Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B

✍ Scribed by Ting-Tsung Chang; Yun-Fan Liaw; Shun-Sheng Wu; Eugene Schiff; Kwang-Hyub Han; Ching-Lung Lai; Rifaat Safadi; Samuel S. Lee; Waldemar Halota; Zachary Goodman; Yun-Chan Chi; Hui Zhang; Robert Hindes; Uchenna Iloeje; Suzanne Beebe; Bruce Kreter

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 679 KB
• Volume: 52
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.23785

✦ Synopsis

One year of treatment with entecavir (0.5 mg daily) in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) resulted in significantly improved liver histology and virological and biochemical endpoints in comparison with lamivudine. Patients who received at least 3 years of cumulative entecavir therapy in phase 3 studies and a long-term rollover study and underwent long-term liver biopsy were evaluated for improvements in histological appearance. Sixty-nine patients [50 HBeAg-positive and 19 HBeAg-negative] receiving entecavir therapy underwent longterm liver biopsy (median time of biopsy 5 6 years, range 5 3-7 years). Histological improvement was analyzed for 57 patients who had adequate baseline biopsy samples, baseline Knodell necroinflammatory scores !2, and adequate long-term biopsy samples. At the time of long-term biopsy, all patients in the cohort had a hepatitis B virus DNA level <300 copies/mL, and 86% had a normalized alanine aminotransferase level. Histological improvement (!2-point decrease in the Knodell necroinflammatory score and no worsening of the Knodell fibrosis score) was observed in 96% of patients, and a !1-point improvement in the Ishak fibrosis score was found in 88% of patients, including all 10 patients with advanced fibrosis or cirrhosis at the phase 3 baseline. Conclusion: The majority of nucleoside-naive patients with CHB who were treated with entecavir in this longterm cohort achieved substantial histological improvement and regression of fibrosis or cirrhosis. (HEPATOLOGY 2010