Advice

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.

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Medicine details

Medicine name:
ledipasvir/sofosbuvir (Harvoni)
SMC ID:
1084/15
Indication:
Treatment of genotype 3 chronic hepatitis C (CHC) in adults
Pharmaceutical company
Gilead Sciences Ltd
BNF chapter
Infections
Submission type
Full
Status
Restricted
Date advice published
07 September 2015