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-na飗e 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-na飗e, 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-na飗e patients according to baseline cirrhosis status are presented below:?
Baseline Cirrhosis Treatment-naive Patients |
|
HBeAg(+) |
HBeAg(+) 牋?/b> |
牋ETV ?/b> |
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?/b> |
96% |
66% |
59% |
36% |
95% |
91% |
57% |
72% |
ALT <1.0 X牋 ULN牋 |
60% |
70% |
52% |
62% |
79% |
79% |
57% |
73% |
Histologic Improvement*牋 |
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 LACE w:st="on">E SchiffLACE> 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. LACE w:st="on">San Francisco, CALACE>. |