RESUMO
BACKGROUND & AIMS: Long-term treatment with entecavir resulted in durable virologic suppression and continued histologic improvement in nucleoside-naive chronic hepatitis B patients. Patients with advanced fibrosis or cirrhosis, who received long-term entecavir treatment, were evaluated for improvement in liver histology. METHODS: The study included a subset of patients from phase III and long-term rollover studies, who received entecavir for at least 3 years, had advanced fibrosis or cirrhosis, and evaluable biopsies at baseline and after long-term treatment. RESULTS: Ten patients had advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score, ≥ 4). After approximately 6 years of cumulative entecavir therapy (range, 267-297 wk), all 10 patients showed improvement in liver histology and Ishak fibrosis score. The mean change from baseline in Ishak fibrosis and Knodell necroinflammatory scores were -2.2 and -7.6, respectively. A reduction in Ishak fibrosis score to 4 or less was observed for all 4 patients who had cirrhosis at baseline. CONCLUSIONS: Chronic hepatitis B patients with advanced fibrosis or cirrhosis demonstrated histologic improvement and reversal of fibrosis and cirrhosis after long-term treatment with entecavir.
Assuntos
Antivirais/administração & dosagem , Guanina/análogos & derivados , Hepatite B Crônica/complicações , Hepatite B Crônica/tratamento farmacológico , Cirrose Hepática/patologia , Ensaios Clínicos como Assunto , Guanina/administração & dosagem , Histocitoquímica , Humanos , Masculino , Microscopia , Pessoa de Meia-Idade , Índice de Gravidade de DoençaRESUMO
UNLABELLED: Sustained virologic suppression is a primary goal of therapy for chronic hepatitis B (CHB). In study entecavir (ETV)-022, 48 weeks of entecavir 0.5 mg was superior to lamivudine for virologic suppression for hepatitis B e antigen (HBeAg)-positive CHB. A total of 183 entecavir-treated patients from ETV-022 subsequently enrolled in study ETV-901. We present the results after up to 5 years (240 weeks) of continuous entecavir therapy. The entecavir long-term cohort consists of patients who received >or=1 year of entecavir 0.5 mg in ETV-022 and then entered ETV-901 with a treatment gap Assuntos
Antivirais/uso terapêutico
, Guanina/análogos & derivados
, Antígenos E da Hepatite B/sangue
, Hepatite B Crônica/sangue
, Hepatite B Crônica/tratamento farmacológico
, Adulto
, Método Duplo-Cego
, Feminino
, Guanina/uso terapêutico
, Humanos
, Masculino
, Fatores de Tempo