Dolutegravir: Tested and proven
The #1 prescribed INI worldwide, with nearly 2 million patient years’ experience1,2

Dolutegravir (DTG) has been studied across diverse patient populations as part of both 3-and 2-drug regimens, including patients who are virologically suppressed, treatment-experienced and treatment-naïve.3-18

The power of DTG has been proven effective as part of:

  • 3-drug regimens across >4000 patients in 13 Phase 3 trials3-15, including five superior efficacy results3–5,8,9
  • 2-drug regimens across >2000 patients in five Phase 3 trials16-18

With the breadth and depth of data we have available, we want to demonstrate to you exactly why we’ve chosen to power our medicines with DTG.



SINGLE is a Phase 3, multicentre, randomised, double-blind, non-inferiority study involving treatment-naïve participants with HIV (N=833). DTG + ABC/3TC was compared with EFV/FTC/TDF at 48, 96 and 144 weeks.3

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ARIA Study


The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-group, non-inferiority Phase 3b study in treatment-naïve women (N=495). DTG/ABC/3TC was compared with ATV/r + TDF/FTC at 48 weeks.4

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FLAMINGO is a multicentre, open-label, Phase 3b, non-inferiority study involving treatment-naïve adults with HIV-1 (N=484). DTG + 2 NRTIs was compared with DRV/r + 2 NRTIs at 48 and 96 weeks.5

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SPRING-2 Study


SPRING-2 is a Phase 3, randomised, double-blind, active-controlled, non-inferiority study of treatment-naïve patients with HIV-1 (N=822). DTG was compared with RAL, both given with an NRTI backbone, over a period of 96 weeks.6

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INSPIRING is a Phase 3b randomised, multicentre, open-label, non-comparative, active-controlled study in ART-naïve patients with HIV-1 with drug-sensitive TB (N=113). Participants receiving rifampicin-based TB treatment ≤8 weeks were given either DTG or EFV alongside two NRTIs for 52 weeks.7

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GEMINI-2 Study


GEMINI-1 and GEMINI-2 are identical ongoing double-blind, non-inferiority Phase 3 studies. Participants were treatment-naïve adults with HIV-1 (N=1433). Participants were randomised 1:1 to DTG + 3TC or DTG + TDF/FTC up until Week 96, with an open-label randomised phase from week 96 up until week 148.


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DAWNING is a Phase 3b, open-label, parallel-group, non-inferiority, active controlled, multicentre trial involving patients with HIV-1 where previous treatment with an NNRTI and two NRTIs has failed (N=624). DTG + 2 NRTIs was compared to LPV/r + 2 NRTIs over a period of 52 weeks.8

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SAILING is a Phase 3, randomised, double-blind, active-controlled, double-placebo, multicentre, non-inferiority study in treatment-experienced, INI-naïve patients with HIV-1 with resistance to at least two classes of ARTs (N=715). Patients were assigned DTG or RAL plus an investigator-selected BR, which were compared over 48 weeks.9

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VIKING-3 Study


VIKING-3 is a single-arm, open-label, multicentre study in treatment-experienced adults (N=183) received DTG while continuing their background regimen for 7 days, after which the regimen was optimised with ≥1 fully active drug and DTG continued.10 

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STRIIVING was a Phase 3b, randomised, open-label, multicentre, active-controlled, non-inferiority study in patients with HIV-1 who had maintained virological suppression on a stable ART regimen for ≥6 months prior to screening (N=553). The efficacy of DTG/ABC/3TC in stably suppressed ART-experienced adults with HIV-1 was investigated, over 48 weeks.11

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SWORD-1 Study


SWORD-1 and SWORD-2 are two identically designed Phase 3, open-label, parallel-group, multicentre, randomised, non-inferiority studies for patients on first or second ART with a stable plasma HIV-1 RNA for 6 months (N=1024). The safety and efficacy of DTG+RPV was investigated over a period of 48 weeks, with maintenance investigated to 148 weeks.18

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TANGO is an ongoing, open-label, multicentre, Phase 3 non-inferiority study enrolling virologically suppressed adults living with HIV-1 (N=741). TANGO was designed to evaluate the efficacy and safety of switching to DTG/3TC vs remaining on a TAF-based regimen.17

