Pegintron (Peginterferon Alfa-2b) Should To Be Given Twice Weekly
Hepatitis C Virus Drug Pegintron (Peginterferon Alfa-2b) Should To Be
Given Twice Weekly
VIENNA, AUSTRIA -- July 29, 2003 -- A study published in the July
issue of the Journal of Viral Hepatitis(1) shows that the currently
prescribed once weekly dosing schedule of peginterferon alfa-2b
(PegIntron�-Schering-Plough) does not provide sustained suppression
of the hepatitis C virus (HCV). The study found that to achieve
continuous drug exposure and to improve viral clearance,
peginterferon alfa-2b has to be given at least twice weekly.
The study, conducted at the University of Vienna, investigated
whether twice weekly dosing of PegIntron� improves viral kinetics
over once weekly dosing. Twenty interferon-na�ve patients with
chronic hepatitis C genotype 1 were randomised to receive either
1.0mcg/kg peginterferon alfa-2b once weekly (Group A, 10 patients) or
twice weekly (Group B, 10 patients) for four weeks. Serum
concentrations and viral load were measured. In Europe, the
monotherapy dose for peginterferon alfa-2b is 0.5 or 1.0 mcg/kg/week,
of which the 1.0 dose was used for this monotherapy study.
Key study findings:
� Serum concentrations of peginterferon alfa-2b reached maximum
levels 24 hours after injection followed by a linear decline over the
subsequent days. On the day before administration of the next dose,
no drug was detectable in 90 per cent of patients in Group A (once
weekly dosing). This same pattern was observed during the next three
weeks of therapy.
� In contrast, in Group B with twice-weekly dosing, drug levels were
detectable at any given time point and higher than in Group A.
� Viral load decreased in all patients within 2 days after the first
dose of peginterferon alfa-2b but increased again on day 3. In Group
A with once weekly dosing, viral load continued to increase
throughout the week, and a similar pattern was observed in the second
week. In contrast, in Group B with twice weekly dosing, viral load
decreased again on day 4 and remained lower throughout the four-week
� The authors noted that the viral load increases in parallel with
the decrease of peginterferon alfa-2b, and this "clearly indicates
that this rebound of HCV RNA is because of insufficient interferon
levels in the body. This rebound may be predictive for nonresponse to
peginterferon alfa-2b/ribavirin therapyi.(1)"
Previous studies have also shown that the once weekly administration
of PegIntron� does not result in the continuous decline in viral load
1. Formann, E et al. Twice-weekly administration of peginterferon
alfa-2b improves viral kinetics in patients with chronic hepatitis C
genotype 1. J. Viral Hepatitis. 2003;10: 271-276.
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