Once-Weekly Epoetin Alfa Improves Anemia and Facilitates Maintenance of Ribavirin Dosing in Hepatitis C Virus-Infected Patients Receiving Ribavirin Plus Interferon Alfa

Douglas T. Dieterich, Ronald Wasserman, Norbert Bräu, Tarek I. Hassanein, Edmund J. Bini, Peter J. Bowers, Mark Sulkowski

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: The aim of this study was to determine the efficacy of epoetin alfa in alleviating anemia and minimizing ribavirin (RBV) dose reductions in patients with chronic hepatitis C virus (HCV) infection receiving combination RBV/interferon alfa (IFN) therapy. METHODS: HCV-infected patients who had Hb levels of 12 g/dl or less during the first 24 wk of combination RBV/IFN therapy (n = 64) were randomized to treatment with epoetin alfa (40,000 units) s.c.q.w. or to standard of care (SOC) for anemia management (RBV dose reduction or discontinuation, transfusions). Primary and secondary efficacy endpoints were changes in Hb level and RBV dosage, respectively, from baseline to week 16 of epoetin alfa therapy. RESULTS: Based on intent-to-treat analysis, the mean changes from baseline Hb levels at week 16 were +2.8 g/dl for epoetin alfa versus +0.4 g/dl for SOC (p <0.0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p = 0.060) for SOC. The mean Hb level at week 16 in the epoetin alfa group (13.8 g/dl) was significantly (p <0.0001) higher than that of the SOC group (11.4 g/dl). At week 4 and subsequently, significantly more patients in the epoetin alfa group did not have RBV dosage reductions (p <0.011). At study end, 83% of epoetin alfa-treated patients maintained RBV dosages of at least 800 mg/day, compared with 54% of patients receiving SOC (p = 0.022). Epoetin alfa was well tolerated. CONCLUSIONS: In anemic HCV-infected patients treated with RBV/IFN, epoetin alfa increases Hb levels and maintains RBV dosing. Based on these results, epoetin alfa seems to be promising in the treatment of HCV treatment-related anemia. Further research is warranted to determine the potential impact on outcomes, including quality of life and sustained viral response rate.

Original languageEnglish (US)
Pages (from-to)2491-2499
Number of pages9
JournalAmerican Journal of Gastroenterology
Volume98
Issue number11
DOIs
StatePublished - Nov 2003
Externally publishedYes

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Epoetin Alfa
Ribavirin
Interferon-alpha
Hepacivirus
Anemia
Maintenance
Standard of Care
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Once-Weekly Epoetin Alfa Improves Anemia and Facilitates Maintenance of Ribavirin Dosing in Hepatitis C Virus-Infected Patients Receiving Ribavirin Plus Interferon Alfa. / Dieterich, Douglas T.; Wasserman, Ronald; Bräu, Norbert; Hassanein, Tarek I.; Bini, Edmund J.; Bowers, Peter J.; Sulkowski, Mark.

In: American Journal of Gastroenterology, Vol. 98, No. 11, 11.2003, p. 2491-2499.

Research output: Contribution to journalArticle

Dieterich, Douglas T. ; Wasserman, Ronald ; Bräu, Norbert ; Hassanein, Tarek I. ; Bini, Edmund J. ; Bowers, Peter J. ; Sulkowski, Mark. / Once-Weekly Epoetin Alfa Improves Anemia and Facilitates Maintenance of Ribavirin Dosing in Hepatitis C Virus-Infected Patients Receiving Ribavirin Plus Interferon Alfa. In: American Journal of Gastroenterology. 2003 ; Vol. 98, No. 11. pp. 2491-2499.
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title = "Once-Weekly Epoetin Alfa Improves Anemia and Facilitates Maintenance of Ribavirin Dosing in Hepatitis C Virus-Infected Patients Receiving Ribavirin Plus Interferon Alfa",
abstract = "OBJECTIVE: The aim of this study was to determine the efficacy of epoetin alfa in alleviating anemia and minimizing ribavirin (RBV) dose reductions in patients with chronic hepatitis C virus (HCV) infection receiving combination RBV/interferon alfa (IFN) therapy. METHODS: HCV-infected patients who had Hb levels of 12 g/dl or less during the first 24 wk of combination RBV/IFN therapy (n = 64) were randomized to treatment with epoetin alfa (40,000 units) s.c.q.w. or to standard of care (SOC) for anemia management (RBV dose reduction or discontinuation, transfusions). Primary and secondary efficacy endpoints were changes in Hb level and RBV dosage, respectively, from baseline to week 16 of epoetin alfa therapy. RESULTS: Based on intent-to-treat analysis, the mean changes from baseline Hb levels at week 16 were +2.8 g/dl for epoetin alfa versus +0.4 g/dl for SOC (p <0.0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p = 0.060) for SOC. The mean Hb level at week 16 in the epoetin alfa group (13.8 g/dl) was significantly (p <0.0001) higher than that of the SOC group (11.4 g/dl). At week 4 and subsequently, significantly more patients in the epoetin alfa group did not have RBV dosage reductions (p <0.011). At study end, 83{\%} of epoetin alfa-treated patients maintained RBV dosages of at least 800 mg/day, compared with 54{\%} of patients receiving SOC (p = 0.022). Epoetin alfa was well tolerated. CONCLUSIONS: In anemic HCV-infected patients treated with RBV/IFN, epoetin alfa increases Hb levels and maintains RBV dosing. Based on these results, epoetin alfa seems to be promising in the treatment of HCV treatment-related anemia. Further research is warranted to determine the potential impact on outcomes, including quality of life and sustained viral response rate.",
author = "Dieterich, {Douglas T.} and Ronald Wasserman and Norbert Br{\"a}u and Hassanein, {Tarek I.} and Bini, {Edmund J.} and Bowers, {Peter J.} and Mark Sulkowski",
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TY - JOUR

