Results of treatments for chronic hepatitis C virus are only estimated and disclosed from pivotal trials.
To report the ‘true life’ results of pegylated interferon and ribavirin in treatment-naive patients.
A prospective, multicenter observatory in 22 general hospitals.
Five-hundred and one patients were included, with 309 men (62%), aged 46±11 years, weighting 70±13 kg, infected with the following hepatitis C virus genotypes: 1 (50%), 2 (12%), 3 (28%), 4 (7.5%), 5 (0.6%). Liver biopsy, available in 436 patients showed stage F3 fibrosis in 24% and F4 in 13%. Two-hundred and seven patients had a comorbid condition. Treatment consisted of interferon α2b in 340 patients and interferon α2a in 161 patients. Dose reductions were necessary in 145 patients (29%). Treatment was prematurely interrupted in 145 patients (29%) owing to lack of efficacy (n=72) or side-effects (n=73). Sustained virological response (SVR) rates were 50% for all patients, and 37.1, 70.5, and 71% for patients with genotype 1, 2 and 3, respectively. At multivariate analysis, age, genotype, and fibrosis severity were the only independent factors of SVR.
In true life, patients are older and more severe, and SVR is about 10% lower than in pivotal trials.