Guidance 1.1. Interferon alpha and ribavirin as combination therapy is recommended for the treatment of moderate to seve re hepatitis C (defined as histological evidence of significant scarring (fibrosis) and/or significant necrotic inflammation), at standard doses for patients over the age of 18 years as follows: - 1.1.1 All treatment-naive patients (that is, those who have not previously had interferon alpha monotherapy or combination therapy) and all patients who have been treated with interferon alpha monotherapy, and have had some response but have since relapsed. Such treatment should be continued for 6 months for all patients.
1.1.2 A further 6 months combination therapy is recommended only for patients infected with hepatitis C virus of genotype 1, who respond to therapy by becoming clear of circulating viral RNA as detected by polymerase chain reaction (PCR) in the first 6 months.
1.1.3 Those in whom liver biopsy poses a substantially increased risk (such as patients with haemophilia) could be treated on clinical grounds without histology.
1.2 Therapy involving either or both of these drugs is not in general recommended for patients who are continuing intravenous drug users. Only where the prescribing clinician can be reliably assured that reinfection, compliance and drug interactions pose no problems should patients in this group be considered for combination therapy. Former intravenous drug users including those on oral maintenance therapy need not be excluded from therapy.
1.3 Therapy involving either or both of these drugs is not in general recommended for patients who are heavy users of alcohol, because of an increased risk of exacerbation of liver damage.
1.4 There is insufficient evidence for making recommendations on combination therapy for patients less than 18 years of age. There is also insufficient evidence for making recommendations for using combination therapy after liver transplantation.
1.5 Interferon alpha monotherapy should be considered only when ribavirin is contra-indicated or not tolerated. The recently licensed pegylated interferon monotherapy has not been considered in this guidance.
1.6 These recommendations are consistent with the European Association of the Study of the Liver (EASL) guidelines (see Appendix C) with the exception that (see para. 1.1.1), those who relapse after initially successful treatment by monotherapy are recommended for 6 months of combination therapy without the necessity of a viral load test after three months.