Indications And Dose
Chronic hepatitis C infection ▶BY MOUTH ▶Adult: 400 mg once daily, for duration of treatment consult product literature
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Individual generic drug information
Extracted information for Sofosbuvir only.
Chronic hepatitis C infection ▶BY MOUTH ▶Adult: 400 mg once daily, for duration of treatment consult product literature
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Manufacturer advises in chronic hepatitis C of genotype 1, 4, 5, or 6, only use sofosbuvir with ribavirin dual therapy in those with intolerance or contra- indications to peginterferon alfa who require urgent treatment.
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Dispense in original container (contains desiccant).
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NICE decisions ▶Sofosbuvir for treating chronic hepatitis C (February 2015) NICE TA330 Sofosbuvir (Sovaldi ®) in combination with peginterferon alfa and ribavirin is an option for treating adults with chronic hepatitis C infection: . of genotype 1 Infection . of genotype 3 with cirrhosis (treatment naive patients) . of genotype 3 that has not adequately responded to interferon-based treatment . of genotype 4, 5, or 6 with cirrhosis. Sofosbuvir (Sovaldi ®) in combination with ribavirin is an option for treating adults with chronic hepatitis C infection: . of genotype 2 who are intolerant to or ineligible for interferon (treatment naive patients) . of genotype 2 that has not adequately responded to interferon-based treatment . of genotype 3 with cirrhosis who are intolerant to or ineligible for interferon (treatment naive patients) . of genotype 3 with cirrhosis that has not adequately responded to interferon-based treatment Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta330 ▶Sofosbuvir for treating chronic hepatitis C (February 2015) NICE TA330 Sofosbuvir (Sovaldi ®) in combination with ribavirin is not recommended for the treatment of adults with chronic hepatitis C infection of genotypes 1, 4, 5, or 6. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta330 Scottish Medicines Consortium (SMC) decisions SMC No. 964/14 The Scottish Medicines Consortium has advised (June 2014) that sofosbuvir (Sovaldi ®) is accepted for restricted use within NHS Scotland for the treatment of chronic hepatitis C infection of genotypes 1 to 6; its use in combination with ribavirin as dual therapy for chronic hepatitis C infection of either genotype 2 (in treatment naive patients) or genotype 3 is restricted to those who cannot use peginterferon alfa because of intolerance or contra- indications.
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Extracted information for Sofosbuvir only.
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 Infection 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: sofosbuvir
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▶Common or very common Alopecia. anaemia. anxiety. appetite decreased. arthralgia. asthenia. chest pain. chills . concentration impaired. constipation. cough. depression. diarrhoea. dizziness. dry mouth. dyspnoea. fever. gastrointestinal discomfort. gastrooesophageal reflux disease. headaches. influenza like illness. insomnia . irritability. memory loss. muscle complaints. nasopharyngitis. nausea. neutropenia. pain. skin reactions. vision blurred. vomiting. weight decreased ▶Frequency not known Arrhythmia SIDE-EFFECTS, FURTHER INFORMATION Side-effects listed are reported when sofosbuvir is used in combination with ribavirin or with ribavirin and peginterferon alfa.
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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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Safety and efficacy not established if eGFR less than 30 mL/minute/1.73 m2—accumulation may occur.
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Extracted information for Sofosbuvir only.
There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21, 25 ▶Sovaldi (Gilead Sciences International Ltd) A Sofosbuvir 400 mg Sovaldi 400mg tablets | 28 tablet P £11,660.98
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Extracted information for Sofosbuvir only.
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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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
400 mg once daily, for duration of treatment
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 687