Journal article
Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy
Gastroenterology (New York, N.Y. 1943), Vol.136(5), pp.1618-1628.e2
2009
DOI: 10.1053/j.gastro.2009.01.039
PMID: 19208349
Abstract
Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy.
This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 μg/kg/wk) plus weight-based ribavirin (800–1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request.
Overall, 22% of the patients attained SVR (56% with undetectable HCV-RNA and 12% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38%) than nonresponders (14%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25%) than peginterferon alfa-ribavirin (17%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4;
P < .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7;
P < .0001), and baseline viral load (≤600,000 vs >600,000 IU/mL; OR, 1.4;
P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups.
Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.
Details
- Title: Subtitle
- Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy
- Creators
- Warren Schmidt - University of Iowa Hospitals and Clinics, Iowa City, IowaThierry Poynard - Service d'hepatologie, Université Pierre et Marie Curie Liver Center, Hôpital La Pitié Salpêtrière, Paris, FranceMassimo Colombo - First Division of Gastroenterology, Fondazione IRCCS Maggiore Hospital, University of Milan, Milan, ItalyEugene Schiff - University of Miami School of Medicine, Miami, FloridaRuben Terg - Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo, Capital Federal, ArgentinaSteven Flamm - Northwestern University, Chicago, IllinoisRicardo Moreno-Otero - Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas (Instituto de Salud Carlos III), Madrid, SpainFlair Carrilho - Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, BrazilThomas Berg - Charité, Campus Virchow Klinikum, Universitätsmedizin Berlin, GermanyThomas McGarrity - Milton S. Hershey Medical Center, Hershey, PennsylvaniaE. Jenny Heathcote - University Health Network, Toronto, ON, CanadaFernando Gonçales - Department of Medical Clinical, Faculty of Medical Sciences, University of Campinas, Campinas, BrazilMoises Diago - Hospital General Universitario de Valencia, Valencia, SpainAntonio Craxi - GI and Liver Unit, DIBIMIS, University of Palermo, Palermo, ItalyMarcelo Silva - Hospital Universitario Austral, Pilar, ArgentinaPierre Bedossa - Anatomie Pathologique, Hôpital Beaujon, Clichy, FrancePabak Mukhopadhyay - Schering–Plough Research Institute, Kenilworth, New JerseyLouis Griffel - Schering–Plough Research Institute, Kenilworth, New JerseyMargaret Burroughs - Schering–Plough Research Institute, Kenilworth, New JerseyClifford Brass - Schering–Plough Research Institute, Kenilworth, New JerseyJanice Albrecht - Schering–Plough Research Institute, Kenilworth, New JerseyThe Epic Study Group
- Resource Type
- Journal article
- Publication Details
- Gastroenterology (New York, N.Y. 1943), Vol.136(5), pp.1618-1628.e2
- DOI
- 10.1053/j.gastro.2009.01.039
- PMID
- 19208349
- NLM abbreviation
- Gastroenterology
- ISSN
- 0016-5085
- eISSN
- 1528-0012
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 2009
- Academic Unit
- Gastroenterology and Hepatology; Internal Medicine
- Record Identifier
- 9984094719402771
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