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PMID: 15565613 Published · ppublish English Clinical Trial Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Epoetin alfa improves quality of life in anemic HCV-infected patients receiving combination therapy.

Hepatology (Baltimore, Md.) ·Vol. 40 ·No. 6 ·2004-12-00 ·Pages 1450-8

Pockros PJ, Shiffman ML, Schiff ER, Sulkowski MS, Younossi Z, Dieterich DT, Wright TL, Mody SH, Tang KL, Goon BL, Bowers PJ, Leitz G, Afdhal NH, PROACTIVE Study Group

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.

MeSH Terms
Adult Aged Anemia/drug therapy,etiology Antiviral Agents/administration & dosage,adverse effects Drug Therapy, Combination Epoetin Alfa Erythropoietin/administration & dosage,adverse effects Female Hematinics/administration & dosage,adverse effects Hemoglobins Hepatitis C, Chronic/complications,drug therapy Humans Interferon-alpha/administration & dosage,adverse effects Liver Cirrhosis/drug therapy,virology Male Middle Aged Quality of Life Recombinant Proteins Ribavirin/administration & dosage,adverse effects
Chemicals
Antiviral Agents Hematinics Hemoglobins Interferon-alpha Recombinant Proteins Erythropoietin Ribavirin Epoetin Alfa
Authors & Affiliations
14 authors, click to expand affiliations / ORCID
Pockros Paul J
Scripps Clinic, La Jolla, CA 92037, USA. ppockros@scrippsclinic.com
Shiffman Mitchell L
Schiff Eugene R
Sulkowski Mark S
Younossi Zobair
Dieterich Douglas T
Wright Teresa L
Mody Samir H
Tang K Linda
Goon Betty L
Bowers Peter J
Leitz Gerhard
Afdhal Nezam H
PROACTIVE Study Group
Article Info
Journal
Hepatology (Baltimore, Md.)
Abbr.
Hepatology
ISSN
0270-9139
Published
2004-12-00
Pages
1450-8
Language
English
Region
United States
NLM ID
8302946
Subset
IM
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