Advice
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.
Download detailed advice219KB (PDF)
Medicine details
- Medicine name:
- ledipasvir-sofosbuvir (Harvoni)
- SMC ID:
- 1030/15
- Indication:
- Treatment of chronic hepatitis C (CHC) in adults.
- Pharmaceutical company
- Gilead Sciences Ltd
- BNF chapter
- Infections
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 09 March 2015