NDLI: Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Bacon, Bruce R. Shiffman, Mitchell L. Mendes, Flavia Ghalib, Reem Hassanein, Tarek Morelli, Giuseppe Joshi, Shobha Rothstein, Kenneth Kwo, Paul Gitlin, Norman
Description	Country affiliation: United States Author Affiliation: Bacon BR ( Saint Louis University Liver Center, Saint Louis University School of Medicine, St. Louis, MO 63110-0250, USA. baconbr@slu.edu)
Abstract	UNLABELLED: Up to 50% of patients with chronic hepatitis C fail to respond to initial therapy with pegylated interferon (PEG-IFN) and ribavirin (RBV). With unsuccessful viral eradication, these patients remain at risk for developing progression of their liver disease. Retreatment with PEG-IFN/RBV yields sustained virologic response (SVR) rates that are under 10%. A wholly synthetic interferon, interferon alfacon-1 or consensus interferon (CIFN) given with RBV, was evaluated in patients who failed initial PEG-IFN/RBV therapy. The intent-to-treat analysis included 487 patients; 245 received CIFN 9 microg/day and RBV, and 242 received CIFN 15 microg/day and RBV. Within this group of patients, 59.3% had documented advanced fibrosis at baseline liver biopsy (stage F3 or F4). SVR rates were 6.9% (17/245 patients) in the 9 microg group and 10.7% (26/242) in the 15 microg group. In the intent-to-treat analysis, SVR rates were higher among patients with a >2-log(10) decrease in hepatitis C virus RNA during prior PEG-IFN/RBV therapy: 11% (4/38) in the 9 mug group and 23% (7/31) in the 15 microg group. Among patients with lower baseline fibrosis scores (F0-F3), SVR rates were 7.8% (15/192) in the 9 microg group and 13.1% (23/175) in the 15 microg group. In this same group of patients (F0-F3), if a >2-log(10) decrease in hepatitis C virus RNA with previous PEG-IFN/RBV treatment was achieved, SVR rates improved to 10.7% and 31.6% in the 9 microg and 15 microg groups, respectively. CIFN/RBV combination retreatment was safe and well tolerated. CONCLUSION: Retreatment of PEG-IFN and RBV nonresponders with CIFN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores.
File Format	HTM / HTML
ISSN	02709139
Issue Number	6
Volume Number	49
e-ISSN	15273350
Journal	Hepatology
Language	English
Publisher	Wiley
Publisher Date	2009-06-01
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Discipline Hepatology Antiviral Agents Administration & Dosage Hepatitis C, Chronic Drug Therapy Interferon Type I Interferon-alpha Therapeutic Use Polyethylene Glycols Ribavirin Drug Administration Schedule Drug Therapy, Combination Female Humans Male Middle Aged Recombinant Proteins Retreatment Treatment Failure Clinical Trial, Phase Iii Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Hepatology

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