Etanercept as an adjuvant to interferon and ribavirin in treatment-naive patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study.
OBJECTIVE
Current therapies for patients with chronic hepatitis C virus (HCV) do not achieve sustained viral clearance in most patients, and are associated with severe toxic effects. Our aim was to investigate the efficacy and safety of etanercept as adjuvant to interferon and ribavirin in treatment-naive patients with HCV.


METHODS
Double-blind, randomized, placebo controlled trial. Fifty patients with chronic HCV were randomly assigned to receive interferon alfa-2b and ribavirin with either etanercept or placebo for 24 weeks. The main outcome measure was the absence of HCV RNA at 24 weeks, the on treatment response at the end of the etanercept randomization period.


RESULTS
At 24 weeks, HCV RNA was absent in 63% (12/19) etanercept patients compared to 32% (8/25) placebo patients (P=0.04). In addition, patients receiving etanercept had lower frequency of most adverse events categories compared to placebo.


CONCLUSIONS
Etanercept given for 24 weeks as adjuvant therapy to interferon and ribavirin significantly improved virologic response at the end of the etanercept randomization period among patients with HCV, and was associated with decreased incidence of most adverse effects associated with interferon and ribavirin.
Zein
Nizar N
NN
Division of Gastroenterology and Hepatology and Internal Medicine, Mayo Clinic, Rochester, MN, USA. zeinn@ccf.org
D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use* / Q000633:toxicity; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use* / Q000633:toxicity; D008297:Male; D010919:Placebos; D012367:RNA, Viral / Q000097:blood; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use / Q000633:toxicity; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use* / Q000633:toxicity; D016896:Treatment Outcome; D019562:Viral Load
D007074:Immunoglobulin G; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D010919:Placebos; D012367:RNA, Viral; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D011994:Recombinant Proteins; D012254:Ribavirin; D000068800:Etanercept