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]

Data in diverse populations RCT data RWE data vs. BIC/FTC/TAF

Proven efficacy in diverse naïve to treatment populations[1,2,4–6]

High rates of viral suppression (<50 copies/mL) in those with baseline viral load ≥500,000 copies/mL[1,2,4–6]

Adapted from Figueroa M et al. 2025; Rolle C et al. 2023; Cahn P et al. 2022; Zhao et al. 2022; Inan A et al. 2023.[1,2,4–6]

Rapid viral suppression from diagnosis[1]

Newly diagnosed participants with a low CD4+ T-cell count, including in those with very high baseline viral load‡,[1,8]

DOVATO demonstrated robust viral suppression, including in those with very high baseline viral load‡,[1,8]

Adapted from Figueroa M et al. 2025 and Brites C et al. 2025.[1,8]

Rapid viral suppression observed from Week 4[9]

Adapted from Figueroa M et al. 2024.[9]

Primary endpoint: proportion of participants with plasma viral load <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot analysis).[1]

  • DOLCE: study design

    DOLCE is a phase IV, open-label, multicentre, randomised (2:1), controlled trial which assessed the antiretroviral activity of DOVATO vs. DTG + TDF/XTC.[1]

    Adapted from Figueroa M et al. 2025.[1]

  • DOLCE: baseline characteristics

    Adapted from Figueroa M et al. 2025.[1]

Efficacy reinforced vs. BIC/FTC/TAF in a real-world setting[10]

Newly diagnosed participants with a low CD4+ T-cell count, including those with a high baseline viral load§,||,[10]

Primary endpoint: rates of viral suppression at Week 48 in a retrospective analysis:[10]

Adapted from Schuettfort G et al. 2024.[10]

  • ATTEND: study design

    ATTEND is a retrospective, real-world study conducted in 15 sites across Germany, Spain and Portugal, that assessed the effectiveness of DOVATO (n=69) vs. BIC/FTC/TAF (n=69) in people naïve to treatment living with HIV who have a low CD4+ T-cell count (<200 cells/µL) at baseline.[10]

  • ATTEND: baseline characteristics

    Adapted from Schuettfort G et al. 2024.[10]

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

Discover barrier to resistance

A well-established safety profile[3]

Explore safety data

*DTG 50 mg + 3TC 300 mg were used in the GEMINI I and II studies.[2]
†In GEMINI I and II the primary endpoint was the proportion of participants with plasma viral load <50 copies/mL at Week 48: DTG + 3TC 91.4%, n=655/716 vs. DTG + TDF/FTC 93.3%, n=669/717; ITT-E population, FDA Snapshot algorithm.[3,11] In STAT, the primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 24:DOVATO 77.9%, n=102/131; ITT-E population missing=failure analysis.[7]
‡Very high baseline viral load was defined as >500,000 copies/mL and low baseline CD4+ T-cell count was defined as ≤200 cells/mm3.[1]
§The primary endpoint was the proportion of people living with HIV achieving viral suppression, defined as HIV-1 RNA <50 copies/mL, after 48 weeks using the FDA Snapshot algorithm.[10]
||Low baseline CD4+ T-cell count was defined as <200 cells/μL.[10]

3DR, 3-drug regimen; 3TC, lamivudine; ART, antiretroviral therapy; BIC, bictegravir; CI, confidence interval; DTG, dolutegravir; FDA, United States Food and Drug Administration; FTC, emtricitabine; HBV, hepatitis B virus; IQR, interquartile range; ITT-E, intention-to-treat-exposed; RCT, randomised controlled trial; RWE, real-world evidence; SD, standard deviation; TAF, tenofovir alafenamide; 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. Rolle C et al. Open Forum Infect Dis 2023; 10(3): ofad101.
  5. Zhao F et al. J Acquir Immune Defic Syndr 2022; 91(S1): S16–S19.
  6. Inan A et al. Poster presented at European AIDS Conference (EACS). 18–21 October 2023. Warsaw, Poland. ePA055.
  7. Rolle C et al. AIDS 2021; 35(12): 1957–1965.
  8. Brites C et al. Abstract presented at the European AIDS Conference (EACS). 15–18 October 2025. Paris, France. eP134.
  9. Figueroa M et al. Slides presented at HIV Glasgow. 10–13 November 2024. Glasgow, UK. O24.
  10. Schuettfort G et al. Poster presented at HIV Glasgow. 10–13 November 2024. Glasgow, UK. P057.
  11. Cahn P et al. Lancet 2019; 393(10167): 143–155.

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.