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

  • TRIAL DESIGN

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

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

    PASO DOBLE is a multicenter study conducted in Spain.1

    Select Eligibility Criteria1
    • Virologically suppressed ≥24 weeks
    • On current regimen containing >1 daily pill, 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
    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

    Baseline Characteristics, n (%) or median (IQR) 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%)
    Weight at baseline, kg, median (IQR)3 72.8 (63.4–83.3) 72.8 (63.0–81.8)
    BMI, kg/m2, median (IQR) 25.1 (22.3-28.5) 24.8 (22.2-28.2)
    Overweight/obese (BMI >25 kg/m2), n (%) 143 (51.8%) 134 (48.6%)
    Baseline Characteristics, n (%) or median (IQR) 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%)
    Weight at baseline, kg, median (IQR)3 72.8 (63.4–83.3) 72.8 (63.0–81.8)
    BMI, kg/m2, median (IQR) 25.1 (22.3-28.5) 24.8 (22.2-28.2)
    Overweight/obese (BMI >25 kg/m2), n (%) 143 (51.8%) 134 (48.6%)
    Baseline Characteristics, n (%) or median (IQR) DOVATO
    (n=277)
    Age, years, median (IQR) 50 (41–57)
    Sex, n (%)  
    Female 74 (26.7%)
    Ethnicity, n (%)  
    Caucasian 201 (72.6%)
    Latin 66 (23.8%)
    Black 4 (1.4%)
    CD4+ <350 cells/mm3, n (%) 26 (9.4%)
    Years on ART, years, median (IQR) 11.7 (7.2-19.3)
    Duration of prior ART regimen, months, median (IQR) 66.2 (43.5–97.0)
    Presence of TAF in previous ART, n (%) 77 (27.8%)
    Presence of TDF in previous ART, n (%) 92 (33.2%)
    Weight at baseline, kg, median (IQR) 72.8 (63.4–83.3)
    BMI, kg/m2, median (IQR) 25.1 (22.3-28.5)
    Overweight/obese (BMI >25 kg/m2), n (%) 143 (51.8%)
    Baseline Characteristics, n (%) or median (IQR) BIKTARVY
    (n=276)
    Age, years, median (IQR) 51 (39–58)
    Sex, n (%)  
    Female 73 (26.4%)
    Ethnicity, n (%)  
    Caucasian 201 (72.8%)
    Latin 67 (24.3%)
    Black 5 (1.8%)
    CD4+ <350 cells/mm3, n (%) 24 (8.7%)
    Years on ART, years, median (IQR) 11.1 (7.0-19.2)
    Duration of prior ART regimen, months, median (IQR) 62.8 (41.1–88.7)
    Presence of TAF in previous ART, n (%) 78 (28.3%)
    Presence of TDF in previous ART, n (%) 103 (37.3%)
    Weight at baseline, kg, median (IQR) 72.8 (63.0–81.8)
    BMI, kg/m2, median (IQR) 24.8 (22.2-28.2)
    Overweight/obese (BMI >25 kg/m2), n (%) 134 (48.6%)

  • EFFICACY

    DOVATO Was Noninferior to BIKTARVY at 48 Weeks

    Snapshot Outcomes at Week 48 in ITT–E Population1

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

  • RESISTANCE

    DOVATO Had a High Barrier to Resistance Similar to BIKTARVY at Week 481

    Cases of CVF With Treatment-Emergent Resistance Through Week 481†‡

      DOVATO
    (n=277)    		 BIKTARVY
    (n=276)
    Confirmed virologic failure 0 1
    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 48, DOVATO Participants Experienced Statistically Significantly Less Weight Gain vs Those on BIKTARVY1

    Adjusted Mean Weight Change1

    Adjusted by baseline value, sex, presence of TAF in previous ART, age, and ethnicity.1

    The clinical significance of these findings is unknown. 

    Change in weight from baseline at Week 48 for DOVATO was consistent with the TANGO study.3
    Data from Week 48 was a prespecified secondary endpoint. Data from Weeks 6 and 24 were not specified endpoints.2

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

    Proportion of Participants With Weight Change >5% of Baseline1

    The adjusted odds ratio§ at Week 48 was 1.81 (95% CI; 1.19, 2.76; P=0.006) with fewer DOVATO participants gaining >5% of baseline weight.1

    Weight gain >5% of baseline at Week 48 was a prespecified secondary endpoint. Data from Weeks 6 and 24 were not specified endpoints.2

    §Adjusted by baseline value, sex, presence of TAF in previous ART, age, and ethnicity.1

*The other clinical trials comparing DOVATO vs BIKTARVY are DYAD (N=222) and RUMBA (N=134).4,5

ART=antiretroviral therapy; BIC=bictegravir; BMI=body mass index; CI=confidence interval; COBI=cobicistat; DTG=dolutegravir; EFV=efavirenz; IQR=interquartile range; ITT–E=intent-to-treat–exposed; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

References:

  1. 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.
  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. Data on file, ViiV Healthcare.
  4. 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.
  5. 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-DLLWCNT240049 January 2025