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Safety

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Adverse reactions

In the Phase IIb to IIIb clinical trials 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] were nausea (12%), insomnia (7%), dizziness (6%) and headache (6%). 1

Below you can find a summary of the very common (≥ 1/10) and common (≥1/100 to <1/10) adverse reactions considered at least possibly related to treatment with the components of TRIUMEQ from both clinical study and post-marketing experience. 1

Triumeq adverse reactions

*Read about hypersensitivity reactions and HLA-B*5701 screening below.
aThis adverse reaction was identified from clinical studies or post-marketing experience for dolutegravir, abacavir or lamivudine when used with other antiretrovirals or post-marketing experience with Triumeq. 1

HLA-B*5701 screening and hypersensitivity reactions

Before initiating treatment with abacavir-containing products, like TRIUMEQ, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient. Abacavir should not be used in patients known to carry the HLA-B*5701 allele. 1

Prospective HLA-B*5701 screening: No immunologically confirmed hypersensitivity reaction (HSR) and significant reduction of clinically suspected HSR in the PREDICT-1 study. 2

HLA-B*5701 screening

HLA-B*5701 screening significantly reduces the risk of an ABC hypersensitivity reaction. 2

Clinical description of ABC HSRs: 1

  • Almost all patients developing ABC HSRs will have fever and/or rash.
  • Other key symptoms include: gastrointestinal, respiratory, or constitutional symptoms such as lethargy and malaise.

If suspected: 1

  • TRIUMEQ must be stopped without delay, even in the absence of the HLA-B*5701 allele.
  • After stopping treatment with TRIUMEQ for a suspected HSR, TRIUMEQ or any other medicinal product containing ABC or DTG, must never be re-initiated.

For more information on HLA-B*5701 screening and hypersensitivity reactions, please see:
TRIUMEQ Summary of product Characteristics.
Informasjonsbrosjyre om hypersensitivitetsreaksjoner for Abakavir i Felleskatalogen and the Abacavir HSR Support Website

Drug-drug interactions

TRIUMEQ has few clinically significant drug-drug interactions. 1

Triumeq drug-drug interactions
  • Co-administration with dofetilide is contraindicated. 1
  • Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John’s wort, TRIUMEQ is not recommended for patients taking these drugs. 1
  • TRIUMEQ can be co-administered with etravirine only if a boosted protease inhibitor (atazanavir/r, lopinavir/r or darunavir/r) is also administered. 1

For a more comprehensive list of interactions, please see the HIV DDI database of University of Liverpool.

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

References:

  1. TRIUMEQ preparatomtale
  2. Mallal S, Phillips E, Carosi G, et al; for the PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med.

TRIUMEQ trademark is owned by or licensed to the ViiV Healthcare group of companies.