Pharmacokinetics of Pegasys Compared to PEG-Intron in Treatment-Naïve Patients with Chronic Hepatitis C
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).
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: The investigators conclude, 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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