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Pegylated Interferon (PegIntron) and Ribavirin for Hep C Patients who were
Previous Nonresponders
Reported by Jules Levin
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This is the second study reported in an oral presentation on treating
previous nonresponders or relapsers to previous therapy with PegIntron and
ribavirin. The first study reported here by Ira Jacobson was reported by me
yesterday. Eric Lawitz (Alamo Study Group; Brooke Army Medical Center, San
Antonio, Tx.) reported these study results.
There have been only preliminary study results on treating nonresponders and
relapsers to standard interferon plus ribavirin with Pegylated Interferon and
ribavirin. The utility of treating nonresponders and relapsers with peg+RBV
has not been well characterized yet. This study and the Jacobson study are
showing only preliminary data so far. We should wait for final study results.
This study compared to effectiveness of induction PegIntron and ribavirin to
a fixed dose of PegIntron/RBV in previous combination nonresponders and
relapsers and IFN monotherapy nonresponders.
The induction regimen: patients received PegIntron 1.5 mcg/kg weekly +
ribavirin 1000/1200 mg day for 12 weeks followed by PegIntron 1.0 mcg/kg +
800 mg RBV. The fixed dose regimen was PegIntron 1.0 mcg/kg weekly + RBV 800
mg/day.
680 patients enrolled at 46 sites in this randomized open-label study. There
were 473 standard combination nonresponders, 108 monotherapy nonresponders,
and 99 standard combination relapsers. 447 have completed 48 weeks. Average
age was 46 in both groups; 68% male; 17% African-American; 85% genotype 1;
44% fibrosis stage 3/4.
RESULTS
In the combination nonresponders: after 24 weeks of therapy 32% (n=241) in
the induction group and 25% (n=232) in the fixed dose group had HCV viral
load clearance. At the end of 48 weeks of treatment, 25% (n=166) in the
induction group cleared HCV-RNA and 15% (n=140) cleared HCV in the fixed dose
group. Following 24 weeks of follow-up after therapy ends, when we see the
SVR (sustained viral response) you expect a lower response rate.
Interim 24 week results were reported on patients who had a partial response
during their previous therapy with standard combination therapy (partial
response defined as a log or greater reduction in viral load on previous
therapy). As expected these patients appear to respond better: after 24 weeks
of therapy 46% (n=129) were PCR negative.
Also as expected, nonresponders to prior IFN monotherapy did better: 44%
(fixed & induction regimens) cleared HCV after 24 weeks, and 30% (n=44) in
the fixed dose regimen & 34% (n=38) in the induction regimen cleared HCV.
Also as expected, relapsers to combination therapy responded the best: after
24 weeks of therapy about 70% in both groups cleared HCV (n=100), and 58%
(n=33) in the fixed and 55% (n=29) in the induction regimen cleared HCV.
29% of genotype 1 patients who were combination nonresponders (n=205) &
received the induction dose cleared HCV at week 24 compared to 21% (n=197)
who received the fixed dose. About 65% of the relapsers with genotype 1
cleared HCV at week 24. About 36% of the genotype 1 nonresponders to IFN
monotherapy & cleared HCV at week 24.
Dose reductions to RBV & IFN were about the same in fixed & induction groups:
6% (RBV), 7% (IFN). Discontinuations were also about the same in both groups:
22%.
The authors concluded that neither genotype 1 or advanced liver disease
precluded response to therapy.
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