Efficacy and Resistance: DOVATO Data Summary

DOVATO data reflect noninferior viral suppression and high barrier to resistance in pivotal and head-to-head studies.

Treatment-Naïve Data

Switch Data

*After the 48-week randomized controlled phase of DYAD, the observational extension phase followed patients through Week 96.5,6

ART=antiretroviral therapy; DTG=dolutegravir; FTC=emtricitabine; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

References:

  1. Data on file, ViiV Healthcare.
  2. Cahn P, Madero JS, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
  3. 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
  4. De Wit S, Bonnet F, Osiyemi O, et al. Durable efficacy of switching from a 3- or 4-drug tenofovir alafenamide-based regimen to the 2-drug regimen dolutegravir/lamivudine in the TANGO study through week 196. J Acquir Immune Defic Syndr. 2024;96(2):156-160. doi:10.1097/QAI.0000000000003395
  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
  6. 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.
  7. 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
  8. 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.

PMUS-DLLWCNT250021 March 2026