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ledipasvir-sofosbuvir (Harvoni)


following a full submission

ledipasvir/sofosbuvir (Harvoni®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of chronic hepatitis C (CHC) in adults.

SMC restriction: genotype 1 and 4 CHC only.

In three, uncontrolled phase III studies conducted in treatment-naïve and treatment-experienced non-cirrhotic and cirrhotic patients with genotype 1 CHC, ledipasvir/sofosbuvir ± ribavirin achieved sustained virological response (at 12 weeks post treatment) rates of 93% to 99%, which were significantly superior to historical control rates.

No clinical or economic data were presented for genotype 3 patients with cirrhosis and/or prior treatment failure.

Drug Details

Drug Name: ledipasvir-sofosbuvir (Harvoni)
SMC Drug ID: 1030/15
Manufacturer: Gilead Sciences Ltd
Indication: Treatment of chronic hepatitis C (CHC) in adults.
BNF Category:
Sub Category: 5.3 Antiviral Drugs
Submission Type: Full submission
Status: Restricted
Date Advice Published: 9 March 2015