[5]
Jilg W. Selective risk group strategies in
Europe
. Vaccine 1995; 13:1 S44 S46
-------------------------------------------------------------------------------------------------------------------------
Sebivo
®
(
telbivudine
) receives
UK
authorisation
for treatment of chronic hepatitis B
-
Telbivudine receives Marketing
Authorisation
in the UK
-
One year GLOBE data shows that
telbivudine
has greater antiviral efficacy than
lamivudine
Frimley,
12th July 2007
– Sebivo® (
telbivudine
) has received Marketing
Authorisation
from the European Agency for the Evaluation of Medicinal
Products (EMEA) and is now available in the
UK
for the treatment of patients over 16 with chronic hepatitis B (CHB).
Sebivo is indicated for the treatment of chronic
hepatits
B in adult patients with compensated liver disease and evidence
of viral replication, persistently elevated serum
alanine
aminotransferase
(ALT) levels and histological evidence of active inflammation
and/or fibrosis1.
The safety and efficacy of Sebivo were established in the GLOBE
study, a phase III clinical trial with 1,367 patients which
compared
telbivudine
to
lamivudine
for a treatment period up to 104 weeks. After one year, in
HBeAg
-positive patients,
telbivudine
was superior to
lamivudine
in terms of therapeutic response1.
“Chronic hepatitis B is a serious condition that can lead to
liver cirrhosis, liver cancer, liver failure, and ultimately
death,” said
Geoffrey Dusheiko
,
Professor of Medicine and an Honorary Consultant at the Centre
for
Hepatology
of the Royal Free and University College School of Medicine,
Royal
Free
Hospital
,
London
.
“There is no cure for chronic hepatitis B, but high viral load
increases the risk of serious complications. To reduce this
risk, the goal of therapy is to suppress the hepatitis B virus
as much as possible, and to maintain that decrease over time.
The GLOBE study shows that
telbivudine
does this more effectively than
lamivudine
, but resistance may still occur, particularly in patients who
do not have undetectable HBV DNA after 6 months of treatment
with either agent. The results of the GLOBE trial showed that
the rapid viral suppression achieved with
telbivudine
at six months can predict outcomes through two years of study
which could lead to improved paradigms of treatment.”
Key 1 year findings from the GLOBE study
1
Data from the GLOBE study show that after one year, regardless
of baseline characteristics, the majority of patients taking
telbivudine
responded to treatment. In
HBeAg
-positive patients,
telbivudine
was superior to
lamivudine
in therapeutic response (75.3%
vs
67% responders; p = 0.0047) 1.
At week 24, 203
HBeAg
-positive and 178
HBeAg
-negative patients achieved non-
detectable
HBV
DNA levels. Of those
HBeAg
-positive subjects, 95% achieved non-detectable HBV DNA, 39%
achieved
HBeAg
seroconversion
,
90
% achieved ALT normalization at week 52 and 0.5% exhibited
resistance at week 48. Similarly of those
HBeAg
-negative patients, 96% achieved non-detectable HBV DNA, 79%
achieved ALT normalization at week 52 and 0% exhibited
resistance at week 481.
Patients with lower HBV DNA levels at 24 weeks had the most
favourable
treatment responses1.
Telbivudine
®
has also been compared to adefovir2
An additional study of 135
HBe
-Ag-positive patients compared the efficacy of
telbivudine
and
adefovir
. Twice the number of
telbivudine
patients achieved HBV DNA PCR negativity within six months (38
percent with
telbivudine
versus 12 percent with
adefovir
, p<0.001)2. Moreover,
adefovir
-treated patients who did not achieve this goal at six months,
and were then switched to
telbivudine
, achieved a two times greater log reduction at one year
compared to those who remained on
adefovir
(2.1 log10 vs. 0.8 log10, respectively)2.
Hepatitis B
A
pproximately 350 million people worldwide are living with
chronic hepatitis B,
a virus that affects the liver and is estimated to be 100 times
more infectious than human immunodeficiency virus (HIV
)3
. Chronic hepatitis B can lead to cirrhosis,
hepatocellular
carcinoma, organ failure and death3. Worldwide,
Hepatitis B is the second most common cause of cancer after
smoking,
and up to one million people are estimated to die annually from
hepatitis B-related chronic liver disease3.
In the
UK
, the Department of Health estimates that around 180,000 people
are currently suffering from chronic hepatitis B
3
.
###
References
1.
Sebivo, Summary of Product Characteristics, Novartis 2007
2.
Bzowej N et al. A randomized trial of telbivudine vs adefovir
for HbeAG-positive chronic hepatitis B: efficacy through week
76, predictors of response and effects of switching to
telbivudine. DDW 2007. Abstract S1774
3.
Hepatitis B: Out of the Shadows, Foundation for Liver Research,
October 2004, www.britishlivertrust.org.uk
