title: Epoetin alfa improves quality of life in anemic HCV-infected patients receiving combination therapy.
abstract: Anemia and decreased health-related quality of life (HRQL) are common in patients receiving combination therapy of interferon alfa (IFN) and ribavirin (RBV) for chronic hepatitis C virus (HCV) infection. In a randomized, prospective study evaluating the effectiveness of epoetin alfa in maintaining RBV dose, alleviating anemia, and improving HRQL in anemic (Hb < or = 12 g/dL) HCV-infected patients receiving combination therapy, patients receiving epoetin alfa had significant improvements in HRQL compared with placebo. In this study, 185 patients were randomized to 40,000 units of epoetin alfa subcutaneously weekly or placebo for an 8-week double-blind phase (DBP), followed by an 8-week open-label phase during which all patients received epoetin alfa. To further assess the impact of epoetin alfa on HRQL, post hoc analyses were conducted in the same patient population to compare the HRQL of these patients at randomization with norms of other populations, and to determine the critical relationship between hemoglobin (Hb) levels and HRQL. Mean HRQL scores of anemic HCV-infected patients receiving combination therapy at randomization were significantly lower than those of both the general population and patients who had other chronic conditions. Patients receiving epoetin alfa who had the greatest Hb increases from randomization to the end of the DBP also had the largest improvements in HRQL. Hb improvement was an independent predictor of HRQL improvement in these patients. In conclusion, epoetin alfa provided clinically significant HRQL improvement in HCV-infected patients receiving IFN/RBV therapy.
authors.affiliation: Scripps Clinic, La Jolla, CA 92037, USA. ppockros@scrippsclinic.com
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Schiff
authors.forename: Mark S
authors.initials: MS
authors.lastname: Sulkowski
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.forename: Douglas T
authors.initials: DT
authors.lastname: Dieterich
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Wright
authors.forename: Samir H
authors.initials: SH
authors.lastname: Mody
authors.forename: K Linda
authors.initials: KL
authors.lastname: Tang
authors.forename: Betty L
authors.initials: BL
authors.lastname: Goon
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Bowers
authors.forename: Gerhard
authors.initials: G
authors.lastname: Leitz
authors.forename: Nezam H
authors.initials: NH
authors.lastname: Afdhal
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000821:virology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D006397:Hematinics; D006454:Hemoglobins; D016898:Interferon-alpha; D011994:Recombinant Proteins; D004921:Erythropoietin; D012254:Ribavirin; D000068817:Epoetin Alfa