volume":"82","author":[{"given":"Maria Ines","family":"Figueroa","sequence":"first","affiliation":[{"name":"Research Department, Fundaci\u00f3n Hu\u00e9sped , Ciudad de Buenos Aires 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