Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients: A Prospective, Double-Blind, Randomized Controlled Study

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

Research output: Contribution to journalArticle

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Abstract

Background & Aims: Combination therapy with Interferon α (IFN-α) and ribavirin (RBV) or pegylated IFN-α (PEG-IFN-α)/ 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 ≤ 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.

Original languageEnglish
Pages (from-to)1302-1311
Number of pages10
JournalGastroenterology
Volume126
Issue number5
DOIs
StatePublished - May 1 2004

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Epoetin Alfa
Ribavirin
Hepacivirus
Placebos
Hemoglobins
Quality of Life
Interferons
Anemia
Controlled Clinical Trials
Chronic Hepatitis C
Virus Diseases
Nausea

ASJC Scopus subject areas

  • Gastroenterology

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Afdhal, N. H., Dieterich, D. T., Pockros, P. J., Schiff, E. R., Shiffman, M. L., Sulkowski, M. S., ... Bowers, P. J. (2004). Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients: A Prospective, Double-Blind, Randomized Controlled Study. Gastroenterology, 126(5), 1302-1311. https://doi.org/10.1053/j.gastro.2004.01.027

Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients : A Prospective, Double-Blind, Randomized Controlled Study. / Afdhal, Nezam H.; Dieterich, Douglas T.; Pockros, Paul J.; Schiff, Eugene R; Shiffman, Mitchell L.; Sulkowski, Mark S.; Wright, Teresa; Younossi, Zobair; Goon, Betty L.; Tang, K. Linda; Bowers, Peter J.

In: Gastroenterology, Vol. 126, No. 5, 01.05.2004, p. 1302-1311.

Research output: Contribution to journalArticle

Afdhal, NH, Dieterich, DT, Pockros, PJ, Schiff, ER, Shiffman, ML, Sulkowski, MS, Wright, T, Younossi, Z, Goon, BL, Tang, KL & Bowers, PJ 2004, 'Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients: A Prospective, Double-Blind, Randomized Controlled Study', Gastroenterology, vol. 126, no. 5, pp. 1302-1311. https://doi.org/10.1053/j.gastro.2004.01.027
Afdhal, Nezam H. ; Dieterich, Douglas T. ; Pockros, Paul J. ; Schiff, Eugene R ; Shiffman, Mitchell L. ; Sulkowski, Mark S. ; Wright, Teresa ; Younossi, Zobair ; Goon, Betty L. ; Tang, K. Linda ; Bowers, Peter J. / Epoetin Alfa Maintains Ribavirin Dose in HCV-Infected Patients : A Prospective, Double-Blind, Randomized Controlled Study. In: Gastroenterology. 2004 ; Vol. 126, No. 5. pp. 1302-1311.
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T2 - A Prospective, Double-Blind, Randomized Controlled Study

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AU - Dieterich, Douglas T.

AU - Pockros, Paul J.

AU - Schiff, Eugene R

AU - Shiffman, Mitchell L.

AU - Sulkowski, Mark S.

AU - Wright, Teresa

AU - Younossi, Zobair

AU - Goon, Betty L.

AU - Tang, K. Linda

AU - Bowers, Peter J.

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N2 - Background & Aims: Combination therapy with Interferon α (IFN-α) and ribavirin (RBV) or pegylated IFN-α (PEG-IFN-α)/ 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 ≤ 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.

AB - Background & Aims: Combination therapy with Interferon α (IFN-α) and ribavirin (RBV) or pegylated IFN-α (PEG-IFN-α)/ 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 ≤ 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.

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