DOLCE Studied Treatment-Naïve Adults With CD4+ Count ≤200 cells/mm3 Through 48 Weeks

  • TRIAL DESIGN

    Phase 4, Randomized, Open-label, Noncomparative, Multicenter Study1

    Randomization was stratified by country and by plasma HIV-1 RNA at screening (> or ≤100,000 copies/mL).
    DOLCE was a multicenter study conducted in Argentina and Brazil.

    DOLCE is a randomized, hypothesis-based, open-label, multicenter study assessing the antiviral efficacy of DOVATO at Week 48 in treatment-naïve people with HIV-1 with CD4+ counts ≤200 cells/mm3.

    Inclusion Criteria
    • ART-naïve patients with CD4+ cell count ≤200 cells/mm3
    • ≥18 years of age
    • HIV-1 RNA >1000 copies/mL
    Exclusion Criteria
    • Positive test for hepatitis B surface antigen (+HBsAg) at screening

  • BASELINE CHARACTERISTICS

    DOLCE Baseline Characteristics1

    Baseline Characteristics DOVATO
    (n=153)    		 Triple Therapy*
    (n=77)
    Sex at birth, n (%)    
    Female 35 (23%) 21 (27%)
    Male 118 (77%) 56 (73%)
    Age, median (IQR) 36 (29, 48) 34 (28, 47)
    Race, n (%)    
    Black 26 (17%) 9 (12%)
    Native 8 (5%) 0 (0%)
    Other races (Hispanic–Latino/Mixed) 67 (44%) 31 (40%)
    White 52 (34%) 37 (48%)
    CD4+ count    
    CD4+ cell count, cells/mL, median (IQR) 109 (48.8–177) 128 (58.5–200)
    CD4+ cell count ≤100 cells/mL, n (%) 69 (45%) 29 (39%)
    HIV-1 RNA    
    HIV-1 viral load, copies/mL, median (IQR) 180,000 (57,310–468,691) 137,084 (43,902–419,628)
    HIV-1 RNA >100,000 copies/mL, n (%) 94 (61%) 47 (61%)
    HIV-1 RNA ≥500,000 copies/mL, n (%) 35 (23%) 18 (23%)
    HIV-1 RNA ≥1,000,000 copies/mL, n (%) 16 (11%) 7 (9%)

    *Triple Therapy=DTG + TDF/XTC.

  • EFFICACY

    Primary Endpoint: Proportion of Patients With Viral Load Count <50 copies/mL at Week 481

    Virological Outcomes at Week 48: HIV-1 RNA <50 copies/mL (FDA Snapshot, ITT-E Population)

    Data should be considered descriptive only as statistical testing for comparison was not conducted. No clinical comparisons between treatment arms should be drawn.

    *Triple Therapy=DTG + TDF/XTC.

    †One-sided noninferiority test with a significance level of 0.05.

    Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48 by Baseline Viral Load2,3

    Viral Load Count by Baseline Subgroup: HIV-1 RNA <50 copies/mL (FDA Snapshot, ITT-E Population)

    Data are descriptive only. Analysis not designed to provide clinical efficacy comparison between arms, and no comparative statistical testing was conducted.

    Treatment-Naïve Participants Showed Increase in CD4+ Count Through Week 481

    Prespecified secondary endpoint.

    Analysis not designed to provide comparative efficacy data.

    Data are descriptive only. Analysis not designed to provide clinical efficacy comparison between arms, and no comparative statistical testing was conducted.

    DOLCE: Plasma Viral Load Decline in DOVATO and Triple Therapy at Week 482

    Mean Viral Load Log Over Time

    Data are descriptive only. Analysis not designed to provide clinical efficacy comparison between arms, and no comparative statistical testing was conducted.

  • RESISTANCE

    0 Cases of Treatment-Emergent Resistance in Either Treatment Arm at Week 481,2

      DOVATO
    (n=152)    		 Triple Therapy*
    (n=77)
    Protocol-defined virological failure (PDVF), n (%)† 7 (5%) 4 (5%)
    Cases of treatment-emergent resistance by type    
    INSTI resistance 0 0
    NRTI resistance 0 0

    Data are descriptive only. Analysis not designed to provide clinical efficacy comparison between arms, and no comparative statistical testing was conducted.

    Protocol-defined virological failure is defined as a decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 12 with subsequent confirmation; or by confirmed plasma HIV-RNA levels ≥200 copies/mL on Week 24 onwards; or confirmed pVL ≥50 copies/mL at Week 4B.

    *Triple Therapy=DTG + TDF/XTC.

    †11 PDVF cases were successfully amplified, and no INSTI or NRTI resistance mutations were found (7 DOVATO; 4 Triple Therapy).

3TC=lamivudine; ART=antiretroviral therapy; DTG=dolutegravir; FDC=fixed-dose combination; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; ITT–E=intent-to-treat–exposed; NRTI=nucleoside reverse transcriptase inhibitor; pVL=plasma viral load; QD=once daily; STR=single-tablet regimen; TDF=tenofovir disoproxil fumarate; XTC=lamivudine or emtricitabine.

References:

  1. Figueroa MI, Brites C, Cecchini D, et al; DOLCE study group. 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. Clin Infect Dis. 2025;ciaf415. doi:10.1093/cid/ciaf415
  2. Figueroa MI, Brites C, Cecchini D, et al; DOLCE study group. Comparable efficacy and safety of dolutegravir/lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at: HIV Drug Therapy Glasgow; November 10-13, 2024; Virtual and Glasgow, Scotland. Oral presentation O24.
  3. Data on file, ViiV Healthcare.

PMUS-DLLWCNT250018 March 2026