A phase II dose finding study of darbepoetin alpha and filgrastim for the management of anaemia and neutropenia in chronic hepatitis C treatment

Dose reductions of pegylated interferon alpha and ribavirin may be avoided by using growth factors. This phase II clinical trial assesses the dose, efficacy and safety of darbepoetin alpha and filgrastim for treatment of anaemia and neutropenia associated with combination therapy for hepatitis C vir...

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Bibliographic Details
Published in:Journal of viral hepatitis 2008-05, Vol.15 (5), p.370-378
Main Authors: Younossi, Z. M., Nader, F. H., Bai, C., Sjogren, R., Ong, J. P., Collantes, R., Sjogren, M., Farmer, D., Ramsey, L., Terra, K., Gujral, H., Gurung, C., Srishord, M., Fang, Y.
Format: Article
Language:English
Subjects:
Adult
Anemia - drug therapy
Anemia - psychology
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Darbepoetin alfa
darbepoetin alpha and filgrastim
Erythropoietin - administration & dosage
Erythropoietin - adverse effects
Erythropoietin - analogs & derivatives
Erythropoietin - pharmacology
Female
Filgrastim
Granulocyte Colony-Stimulating Factor - administration & dosage
Granulocyte Colony-Stimulating Factor - adverse effects
Granulocyte Colony-Stimulating Factor - pharmacology
growth factors
HCV
Hematinics - administration & dosage
Hematinics - adverse effects
Hematinics - pharmacology
Hemoglobins - analysis
Hepatitis C virus
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - drug therapy
Humans
Interferon-alpha - administration & dosage
Interferon-alpha - therapeutic use
Male
Middle Aged
Neutropenia - drug therapy
Polyethylene Glycols
Quality of Life
Recombinant Proteins
Ribavirin - administration & dosage
Ribavirin - therapeutic use
Treatment Outcome
Viral Load
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Summary:Dose reductions of pegylated interferon alpha and ribavirin may be avoided by using growth factors. This phase II clinical trial assesses the dose, efficacy and safety of darbepoetin alpha and filgrastim for treatment of anaemia and neutropenia associated with combination therapy for hepatitis C virus (HCV). Chronic hepatitis C patients (n = 101) received pegylated interferon alpha‐2b (1.5 μg/kg once weekly) and ribavirin (800–1400 mg once daily). Patients with anaemia [haemoglobin (Hb) ≤ 10.5 g/dL] received darbepoetin alpha (3 μg/kg once every 2 weeks); the dose was titrated to achieve a Hb level of 12.0 g/dL. Patients with neutropenia [absolute neutrophil count (ANC) ≤ 0.75 × 109/L] received filgrastim with the dose titrated from 150 μg QW to 300 μg thrice weekly to maintain ANC ≥ 0.75 × 109/L and
ISSN:1352-0504
1365-2893
DOI:10.1111/j.1365-2893.2007.00956.x