The Largest Head-to-Head Clinical Trial of DOVATO vs BIKTARVY to Date*

  • TRIAL DESIGN

    Phase 4, Randomized (1:1), Open-Label, Noninferiority Trial of DOVATO vs BIKTARVY1,2

    Stratification by use of TAF-containing regimen at baseline and sex at birth.

    PASO DOBLE is a multicenter study conducted in Spain.1

    Select Inclusion Criteria1
    • Virologically suppressed ≥24 weeks
    • On current regimen containing ≥1 daily pill, or any STR containing at least one of the following: COBI booster, EFV, or TDF
    • No evidence of previous viral failure
    • No known or suspected resistance to study drugs
    Select Exclusion Criteria1
    • Previously treated with DTG or BIC
    • Chronic hepatitis B
    • Any clinical conditions diagnosed within 6 months of trial that might alter weight (with exception of controlled diabetes)
    Primary Endpoint1
    • Proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at Week 48 in the ITT–E population (FDA Snapshot, 4% noninferiority margin)
    Secondary Endpoints1,2
    • Proportion of participants with plasma HIV-1 RNA <50 copies/mL at Weeks 48 and 96 in the ITT–E population (FDA Snapshot, -8% noninferiority margin)
    • Absolute weight change at Week 48 and Week 96
    • Proportion of participants with weight change >5% from baseline at Week 48 and Week 96

  • BASELINE CHARACTERISTICS

    PASO DOBLE Studied >500 Patients Who Had on Average ~11 Years on ART1,3,4

    Baseline Characteristics DOVATO
    (n=277)    		 BIKTARVY
    (n=276)
    Age, years, median (IQR) 50 (41–57) 51 (39–58)
    Sex, n (%)    
    Female 74 (26.7%) 73 (26.4%)
    Ethnicity, n (%)    
    Caucasian 201 (72.6%) 201 (72.8%)
    Latin 66 (23.8%) 67 (24.3%)
    Black 4 (1.4%) 5 (1.8%)
    CD4+ <350 cells/mm3, n (%) 26 (9.4%) 24 (8.7%)
    Years on ART, years, median (IQR) 11.7 (7.2-19.3) 11.1 (7.0-19.2)
    Duration of prior ART regimen, months, median (IQR) 66.2 (43.5–97.0) 62.8 (41.1–88.7)
    Presence of TAF in previous ART, n (%) 77 (27.8%) 78 (28.3%)
    Presence of TDF in previous ART, n (%) 92 (33.2%) 103 (37.3%)
    Presence of ABC in previous ART, n (%) 59 (21.3%) 52 (18.8%)
    Weight at baseline, kg, median (IQR) 72.8 (63.4–83.3) 72.8 (63.0–81.8)
    BMI, kg/m2, median (IQR) 25.1 (22.3-28.4) 24.8 (22.0-27.8)
    Overweight/obese (BMI >25 kg/m2), n (%) 143 (51.8%) 134 (48.6%)

  • EFFICACY

    DOVATO Was Noninferior to BIKTARVY at 48 and 96 Weeks1,3,5

    Snapshot Outcomes at Weeks 48 and 96 in ITT–E Population

    At Week 48, 13 (4.7%) participants on DOVATO and 26 (9.4%) participants on BIKTARVY had no virologic data.

    At Week 96, 26 (9.4%) participants on DOVATO and 35 (13%) participants on BIKTARVY had no virologic data.

  • RESISTANCE

    DOVATO Had a High Barrier to Resistance Similar to That of BIKTARVY at Week 965

    Cases of CVF With Treatment-Emergent Resistance Through Week 96*†

      DOVATO
    (n=277)    		 BIKTARVY
    (n=276)
    Confirmed virologic failure 0 3
    Emergent resistance 0 0

    *Only participants meeting CVF criteria were assessed for treatment-emergent resistance.

    †Confirmed virologic failure was defined as HIV-1 RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA assessment ≥200 copies/mL.

  • WEIGHT CHANGE DATA

    At Week 96, DOVATO Participants Experienced Statistically Significantly Less Weight Gain vs Those on BIKTARVY5

    Adjusted Mean Weight Change

    There was a statistically significant increase in weight from baseline at 48 and 96 weeks in both treatment arms.

    The clinical significance of these findings is unknown. 

    Data from Week 48 and 96 were prespecified secondary endpoints. Data from Weeks 6, 24, and 72 were not specified endpoints.1,5

    Adjusted by baseline weight, sex, presence of TAF in previous ART, age, and ethnicity.

    BIKTARVY Had Statistically Significantly More Participants Who Gained >5% of Their Baseline Weight vs DOVATO1,5

    Proportion of Participants With Weight Change >5% of Baseline

    Weight gain >5% of baseline at Week 48 and 96 were prespecified secondary endpoints. Data from Weeks 6, 24, and 72 were not specified endpoints.1,5

    *Weight-change analysis was adjusted for participant factors, including: sex, age, ethnicity, and concomitant vs individual EFV and TDF treatment.5

*The other clinical trials comparing DOVATO vs BIKTARVY are DYAD (N=222) and RUMBA (N=134).6,7

ABC=abacavir; ART=antiretroviral therapy; BIC=bictegravir; BMI=body mass index; CI=confidence interval; COBI=cobicistat; CVF=confirmed virologic failure; DTG=dolutegravir; EFV=efavirenz; IQR=interquartile range; ITT–E=intent-to-treat–exposed; STR=single-tablet regimen; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

References:

  1. Ryan P, Blanco JL, Masia M, et al; PASO-DOBLE study group. Maintenance therapy with dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV (PASO-DOBLE): 48-week results from a randomised, multicentre, open-label, non-inferiority trial. Lancet HIV. 2025;12(7):e473-e484. doi:10.1016/S2352-3018(25)00105-5
  2. ClinicalTrials.gov. DTG/3TC vs. BIC/FTC/TAF maintenance therapy in people living with HIV: (PASO-DOBLE). NCT04884139. Updated August 25, 2023. Accessed July 19, 2024.
  3. Ryan P, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASO-DOBLE (GeSIDA 11720) randomized clinical trial. Abstract presented at: AIDS 2024; July 22-26, 2024; Virtual and Munich, Germany. Oral abstract OAB3606LB.
  4. Data on file, ViiV Healthcare.
  5. Masia M, Domingo P, Curran A, et al; PASO-DOBLE (GeSIDA 11720) Study Group. Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial. Abstract presented at: European AIDS Conference 2025; October 15-18, 2025. Slides RO3.8.LB.
  6. Vandekerckhove L, Trypsteen W, Blomme E, et al. Impact of switch towards 3TC/dolutegravir on the intact and total HIV-1 viral reservoir in the RUMBA study. Presented at: HIV Drug Therapy Glasgow; October 23-26, 2022; Virtual and Glasgow, Scotland. Slides MO42.
  7. Rolle C-P, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Efficacy, safety, and tolerability of switching from bictegravir/emtricitabine/tenofovir alafenamide to dolutegravir/lamivudine among adults with virologically suppressed HIV: the DYAD study. Open Forum Infect Dis. 2024;11(10):1-10. doi:10.1093/ofid/ofae560

PMUS-DLLWCNT250019 March 2026