title: Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study.
abstract: 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.
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. nafdhal@caregroup.harvard.edu
authors.forename: Nezam H
authors.initials: NH
authors.lastname: Afdhal
authors.forename: Douglas T
authors.initials: DT
authors.lastname: Dieterich
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Schiff
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Mark S
authors.initials: MS
authors.lastname: Sulkowski
authors.forename: Teresa
authors.initials: T
authors.lastname: Wright
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.forename: Betty L
authors.initials: BL
authors.lastname: Goon
authors.forename: K Linda
authors.initials: KL
authors.lastname: Tang
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Bowers
mesh_terms: 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
chemical_list: D000998:Antiviral Agents; D006397:Hematinics; D006454:Hemoglobins; D016898:Interferon-alpha; D011994:Recombinant Proteins; D004921:Erythropoietin; D012254:Ribavirin; D000068817:Epoetin Alfa