Drug reference
Chronic hepatitis C (specialist use only) ▶BY MOUTH ▶Adult: 300/120 mg once daily, for duration of treatment, consult product literature DOSE EQUIVALENCE AND CONVERSION ▶Dose expressed as x/y mg glecaprevir/pibrentasvir.
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Hepatitis B infection. post-liver transplant patients. re-treatment of patients with prior exposure to NS3/4A- or NS5A-inhibitors—efficacy not established
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NICE decisions ▶Glecaprevir–pibrentasvir for treating chronic hepatitis C (January 2018) NICE TA499 Glecaprevir with pibrentasvir is recommended, within its marketing authorisation, as an option for treating chronic hepatitis C in adults, only if the manufacturer provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit. www.nice.org.uk/guidance/ta499 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (November 2017) that glecaprevir with pibrentasvir (Maviret ®) is accepted for use within NHS Scotland for the treatment of chronic hepatitis C virus (HCV) infection in adults. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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HEPATITIS B INFECTION Cases of hepatitis B reactivation, sometimes fatal, have been reported in patients co-infected with hepatitis B and C viruses; manufacturer advises to assess patients for hepatitis B prior to initiation of therapy and manage according to current clinical guidelines. MHRA/CHM ADVICE: DIRECT-ACTING ANTIVIRALS TO TREAT CHRONIC HEPATITIS C: RISK OF INTERACTION WITH VITAMIN K ANTAGONISTS AND CHANGES IN INR (JANUARY 2017) An EU-wide review has identified that changes in liver function, secondary to hepatitis C treatment with direct- acting antivirals, may affect the efficacy of vitamin K antagonists; the MHRA has advised that INR should be monitored closely in patients receiving concomitant treatment. MHRA/CHM ADVICE: DIRECT-ACTING ANTIVIRALS FOR CHRONIC HEPATITIS C: RISK OF HYPOGLYCAEMIA IN PATIENTS WITH DIABETES (DECEMBER 2018) Rapid reduction in hepatitis C viral load during direct- acting antiviral therapy for hepatitis C may improve glucose metabolism in patients with diabetes and result in symptomatic hypoglycaemia if diabetic treatment is continued at the same dose. The MHRA advises healthcare professionals: . to monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, especially within the first 3 months of treatment and modify diabetic medication or doses when necessary; . to be vigilant for changes in glucose tolerance and advise patients of the risk of hypoglycaemia; . to inform the healthcare professional in charge of the diabetic care of the patient when direct-acting antiviral therapy is initiated.
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→Appendix 1: glecaprevir. pibrentasvir Infection
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▶Common or very common Asthenia. diarrhoea. headache. nausea ▶Frequency not known Pruritus. transient ischaemic attack
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises avoid in moderate to severe impairment (risk of increased exposure).
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21, 25 ▶Maviret (AbbVie Ltd) A Pibrentasvir 40 mg, Glecaprevir 100 mg Maviret 100mg/40mg tablets | 84 tablet P £12,993.66 ANTIVIRALS › OTHER
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Missed doses Manufacturer advises if a dose is more than 18 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.
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300/120 mg once daily, for duration of
First-line fragment. Read the complete Indications and Dose section above.
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