Dose comparison study of pegylated interferon-alpha-2b plus ribavirin in naïve Japanese patients with hepatitis C virus genotype 2: a randomized clinical trial.
OBJECTIVE
To compare the efficacy and safety of pegylated interferon (PEG-I) at 1 and 1.5 microg/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 microg/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-microg/kg PEG-I-RBV group (38.5%, 10/26) was lower than that of the 1.5-microg/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-microg/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-microg/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 microg/kg) as significant determinants of SVR.


CONCLUSIONS
The dose of PEG-I to be used at the start of therapy should be 1.5-microg/kg BW in naïve Japanese patients infected with hepatitis C virus genotype 2.
Kawaoka
Tomokazu
T
Department of Medicine and Molecular Science, Hiroshima University, Minami-ku, Hiroshima, Japan.
Kawakami
Yoshiiku
Y
Tsuji
Keiji
K
Ito
Hiroyuki
H
Kitamoto
Mikiya
M
Aimitsu
Shiomi
S
Kawakami
Hiroiku
H
Jeong
Soo Cheol
SC
Imamura
Michio
M
Aikata
Hiroshi
H
Takahashi
Shoichi
S
Chayama
Kazuaki
K
D000328:Adult; D000367:Age Factors; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b