Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study1 1The other PROACTIVE Study Group investigators included the following: Vijayan Balan, M.D., Mayo Clinic Scottsdale, Scottsdale, Arizona; Norbert Bräu, M.D., Bronx VA Medical Center, Bronx, New York; Robert Brown, M.D., M.P.H., NY Presbyterian Medical Center, New York, New York; William Carey, M.D., Cleveland Clinic Foundation, Cleveland, Ohio; Andrea Duchini, M.D., Baylor College of Medicine, Houston, Texas; Greg Everson, M.D., University of Colorado Health Sciences Center, Denver, Colorado; Michael Fried, M.D., University of North Carolina, Chapel Hill, North Carolina; Robert Gish, M.D., California Pacific Medical Center, San Francisco, California; Ira Jacobson, M.D., Weill Medical College of Cornell University, New York, New York; John W. King, LSU Health Sciences Center, Shreveport, LA; Raymond Koff, M.D., University of Massachusetts Memorial Health Care, Worcester, Massachusetts; William Lee, M.D., University of Texas Southwestern Medical Center, Dallas, Texas; Mark A. Levstik, M.D., The University of Tennessee, Memphis, Tennessee; John G. McHutchison, M.D., Scripps Clinic, La Jolla, California; Marion Peters, M.D., University of California San Francisco, San Francisco, California; Kenneth Sherman, M.D., Ph.D., University of Cincinnati College of Medicine, Cincinnati, Ohio; Coleman Smith, M.D., Minnesota Clinical Research Center, St. Paul, MN; Ronald Wasserman, M.D., Hepatitis Resource Center, Walnut Creek, California
| Autor: | Mitchell L. Shiffman, Mark S. Sulkowski, Zobair M. Younossi, Paul J. Pockros, Eugene R. Schiff, Peter J. Bowers, Betty L. Goon, Douglas T. Dieterich, Nezam H. Afdhal, K. Linda Tang, Teresa L. Wright |
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| Rok vydání: | 2004 |
| Předmět: |
medicine.medical_specialty
Hepatology Combination therapy business.industry Anemia Ribavirin Gastroenterology virus diseases Epoetin alfa Placebo medicine.disease digestive system diseases law.invention Discontinuation Clinical trial chemistry.chemical_compound chemistry Randomized controlled trial law Internal medicine Immunology Medicine business medicine.drug |
| Zdroj: | Gastroenterology. 126:1302-1311 |
| ISSN: | 0016-5085 |
| DOI: | 10.1053/j.gastro.2004.01.027 |
| Popis: | Background & Aims: Combination therapy with interferon α (IFN-α) and ribavirin (RBV) or pegylated IFN-α (PEG-IFN-α)/RBV for chronic hepatitis C virus (HCV) infection often causes anemia, prompting RBV dose reduction/discontinuation. This study assessed whether epoetin alfa could maintain RBV dose, improve quality of life (QOL), and increase hemoglobin (Hb) in anemic HCV-infected patients. Methods: HCV-infected patients (n = 185) on combination therapy who developed anemia (Hb ≤ 12 g/dL) were randomized into a U. S. multicenter, placebo-controlled, clinical trial of epoetin alfa, 40,000 U subcutaneously, once weekly vs. matching placebo. The study design used an 8-week, double-blind phase (DBP) followed by an 8-week, open-label phase (OLP), in which placebo patients were crossed over to epoetin alfa. Results: At the end of the DBP, RBV doses were maintained in 88% of patients receiving epoetin alfa vs. 60% of patients receiving placebo ( P P |
| Databáze: | OpenAIRE |
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