Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients: A Prospective, Double-Blind, Randomized Controlled Study

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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289 Scopus citations

Abstract

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 < 0.001). 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 (P < 0.001). 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. Conclusions: Epoetin alfa maintained RBV dose and improved QOL and Hb in anemic HCV-infected patients receiving combination therapy.

Original languageEnglish (US)
Pages (from-to)1302-1311
Number of pages10
JournalGastroenterology
Volume126
Issue number5
DOIs
StatePublished - May 2004

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Afdhal, N. H., Dieterich, D. T., Pockros, P. J., Schiff, E. R., Shiffman, M. L., Sulkowski, M. S., Wright, T., Younossi, Z., Goon, B. L., Tang, K. L., & Bowers, P. J. (2004). Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients: A Prospective, Double-Blind, Randomized Controlled Study. Gastroenterology, 126(5), 1302-1311. https://doi.org/10.1053/j.gastro.2004.01.027