OPERA & TANDEM: Real-World Data Complement Phase 3 Clinical Trials of DOVATO

Review US real-world data from the OPERA and TANDEM studies. See what data collected from a wide range of settings in OPERA and a diverse population of people living with HIV in TANDEM.1,2

  • OPERA

    See Real-World Study Data in Addition to TANGO and GEMINI Studies

    OPERA Study

    The inclusion criteria required patients to be ≥13 years old (the study population did not include any patients <18 years of age), virologically suppressed (<50 copies/mL), and have had no known history of virologic failure or resistance.1

    This Cohort Included 787 People Living With HIV in the US1

    Loss of Suppression Rates1†

    *People living with HIV switched to DOVATO from DTG/ABC/3TC (n=421), BIC/TAF/FTC (n=240), or DTG + TAF/FTC (n=126).
    †Loss of suppression was defined as the first HIV-1 RNA ≥50 copies/mL or 2 consecutive viral loads ≥200 copies/mL.
    ‡    CVF was defined as 2 consecutive HIV-1 RNA ≥200 copies/mL or discontinuation after 1 HIV-1 RNA ≥200 copies/mL.
    §Discontinuations due to detectable VL, adverse diagnosis/side effect, or lab abnormality. Non-treatment-related discontinuations were due to other reasons (n=66) or none identified (n=101). There was no further safety information provided by the authors.

  • TANDEM

    TANDEM: Evidence in a Diverse, Real-World, US Population2

    People living with HIV (N=318) were ≥18 years old and initiated on DOVATO with ≥6 months of follow-up. People living with HIV were treatment-naïve or virologically suppressed (HIV-1 RNA <50 copies/mL for ≥3 months).

    Across Both Cohorts, the Following Were Included (Mean %):

    Suppressed Switch (n=192)

    Rate of treatment-related discontinuations: 1.6% (n=3)‖

    Treatment-Naïve (n=126)

    Rate of treatment-related discontinuations: 0.8% (n=1)#

    ǁDiscontinuations due to toxicity/intolerance (n=1), concerns about weight gain (n=1), and preference (n=1). There was no further safety information provided by the authors.
    4.8% of people living with HIV rebounded. 5.6% were lost to follow-up.
    #Discontinuation due to viremia.

3TC=lamivudine; ABC=abacavir; ADAP=AIDS Drug Assistance Program; ART=antiretroviral therapy; BIC=bictegravir; CI=confidence interval; CVF=confirmed virologic failure; DTG=dolutegravir; FTC=emtricitabine; IQR=interquartile range; IR=incidence rate; py=person-years; TAF=tenofovir alafenamide; VL=viral load.

References:

  1. Pierone G, Brunet L, Fusco JS, et al. Switching to dolutegravir/lamivudine two-drug regimen: durability and virologic outcomes by age, sex, and race in routine US clinical care. HIV AIDS (Auckl). 2024;16:133-140. doi:10.2147/HIV.S452130
  2. Schneider S, Blick G, Burke C, et al. Two-drug regimens dolutegravir/lamivudine and dolutegravir/rilpivirine are effective with few discontinuations in US real-world settings: results from the TANDEM study. Infect Dis Ther. 2024;13(4):891-906. doi:10.1007/s40121-024-00961-y
  3. Data on file, ViiV Healthcare.

PMUS-DLLWCNT240052 January 2025