Brief communicationLong-Term Treatment With Entecavir Induces Reversal of Advanced Fibrosis or Cirrhosis in Patients With Chronic Hepatitis B
Section snippets
Methods
Nucleoside-naive, HBeAg(+) and HBeAg(−) patients, who had been treated with 0.5 mg entecavir in the phase III studies ETV-022 and ETV-027, followed by 1.0 mg entecavir daily in an open-label rollover study (ETV-901) and had cirrhosis/advanced fibrosis at baseline (Ishak fibrosis score, ≥4) were included in this analysis.6, 7 Patients had received at least 3 years of entecavir and had evaluable biopsies at baseline and long term. They were evaluated for histologic improvement (≥2-point decrease
Results
Ten patients (7 HBeAg[+] and 3 HBeAg[−]) had an Ishak fibrosis score of 4 to 6 (mean, 4.6) at baseline, indicating advanced fibrosis or cirrhosis (Supplementary Table 1). All patients were male (mean age, 49.5 y) and 4 were of Asian ethnic origin. At baseline, mean ALT levels were 168 U/L, mean HBV DNA level was 8.7 log10 copies/mL, and the mean Knodell necroinflammatory and Ishak fibrosis scores were 10.3 and 4.6, respectively. Mean baseline albumin levels were 4.3 g/dL and the mean baseline
Discussion
Patients with CHB infection who have developed advanced liver fibrosis or cirrhosis are at increased risk of developing further complications, such as HCC. The efficacy and safety of long-term treatment with entecavir in nucleoside-naive HBeAg(+) and (−) CHB patients with advanced fibrosis or cirrhosis was investigated in this analysis. All patients demonstrated improvement in liver histology and regression of fibrosis after a median treatment period of approximately 6 years with entecavir. A
Acknowledgments
Editorial support was provided by Katrin Guðmundsdóttir; this assistance was funded by Bristol-Myers Squibb Company.
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Conflicts of interest These authors disclose the following: Eugene Schiff is a member of the scientific advisory board for Bristol-Myers Squibb Company, Gilead, GlobeImmune Inc, Johnson and Johnson, Merck, Roche Molecular, Schering-Plough, and Vertex Pharmaceuticals; is a member of the Data and safety Monitoring Board for Daiichi-Sankyo, Johnson and Johnson, Pfizer, Salix Pharmaceuticals Inc, and Sanofi Aventis; and has received grant/research support including clinical trials from Abbott, Anadys, Bristol-Myers Squibb Company, Gilead, GlobeImmune Inc, Merck, Medtronics, Roche Diagnostics, Roche Molecular, Salix Pharmaceuticals Inc, Sanofi Aventis, Schering-Plough, Sciclone, and Vertex Pharmaceuticals. Samuel Lee has received consulting, research grants, and speakers' honoraria from Bristol-Myers Squibb Company. Yoav Lurie has received speakers' honoraria from Bristol-Myers Squibb Company. Suzanne Beebe, Dong Xu, Hong Tang, and Uchenna Iloeje are employees of Bristol-Myers Squibb. The remaining authors disclose no conflicts.
Funding This study was sponsored by Bristol-Myers Squibb Company. The sponsor collated the data, monitored study conduct, performed the statistical analysis, and coordinated the writing of the manuscript with the authors.