POWERED BY DOLUTEGRAVIR AT THE CORE
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 (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.

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

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.
PM-GB-DLL-WCNT-210002 | April 2021