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Dose comparison study of pegylated interferon‐α‐2b plus ribavirin in naïve Japanese patients with hepatitis C virus genotype 2: A randomized clinical trial
Author(s) -
Kawaoka Tomokazu,
Kawakami Yoshiiku,
Tsuji Keiji,
Ito Hiroyuki,
Kitamoto Mikiya,
Aimitsu Shiomi,
Kawakami Hiroiku,
Jeong Soo Cheol,
Imamura Michio,
Aikata Hiroshi,
Takahashi Shoichi,
Chayama Kazuaki
Publication year - 2009
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2008.05650.x
Subject(s) - medicine , ribavirin , pegylated interferon , gastroenterology , neutropenia , peg ratio , randomized controlled trial , hepatitis c virus , immunology , chemotherapy , virus , economics , finance
Background and Aim: To compare the efficacy and safety of pegylated interferon (PEG‐I) at 1 and 1.5 µg/kg, and in combination with ribavirin (RBV) for 24 weeks in naïve Japanese patients infected with hepatitis C virus genotype 2. Methods: The present study was an open‐label, randomized trial of 55 patients receiving PEG‐I (1 or 1.5 µg/kg body weight [BW], subcutaneously, once a week) and RBV for 24 weeks. The patients were followed up for 24 weeks without treatment. Results: The intention‐to‐treat analyses showed that the proportion of patients with a sustained virological response (SVR) in the 1‐µg/kg PEG‐I–RBV group (38.5%, 10/26) was lower than that of the 1.5‐µg/kg PEG‐I–RBV group (74.1%, 20/27; P = 0.013). The PEG‐I dose was reduced in two of the 26 patients of the 1‐µg/kg PEG‐I–RBV group (one because of thrombocytopenia at 2 weeks, and one because of generalized fatigue at 20 weeks), and four of the 27 patients of the 1.5‐µg/kg PEG‐I–RBV group (one because of neutropenia at 20 weeks, and three because of generalized fatigue at 1, 5, and 8 weeks). The multivariate analysis identified age (< 60 years) and dose of PEG‐I (1.5 µg/kg) as significant determinants of SVR. Conclusion: The dose of PEG‐I to be used at the start of therapy should be 1.5‐µg/kg BW in naïve Japanese patients infected with hepatitis C virus genotype 2.