Article Text
Abstract
Introduction Combination therapy, with pegylated interferon and ribavarin, is the mainstay of treatment for chronic hepatitis C (CHC), and has been shown to be effective in achieving clearance of the virus in randomised controlled trials. We report efficacy of combination therapy in normal clinical practice, using a large cohort of CHC patients treated in a single tertiary referral centre in Leeds, UK.
Methods Data for all individuals receiving combination therapy for CHC were collected prospectively between February 2001 and May 2008. Patient age, gender, ethnicity, type of interferon used (α-2a or α-2b), route of acquisition, genotype, presence of cirrhosis, body mass index (BMI), alcohol use, and history of previous psychiatric illness were recorded prior to commencement of therapy. Data from individuals being re-treated for CHC were not analysed. We defined efficacious therapy as a sustained viral response (SVR) 6 months after end of treatment with an undetectable hepatitis C viral load by PCR. Individuals with no SVR data at 6 months after end of therapy were classed as treatment failures.
Results Between February 2001 and May 2008 there were 394 individuals with CHC who commenced combination therapy (257 (65%) male, 137 female, mean age 42 years (range 21–74)). Mean BMI at commencement of therapy was 26.6 (range 17.3–57.8). Genotypes were as follows: 139 (35%) genotype 1, 30 (8%) genotype 2, 206 (52%) genotype 3, 15 (4%) genotype 4, and one patient had genotype 5. A definite route of acquisition was determined in 280 (71%) individuals: intravenous drug use in 184 (47%) individuals, blood transfusion in 55 (14%), injection/needlestick injury in 20 (5%), sexual in 15 (4%), tattooing in 6 (1.5%), and in the remaining 114 this issue was unclear. 301 (76%) individuals were White Caucasian and 84 (21%) South Asian. There were 99 (25%) individuals with biopsy-proven cirrhosis, 104 (26%) consumed alcohol, and 75 (19%) had a history of psychiatric illness. The majority of patients (76%) received pegylated interferon α-2b. The overall SVR rate was 61% (240 of 394 treated), and SVRs by genotype were as follows: 44% (61/139) for genotype 1, 73% (22/30) for genotype 2, 73% (151/206) for genotype 3, 27% (4/15) for genotype 4, and 100% (1/1) for genotype 5.
Conclusion Data from this large cohort of patients with CHC treated with combination therapy demonstrate SVR rates comparable to those in the clinical trial literature, using strict criteria to define an SVR, emphasising that results from intervention studies can be extrapolated to patients encountered in usual clinical practice.