Dolutegravir: HIV Treatment Information

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.

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.

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
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) 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.