Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study
| Autor: | Nezam H, Afdhal, Douglas T, Dieterich, Paul J, Pockros, Eugene R, Schiff, Mitchell L, Shiffman, Mark S, Sulkowski, Teresa, Wright, Zobair, Younossi, Betty L, Goon, K Linda, Tang, Peter J, Bowers |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Dose-Response Relationship Drug Interferon-alpha Anemia Drug Synergism Middle Aged Viral Load Antiviral Agents Hepatitis C Recombinant Proteins Epoetin Alfa Hemoglobins Double-Blind Method Liver Liver Function Tests Ribavirin Hematinics Quality of Life Humans Drug Therapy Combination Female Erythropoietin Aged |
| Zdroj: | Gastroenterology. 126(5) |
| ISSN: | 0016-5085 |
| Popis: | Combination therapy with interferon alpha (IFN-alpha) and ribavirin (RBV) or pegylated IFN-alpha (PEG-IFN-alpha)/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.HCV-infected patients (n = 185) on combination therapy who developed anemia (Hbor = 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.At the end of the DBP, RBV doses were maintained in 88% of patients receiving epoetin alfa vs. 60% of patients receiving placebo (P0.001). Mean QOL scores at the end of the DBP improved significantly on all domains of the Linear Analog Scale Assessment (LASA) and on 7 of the 8 domains of the Short Form-36, version 2 (SF-36v2). Mean Hb increased by 2.2 +/- 1.3 g/dL (epoetin alfa) and by 0.1 +/- 1.0 g/dL (placebo) in the DBP (P0.001). Similar results were demonstrated in patients who switched from placebo to epoetin alfa in the OLP. Epoetin alfa was well tolerated; the most common adverse effects were headache and nausea.Epoetin alfa maintained RBV dose and improved QOL and Hb in anemic HCV-infected patients receiving combination therapy. |
| Databáze: | OpenAIRE |
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