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Optimal Dosing
Frequency of Pegylated Interferon Alfa-2b (PegIntron) Monotherapy
Pegylated
interferon alfa-2b/PEG-IFN-alfa2b (PegIntron)
has
been shown to provide superior efficacy to IFN-alfa2b
in patients with chronic
hepatitis C (predominantly genotype
1) infection as measured by viral clearance.
This study was conducted to determine the optimal dosing
regimen of PEG-IFN-alfa2b required
to obtain a maximum decrease of hepatitis C viral RNA.
This
was a 24-week, open-label, multicenter, parallel-group, randomized,
active-controlled trial in the United Kingdom, France, and
Israel. Individuals (n = 61) with chronic hepatitis C infection,
genotype 1, received IFN-alfa2b 3 mIU 3 times weekly
for 24 weeks, or PEG-IFN-alfa2b 1.5 or 3.0 μg/kg/wk,
as total weekly full or split doses, for 12 weeks.
At
week 12, serum RNA titer was measured, and all PEG-IFN-alfa2b
patients continued with 1.5 μg/kg/wk for a further 12
weeks.
Results
· Mean
serum hepatitis C RNA levels decreased in all groups at weeks
12 and 24.
· PEG-IFN-alfa2b
1.5 μg/kg/wk was superior to IFN-alfa2b in
decreasing mean serum hepatitis C RNA (P < .05 at
week 12).
· The
efficacy of split-dose
PEG-IFN-alfa2b 1.5 or 3.0 μg/kg/wk regimens
was not significantly different from full-dose
PEG-IFN-alfa2b 1.5 μg/kg/wk.
· However,
there was a significant decrease in neutrophil count in groups
receiving PEG-IFN-alfa2b 3.0 μg/kg/wk or lower,
multiple-dose per week regimens.
According
to the authors, “PEG-IFN-alfa2b 1.5 μg/kg
once weekly is the optimal dosing frequency for patients with
chronic hepatitis C with predominantly genotype 1 infection.”
“More
frequent dosing or increasing the dose to 3.0 μg/kg/wk
did not result in improved antiviral effects, but did decrease
neutrophil counts.”
06/29/05
Reference
Y
Lurie and others. Optimal Dosing Frequency of Pegylated Interferon
Alfa-2b Monotherapy for Chronic Hepatitis C Virus Infection.
Clinical Gestroenterology and Hepatology 3(6): 610-615. June 2005.
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