A Head-to-Head, Randomized (2:1), Open-Label, Noninferiority Trial of DOVATO vs BIKTARVY1

  • TRIAL DESIGN

    222 Adult Participants Who Started on BIKTARVY Either Switched to DOVATO or Continued BIKTARVY1,2

    Select Inclusion Criteria1
    • Participants virologically suppressed on BIKTARVY for ≥3 months
    • At least 2 documented measurements of HIV suppression on BIKTARVY at least 3 months apart
    • Participants ≥18 years of age
    • Stable form of insurance that was expected to continue without significant changes for at least 12 months
    Select Exclusion Criteria1
    • HBV infection or acute need for HCV therapy
    • History of prior viral failure
    • Suspected or documented INSTI resistance
    • Major NRTI resistance
    Primary Endpoint1
    • Proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA Snapshot algorithm (ITT–E) and a 6% noninferiority margin
    Secondary Endpoints1
    • Proportion of participants with plasma HIV-1 RNA <50 copies/mL at Weeks 48, 96, and 144 in the ITT–E population
    • Mean change in weight from baseline at Week 48, compared using 2-sample t-tests

    *Observational extension phase follows participants after completing the randomized controlled phase of the DYAD study. Please see additional information on the observational extension phase in the 96-Week data section.

  • BASELINE CHARACTERISTICS

    The Median Participant Was on ART for ~10 Years and Took 3 Prior ART Regimens1

    Baseline Characteristics DOVATO
    (n=149)    		 BIKTARVY
    (n=73)
    Age, median (range), years 49
    (24–73)    		 51
    (20–73)
    ≥50, n (%) 74 (50%) 44 (60%)
    Female, n (%) 24 (16%) 12 (16%)
    Race, n (%)    
    Caucasian 102 (68%) 54 (74%)
    Black 44 (30%) 18 (25%)
    Asian 1 (1%) 0 (0%)
    Ethnicity, n (%)    
    Hispanic or Latino 43 (29%) 22 (30%)
    Weight, median (range), kg 90.4
    (53.1–171.9)    		 88.5
    (59.1–123.5)
    CD4+ T-cell count, median (range), cells/mm3 720.5
    (214–1479)    		 734.5
    (151–1573)
    Duration of ART prior to Day 1, median (range), years 12 (1–32) 9.5 (1–27)
    Number of prior ART regimens 3 (1–9) 3 (1–10)
    Participants with unknown genotype, n (%) 89 (60%) 36 (49%)
    Current insurance coverage, n (%)    
    Private 132 (89) 59 (81)
    Medicare 12 (8) 10 (13)
    Medicaid 5 (3) 2 (3)
    Ryan White 0 (0) 2 (3)
    The study population had a median age of ~50 years, 16% female, and ~30% non-white people living with HIV1

  • EFFICACY

    DOVATO Was Noninferior to BIKTARVY at 48* Weeks, With Fewer Medicines1

    Virologic Outcomes at Week 48 by FDA Snapshot Analysis1

    Noninferiority criteria were not specified for the HIV-1 RNA <50 copies/mL endpoint. 

    There were no virologic data for 16 (11%) participants in the DOVATO arm and 9 (12%) participants in the BIKTARVY arm.

    *Noninferiority analysis with a 6% margin using the Farrington-Manning Score Test.1

  • RESISTANCE

    A High Barrier to Resistance With No Cases of INSTI Resistance for DOVATO Through Week 481

    Cases of Confirmed Virologic Withdrawal With Treatment-Emergent Resistance*†

      DOVATO
    (n=149)    		 BIKTARVY
    (n=73)
    Confirmed virologic withdrawal 12 (8.1%) 6 (8.2%)
    And with treatment-emergent resistance†‡ 1 1
    Cases by type    
    NRTI resistance 1 1
    INSTI resistance 0 1
      DOVATO
    (n=149)    		 BIKTARVY
    (n=73)
    Confirmed virologic withdrawal 12 (8.1%) 6 (8.2%)
    And with treatment-emergent resistance†‡ 1 1
    Cases by type    
    NRTI resistance 1 1
    INSTI resistance 0 1

    *Confirmed virologic withdrawal (CVW) was defined as 2 consecutive HIV-1 RNA values ≥50 copies/mL. Only participants meeting criteria for CVW were assessed for treatment-emergent resistance.

