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unlike conventional therapies whose
relapse rates are high after treatment
cessation.
6
High morbidity and mortality
have been found in Asia among
HBsAg-positive patients, even in the
absence of overt liver disease.
7,8
Kato
and coworkers while studying the
spontaneous loss of HBsAg in chronic
carriers, found the yearly loss to be
around 2.5%.
9
The goal of treatment
for CHB is to prevent cirrhosis,
hepatic failure, and HCC. This goal
is best achieved by eradicating HBV
before irreversible liver damage
occurs.
10
Hence the ultimate endpoint
of antiviral therapy for CHB
infection is loss of HBsAg, which is
accompanied by disease remission in
terms of ALT normalization.
11
In this study, HBsAg cleared in 10
patients and ALT normalization was
obtained in 64 patients. This coupled
with its excellent safety profile may
make HD-03/ES an alternative to
conventional therapies like IFN-
α
and lamivudine, which are costly at
present and whose use are associated
with dose-limiting side effects in the
management of CHB.
12-14
Our results should be interpreted as
encouraging from several points of
view. First, all the patients tolerated
the treatment well without major side
effects. Second, most patients had a
long-term chronic infection and in
most patients there was a significant
improvement in patient symptoms.
This study has several obvious
limitations and one among these is the
small sample size.
In summary, in this controlled
study HD-03/ES showed clinically
significant antiviral effect in patients
with CHB infection. Further studies
using critical clinical trial designs are
warranted.
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