The National Institute of Clinical Excellence (NICE) has issued draft recommendations on the use of interferon alpha (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C in England and Wales. If no objections are raised by December 15, it is likely that the recommendations will become binding on NHS trusts and primary care trusts in England and Wales when making decisions about paying for treatment, which individuals should be treated and what treatment they should receive.
NICE estimates that anywhere between 50,000 and 400,000 people in England and Wales are infected with hepatitis C. Around 2,000 people each year are being treated for HCV infection at present, and NICE estimates that if the annual number of treatments remains stable, the cost to the NHS of pegylated interferon plus ribavirin would amount to an extra £17 million per year (including the cost of re-treatment for individuals who experienced previous treatment failure). However the report warns that as people become more aware of the condition and improvements in treatment, this cost will increase.
NICE will review its guidance next year after the results of two clinical trials in patients with mild/early hepatitis C infection have been reported, in order to determine whether the recommendation for treatment should be extended.
Recommendations made by the Appraisal Committee are as follows:
1. Combination therapy with pegylated interferon alpha and ribavirin is recommended within its licensed indications for the treatment of people aged 18 years and over with moderate to severe chronic hepatitis C (CHC), defined as histological evidence of significant scarring (fibrosis) and/or significant necrotic inflammation.
2. People with moderate to severe CHC are suitable for treatment if they have:
- Not previously been treated with interferon alpha or peg interferon alpha, or
- Been treated previously with interferon alpha (as monotherapy or in combination therapy), and/or
- Previously received peg interferon alpha monotherapy only and responded at the end of treatment but subsequently relapsed, or did not respond at the end of treatment.
3. People currently being treated with interferon alpha, either as combination therapy or monotherapy may be switched to the corresponding therapy with peg interferon alpha.
4. Treatment for the groups identified in Sections 1.and 2 should be as follows.
- People infected with hepatitis C virus (HCV) of genotype 2 and/or 3 should be treated for 24 weeks. For people infected with HCV of genotype 1, 4, 5 or 6, initial treatment should be for 12 weeks. Only people showing, at 12 weeks, a reduction in viral load to less than 1% of its level at the start of treatment (at least a 2-log reduction, see Section 4.1.2.5) should continue treatment until 48 weeks. For people in whom viral load at 12 weeks exceeds 1% of its level at the start of treatment, treatment should be discontinued.
- People infected with more than one genotype that includes one or more of genotypes 1, 4, 5, or 6 should be treated as for genotype 1.
5. People satisfying the conditions in Sections 1.1 and 1.2 but for whom ribavirin is contraindicated or is not tolerated should be treated with peg interferon alpha monotherapy. Regardless of genotype, individuals should be tested for viral load at 12 weeks, and if the viral load has reduced to less than 1% of its level at the start of treatment, treatment should be continued for a total of 48 weeks. If viral load has not fallen to this extent, treatment should stop at 12 weeks.
6. People for whom liver biopsy poses a substantial risk (such as those with haemophilia, or those who have experienced an adverse event after undergoing a previous liver biopsy), and people with symptoms of extra-hepatic HCV infection sufficient to impair quality of life, may be treated on clinical grounds without prior histological classification.
7. There is insufficient evidence to recommend combination therapy using peg interferon alpha or interferon alpha in people who:
- have previously been treated with combination therapy using peg interferon alpha, and/or
- are younger than 18 years of age, and/or
- have had a liver transplantation. Treatment of CHC recurrence after liver transplantation (whether or not the person had been treated with interferon alpha or peg interferon alpha therapy at any time prior to transplantation) should be considered as experimental and carried out only in the context of a clinical trial.