A study of low dose peginterferon alpha-2b with ribavirin for the initial treatment of chronic hepatitis C.
OBJECTIVE
A prospective randomized trial was undertaken to test the efficacy of low and standard doses of pegylated interferon alpha-2b in combination with ribavirin for the initial treatment of chronic hepatitis C. By nature of its design the study also provided data on response to therapy over a spectrum of doses of both pegylated interferon alpha-2b and ribavirin calculated on a body weight basis.


METHODS
Fifty micrograms of pegylated interferon alpha-2b or 100 microg for patients weighing<75 kg or 150 microg for patients>or=75 kg were administered weekly with 1000 mg ribavirin daily for 48 wk if serum hepatitis C virus (HCV) RNA was undetectable after the first 24 wk of therapy.


RESULTS
Overall sustained viral response (SVR) was 45% for standard dose and 33% for low dose, p=0.02. For genotypes 2 and 3 SVR was 65% for standard dose, and 56% for low dose, p=0.51. For genotype 1 SVR was 38% for standard dose, and 24% for low dose, p=0.03. For genotype 1 patients whose doses exceeded the 1-2-5 threshold, that is >or=1.25 microg/kg body weight pegylated interferon alpha-2b weekly and >or=12.5 mg/kg body weight ribavirin daily, SVR was 51%.


CONCLUSIONS
The results of this study underscore the importance of adequate dosing of ribavirin as well as pegylated interferons in achieving an SVR when treating genotype 1 chronic hepatitis C patients with combination therapy.
Krawitt
Edward L
EL
Department of Medicine, University of Vermont, Burlington, Vermont, and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Gordon
Stuart R
SR
Grace
Norman D
ND
Ashikaga
Takamaru
T
Ray
Mary Ann
MA
Palmer
Melissa
M
Yarze
Joseph C
JC
Moskowitz
Sam
S
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009511:New England; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b