Drug reference
Chronic hepatitis C of genotype 1 (in combination with dasabuvir, with or without ribavirin) | Chronic hepatitis C of genotype 4 (in combination with ribavirin) ▶BY MOUTH ▶Adult: 2 tablets once daily for duration of treatment consult product literature, to be taken with food
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HIV co-infection without suppressive antiretroviral therapy
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Psychiatric disorders. retreatment—efficacy not established
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NICE decisions ▶Ombitasvir with paritaprevir and ritonavir with or without dasabuvir for treating chronic hepatitis C (November 2015) NICE TA365 Ombitasvir with paritaprevir and ritonavir with or without dasabuvir is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta365
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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 ANTIVIRAL INTERFERON- FREE REGIMENS TO TREAT CHRONIC HEPATITIS C: RISK OF HEPATITIS B REACTIVATION (JANUARY 2017) An EU-wide review has concluded that direct-acting antiviral interferon-free regimens for chronic hepatitis C can cause hepatitis B reactivation in patients co-infected with hepatitis B and C viruses; the MHRA recommends to screen patients for hepatitis B before starting treatment—patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines. 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: HIV-protease inhibitors. ombitasvir. paritaprevir
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▶Common or very common Anaemia. asthenia. insomnia. nausea. pruritus ▶Rare or very rare Angioedema ▶Frequency not known Depression. suicidal behaviour SIDE-EFFECTS, FURTHER INFORMATION Side-effects listed are reported when ombitasvir with paritaprevir and ritonavir is used in combination with dasabuvir, with or without ribavirin.
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For women of child- bearing potential, exclude pregnancy before initiation of treatment; effective contraception should be used during treatment.
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Manufacturer advises avoid—toxicity in animal studies.
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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.
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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 EXCIPIENTS: May contain Propylene glycol ▶Viekirax (AbbVie Ltd) A Ombitasvir 12.5 mg, Ritonavir 50 mg, Paritaprevir 75 mg Viekirax 12.5mg/75mg/50mg tablets | 56 tablet P £10,733.33 ANTIVIRALS › NUCLEOSIDE ANALOGUES
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Missed doses If a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.
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2 tablets once daily for duration of treatment
First-line fragment. Read the complete Indications and Dose section above.
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