NICE recommends ledipasvir-sofosbuvir (Harvoni) as a treatment option for some adults with genotype 1 or 4 hepatitis C.

In draft guidance published today healthcare guidance body NICE has recommended ledipasvir-sofosbuvir (Harvoni) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.

The Committee also considered ledipasvir-sofosbuvir in combination with ribavirin  for people with genotype 3 chronic hepatitis C. Based on the evidence presented the Committee concluded that this could not be considered a cost-effective use of NHS resources.

Stakeholders are now able to comment on the draft recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee at the next meeting, and following this meeting the next draft guidance will be issued. The closing date for comments on the draft guidance is 23 March 2015.

This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Genotype 1 treatment naive

8 weeks’ treatment recommended for people without cirrhosis

12 weeks’ treatment recommended for people with cirrhosis

Genotype 1 treatment experienced

12 weeks’ treatment recommended for people without cirrhosis

24 weeks’ treatment not recommended for people without cirrhosis

24 weeks’ treatment not recommended for people with cirrhosis

Genotype 3 - All

Not licensed for this population

Genotype 4 treatment naive

12 weeks’ treatment not recommended for people without cirrhosis

12 weeks’ treatment recommended for people with cirrhosis

24 weeks’ treatment not recommended for people with cirrhosis

Genotype 4 treatment treatment experienced

12 weeks’ treatment recommended for people without cirrhosis

24 weeks’ treatment not recommended for people without cirrhosis

24 weeks’ treatment not recommended for people with cirrhosis

Ribaviron is not  licensed for use with any of the above

About ledipasvir-sofosbuvir

Ledipasvir-sofosbuvir (Harvoni, Gilead Sciences) prevents hepatitis C virus replication by inhibiting the NS5A (targeted by ledipasvir) and NS5B (targeted by sofosbuvir) proteins.

Ledipasvir-sofosbuvir has a marketing authorisation in the UK for treating chronic hepatitis C in adults. However, the marketing authorisation recommends specific treatment regimens for HCV genotypes 1, 3 and 4 only, and states that ledipasvir–sofosbuvir should not be used in people with HCV genotypes 2, 5 and 6.

The recommended dose is 1 daily tablet containing 90 mg ledipasvir and 400 mg sofosbuvir. It is taken orally as a fixed-dose combination tablet for 8, 12 or 24 weeks, with or without ribavirin. The recommended treatment duration and whether ribavirin is co-administered depends on genotype, treatment history and presence of cirrhosis. For full details of the recommended treatment durations for ledipasvir-sofosbuvir with or without ribavirin, see table 1 of its summary of product characteristics.

Ledipasvir-sofosbuvir costs £12,993.33 per 28 tablet pack (excluding VAT; company’s evidence submission). The cost of a 12 week course of treatment is £38,979.99 and a 24 week course is £77,959.98 (both excluding VAT), not including the cost for ribavirin. Costs may vary in different settings because of negotiated procurement discounts.

To read more documents on this to go the NICE website