BACKGROUND: Results of treatments for chronic hepatitis C virus are only estimated and disclosed from pivotal trials. AIM: To report the 'true life' results of pegylated interferon and ribavirin in treatment-naive patients. METHODS: A prospective, multicenter observatory in 22 general hospitals. RESULTS: 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 alpha 2b in 340 patients and interferon alpha 2a 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. CONCLUSION: In true life, patients are older and more severe, and SVR is about 10% lower than in pivotal trials.
BACKGROUND: Results of treatments for chronic hepatitis C virus are only estimated and disclosed from pivotal trials. AIM: To report the 'true life' results of pegylated interferon and ribavirin in treatment-naive patients. METHODS: A prospective, multicenter observatory in 22 general hospitals. RESULTS: 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 alpha 2b in 340 patients and interferon alpha 2a 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. CONCLUSION: In true life, patients are older and more severe, and SVR is about 10% lower than in pivotal trials.
Authors: N Deborah Friedman; Joanne H Green; Hanna M Weber; Shiny Stephen; Stephen E Lane; Alvin Y Ting; Jonathan P Watson Journal: J Clin Exp Hepatol Date: 2014-07-25
Authors: Hyun Seok Lee; Young Oh Kweon; Won Young Tak; Soo Young Park; Eun Jung Kang; Yu Lim Lee; Hae Min Yang; Hyun Woo Park Journal: Clin Mol Hepatol Date: 2013-06-27