Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study.

Abstract

BACKGROUND & AIMS:

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.

METHODS:

HCV-infected patients (n = 185) on combination therapy who developed anemia (Hb < or = 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.

• Authors: 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, Proactive Study Group
• Journal: Gastroenterology (Gastroenterology) Vol. 126 Issue 5 Pg. 1302-11 (May 2004) ISSN: 0016-5085 [Print] United States
• PMID: 15131791 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Hematinics
• Hemoglobins
• Interferon-alpha
• Recombinant Proteins
• Erythropoietin
• Ribavirin
• Epoetin Alfa

Topics

• Adult
• Aged
• Anemia (chemically induced, drug therapy)
• Antiviral Agents (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Synergism
• Drug Therapy, Combination
• Epoetin Alfa
• Erythropoietin (adverse effects, therapeutic use)
• Female
• Hematinics (adverse effects, therapeutic use)
• Hemoglobins (metabolism)
• Hepatitis C (drug therapy, physiopathology)
• Humans
• Interferon-alpha (therapeutic use)
• Liver (physiopathology)
• Liver Function Tests
• Male
• Middle Aged
• Quality of Life
• Recombinant Proteins
• Ribavirin (administration & dosage, adverse effects)
• Viral Load