    †One non-CVW DOVATO participant developed SVF at Week 4 with an HIV-1 RNA of 148 copies/mL but did not return for confirmatory testing. At Week 12, HIV-1 RNA was 87 copies/mL, and a genotype was inadvertently collected at this initial episode of unconfirmed viremia. Genotypic testing demonstrated K65R, M184V, T215S, and K219E. The participant was discontinued from the trial, at which time they had an HIV-1 RNA <50 copies/mL on DOVATO. The participant was suppressed when they discontinued DOVATO and transitioned to a DTG-based regimen (DTG + DRV/c). A baseline genotypic test demonstrated no NRTI or INSTI resistance.

    ‡One participant in the DOVATO arm demonstrated TAMs and M184V resistance but no integrase resistance. This participant switched to a DTG-based regimen (DTG + DRV/c) and was suppressed at the time of the switch. In the BIKTARVY arm, 1 participant demonstrated M184M/I and integrase resistance (G140G/S). The participant in the BIKTARVY arm was suppressed when they discontinued from the study, and they remained on BIKTARVY.

  • WEIGHT CHANGE DATA

    Mean Change in Weight at Week 481

    Clinical significance of these data is unknown. 

  • 96-WEEK OBSERVATIONAL EXTENSION

    Observational Extension Phase2

    The Week 96 data are from the observational extension phase. After completing the randomized phase, 124 of 134 participants on DOVATO and 63 of 65 on BIKTARVY continued into this phase, with efficacy and safety outcomes obtained from electronic health records in routine practice. Results should be interpreted with caution due to the observational design.

    Virologic Outcomes at Week 96 by FDA Snapshot Analysis

    (ITT-E: DOVATO, n=149; BIKTARVY, n=73; Efficacy-data-evaluable analyses: DOVATO, n=102; BIKTARVY, n=53)

    HIV-1 RNA ≥50 copies/mL
    • ITT-E: DOVATO, 2%; BIKTARVY, 1%
      • Adjusted treatment difference: 0.6%; 95% CI; -4.6%, 5.5%
    • Efficacy data evaluable: DOVATO, 3%; BIKTARVY, 2%
    HIV-1 RNA <50 copies/mL
    • ITT-E: DOVATO, 66%; BIKTARVY, 71%
      • Adjusted treatment difference: -4.8%; 95% CI; -17.0%, 8.5%
    • Efficacy data evaluable: DOVATO, 97%; BIKTARVY, 98%

    No virologic data were available for 32% of participants on DOVATO and 27% on BIKTARVY.

    Mean Change in Weight

    There was no statistically significant difference between arms in mean change in weight from baseline.

    • DOVATO, n=100; –1.8 kg
    • BIKTARVY, n=51; –1.1 kg

    The clinical significance of these findings is unknown.

    Confirmed Virologic Withdrawal* and Resistance

    There was 1 reported case of CVW for DOVATO between Weeks 48 and 96. No cases of treatment-emergent INSTI or NRTI substitutions conferring resistance occurred in the DOVATO or BIKTARVY arm between Weeks 48 and 96.

    *Confirmed virologic withdrawal (CVW) was defined as 2 consecutive HIV-1 RNA values ≥50 copies/mL. Only participants meeting criteria for CVW were assessed for treatment-emergent resistance.1

ART=antiretroviral therapy; CI=confidence interval; CVF=confirmed virologic failure; DRV/c=darunavir/cobicistat; DTG=dolutegravir; HBV=hepatitis B virus; HCV=hepatitis C virus; INSTI=integrase strand transfer inhibitor; ITT–E=intent-to-treat–exposed; NRTI=nucleoside reverse transcriptase inhibitor; ns=not significant; SVF=suspected virologic failure; TAM=thymidine analogue mutation.

Reference:

  1. 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
  2. Rolle C-P, Castano J, Nguyen V, Hinestrosa F, DeJesus E. Real-world efficacy, safety and persistence of dolutegravir/lamivudine vs. bictegravir/emtricitabine/tenofovir alafenamide among virologically suppressed adults with HIV--results from the 96-week observational extension phase of the DYAD study. Presented at: IDWeek 2025; October 19-22, 2025; Atlanta, GA. Abstract ID P-348.

PMUS-DLLWCNT250019 March 2026