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. 2025 Aug 28:ciaf415.
doi: 10.1093/cid/ciaf415. Online ahead of print.

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

Maria Ines Figueroa  1 , Carlos Brites  2   3 , Diego Cecchini  4 , Aline Ramalho  5   6 , Jose Luis Francos  7 , Marcus Lacerda  8 , Maria Jose Rolon  9 , Jose Valdez Madruga  10 , Eduardo Sprinz  11 , Tamara Newman Lobato Souza  12 , Pablo Parenti  13 , Daniela Converso  1 , Gissella Mernies  1 , Omar Sued  1 , Pedro Cahn  1 ; DOLCE study group
Collaborators, Affiliations

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

Maria Ines Figueroa et al. Clin Infect Dis. .

Abstract

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 (125/152), and the CD4 count increased by +200 cells/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%).

Conclusions: 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.

Clinical trials registration: NCT04880395.

Keywords: HIV; advanced disease; dual therapy; naive.

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Conflict of interest statement

Potential conflict of interest. M. I. F. served as an investigator for GlaxoSmithKline, ViiV Healthcare, and Merck; C. B. has participated on advisory boards and served as speaker for Gilead, GSK, and Merck and served as an investigator for GSK and Merck. P. C. has participated at advisory boards for Gilead, ViiV, and Merck and DSMB for Moderna. A. R. served as an investigator for GlaxoSmithKline, ViiV Healthcare, Gilead, and Johnson; A. R. has participated on advisory boards for Johnson and as a speaker for Johnson, AbbVie, and Novartis. D. C. served as an Advisory Board and speaker for GSK and also as a speaker for Gilead/Gador and MSD. M. J. R. has participated in advisory boards for ViiV Healthcare. P. P. has no conflict of interest in this study.

Associated data