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]

RCT data vs. BIC/FTC/TAF    Long-term RCT data

DOVATO demonstrated non-inferior efficacy vs. BIC/FTC/TAF[4,5]

The largest head-to-head RCT of DOVATO vs. BIC/FTC/TAF[5]

Snapshot outcomes in the ITT-E population at Week 96[4]

Adapted from Masia M et al. 2025.[4]

Primary endpoint: the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at Week 48 in the ITT-E population, FDA Snapshot, 4% non-inferiority margin: 2.2% (n=6/277) with DOVATO vs. 0.7% (n=2/276) with BIC/FTC/TAF (95% CI: -0.5, 3.4).[5]

Durable and robust long-term efficacy through ~4 years[3,7,8]

Non-inferior efficacy vs. TAF-based 3/4DRs at Week 144 (FDA Snapshot Algorithm, ITT-E population)[7]

Adapted from Osiyemi O et al. 2022.[7]

~4-year data (196 weeks) confirms durable viral suppression in early switch participants (n=369)[8]
0%
(n=306/369) of participants on DOVATO maintained viral suppression (FDA Snapshot algorithm, ITT-E analysis)[8]
0%
(n=306/309) of participants on DOVATO maintained viral suppression (observed analysis)[8]

Primary endpoint: The proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at Week 48 (FDA Snapshot algorithm; ITT-E population, 4% non-inferiority margin: 0.3% (n=1/369) with DOVATO vs. 0.5% (2/372) with TAF-based 3/4DRs (adjusted treatment difference: -0.3; 95% CI:-1.2, 0.7).[3,9]

  • TANGO: study design

    TANGO is a phase III, randomised, switch study evaluating the efficacy of DOVATO in treatment-experienced participants vs. TAF-containing regimens, with 741 participants combined across arms.[7]

    Adapted from Van Wyk J et al. 2020, Osiyemi O et al. 2022 and De Wit J et al. 2024.[7–9]

  • TANGO: baseline characteristics

    Adapted from Osiyemi O et al. 2022.[7]

Weight gain data from the largest head-to-head RCT of DOVATO vs. BIC/FTC/TAF in treatment-experienced participants[4]

Explore weight data

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

Discover barrier to resistance

A well-established safety profile[3]

Explore safety data

*Baseline third agent class included (DOVATO vs. TAF-containing regimens, respectively): INSTI (289/369 vs. 296/372), EVG/c (243/369 vs. 249/372), NNRTI (51/369 vs. 48/372), RPV (43/369 vs. 45/372), PI (29/369 vs. 28/372), bDRV (25/369 vs. 27/372).[7]
†Historical resistance results (post hoc analysis) provided at screening were not recorded in the electronic case report form, nor were they part of the locked database, but are data on file that have been source-verified and archived in the study master file.[7]

3DR, 3-drug regimen; 3/4DR, 3- or 4-drug regimen; ART, antiretroviral therapy; bDRV, boosted darunavir; BIC, bictegravir; BMI, body mass index; CI, confidence interval; COBI, cobicistat; DTG, dolutegravir; EFV, efavirenz; EVG/c, elvitegravir boosted with cobicistat; FDA, United States Food and Drug Administration; FTC, emtricitabine; HBV, hepatitis B virus; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; ITT-E, intention-to-treat-exposed; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RCT, randomised controlled trial; RPV, rilpivirine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

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. Masia M et al. Abstract presented at the European AIDS Conference (EACS). 15–18 October 2025. Paris, France. 1515.
  5. Ryan P et al. Lancet HIV 2025; 12(7): e473-e484.
  6. Ryan P et al. Slides presented at the International AIDS Society (IAS) conference on HIV Science. 22–26 July 2024. Munich, Germany. OAB3606LB.
  7. Osiyemi O et al. Poster presented at IDWeek. 29 September–3 October 2021. Virtual. 900.
  8. De Wit S et al. J Acquir Immune Defic Syndr 2024; 96(2): 156–160.
  9. Van Wyk J et al. Clin Infect Dis 2020; 71(8): 1920–1929.

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.