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Intron
A and Ribavirin for the Treatment of HCV Patients Who Failed
Prior Therapy
Eradicating HCV in the majority of infected patients remains
an elusive goal, particularly in previously treated patients
who failed or relapsed following prior therapy. In this study,
investigators hypothesize that response rates in these patients
who are re-treated with pegylated interferon and ribavirin
will be improved compared to standard interferon preparations
with or without ribavirin.
The present prospective study is designed to determine the
efficacy and safety of treatment with PEG-Intron (pegylated
interferon alfa-2b) and ribavirin in a group of patients who
failed prior therapy with "standard" Interferon
with or without Ribavirin.
454 patients are presently enrolled in this multi-center study.
The first 250 enrolled patients were treated with 1.5 mg/kg
of PEG-Intron sc q week, and ribavirin 800 mg po qd, which
was standard at the time.
The intended duration of treatment is 48 weeks. 243 patients
have been treated for at least 48 weeks and week 72 data is
available in 189 patients.
Adverse events: Dose reduction was required in 22%
of pts most commonly due to leukopenia and anemia. Permanent
discontinuation of therapy was required in 8% most often due
to: depression or anxiety Serious adverse events: (1.8% of
pts) included one patient each with neutropenia/MRSA sepsis,
optic neuritis with monocular blindness, peri-rectal abscess,
cellulitis and multi-organ failure, cutaneous and pulmonary
sarcoidosis, pneumonia, homicidal ideation, and suicide.
Conclusions
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Overall ETR was 53% and SVR was 41%;
•
SVR was significant in genotype non-1 patients
and patients who failed or relapsed after previous monotherapy;
and
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20% of G1 nonresponders to Rebetron achieved
an SVR, 21% of White and 19% of African Americans.
05/19/04
Reference
P J Gaglio and others. Pegylated Interferon (alpha-2B) and
Ribavirin (Rebetol) for the Treatment Of HCV-infected Patients
Who Failed Prior Therapy: Sustained Response Data. Abstract
1230 (poster). Digestive Disease Week. May 15-20, 2004. New
Orleans, LA.
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