Treatment of chronic hepatitis C virus genotype 1 with peginterferon, ribavirin, and epoetin alpha

Successful treatment of chronic HCV with peginterferon (PEGIFN) and ribavirin (RVN) is often limited by anemia. We performed the present study to determine if utilizing epoetin alpha (EPO) with or without a higher dose of RVN could enhance sustained virologic response (SVR). We randomized 150 treatm...

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Bibliographic Details
Published in:Hepatology (Baltimore, Md.) Md.), 2007-08, Vol.46 (2), p.371-379
Main Authors: Shiffman, Mitchell L., Salvatore, Jennifer, Hubbard, Sarah, Price, Angie, Sterling, Richard K., Stravitz, R. Todd, Luketic, Velimir A., Sanyal, Arun J.
Format: Article
Language:English
Subjects:
Adult
Anemias. Hemoglobinopathies
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Biological and medical sciences
Diseases of red blood cells
Drug Therapy, Combination
Epoetin Alfa
Erythropoietin - administration & dosage
Female
Genotype
Hematologic and hematopoietic diseases
Hemoglobins - analysis
Hepacivirus - classification
Hepacivirus - genetics
Hepatitis C, Chronic - blood
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Human viral diseases
Humans
Infectious diseases
Interferon-alpha - administration & dosage
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Polyethylene Glycols
Recombinant Proteins
Ribavirin - administration & dosage
RNA, Viral - blood
Viral diseases
Viral hepatitis
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Summary:Successful treatment of chronic HCV with peginterferon (PEGIFN) and ribavirin (RVN) is often limited by anemia. We performed the present study to determine if utilizing epoetin alpha (EPO) with or without a higher dose of RVN could enhance sustained virologic response (SVR). We randomized 150 treatment‐naive patients with chronic HCV genotype 1 into 3 treatment groups: (1) PEGIFN alpha‐2b (1.5 μg/kg/week) + weight‐based RVN (WBR) 13.3 mg/kg/day (800 to 1400 mg/day); (2) PEGIFN alpha‐2b + WBRVN + EPO (40,000 U/week); or (3) PEGIFN alpha‐2b + higher dose WBR 15.2 mg/kg/day (1000 to 1600 mg/day) + EPO. We initiated EPO at the onset of therapy to maintain the hemoglobin between 12 and 15 g/dL. When required, we reduced RVN by 200‐mg steps. African Americans compose 36% of the population. A significantly smaller percentage of group 2 patients had a decline in hemoglobin to less than 10 g/dL (9% versus 34%; P < 0.05) and required that the RVN dose be reduced (10% versus 40%; P < 0.05) compared to group 1 patients. Despite this, SVR was similar in these groups (19% to 29%). SVR was significantly greater (P < 0.05) in group 3 patients (49%). This resulted from a significant decline (P < 0.05) in relapse rate; only 8% versus 38% for groups 1 and 2. Conclusion: We conclude that using EPO in all subjects at the initiation of PEGIFN and RVN treatment will not enhance SVR given the same starting dose of RVN. In contrast, a higher starting dose of RVN was associated with a lower relapse rate and higher rate of SVR. (HEPATOLOGY 2007.)
ISSN:0270-9139
1527-3350
DOI:10.1002/hep.21712