Once-daily
Clevudine Demonstrates Early HBV Suppression and Biochemical Improvement in Hepatitis
B Patients with Liver Cirrhosis
Clevudine
is an oral, once-daily pyrimidine nucleoside analog that Pharmasset is developing
for the treatment of HBV
Clevudine
is an experimental antiviral drug in Phase III development for the treatment of
chronic hepatitis B.
The
present study, presented at the HEP-DART conference in Lahaina, Hawaii (December
9-13, 2007), was conducted to evaluate early biochemical and virological response
to clevudine in chronic hepatitis B patients with liver cirrhosis.
Data
on 13 patients diagnosed with chronic hepatitis B and liver cirrhosis were collected
from a single hospital. All patients in the present analysis had been treated
for at least 1 month with 30 mg once-daily clevudine.
HBV
DNA was quantified by a bDNA assay with a lower limit of detection of 141,500
copies/mL.
Results
•
The
median HBV DNA level before therapy was 7.3 log10
copies/mL.
•
The
median change in HBV DNA levels from baseline was -1.5 log10
copies/mL after 1 month (n=13) and -2.7 log10
copies/mL after 3 months of therapy (n=4).
•
Serum
HBV DNA levels were below 141,500 copies/mL in 46% of patients (6 of 13) at 1
month and 75% of patients (3 of 4) after 3 months of therapy.
•
At
baseline, the median ALT was 51 IU/L and 3 patients had normal ALT.
•
46%
(6 of 13) at 1 month and 100% (4 of 4) at 3 months had normal ALT.
Conclusion
These
promising findings led the researchers to conclude that once-daily clevudine therapy
produced early viral suppression and significant biochemical improvement in hepatitis
B patients with liver cirrhosis.
Ewha
Womans University, Konkuk University Hospital, Inje University Ilsan Paik Hospital,
Youngnam University Medical Center, Kosin Medical School, 6Inje University Sanggye
Paik Hospital, Sungkyunkwan University Samsung Medical Center, Kyungpook National
University Hospital, Inje University Busan Paik Hospital.
1/015/08
Reference
K W Chung, C Hong Lee , J Sung Lee, and others. Early biochemical and
virological response of clevudine therapy in patients with HBV associated liver
cirrhosis. Abstracts of the Frontiers in Drug Development in Viral Hepatitis (HEP
DART) conference. Lahaina, Hawaii. December 9 - 13, 2007.
