Telbivudine
Provides
Greater
Antiviral
and
Clinical
Efficacy
Compared
to
Lamivudine
in
Patients
with
Chronic
Hepatitis
B  Idenix
Pharmaceuticals
and
Swiss
titan
drugmaker
Novartis
announced
new
data
from
a Chinese
study
demonstrating
that
the
experimental
anti-HBV
drug
telbivudine
provides
significantly
greater
antiviral
and
clinical
efficacy
after
one-year
of
treatment
when
compared
with
lamivudine
(Epivir-HBV).
Telbivudine
is
an
oral
nucleoside
analogue
agent
administered
once
daily.
The
one-year
results
from
a Phase
III
registration
trial
of
telbivudine
conducted
in
China
were
presented
March
27,
2006
at
the
biennial
meeting
of
the
International
Liver
Congress
in
Shanghai,
China.
In
a joint
announcement,
Idenix
and
Novartis
said
the
data
would
be
submitted
to
Chinese
health
authorities
for
marketing
approval
of
telbivudine,
following
recent
submissions
to
the
US
FDA
and
European
regulatory
authorities.
The
companies
submitted
these
new
data
along
with
one-year
data
from
the
international
Phase
III
GLOBE
study
of
telbivudine,
the
largest
registration
trial
ever
conducted
for
a chronic
hepatitis
B treatment.
The
GLOBE
study,
a two-year
Phase
III
clinical
trial,
also
compared
telbivudine
with
lamivudine.
Participants
included
1,367
adults
with
chronic
hepatitis
B
from
112
clinical
centers
in
20
countries
worldwide. Following
are
excerpts
from
the
announcement
of
the
Chinese
study
results: 
"The
results
from
this
study
are
very
promising,"
said
Dr.
Jinlin
Hou,
Director
and
Professor
of
Hepatology
Unit
and
Department
of
Infectious
Diseases
at
Nanfang
Hospital,
Southern
Medical
University,
Guangzhou,
China
and
a principal
investigator
in
the
study.
"Telbivudine
displayed
increased
efficacy
compared
to
lamivudine
on
the
key
viral
and
clinical
markers
including
significantly
greater
viral
suppression,
a higher
percentage
of
patients
with
normalization
of
liver
enzymes
and
a higher
proportion
of
patients
with
HBeAg
loss
at
one
year.
“These
data
suggest
that
telbivudine,
if
approved
in
China,
may
become
an
important
new
treatment
option
for
the
millions
of
Chinese
patients
with
this
potentially
life-threatening
disease."
"Chronic
hepatitis
B is
a major
public
health
threat
worldwide
and
is
a particularly
serious
problem
in
China,
where
nearly
1 out
of
10
people
are
infected.
We
are
pleased
that
telbivudine
has
now
been
submitted
for
regulatory
approval
in
China
and
could
provide
a new
treatment
option
for
those
patients,"
said
Jean-Pierre
Sommadossi,
chairman
and
chief
executive
officer
of
Idenix.
"The
positive
results
achieved
in
this
trial
are
similar
to
the
one-year
results
seen
in
the
GLOBE
study
and
demonstrated
that
telbivudine
provides
rapid
and
profound
viral
suppression
in
patients
with
chronic
hepatitis
B."
One-year
Results
of
Chinese
Phase
III
Trial
This
trial
is
an
ongoing,
randomized,
double-blind
trial
comparing
2 years
of
treatment
with
telbivudine
or
lamivudine
in
332
Chinese
adults
with
chronic
hepatitis
B.
The
majority
of
patients
in
this
trial
were
HBeAg-positive
(n=290)
although
HBeAg-negative
patients
also
participated
(n=42). After
one
year
of
treatment,
telbivudine
displayed
significantly
greater
antiviral
and
clinical
efficacy
compared
with
lamivudine.
Telbivudine
significantly
reduced
virus
levels
(HBV
DNA)
by
6.22
log10
or
more
than
1 million-fold,
compared
with
5.4
log10
for
lamivudine
(p<0.001).
In
addition,
undetectable
HBV
levels
were
achieved
by
significantly
more
telbivudine-treated
patients
compared
with
lamivudine-treated
patients
(70
and
43
percent,
respectively;
p<0.001).
Therapeutic
response
(defined
as
a reduction
of
HBV
DNA
to
below
5 log
10
copies/mL
with
HBeAg
loss
or
ALT
normalization)
was
achieved
by
a significantly
higher
percentage
of
telbivudine-treated
patients
compared
with
lamivudine-treated
patients
(87
and
64
percent,
respectively
(p<0.001). Significantly
more
telbivudine-treated
patients
achieved
normalization
of
liver
enzymes
(ALT)
compared
with
lamivudine-treated
patients
(89
and
76
percent,
respectively;
p=0.003).
In
addition,
HBeAg
loss
(in
HBeAg
positive
patients
only
and
an
indicator
of
a potential
durable
response
to
treatment)
occurred
in
a significantly
higher
percent
of
telbivudine-treated
patients
compared
with
lamivudine-treated
patients
(31
and
20
percent,
respectively;
p=0.047). Seroconversion
rates
(in
HBeAg
positive
patients
only)
were
25
percent
for
telbivudine
and
18
percent
for
lamivudine.
Resistance
rates
were
4.5
percent
for
telbivudine
and
10.1
percent
for
lamivudine. Safety
Profile The
overall
safety
profiles
for
telbivudine
and
lamivudine
in
this
study
closely
resembled
the
recently-reported
results
from
the
GLOBE
study
of
telbivudine.
The
rate
of
clinical
adverse
events
was
similar
between
the
telbivudine
and
lamivudine
treatment
groups,
with
nasopharyngitis,
(25
and
21
percent
respectively)
upper
respiratory
tract
infection,
(3.0
and
4.8
percent
respectively)
and
fatigue,
(3.6
percent
for
both
treatment
groups)
occurring
most
commonly.
As
in
the
GLOBE
study,
serum
ALT
elevations
were
more
common
in
lamivudine-treated
patients
compared
to
telbivudine
and
creatine
kinase
elevations,
not
requiring
treatment
modification,
were
more
common
with
telbivudine
compared
to
lamivudine. 03/31/06 Source
PR
Newswire-FirstCall.
March
27,
2006.
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