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Efficacy
and Safety of Entecavir and Lamivudine in HBV Patients with Cirrhosis
The long-term outcome of chronic HBV treatment depends
upon potent virologic control; antiviral treatment
has been shown to slow or reverse disease progression in patients with
advanced liver disease.
Entecavir (ETV) [Baraclude] was superior to lamivudine
(LVD) [Epivir-HBV] in achieving
histologic improvement in Phase III studies of compensated,
treatment-naļve and LVD-refractory patients. This report investigates
if severity of liver disease at baseline influenced treatment response
in the ETV Phase III program.
Study ETV-022 and ETV-027 enrolled treatment-naļve, HBeAg(+) and HBeAg(-) patients,
respectively. ETV-026 enrolled LVD-refractory, HBeAg(+) patients.
Liver biopsies were performed before study entry and
after 48 weeks of therapy. Baseline
cirrhosis was defined in patients with evaluable
biopsies as a Knodell fibrosis score of 4.
Results
- Approximately 8% of patients had cirrhosis
at baseline; the distribution of cirrhotic patients was balanced between treatment groups.
- Cirrhotic patients on ETV were more likely than those on LVD to have
histologic improvement, ALT normalization
and undetectable HBV DNA, although the relatively small patient number
limits interpretation.
- Efficacy
results after 48 weeks of therapy for treatment-naļve patients according
to baseline cirrhosis status are presented below:
|
Baseline
Cirrhosis Treatment-naive Patients
|
| |
HBeAg(+)
|
HBeAg(+)
|
|
ETV
|
LVD
|
ETV
|
LVD
|
| Present |
Absent |
Present |
Absent |
Present |
Absent |
Present |
Absent |
| Week
48 |
N=25
|
N=304
|
N=27
|
N=303
|
N=19
|
N=284
|
N=28
|
N=265
|
| HBV
DNA <300 c/mL |
96%
|
66%
|
59%
|
36%
|
95%
|
91%
|
57%
|
72%
|
| ALT
<1.0 X ULN |
60%
|
70%
|
52%
|
62%
|
79%
|
79%
|
57%
|
73%
|
| Histologic
Improvement* |
76%
|
72%
|
67%
|
62%
|
74%
|
70%
|
54%
|
61%
|
*
>/= 2 point decrease in baseline Knodel inflammatory
Score with no worsening of fibrosis. Patients had baseline Knodell
Inflammatory Score >/= 2.
11/16/05
Reference
E Schiff and others. Efficacy and Safety of Entecavir
(ETV) and Lamivudine (LVD) in Compensated, Cirrhotic Patients with Chronic Hepatitis
B. Abstract 986. Program and Abstracts of the 56th annual meeting of the
American Association for the Study of Liver Diseases. November
11-15, 2005. San Francisco,
CA.
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FDA-Approved
Drugs for HBV infection
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