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A
COMPARATIVE STUDY BETWEEN PEGYLATED
VERSUS CONVENTIONAL INTERFERON FOR THE
TREATMENT OF CHRONIC HEPATITIS C
INFECTION IN ADULT TRANSFUSION DEPENDENT
THALASSEMIC PATIENTS: AN OPEN LABEL,
RANDOMIZED TRIAL
S. Mirmomen1, N. E. Daryani1, B.
Haghpanah1, P. Poorsamimi2, S. Alavian3,
R. Malekzadeh4, M. R. Zalli5
1Gastroenterology and Hepatology, Imam
Khomeini Hospital, 2Infectious disease,
Private, 3Gastroenterology and
Hepatology, Tehran Hepatitis Center,
4Gastroenterology and Hepatology,
Digestive disease reaserch center,
5Gastroenterology and Hepatology,
Taleghani hospital, Tehran, Iran
(Islamic Republic of)
INTRODUCTION: Interferon monotherapy is
currently the only approved treatment
for chronic hepatitis C (CHC) infection
in transfusion dependent (TD)thalassemic
patients, in which ribavirin has limited
use because of its hematologic
complications.
AIMS & METHODS: Our aim was to compare
the efficacy and safety of conventional
Interferon Alfa (CINF) with that of
Pegylated interferon Alfa (PINF) for
these patients.This trial was a
multicenter, open label, randomized
prospective study. 50 TD-thalassemic
patients, with CHC infection were
randomized to receive either CINF 3 MU,
three times per week (n=25) or PINF (PEGASYS)
180 Mic-g, once weekly (n=25) for a
period of 48 weeks. Efficacy was
assessed by measuring serum HCV-RNA
following a 24 week treatment-free
period (SVR)
RESULTS: there was no significant
difference between the pretreatment
liver histology (including fibrosis and siderosis) between the groups. HCV
genotype 1 was dominant in both groups
(> 75%). Three cases of neutropenia
occurred in PINF group, which warranted
dose reduction, but in CINF group one
such a case happened. In PINF group two
patients had an elevated end of
treatment serum ALT instead of negative
HCVRNA but their ALT returned to normal
as soon as the treatment stopped, these
2 patients were considered to have INF
toxicity. Two patients in PINF and one
in CINF group missed follow up
(unrelated to drug adverse reactions).
Perprotocol analysis showed that; SVR
was 60.9% (14 out of 23) in PINF group
and 29.2% (7 out of 24) in CINF group
(P=0.029)
CONCLUSION: Our study showed that in TD-thalassemic
patients, in which ribavirin is not
approved; monotherapy with PIFN is
superior to CINF.
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