Outcome, tolerability and compliance of compassionate use interferon and ribavirin for hepatitis C infection in a shared care hospital clinic.

ABSTRACT

BACKGROUND AND AIMS: To determine response rate, side-effects and compliance in patients with chronic hepatitis C virus (HCV) infection following treatment with interferon-alpha-2b and ribavirin in a 'shared care' hospital clinic. METHODS: Data were collected prospectively on 81 patients treated with combination therapy for chronic HCV infection between 1999 and 2001. All had biochemical and virological evidence of active infection. All patients had undergone liver biopsy except haemophiliac patients. Patients infected with genotype 1 were treated for 12 months. Patients infected with genotypes 2 and 3 were treated for 6 months. Patient care was shared with the referring general practitioner. Intention to treat, end of treatment and sustained virological response (SVR) rates, side-effects and compliance were assessed. RESULTS: Eighty-one patients with chronic HCV infection were treated with combination therapy. The majority of HCV patients were genotype 1 (n = 46; 57%). There were 12 patients (15%) with cirrhosis. SVR rates were (i) 24% for genotype 1, (ii) 58% for genotype 3 and (iii) 75% for genotype 2. SVR was achieved in three (23%) cirrhotic patients. Compliance with the treatment regimen was 98%. Seven per cent of patients were withdrawn from therapy prematurely because of side-effects. CONCLUSIONS: These 'shared care' clinic results compare well with controlled clinical trials using combination therapy for chronic HCV infection. Outcomes were poorer in genotype 1 patients and in patients with cirrhosis. Compliance with therapy was excellent because of the 'Shared Care Programme' with participation of general practitioners, psychiatrists and hepatitis C nurse practitioners in the management protocol.