Summary of the safety profile In pooled Phase 2 and 3 clinical studies of adult subjects receiving Maviret with genotype 1, 2, 3, 4, 5 or 6 HCV infection the most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack). 1%. Tabulated list of adverse reactions The following adverse reactions were identified in registrational Phase 2 and 3 studies in HCV-infected adults with or without cirrhosis treated with Maviret for 8, 12 or 16 weeks, or during post-marketing experience.
The adverse reactions are listed below by body system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) or not known (cannot be estimated from the available data).
Table 5:
Adverse reactions identified with Maviret Frequency Adverse reactions Immune system disorders Uncommon angioedema Nervous system disorders Very common headache Gastrointestinal disorders Common diarrhoea, nausea Skin and subcutaneous tissue disorders Not known pruritus General disorders and administration site conditions Very common fatigue Common asthenia Investigations Common elevation in total bilirubin Description of selected adverse reactions Adverse reactions in subjects with severe renal impairment including subjects on dialysis The safety of Maviret in subjects with chronic kidney disease (including subjects on dialysis) and genotypes 1, 2, 3, 4, 5 or 6 chronic HCV infection with compensated liver disease (with or without cirrhosis) was assessed in adults in EXPEDITION-4 (n=104) and EXPEDITION-5 (n=101).
9%) in EXPEDITION-5. Adverse reactions in subjects with liver or kidney transplant The safety of Maviret was assessed in 100 post-liver or -kidney transplant adult recipients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis (MAGELLAN-2).
The overall safety profile in transplant recipients was comparable to that observed in subjects in the Phase 2 and 3 studies. Adverse reactions observed in greater than or equal to 5% of subjects receiving Maviret for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%).
Safety in HCV/HIV-1 co-infected subjects The overall safety profile in HCV/HIV-1 co-infected adult subjects (ENDURANCE-1 and EXPEDITION-2) was comparable to that observed in HCV mono-infected adult subjects. Paediatric population The safety of Maviret in HCV GT1-6 infected adolescents is based on data from a Phase 2/3 open-label study in 47 subjects aged 12 years to < 18 years treated with Maviret tablets for 8 to 16 weeks (DORA Part 1).
The adverse reactions observed were comparable with those observed in clinical studies of Maviret in adults. The safety of Maviret in HCV GT1-6 infected children aged 3 to less than 12 years is based on data from a Phase 2/3 open-label study in 80 subjects aged 3 to < 12 years treated with weight-based Maviret coated granules for 8, 12, or 16 weeks (DORA Part 2).
The pattern of adverse reactions observed was comparable with that observed in clinical studies of Maviret film-coated tablets in adolescents and adults. 8% vs. 8% vs. 5% vs. 1% respectively). 3% of subjects related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism.
Bilirubin elevations were asymptomatic, transient, and typically occurred early during treatment. Bilirubin elevations were predominantly indirect and not associated with ALT elevations. 3% of subjects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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