NICE decision on ledipasvir/sofosbuvir for chronic HCV
On 25 November, NICE published guidance for the limited use of sofosbuvir/ledipasvir for chronic hepatitis C (HCV). 
As with the NICE approach to other new direct acting antivirals DAAs), the recommendation are categorised both by genotype and treatment experience, see Table 1.
For full details of the guidelines are available online.
NHS treatment with ledipasvir/sofosbuvir should be available within three months of this decision.
The coformulation of ledipasvir.sofosbuvir is manufacture by Gilead Sciences and marketed under the tradename Harvoni.
|HCV treatment-naive patients|
|G1 without cirrhosis||8 weeks treatment|
|G1 or G4 with cirrhosis||12 weeks treatment|
|HCV treatment-experienced patients|
|G1 or G4 without cirrhosis||12 weeks treatment|
|G1 or G4 with cirrhosis||12 weeks treatment, but only if there is a low risk of disease progression|
A price for ledipasvir/sofosbuvir is approximately £26,000 for 8-weeks and £38,000 for 12-weeks of treatment, both excluding VAT.
The guidance notes that a nationally available price reduction for ledipasvir/sofosbuvir has been agreed with the Commercial Medicines Unit, but also that this was not considered as part of the submission. No details of the reduced price have been published.
NICE. Ledipasvir–sofosbuvir for treating chronic hepatitis C. NICE technology appraisals [TA363]. (25 November 2015)