Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic hepatitis B infection.
J Hepatol
; 52(6): 791-9, 2010 Jun.
Article
en En
| MEDLINE
| ID: mdl-20409606
ABSTRACT
BACKGROUND & AIMS:
To evaluate the long-term efficacy of entecavir in nucleoside-naïve chronic hepatitis B patients.METHODS:
One hundred and sixty-seven patients treated with entecavir 0.01mg, 0.1mg or 0.5mg for 24-52weeks in Phase II studies entered rollover study ETV-060 and received entecavir 0.5mg daily. Responses were evaluated among patients with available samples.RESULTS:
After 96weeks in ETV-060 (120-148weeks total entecavir treatment time), 88% (127/144) of patients had HBV-DNA <400 copies/ml; 90.1% (128/142) had alanine aminotransferase (ALT) 1x the upper limit of normal (ULN) among those with abnormal baseline ALT; and 26% (32/121) achieved HBe seroconversion among those HBeAg(+) at baseline. A subset of 66 patients received entecavir 0.5mg (approved dose) from Phase II baseline at week 96 in ETV-060, 83% (48/58) had HBV-DNA <400 copies/ml, 88% (52/59) had ALT 1x ULN, and 20% (10/49) achieved HBe seroconversion. Twenty-one out of 66 patients had paired baseline and on-treatment biopsies 100% (21/21) and 57% (12/21) demonstrated histologic improvement, and improvement in fibrosis, respectively, over 3years. The 3-year cumulative probability of resistance was 3.3% for all patients and 1.7% for the 0.5mg subset.CONCLUSIONS:
Long-term entecavir for nucleoside-naïve patients resulted in high rates of virological, biochemical, and histological response, with minimal resistance.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Antivirales
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Hepatitis B Crónica
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Farmacorresistencia Viral
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Pueblo Asiatico
/
Guanina
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Observational_studies
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Risk_factors_studies
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Hepatol
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2010
Tipo del documento:
Article
País de afiliación:
Japón