Efficacy of Entecavir and Lamivudine in Chronic Hepatitis B Patients with Advanced
Fibrosis or Cirrhosis By
Liz Highleyman Over
time, chronic hepatitis B virus (HBV) infection
can cause severe liver disease including cirrhosis
and hepatocellular carcinoma,
but effective treatment may reduce the risk of liver disease progression.  In
prior studies, antiviral treatment with lamivudine
(Epivir-HBV) was shown to slow or reverse disease progression in chronic hepatitis
B patients with advanced liver disease, but lamivudine therapy is limited by the
rapid emergence of drug-resistant virus.
 In
Phase III trials, entecavir (Baraclude)
was superior to lamivudine (both
used as monotherapy) in achieving histological improvement in nucleoside-naive,
lamivudine-refractory patients with compensated
liver disease.
In
the current analysis, presented at the recent 42nd Annual Meeting of the European
Association for the Study of the Liver, researchers assessed treatment response
among 245 patients with advanced liver disease in the entecavir Phase III drug-development
program:
- ETV-022: nucleoside-naive HBeAg
positive patients;
- ETV-027: nucleoside-naive HBeAg
negative patients;
- ETV-026: lamivudine-refractory
HBeAg positive patients.
Liver
biopsies were performed before study entry and after 48 weeks of therapy.
Advanced liver fibrosis/cirrhosis was defined as an Ishak fibrosis score of 4-6
in patients with evaluable paired liver biopsies.
Results
- Approximately 15% of patients
had advanced liver fibrosis/cirrhosis at baseline, and the distribution was well
balanced between treatment arms.
- Efficacy results after 48 weeks
of therapy for patients with advanced liver fibrosis or cirrhosis at baselines
are shown in the table below.
- Patients with advanced disease
receiving entecavir were more likely to experience histological improvement, undetectable
HBV DNA (< 300 copies/mL), and ALT normalization compared
with those receiving lamivudine.
- Safety profiles of entecavir and
lamivudine were comparable in patients
with advanced liver fibrosis/cirrhosis.
Conclusion “Entecavir
treatment was effective in patients with chronic hepatitis B and advanced liver
fibrosis/cirrhosis,” the researchers concluded. “In general, response to entecavir
was comparable between [patients with]
advanced liver fibrosis/cirrhosis and the total patient population.” Hacettepe
University Medical School, Ankara, Turkey; University of Miami School Of Medicine,
Miami, FL; Armed Forces Institute Of Pathology, Washington, DC; Bristol-Myers
Squibb, Wallingford, CT. 05/01/07 Reference
Simsek, E Schiff, Z Goodman, and others. Efficacy of
Entecavir and Lamivudine in Chronic Hepatitis B Patients with Advanced Liver Fibrosis/Cirrhosis.
42nd Annual Meeting of the European Association for the Study of the Liver. April
11-15, 2007. Barcelona, Spain. | 