T1 - Once-Weekly Epoetin Alfa Improves Anemia and Facilitates Maintenance of Ribavirin Dosing in Hepatitis C Virus-Infected Patients Receiving Ribavirin Plus Interferon Alfa

AU - Dieterich, Douglas T.

AU - Wasserman, Ronald

AU - Bräu, Norbert

AU - Hassanein, Tarek I.

AU - Bini, Edmund J.

AU - Bowers, Peter J.

AU - Sulkowski, Mark

PY - 2003/11

Y1 - 2003/11

N2 - OBJECTIVE: The aim of this study was to determine the efficacy of epoetin alfa in alleviating anemia and minimizing ribavirin (RBV) dose reductions in patients with chronic hepatitis C virus (HCV) infection receiving combination RBV/interferon alfa (IFN) therapy. METHODS: HCV-infected patients who had Hb levels of 12 g/dl or less during the first 24 wk of combination RBV/IFN therapy (n = 64) were randomized to treatment with epoetin alfa (40,000 units) s.c.q.w. or to standard of care (SOC) for anemia management (RBV dose reduction or discontinuation, transfusions). Primary and secondary efficacy endpoints were changes in Hb level and RBV dosage, respectively, from baseline to week 16 of epoetin alfa therapy. RESULTS: Based on intent-to-treat analysis, the mean changes from baseline Hb levels at week 16 were +2.8 g/dl for epoetin alfa versus +0.4 g/dl for SOC (p <0.0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p = 0.060) for SOC. The mean Hb level at week 16 in the epoetin alfa group (13.8 g/dl) was significantly (p <0.0001) higher than that of the SOC group (11.4 g/dl). At week 4 and subsequently, significantly more patients in the epoetin alfa group did not have RBV dosage reductions (p <0.011). At study end, 83% of epoetin alfa-treated patients maintained RBV dosages of at least 800 mg/day, compared with 54% of patients receiving SOC (p = 0.022). Epoetin alfa was well tolerated. CONCLUSIONS: In anemic HCV-infected patients treated with RBV/IFN, epoetin alfa increases Hb levels and maintains RBV dosing. Based on these results, epoetin alfa seems to be promising in the treatment of HCV treatment-related anemia. Further research is warranted to determine the potential impact on outcomes, including quality of life and sustained viral response rate.

AB - OBJECTIVE: The aim of this study was to determine the efficacy of epoetin alfa in alleviating anemia and minimizing ribavirin (RBV) dose reductions in patients with chronic hepatitis C virus (HCV) infection receiving combination RBV/interferon alfa (IFN) therapy. METHODS: HCV-infected patients who had Hb levels of 12 g/dl or less during the first 24 wk of combination RBV/IFN therapy (n = 64) were randomized to treatment with epoetin alfa (40,000 units) s.c.q.w. or to standard of care (SOC) for anemia management (RBV dose reduction or discontinuation, transfusions). Primary and secondary efficacy endpoints were changes in Hb level and RBV dosage, respectively, from baseline to week 16 of epoetin alfa therapy. RESULTS: Based on intent-to-treat analysis, the mean changes from baseline Hb levels at week 16 were +2.8 g/dl for epoetin alfa versus +0.4 g/dl for SOC (p <0.0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p = 0.060) for SOC. The mean Hb level at week 16 in the epoetin alfa group (13.8 g/dl) was significantly (p <0.0001) higher than that of the SOC group (11.4 g/dl). At week 4 and subsequently, significantly more patients in the epoetin alfa group did not have RBV dosage reductions (p <0.011). At study end, 83% of epoetin alfa-treated patients maintained RBV dosages of at least 800 mg/day, compared with 54% of patients receiving SOC (p = 0.022). Epoetin alfa was well tolerated. CONCLUSIONS: In anemic HCV-infected patients treated with RBV/IFN, epoetin alfa increases Hb levels and maintains RBV dosing. Based on these results, epoetin alfa seems to be promising in the treatment of HCV treatment-related anemia. Further research is warranted to determine the potential impact on outcomes, including quality of life and sustained viral response rate.

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