Drug Action
Sofosbuvir is a nucleotide analogue inhibitor and ledipasvir is an HCV inhibitor; they reduce viral load by inhibiting hepatitis C virus RNA replication.
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Drug reference
Sofosbuvir is a nucleotide analogue inhibitor and ledipasvir is an HCV inhibitor; they reduce viral load by inhibiting hepatitis C virus RNA replication.
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Chronic hepatitis C infection (initiated by a specialist) ▶BY MOUTH ▶Adult: 90/400 mg once daily, for duration of treatment consult product literature
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DUE TO INTERACTIONS ▶Manufacturer advises reduce dose of concurrent H2- receptor antagonist if above a dose comparable to famotidine 40 mg twice daily. ▶Manufacturer advises reduce dose of concurrent proton pump inhibitor if above a dose comparable to omeprazole 20 mg; take at the same time as sofosbuvir with ledipasvir. DOSE EQUIVALENCE AND CONVERSION ▶Dose expressed as x/y mg ledipasvir/sofosbuvir.
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Retreatment following treatment failure— efficacy not established
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Dispense in original container (contains desiccant).
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NICE decisions ▶Ledipasvir–sofosbuvir for treating chronic hepatitis C (November 2015) NICE TA363 Ledipasvir with sofosbuvir is recommended as an option for treating adults with chronic hepatitis C infection: . of genotype 1 without cirrhosis (treatment naive patients)—8 weeks’ treatment . of genotype 1 or 4 with cirrhosis (treatment naive patients)—12 weeks’ treatment . of genotype 1 or 4 without cirrhosis (or with cirrhosis but only if the person has a low risk of the disease getting worse) that has not responded adequately to previous treatment—12 weeks’ treatment In addition, ledipasvir with sofosbuvir is only recommended in patients with cirrhosis for the durations mentioned above if the following criteria are met: . Child-Pugh class A . platelet count of 75 000/mm3 or more . no features of portal hypertension . no history of an HCV-associated decompensation episode . not previously treated with an NS5A inhibitor Patients whose treatment with ledipasvir with sofosbuvir is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta363 Scottish Medicines Consortium (SMC) decisions SMC No. 1030/15 The Scottish Medicines Consortium has advised (March 2015) that ledipasvir with sofosbuvir (Harvoni ®) is accepted for restricted use within NHS Scotland for the treatment of chronic hepatitis C infection of genotypes 1 and 4 only. SMC No. 1084/15 The Scottish Medicines Consortium has advised (September 2015) that ledipasvir with sofosbuvir (Harvoni ®) is accepted for restricted use within NHS Scotland for the treatment of chronic hepatitis C infection of genotype 3 in patients who are ineligible for, or unable to tolerate interferon.
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→Appendix 1: ledipasvir. sofosbuvir
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▶Common or very common Fatigue. headache. rash ▶Frequency not known Angioedema. arrhythmia
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Harvoni (Gilead Sciences International Ltd) A Ledipasvir 90 mg, Sofosbuvir 400 mg Harvoni 90mg/400mg tablets | 28 tablet P £12,993.33
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Vomiting If vomiting occurs within 5 hours of administration, an additional dose should be taken. Missed doses 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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90/400 mg once daily, for duration of treatment
First-line fragment. Read the complete Indications and Dose section above.
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