Entecavir
versus
Lamivudine
for
Patients
with
HBeAg-negative
Chronic
Hepatitis
B Entecavir
(Baraclude)
is
a potent
and
selective
antiviral
drug
that
has
shown
efficacy
in
prior
Phase
2 studies
among
patients
with
hepatitis
B e
antigen
(HBeAg)-negative
chronic
hepatitis
B.
Like
the
large
study
summarized
above,
this
was
a Phase
3,
multicenter,
multinational
trial.
Researchers
randomly
assigned
648
treatment-naïve
patients
with
HBeAg-negative
chronic
hepatitis
B who
to
receive
0.5
mg
of
entecavir
or
100
mg
of
lamivudine
once
daily
for
a minimum
of
52
weeks.
As
in
the
trial
among
HBeAg-positive
patients,
the
primary
efficacy
end
point
was
histologic
improvement,
defined
as
a decrease
by
at
least
two
points
in
the
Knodell
necroinflammatory
score,
without
worsening
of
fibrosis.
Results
After
48
weeks
of
treatment,
liver
histology
improved
in
208
of
296
patients
(70%)
in
the
entecavir
group,
compared
with
174
of
287
patients
(61%)
in
the
lamivudine
group.
Significantly
more
patients
in
the
entecavir
group
than
in
the
lamivudine
group
had
undetectable
HBV
DNA
levels
according
to
a polymerase-chain-reaction
assay
(90
percent
vs.
72
percent)
and
normalization
of
ALT
levels
(78%
vs.
71%).
The
mean
reduction
in
serum
HBV
DNA
levels
from
baseline
to
week
48
was
greater
with
entecavir
than
with
lamivudine
(5.0
vs.
4.5
log
copies
per
milliliter).
No
evidence
of
resistance
to
entecavir
emerged.
The
two
groups
had
similar
safety
and
adverse-event
profiles.
Based
on
these
findings,
the
study
authors
conclude,
"Among
patients
with
HBeAg-negative
chronic
hepatitis
B who
had
not
previously
been
treated
with
a nucleoside
analogue,
the
rates
of
histologic
improvement,
virologic
response,
and
normalization
of
alanine
aminotransferase
levels
were
significantly
higher
at
48
weeks
with
entecavir
than
with
lamivudine.
The
safety
profile
of
the
two
agents
was
similar,
and
there
was
no
evidence
of
viral
resistance
to
entecavir."
03/10/06
Reference
C-L
Lai,
D Shouval
and
A S
Lok
(for
the
BEHoLD
AI463027
Study
Group).
Entecavir
versus
Lamivudine
for
Patients
with
HBeAg-Negative
Chronic
Hepatitis
B.
The
New
England
Journal
of
Medicine
354(10):
1011-1020.
March
9,
2006.
|
Entecavir
(Baraclude)
Brand
Name:
Baraclude
Drug
Class:
Nucleoside
analogue
reverse
transcriptase
inhibitor
|
|
|
|
