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Statistically Superior Efficacy

DOLUTEGRAVIR▼ – demonstrated superior efficacy vs 4 core agent comparators

* DTG 50mg + ABC 600mg/3TC 300mg were used. Bioequivalence has been demonstrated.5

† In STRIIVING, 551 virologically suppressed patients were randomised; 274 receiving
Triumeq (DTG/ABC/3TC) and 277 continued their current ART regimens (42% PIs, 27% INIs and 31% NNRTIs).
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Dolutegravir – the only integrase inhibitor with statistically superior efficacy vs 3 core agent comparators in treatment-naïve patients:

* In this Phase III, 96-week, double-blind, double-dummy, multicentre, fully powered, non-inferiority study, 833 HIV-1 RNA-infected, treatment-naïve adults were randomised to receive at least 1 dose of either dolutegravir 50mg once daily with fixed-dose ABC/3TC or fixed-dose  TDF/FTC/EFV.6

† DTG 50mg + ABC 600mg/3TC 300mg were used. Bioequivalence has been demonstrated.5

‡ In this Phase III, 96-week, open-label, multicentre study, 484 HIV-1 RNA-infected, treatment-naïve adults were randomised to receive dolutegravir 50mg once daily plus 2 NRTIs or darunavir/r 800mg/100mg once daily plus 2 NRTIs.7

In this phase IIIb, open label, randomised, non-inferiority study, 495 treatment-naive women were randomised to recieve Triumeq once daily or atazanavir/r plus fixed dose TDF/FTC

Triumeq is indicated for the treatment of HIV-infected adults and adolescents above 12 years of age weighing at least 40 kg.

Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.5

Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir. WOCBP who are taking dolutegravir should use effective contraception throughout treatment.5

For further information, please see the Summary of Product Characteristics.

References:

  1. Walmsley S, Baumgarten A, Berenguer J, et al. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naïve patients: week 96 and week 144 results from the SINGLE randomised clinical trial. J Acquir Immune Defic Syndr. 2015;70:515-519.
  2. Molina J-M, Clotet B, van Lunzen J, et al; on behalf of the FLAMINGO Study Team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naïve adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2(4):e127-e136.
  3. Orrell C, Hagins D, Belonosova E, et al. Superior efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) compared with ritonavir (RTV) boosted atazanavir (ATV) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve women with HIV-1 infection (ARIA Study). Presented at: Annual International AIDS Conference 2016; July 18-22, 2016. Durban, South Africa.
  4. Raffi F, Jaeger H, Quiros-Roldan E, et al;  on behalf of the SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naïve adults with HIV-1 infection (SPRING-2): 96 week results from a randomised, double-bild, non-inferiority trial. Lancet Infect Dis. 2013:13(11):927-935
  5. TRIUMEQ Summary of Product Characteristics.
  6. Walmsley SL, Antela A, Clumeck N, et al; for the SINGLE investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med.2013;369(19):1807-1818. Supplementary appendix.
  7. Clotet B, Feinberg J, van Lunzen J, et al; on behalf of the ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naïve adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383:2222-2231. Supplementary appendix.
  8. Raffi F, Rachlis A, Stellbrink H-J et al; on behalf of the SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naïve adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381(9868):735-743. Supplementary appendix.
  9. Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naïve adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.
  10. Trottier B, Lake J, Logue K, et al. Switching to abacavir/dolutegravir/lamivudine fixed dose combination (ABC/DTG/3TC FDC) from a PI, INI, or NNRTI based regimen maintains HIV suppression. Presented at: Interscience Conference of Antimicrobial Agents and Chemotherapy; September 17-21, 2015; San Diego California.
  11. Trottier B, Lake J, Logue K, et al. Switching to abacavir/dolutegravir/lamivudine fixed dose combination (ABC/DTG/3TC FDC) from a PI, INI, or NNRTI based regimen maintains HIV suppression. Presented at: Interscience Conference of Antimicrobial Agents and Chemotherapy; September 17-21, 2015; San Diego California. Abstract 2015-LB-3271-ASM-ICAAC.
  12. Raffi, Rachlis A, Brinston C, et al. Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naïve HIV-infected individuals in three randomised trials. AIDS. 2015;29(2)167-174.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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