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 S.
N1 - Funding Information:
This research was supported by a grant from Ortho Biotech Products; D.T.D. has received financial support for research and honoraria from and has served as a consultant to Ortho Biotech Products; R.W. has received financial support for research and honoraria from and has served as a consultant to Ortho Biotech Products; N.B. has received financial support for research and honoraria from Ortho Biotech Products; T.I.H. has received financial support for research and honoraria from and has served as a consultant to Ortho Biotech Products; E.J.B. has received financial support for research and honoraria from and has served as a consultant to Ortho Biotech Products; P.J.B. is an employee of Ortho Biotech Products; M.S.S. has received grant and/or research support from Schering-Plough, Roche Laboratories, and Ortho Biotech Products; M.S.S. is also a consultant for Schering-Plough, a member of the Speakers Bureaus for Schering-Plough and Ortho Biotech Products, and has received honoraria from Schering-Plough, Roche Laboratories, and Ortho Biotech Products.
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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U2 - 10.1016/j.amjgastroenterol.2003.08.006
DO - 10.1016/j.amjgastroenterol.2003.08.006
M3 - Article
C2 - 14638354
AN - SCOPUS:0242437747
SN - 0002-9270
VL - 98
SP - 2491
EP - 2499
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 11
ER -