Proven high barrier
to resistance from 
the start[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]

Barrier to resistance data    Mechanism of action    Coordinated PK profiles

Demonstrated high barrier to resistance in >3,400 people living with HIV who are naïve to treatment[1,2,4–6]

Cases of treatment-emergent resistance across diverse treatment populations and settings:

DOVATO blocks the same number of replication sites as most 3DRs††,[3,7,8]

DOVATO pairs the additive effects of DTG, an INSTI, and 3TC, an NRTI, to manage HIV with a proven high barrier to resistance.[1–3]

Steps of replication, assembly, and budding are not shown.

Coordinated PK profiles for a high barrier to resistance[3,9,10]

DTG and 3TC are estimated to remain at therapeutic concentrations ~84 hours post dose[3,9,10]

The once-daily dosing of DOVATO ensures sustained exposure to DTG and 3TC, contributing to a high barrier to resistance[3,9,10]

Adapted from Boffitto M et al. 2020.[10]

Proven efficacy from diagnosis[1–3]

Explore efficacy of DOVATO

Treat Ahead with DOVATO from the start[1–3]

Find out ‘why DOVATO?’

*In total, 249 publications were identified from the systematic literature review, representing 44,436 unique individuals using DTG + 3TC, including 2,346 who were treatment-naïve. Across all studies identified in the systematic literature review reporting resistance outcomes, no treatment-naïve people living with HIV had INSTI mutations detected at virologic failure/blip (n=0/2,346).[6]
†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. In total, 22.9% (n=35/152) participants treated with DOVATO had a high very high baseline viral load in DOLCE.[1]
‡DOLCE is an phase IV, randomised, open-label, hypothesis-based, multicentre trial assessing the antiviral activity of DOVATO (n=152) vs. DTG + TDF/XTC (n=77) at 48 weeks in treatment-naïve participants. Primary endpoint: proportion of participants with plasma viral load <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot analysis).[1]
§STAT is a phase IIIb, open-label, 52-week, single-arm pilot study evaluating the feasibility, efficacy, and safety of DOVATO in 131 newly diagnosed HIV-1 infected adults as a first-line regimen. Primary endpoint: the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 24 (ITT-E population, missing=failure analysis).[4,11]
||D2ARLING is a randomised, open-label, phase IV study designed to assess the efficacy and safety of DOVATO in treatment-naïve people with HIV with no available baseline HIV-1 resistance test results at treatment initiation. Participants were randomised in a 1:1 ratio to receive DTG 50 mg + 3TC 300 mg (n=106) or DTG + TDF/XTC (n=108). Primary endpoint: the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot algorithm).[5]
GEMINI I and II are identical 144-week, phase III, randomised, double-blind (through 96 weeks), multicentre, parallel-group, non-inferiority, controlled clinical trials. Participants were randomised 1:1 to DTG 50 mg + 3TC 300 mg (n=716, pooled) or DTG + TDF/FTC (n=717, pooled). Primary endpoint: the proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 (ITT-E population, FDA Snapshot algorithm).[2,3]
#Participants met CVW criteria if a second and consecutive HIV-1 RNA value met any of the following: decrease from baseline in plasma HIV-1 RNA <1 log10 copies/mL, unless HIV-1 RNA <200 copies/mL, by Week 12; confirmed plasma HIV-1 RNA ≥200 copies/mL at or after Week 24; or plasma HIV-1 RNA ≥200 copies/mL after previous confirmed suppression to HIV-1 RNA <200 copies/mL.[2]
††Most NRTI-based 3DRs.[3,7,8]
‡‡In total, 249 publications were identified from the systematic literature review, representing 44,436 unique individuals using DTG + 3TC including 20,060 who were treatment-experienced. Across all studies included in the systematic literature review reporting resistance outcomes, 4 individuals with prior ART experience had INSTI mutations detected at virologic failure/blip (n=4/20,060).[6]

3DR, 3-drug regimen; 3TC, lamivudine; 3TC-TP, lamivudine triphosphate; ART, antiretroviral therapy; BID, twice-daily; CVW, confirmed-virologic withdrawal; DTG, dolutegravir; FDA, United States Food and Drug administration; FTC, emtricitabine; IC90; 90% maximal inhibitory concentration; INSTI, integrase strand transfer inhibitor; ITT-E, intent-to-treat exposed; NRTI, nucleoside reverse transcriptase inhibitor; PA-IC90; protein-adjusted 90% maximal inhibitory concentration; PK, pharmacokinetic; OD, once daily; 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. Cordova E et al. Lancet HIV 2025; 12(2): e95–e104.
  6. Fraysse J et al. Infect Dis Ther. 2025; 14(2): 357–383.
  7. Tseng A et al. Br J Clin Pharmacol 2014; 79(2): 182–194.
  8. Feng Q et al. BMJ 2019; 366: 1–11.
  9. Min S et al. Antimicrob Agents Chemother 2010; 54(1): 254–258.
  10. Boffito M et al. AIDS Res Hum Retroviruses 2020; 36(1): 13–18.
  11. Rolle C et al. AIDS 2021; 35(12): 1957–1965.

PM-GB-DLL-WCNT-250006 | 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.