Efficacy and Safety of Dual Therapy With Dolutegravir/Lamivudine in Treatment-naive Persons With CD4 Counts <200/mm3: 48-Week Results of the DOLCE Study

作者：María Inés Figueroa, Carlos Brites, Diego Cecchini, Aline de Oliveira Ramalho, José L Francos, Marcus Lacerda, María José Rolón, José Valdez Madruga, Eduardo Sprinz, Tâmara Newman Lobato Souza, Pablo Parenti, Daniela Converso, Gissella Mernies, Omar Sued, Pedro Cahn, the DOLCE study group, JH Pilotto, Pilotto Luis Eduardo Fernandes, C. Fernandes, Ezequiel Córdova, José Barletta, Martín Jaume, Debora Zanin Gotardi, Ana Paulo Bortoli, Carolina Pérez, Patricia Patterson, Andrés Benchetrit, Javier Ricart, Federico Detarsio, Damián Águila · 发表于：Clinical Infectious Diseases · 年份：2025 · DOI：10.1093/cid/ciaf415 · 被引用次数：9 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

BACKGROUND: Dolutegravir (DTG)/lamivudine dual therapy (DT) has demonstrated noninferiority to triple therapy (TT) in the GEMINI trials. Although the population with ≤200 CD4 cells/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 ≤200 cells/mm3. METHODS: 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 ≤200 cells/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 <50 copies/mL at week 48 (Food and Drug Administration snapshot analysis intent-to-treat exposed population). This report presents results at week 48. RESULTS: Baseline characteristics were similar in both arms. In the DT arm, median CD4 cell count was 109 cells/mm (interquartile range [IQR]: 49-177) and median pVL was 180,000 copies/mL (IQR: 53 309-468 691); 45.4% had CD4 <100 cells/mm3, and 61.4% had pVL >100 000 copies/mL. CDC (Centers for Disease Control and Prevention) stage C: 31.4%. At week 48, virological suppression (pVL <50 copies/mL) was achieved 82.2% in the DT (12...