POWERED BY DOLUTEGRAVIR AT THE CORE

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

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 trials^3-15, including five superior efficacy results^3–5,8,9
2-drug regimens across >2000 patients in five Phase 3 trials^16-18

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.

Treatment-naïve

SINGLE (3DR)

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

ARIA (3DR)

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

FLAMINGO (3DR)

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

SPRING-2 (3DR)

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

INSPIRING (3DR)

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

GEMINI-1 and GEMINI-2 (2DR)

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.

Treatment-experienced

DAWNING (3DR)

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

SAILING (3DR)

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

VIKING-3 (3DR)

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

Virologically suppressed

STRIIVING (3DR)

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

SWORD-1 and SWORD-2

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

TANGO (2DR)

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

References:

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

Medicine	Format
Medicine	Prescribing information for DOVATO	Format	PDF	View
Medicine	Prescribing information for JULUCA▼	Format	PDF	View
Medicine	Prescribing information for TRIUMEQ	Format	PDF	View
Medicine	Prescribing information for TIVICAY	Format	PDF	View
Medicine	Prescribing information for TIVICAY 5MG DISPERSIBLE TABLETS	Format	PDF	View

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.

POWERED BY DOLUTEGRAVIR AT THE CORE

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

SINGLE (3DR)

ARIA (3DR)

FLAMINGO (3DR)

SPRING-2 (3DR)

INSPIRING (3DR)

GEMINI-1 and GEMINI-2 (2DR)

Prescribing information

Medicine

Format

Medicine

Format

Medicine

Format

Medicine

Format

Medicine

Format

Medicine

Format

DOVATO (Dolutegravir/ lamivudine)

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