Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study.
OBJECTIVE
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.
Afdhal
Nezam H
NH
Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. nafdhal@caregroup.harvard.edu
Dieterich
Douglas T
DT
Pockros
Paul J
PJ
Schiff
Eugene R
ER
Shiffman
Mitchell L
ML
Sulkowski
Mark S
MS
Wright
Teresa
T
Younossi
Zobair
Z
Goon
Betty L
BL
Tang
K Linda
KL
Bowers
Peter J
PJ
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006526:Hepatitis C / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008099:Liver / Q000503:physiopathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D019562:Viral Load
D000998:Antiviral Agents; D006397:Hematinics; D006454:Hemoglobins; D016898:Interferon-alpha; D011994:Recombinant Proteins; D004921:Erythropoietin; D012254:Ribavirin; D000068817:Epoetin Alfa