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  1. Data on file. IQVIA/IMS INI molecules by prescription volume globally March 2019 (estimate). ViiV Healthcare group of companies. Research Triangle Park, NC.
  2. Data on file. Global dolutegravir (TIVICAY + TRIUMEQ + JULUCA) patient exposure expressed as total patient years (absolute): REF-41556. ViiV Healthcare group of companies. Research Triangle Park, NC.
  3. Walmsley S, et al. J Acquir Immune Defic Syndr. 2015;70(5):515–519.
  4. Orrell C, et al. Lancet HIV. 2017;4(12):e536–e546.
  5. Molina JM, et al. Lancet HIV. 2015;2(4):e127–e136.
  6. Raffi F, et al. The Lancet. 2013;13:927–935.
  7. Dooley KE, et al. Clin Infect Dis. 2020;70:549–556.
  8. Aboud M, et al. The Lancet. 2019;19:253–264.
  9. Cahn P, et al. The Lancet. 2013;382:700–708.
  10. Castagna A, et al. J Infect Dis. 2014;210:354–362.
  11. Trottier B, et al. Antivir Ther. 2017;22:295­–305.
  12. Gatell JM, et al. Clin Infect Dis. 2019;68(4):597-606.
  13. Wohl DA, et al. Lancet HIV. 2019;6(6):e355-e363.
  14. Stellbrink HJ, et al. Lancet HIV. 2019;6(6):e364-e372.
  15. Molina JM, et al. Lancet HIV. 2018;5(7):e357-e365.
  16. Cahn P, et al. HIV Drug Therapy. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster P018.
  17. Van Wyk J, et al. HIV Drug Therapy. Presented at: HIV Glasgow 2020. October 5–8, 2020, Virtual Slides O441.
  18. Van Wyk J, et al. J Acquir Immune Defic. 2020;85(3):325-330.
  • Abbreviations

    ABC, abacavir
    ABC/3TC, abacavir/lamivudine
    AE, adverse event
    ART, antiretroviral therapy
    ATV/r, atazanavir/ritonavir
    BID, twice daily
    BR, background regimen
    CI, confidence interval
    CVW, confirmed virologic withdrawal
    DRV/r, darunavir/ritonavir
    DTG, dolutegravir
    DTG/RPV, dolutegravir/rilpivirine
    EFV, efavirenz
    EFV/TDF/FTC, efavirenz/tenofovir/emtricitabine
    EVG, elvitegravir
    FDA, US Food and Drug Administration
    FDC, fixed-dose combination
    FTC, emtricitabine
    HBV, hepatitis B virus
    HCV, hepatitis C virus
    HDL, high-density lipoprotein
    HLA, human leukocyte antigen
    HIV, human immunodeficiency virus
    IDMC, independent data monitoring committee
    INI, integrase inhibitor
    IRIS, immune reactivation syndrome
    ITT-E, intent-to-treat exposed
    LDL, low-density lipoprotein
    LPV/r, lopinavir/ritonavir
    MTB, mycobacterium tuberculosis
    NNRTI, non-nucleoside reverse transcriptase inhibitor
    NRTI, nucleoside reverse transcriptase inhibitor
    OBR, optimised background regimen
    OD, once daily
    OSS, overall susceptibility score
    PDVF, protocol-defined virologic failure
    PI, protease inhibitor
    RAL, raltegravir
    RIF, rifampicin
    RNA, ribonucleic acid
    RPV, rilpivirine
    RT, reverse transcriptase
    TAF, tenofovir alafenamide fumarate
    TB, tuberculosis
    TBR, TAF-based regimen
    TC:HDL, total-cholesterol-to-HDL ratio
    TDF, tenofovir disoproxil fumarate
    VF, virologic failure
    3TC, lamivudine

Prescribing information

Prescribing information for DOVATO PDF View
Prescribing information for JULUCA
PDF View
Prescribing information for TRIUMEQ PDF View
Prescribing information for TIVICAY PDF View
Prescribing information for TIVICAY 5MG DISPERSIBLE TABLETS PDF View
DOVATO (Dolutegravir/lamivudine)

DOVATO (Dolutegravir/ lamivudine)

Dovato (dolutegravir/lamivudine) 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.

Read more Prescribing information

PM-GB-DLL-WCNT-210002 | April 2021

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline 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.