A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C

Karen L Lindsay; Christian Trepo; Tobias Heintges; Mitchell L Shiffman; Stuart C Gordon; John C Hoefs; Eugene R Schiff; Zachary D Goodman; Mark Laughlin; Ruji Yao; Janice K Albrecht

doi:10.1053/jhep.2001.26371

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A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C

Journal article

Peer reviewed

A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C

Karen L Lindsay, Christian Trepo, Tobias Heintges, Mitchell L Shiffman, Stuart C Gordon, John C Hoefs, Eugene R Schiff, Zachary D Goodman, Mark Laughlin, Ruji Yao, …

Hepatology (Baltimore, Md.), Vol.34(2), pp.395-403

2001-08

DOI: https://doi.org/10.1053/jhep.2001.26371

PMID: 11481625

Abstract

This international, randomized, active-controlled, parallel-group, double-blind dose-finding study compared peginterferon alfa-2b (PegIntron™) to interferon alfa-2b for the initial treatment of compensated chronic hepatitis C. We randomly assigned 1,219 subjects to receive either the standard three-times-weekly (TIW) interferon alfa-2b dose (3 MIU) or the once-weekly (QW) peginterferon alfa-2b (0.5, 1.0, or 1.5 μg/kg). Subjects were treated for 48 weeks and then followed for an additional 24 weeks. All 3 peginterferon alfa-2b doses significantly (P ≤ .042) improved virologic response rates (loss of detectable serum HCV RNA) after treatment and after follow-up, as compared with interferon alfa-2b. Unlike the end-of-treatment virologic response, the sustained virologic response rate was not dose-related above 1.0 μg/kg peginterferon alfa-2b because of a higher relapse rate among patients treated with 1.5 μg/kg peginterferon alfa-2b, particularly among patients infected with genotype 1. All 3 peginterferon alfa-2b doses decreased liver inflammation to a greater extent than did interferon alfa-2b, particularly in subjects with sustained responses. No new adverse events were reported, and the majority of adverse events and changes in laboratory values were mild or moderate. In conclusion, peginterferon alfa-2b maintained (0.5 μg/kg) or surpassed (1.0, 1.5 μg/kg) the clinical efficacy of interferon alfa-2b while preserving its safety profile. The higher rate of virologic response during treatment with 1.5 μg/kg peginterferon alfa-2b in patients infected with genotype 1 and high viral levels warrants further evaluation. (HEPATOLOGY 2001;34:395-403.)

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.125 Hepatitis; 1.125.83 HCV
Web Of Science research areas: Gastroenterology & Hepatology
ESI research areas: Clinical Medicine

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Title: A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C
Creators: Karen L Lindsay - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Christian Trepo - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Tobias Heintges - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Mitchell L Shiffman - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Stuart C Gordon - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
John C Hoefs - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Eugene R Schiff - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Zachary D Goodman - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Mark Laughlin - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Ruji Yao - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Janice K Albrecht - From the 1University of Southern California, Los Angeles, CA; 2Hotel Dieu and Inserm v271, Lyon, France; 3Heinrich-Heine-University, Dusseldorf, Germany; 4Medical College of Virginia, Richmond, VA; 5William Beaumont Hospital, Royal Oak, MI; 6University of California-Irvine, Irvine, CA; 7University of Miami School of Medicine, Miami, FL; 8Armed Forces Institute of Pathology, Washington, DC; 9Schering Plough Research Institute, Kenilworth, NJ; 10Members and affiliations of the Hepatitis Interventional Therapy Group are listed in the Appendix
Publication Details: Hepatology (Baltimore, Md.), Vol.34(2), pp.395-403
Publisher: Elsevier Inc
Academic Unit: Leadership Department; Miller School of Medicine; UMMG Dept of Medicine - Hepatology
Language: English
Resource Type: Journal article
PMID: 11481625
Record Identifier: 991031576051802976