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Clinical trial: comparison of weekly once versus twice half‐dose weekly administration of pegylated interferon alpha 2b in combination with ribavirin for the treatment of HCV‐1 positive patients with chronic hepatitis C
Author(s) -
SEBASTIANI G.,
FERRARI A.,
BOCCATO S.,
PISTIS R.,
ALBERTI A.
Publication year - 2007
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2007.03451.x
Subject(s) - medicine , ribavirin , pegylated interferon , gastroenterology , alpha interferon , hepatitis c , chronic hepatitis , interferon , immunology , virus
Summary Background Pegylated interferon (PEG‐IFN) alpha2b is currently used as a once weekly injection in combination with ribavirin for the treatment of chronic hepatitis C. Aim To test whether twice half‐dose weekly administration may improve the virological response in difficult‐to‐treat hepatitis C virus‐1 patients. Methods Thirty patients were treated with 1.5 μg/kg of PEG‐IFN alpha2b given once weekly for 48 weeks (group A) and were compared with 30 patients treated with the same dose of PEG‐IFN alpha2b divided in twice weekly doses of 0.75 μg/kg for the initial 4 weeks (group B). All patients were hepatitis C virus‐1 positive and received weight‐based ribavirin (800–1400 mg/daily). Results Weekly twice half‐dose administration of PEG‐IFN alpha2b for the first 4 weeks was associated with lower rates of biochemical and virological response at all time points compared with a once weekly schedule, and with significantly higher rates of in‐therapy breakthrough leading to significantly lower rates of end of therapy response (week 48). The rate of sustained virological response was of 56.7% in group A and 36.7% in group B. Conclusions Weekly twice half‐dose administration of PEG‐IFN alpha2b is not superior to the standard once weekly schedule, and might be less efficacious.