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PHARMACOKINETICS OF PEGINTERFERON ALFA-2A (40KD, PEGASYS) COMPARED TO
PEGINTERFERON ALFA-2B (12KD, PEGINTRON) IN NAIVE PATIENTS WITH CHRONIC
HEPATITIS C (CHC)
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R. Bruno*, P. Sacchi, V. Ciappina, E. Maffezzini, S.F.A. Patruno,
C. Zocchetti, G. Filice, *Presenting Author
Infectious And Tropical Diseases, IRCCS San Matteo Hospital - University Of
Pavia, Pavia, Italy
Background: The currently available pegylated interferon (PEG-IFN)
formulations, PEG-IFN ALFA-2A (40KD, PEGASYS) and PEG-IFN ALFA-2B (12KD,
PEG-Intron), have different pharmacokinetic profiles.
Aim: Objective of this randomized trial is to compare the pharmacokinetics of
the two PEG-IFNs in patients with CHC.
Patients & Methods: 30 treatment naive patients with CHC and persistently
elevated ALT levels have been randomized to receive 180 mcg PEGASYS
once-weekly (n=16) or 1.0 mcg/kg once-weekly of PEG-Intron (n=14). Serum
concentrations of both PEG-IFNs were measured at baseline and 24, 48, 120 and
168 hours after administration using a quantitative sandwich ELISA (lower
limit of detection 125 pg/ml).
Results: Serum concentration of PEG-Intron achieved maximum levels at 24
hours after injection and decreased rapidly until 120 hours. Drug was
undetectable 120 and 168 hours after injection in 7 (50%) and 11 (78%)
subjects, respectively. In contrast, PEGASYS concentrations increased
continuously overtime, reaching maximum levels from 48 to 168 hours.
Conclusions: Our data demonstrate substantial differences in plasma
concentration profiles between PEGASYS and PEG-Intron. Five days after
injection concentrations of PEG-Intron are marginal or undetectable, while
those of PEGASYS remain stable overtime. These findings suggest that
PEG-Intron administration should be intensified to twice weekly to avoid
"blips" in viral replication. Differences in pharmacokinetics could explain
the differences observed in HCV decay.
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