Individualized treatment with combination of Peg-interferon alpha 2b and ribavirin in patients infected with HCV genotype 3

Background & Aims The benefit of individualizing treatment for patients with genotype 3 HCV infection on the basis of viral clearance at week 4 (wk4-R) has not been firmly established Methods Four hundred and fourteen patients received Peginterferon alpha-2b plus 1000-1200 mg of ribavirin daily according with body weight > or <75 kg Patients were randomized to standard 24 weeks (Std24) or to a 12 or 36 weeks variable treatment duration (Var12/36) In the variable treatment arm patients with or without wk4-R were allocated to either 12 or 36 weeks duration Results At treatment week 4 HCV RNA was undetectable in 262 patients (63 3%) 136 in the Std24 and 126 in the Van 2/36 group (p = 0 41) In patients with wk4-R end-of-treatment (EOT) responses were 80 4% (Cl 85 4-95 3) and 97 6% (Cl 949-99 9) in the two arms respectively (p = 0 019) In patients without wk4-R, corresponding rates were 61 9% (50 6-73 2) and 75 3% (CI 65 9-846) (p = 0 08) SVR was attained in 302 patients 71 4% (Cl 65 3-77 6) in the St24 group and 743% (CI 58 4-80 3) in the variable 12/36 arm Among patients with wk4-R SVR was 81 6% (Cl 75 1-88 1) and 82 5% (75 9-89 1) respectively In patients without wk4-R SVR amounted to 52 1% (Cl 40 4-63 7) and 61 7 (CI 51 1-72 3) in the two arms (p = 0 25) Conclusions HCV genotype 3 patients with week4-R may be treated safely with 12 weeks of therapy provided that sufficiently high doses of ribavirin are administered For patients still viremic at treatment week 4 SVR rates were numerically higher after 36 weeks of treatment than after the currently recommended 24 weeks (C) 2010 European Association for the Study of the Liver Published by Elsevier B V All rights reserved