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Safety & Tolerability

DOLUTEGRAVIR ▼ has a favourable tolerability profile with few discontinuations in 3 treatment-naïve trials1-3

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SINGLE*1

  • Favourable tolerability: CNS at 48 weeks vs EFV/TDF/FTC1
  • 2 vs 28 patients withdrew due to psychiatric or nervous system disorders with Triumeq vs EFV/TDF/FTC, respectively1

FLAMINGO*2

  • Favourable tolerability: Diarrhoea at 96 weeks vs DRV/r + 2 NRTIs
  • More than twice as many patients experienced drug-related diarrhoea with DRV/r than dolutegravir (57 vs 23, respectively)4

ARIA3

  • Demonstrated favourable tolerability vs ATV/r + TDF/FTC (in women)3
  • ARIA most common drug-related adverse events in the Triumeq arm (all grades ≥5%): Nausea (13%) and Diarrhoea (5%).3

*In studies supporting TRIUMEQ, DTG 50 mg + ABC 600 mg/ 3TC 300 mg were used. Bioequivalence has been demonstrated.4

DTG=dolutegravir; ABC=abacavir; 3TC=lamivudine; EFV=efavirenz; TDF=tenofovir; FTC=emtricitabine

Include DRV/r= darunavir/ritonavir, ATV/r= atazanavir/ritonavir.

Most common adverse events for Triumeq:5

The most frequently reported adverse reactions considered possibly or probably related to dolutegravir and abacavir/lamivudine [pooled data from 679 anti retroviral naïve subjects receiving this combination in the Phase IIb to IIIb clinical trials5

Nausea 12%

Insomnia 7%

Dizziness 6%

Headache 6%

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

Triumeq is indicated for the treatment of HIV-infected adults and adolescents above 12 years of age weighing at least 40kg. Triumeq is contraindicated: in patients with hypersensitivity to dolutegravir, abacavir or lamivudine or to any of the excipients, and with co-administration with dofetilide.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

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 know to carry the HLA-B*5701 allele.5

References:

  1. Walmsley S, 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.
  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. Abstract THAB0205LB
  4. Weller Stephen et al. Bioequivalence of a Dolutegravir, Abacavir, and Lamivudine Fixed-Dose Combination Tablet and the Effect of Food. JAIDS. 2014;66:393-398
  5. Triumeq Summary of Product Characteristics.

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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