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High Barrier to Resistance

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DOLUTEGRAVIR ▼ – an INI with a high barrier to resistance

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

† E157Q/P polymorphism detected with no significant change in phenotypic susceptibility.7

‡ Two subjects receiving DTG/ABC/3TC had either K219/K/Q (TAM) or E138E/G at CVW (confirmed virological withdrawal) with no susceptibility to DTG/ABC/3TC. K219K/Q is not selected for by ABC or 3TC nor does it affect their fold change.3

A visual exploration of dolutegravir and its structure-function relationship

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. TIVICAY Summary of Product Characteristics.
  7. Walmsley S, Berenguer J, Khuong-Josses M, et al. Dolutegravir regimen statistically superior to efavirenz/tenofovir/emtricitabine: 96-week results from the SINGLE study (ING114467). Poster presented at: 21st Conference on Retroviruses and Opportunistic Infections: March 3-6, 2014; Boston, Massachusetts, USA. Poster 543.

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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