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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 genotype 3 chronic hepatitis C (CHC) in adults.

SMC restriction: patients who are ineligible for or unable to tolerate interferon.

Efficacy data are limited to a phase II open-label study. The addition of ledipasvir to sofosbuvir plus ribavirin is expected to increase antiviral activity, although the magnitude of this effect is not well characterised.

SMC has previously accepted ledipasvir/sofosbuvir for restricted use in genotype 1 and 4 CHC; this now extends advice to include use in genotype 3 CHC.

Drug Details

Drug Name: ledipasvir/sofosbuvir (Harvoni)
SMC Drug ID: 1084/15
Manufacturer: Gilead Sciences Ltd
Indication: Treatment of genotype 3 chronic hepatitis C (CHC) in adults
BNF Category:
Sub Category: 5.3 Antiviral Drugs
Submission Type: Full submission
Status: Restricted
Date Advice Published: 7 September 2015