Rapid, potent and durable viral
suppression, with fewer
medicines vs. 3DRs[1–3]

DOVATO is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.[3]

Unknown baseline resistance results    Test-and-treat: RCT data    Test-and-treat: RWE data

Robust viral suppression in those rapidly starting ART[4]

Resistance test results unavailable at baseline[4]

DOVATO demonstrated non-inferior viral suppression rates vs. DTG + TDF/XTC at Week 48 (difference 2.6%; 95% CI: -5.3%, 10.6%)[4]

Adapted from Cordova E et al. 2025[4]

Primary endpoint: the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot algorithm)*,[4]

  • D2ARLING: study design

    In D2ARLING, a randomised, open-label, phase IV study, all baseline genotypic resistance testing was performed on Day 1 and remained double-blinded until the last participant completed the study.[4]

    Adapted from Cordova E et al. 2025.[4]

  • D2ARLING: baseline characteristics

    Adapted from Cordova E et al. 2025.[4]

Efficacy reinforced through 48 weeks in a test-and-treat setting[5]

High proportions of participants maintained virologic outcomes in a test-and-treat setting at Week 48†,[5]

Adapted from Rolle C et al. 2023.[5]

7 participants had HBV infection, and 1 participant had M184V resistance mutation at baseline (n=131)[5]

Primary endpoint: the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 24 (77.9%, n=102/131; ITT-E population, missing=failure).†,[6]

  • STAT: study design

    STAT is a phase IIIb, multicentre, open-label, single-arm, 52-week pilot study assessing the feasibility, efficacy, and safety of DOVATO as a first line regimen in a test-and-treat setting.[5]Participants started receiving DOVATO immediately after initial screening, with laboratory results (including baseline resistance testing results) only becoming available 1 or 4 weeks after treatment initiation.[5]

    Adapted from Rolle C et al. 2023.[5]

  • STAT: baseline characteristics

    Baseline characteristics known at treatment initiation[6]

    Adapted from Rolle C et al. 2021.[6]

    Baseline characteristics unknown at treatment initiation[6]

    Adapted from Rolle C et al. 2021.[6]

Proven real-world effectiveness in a test-and-treat setting[7]

High rates of viral suppression were demonstrated in a real-world test-and-treat cohort[7]

Adapted from Benson P et al. 2024.[7]

  • TANDEM: study design

    TANDEM is a US-based, retrospective chart review. 24 sites abstracted clinical characteristics, treatment history and post-initiation outcomes data from medical charts of people living with HIV (N=469), 126 of whom were naïve to treatment. 48% (n=61/126) of the naïve to treatment cohort received DOVATO as part of a test-and-treat paradigm.[7]

  • TANDEM: baseline characteristics

    • 13% (n=16/126) presented with baseline viral load ≥100,000 copies/mL at DOVATO initiation[7]
    • Average age in the test-and-treat subgroup was 34.4 years[7]

The confidence of a proven high barrier to resistance[1–3]

Discover barrier to resistance

A well-established safety profile[3]

Explore safety data

*Both treatment regimens were offered either as a single tablet or as separate tablets.[4]
†Throughout the study, 10 participants had their treatment with DOVATO modified before Week 48 (5 for baseline HBV co-infection, 1 for baseline M184V mutation, 2 for participant/proxy decision, 1 for pregnancy, and 1 for AE of rash) and remained in the study.[5]
‡Proportion of participants with plasma HIV-1 RNA <50 copies/mL, regardless of ART regimen, among those with available HIV-1 RNA at Week 48.[5]
§Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 48, regardless of ART regimen.[5]
||Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 48 still taking DOVATO.[5]
One (<1%) participant had missing plasma HIV-1 RNA results at baseline.[6]
#Lower limit of quantification is <40 copies/mL.[6]
††Lower limit of quantification is <20 copies/mL.[6]
‡‡Baseline resistance was identified at Week 4 and HBV co-infection was identified at Week 1 from samples taken at baseline.[6]
§§Two participants with HBV co-infection remained on DOVATO.[6]
||||One participant discontinued treatment because of persistent low-level viremia or “viral blips.” No resistance was detected at time of discontinuation.[7]

3DR, 3-drug regimen; 3TC, lamivudine; AE, adverse event; ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; CI, confidence interval; DTG, dolutegravir; FDA, United States Food and Drug Administration; HBV, hepatitis B virus; HCV, hepatitis C virus; IQR, interquartile range; ITT-E, intention-to-treat-exposed; RCT, randomised controlled trial; RWE, real-world evidence; TDF, tenofovir disoproxil fumarate; XTC, emtricitabine or lamivudine.

References:

  1. Figueroa M et al. Clin Infect Dis 2025. https://doi.org/10.1093/cid/ciaf415. [Epub ahead of print].
  2. Cahn P et al. AIDS 2022; 36(1): 39–48.
  3. DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC).
  4. Cordova E et al. Lancet HIV 2025; 12(2): e95–e104.
  5. Rolle C et al. Open Forum Infect Dis 2023; 10(3): ofad101.
  6. Rolle C et al. AIDS 2021; 35(12): 1957–1965.
  7. Benson P et al. Infect Dis Ther 2024; 13(4): 875–889.

PM-GB-DLL-WCNT-250005 | February 2026

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.