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RAPID, POTENT AND DURABLE
VIRAL SUPPRESSION, WITHOUT A
SECOND NRTI[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 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

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DURABLE AND ROBUST LONG-TERM EFFICACY REINFORCED IN TREATMENT-EXPERIENCED PARTICIPANTS, WITH FEWER MEDICINES VS. 3/4DRS[1,2,4]

Primary endpoint results (HIV-1 RNA >50 copies/mL at Week 48): <1 % vs. <1 % for DOVATO (N=1/369) and TAF-based regimen (N=2/372) arms, respectively (treatment difference: –0.3% [95% Cl; –1.2%, 0.7%]).[1,5]

~3-year data: Non-inferior efficacy vs. TAF-based 3/4DRs at Week 144 
(Snapshot ITT-E)[,]

~4-year data (196 Weeks) confirms durable viral suppression in early switch
participants with:[4]

0%

(n=306/369)
of participants on DOVATO maintained HIV-1 RNA <50 copies/mL (Snapshot, ITT-E analysis)

0%

(n=306/369)
of participants on DOVATO maintained viral suppression (observed analysis)

  • Read more about the study design of TANGO

    TANGO is a phase III. randomised, switch study evaluating the efficacy of DOVATO in treatment-experienced participants vs TAF-containing regimens, with >700 participants combined across arms.[1,4]

    Adapted from De Wit J et al, 2024 and Osiyemi O et al, 2022.[1,4]

  • Explore the baseline characteristics of TANGO

    Tested in a diverse treatment-experienced population1[1]

    Baseline characteristics out to ~3 Years (144 Weeks)[1]

    Adapted from Osiyemi O et al, 2022.[1]

Spotlight on the baseline characteristics of the participants included in TANGO
  • 40% (n=148/369) of participants who switched to DOVATO had unknown genotypic resistance history at baseline[†,1]
  • Participants on DOVATO received prior ART for a median duration of ~3 years[1]
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SWITCHING TO DOVATO MAINTAINED HIGH RATES OF VIRAL SUPPRESSION ACROSS AGE GROUPS AT WEEK 48[6]

Pooled results from TANGO and SALSA show comparable rates of viral suppression across age groups at Week 48[6]

Adapted from Walmsley S et al, 2024.[6]

  • Read more about the pooled analysis from SALSA and TANGO

    ~1,200 treatment-experienced participants switched to DOVATO or continued their current regimen in a pooled analysis of Phase 3, randomised, open-label, non-inferiority studies [6]

    Adapted from Walmsley S et al, 2024.[6]

    In TANGO, participants switched from TAF/FTC plus a PI, INSTI, or NNRTI. Participants with initial TDF treatment who switched to TAF ≥3 months before screening, with no changes to other drugs in their regimen were also eligible. In SALSA, participants on uninterrupted ART for ≥3 months switched from regimens composed of 2 NRTIs plus a PI, INSTI, or NNRTI.[6]

  • Explore the baseline characteristics of the pooled analysis of SALSA and TANGO

    A pooled-analysis including diverse virologically suppressed populations[6]

    Adapted from Walmsley S et al, 2024..[6]

    Spotlight on the baseline characteristics of the participants included in the SALSA and TANGO pooled analysis

    0.5 YEARS

    The median duration of ART before Day 1 for DOVATO was ~3.5 years[6]

Real world data

Data vs BIC/FTC/TAF

PROVEN EFFECTIVENESS VS. BIC/FTC/TAF IN TREATMENT-EXPERIENCED PEOPLE LIVING WITH HIV IN REAL CLINICAL SETTINGS[7–10]

People living with HIV who maintained a viral load <50 copies/mL[7–10]

Adapted from a systematic literature review of DTG+3TC from real-life cohorts, including Knobel H et al, 2023, Cheng C et al, 2023, Gan L et al, 2023, Farinacci D et al, 2023.[7–10]

A well-established safety profile[2]

View safety data

Proven high barrier to resistance in data up to 5 years[11–13]

Explore the data

3DR, 3-drug regimen; 3TC, lamivudine; 4DR, four-drug regimen; AE, adverse event; ARV, antiretroviral; ART, antiretroviral therapy; bDRV, boosted darunavir; BIC, bictegravir; CI, confidence interval; DTG, dolutegravir; FDA, FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; IQR, interquartile range; INSTI, integrase strand transfer inhibitors; ITT-E, intention-to-treat exposed; NNRTI, non-nucleoside reverse transcriptase inhibitors; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; ns, non-significant; PI, protease inhibitor; RNA, ribonucleic acid; RPV, rilpivirine; TAF, tenofovir alafenamide;
*Baseline third agent class included (DOVATO vs. TAF-containing regimens respectively): INSTI (n=289/369 vs. 296/372), EVG/c (n=243/369 vs. 249/372); NNRTI (n=51/369 vs. 48/372), RPV (n=43/369 vs. 45/372); PI (n=29/369 vs. 28/372), bDRV (n=25/369 vs. 27/372).[1]
†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 trial master file.[1]
‡ Baseline NRTI for the CAR arm: TDF 18% (n=110/606), TAF 76% (n=462/606), ABC 6% (n=34/606).[6]
§ Baseline third agent class included (DOVATO vs. current antiretroviral regimen, respectively): INSTI (387/615 vs. 394/619), NNRTI (174/615 vs. 172/619), PI (54/615 vs. 53/619).[6]

References:

  1. Osiyemi O et al. Clin Infect Dis 2022; 75(6): 975–986.
  2. DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC)
  3. Cahn P et al. AIDS 2022; 36(1): 39–48.
  4. De Wit S et. J Acquir Immune Defic Syndr 2024. doi: 10.1097/QAI.000000000000339. [Epub ahead of print].
  5. Van Wyk J et al. Clin Infect Dis 2020; 71(8): 1920–1929.
  6. Walmsley S, et al. AIDS Res Ther 2024; 21(1): 17.
  7. Knobel H et al. HIV Res Clin Pract 2023; 24(1): 2239564.
  8. Cheng C et al. Poster presented at the 19th European AIDS Conference. 18–21 October 2023. Warsaw, Poland. e.P.A.051.
  9. Gan L et al. Infect Dis Ther 2023; 12(11): 2581–2593.
  10. Farinacci D et al. Poster presented at the 19th European AIDS Conference. 18–21 October 2023. Warsaw, Poland. e.P.A.038.
  11. Maggiolo F et al. BMC Infect Dis 2022; 22(1): 782.
  12. Ciccullo A et al. JIADS 2021; 1—14.
  13. Taramasso L et al. AIDS Patient Care STDs 2021; 35(9): 342—353.
  14. Rolle C et al. Open Forum Infect Dis 2023; 10(3): 1–9.

PM-GB-DLL-WCNT-240004. September 2024

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.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.