7 Implementation and audit

7 Implementation and audit

7.1 Treatment for CHC should be provided by physicians who are expert and experienced in the diagnosis and management of viral hepatitis, and a clinical nurse specialist for hepatitis with access to supportive services including an accredited virology laboratory, a liver pathologist and a radiology department, consistent with Department of Health (2002) 'Hepatitis C Strategy for England'. London: Department of Health.

7.2 All clinicians who care for people with CHC should review their current practice and policies to take account of the guidance set out in Section 1.

7.3 Local guidelines, protocols or care pathways that refer to the care of people with CHC should incorporate the guidance.

7.4 To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix C.

7.4.1 An individual with moderate to severe CHC who is aged 18 years or older (except a woman who is pregnant or breastfeeding) is treated with peginterferon alfa and ribavirin combination therapy within licensed indications if he or she meets any one of the following.

7.4.1.1 The individual has not previously been treated with interferon alfa or peginterferon alfa.

7.4.1.2 The individual has been treated previously or is currently being treated with interferon alfa as monotherapy or combination therapy.

7.4.1.3 The individual has been previously treated with peginterferon alfa monotherapy only, and either responded at the end of treatment but subsequently relapsed, or was not responding at the end of treatment.

7.4.2 For an individual who meets the criteria in Section 7.4.1, treatment is carried out as follows.

7.4.2.1 If the individual is infected with HCV of genotypes 2 and/or 3, treatment is for 24 weeks.

7.4.2.2 If the individual is infected with HCV of genotypes 1, 4, 5 or 6, (or infected with more than one genotype including at least one of genotypes 1, 4, 5 or 6), initial treatment is for 12 weeks. If the viral load has been reduced to less than 1% of its level at the start of treatment, treatment is continued for 48 weeks. If the viral load exceeds 1% of its level at the start of treatment, treatment is discontinued.

7.4.3 An individual with moderate to severe CHC who is aged 18 years or older (except a woman who is pregnant or breastfeeding) for whom ribavirin is contraindicated or is not tolerated is treated with peginterferon alfa monotherapy. The individual is tested for viral load at 12 weeks of treatment. If the viral load has reduced to less than 1% of its level at the start of treatment, treatment continues for a total of 48 weeks. If the viral load has not fallen to less than 1% of its level at the start of treatment, treatment is stopped at 12 weeks.

7.4.4 Before treatment is given, an individual has a liver biopsy to determine if the individual has moderate or severe CHC, except if the individual meets one of the following.

7.4.4.1 Liver biopsy poses a substantial risk to the individual.

7.4.4.2 The individual has symptoms of extra-hepatic HCV infection sufficient to impair quality of life.