Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients.
Eur J Gastroenterol Hepatol
; 24(5): 535-42, 2012 May.
Article
em En
| MEDLINE
| ID: mdl-22382708
ABSTRACT
BACKGROUND:
Entecavir is an effective treatment for chronic hepatitis B. However, data from clinical practice are limited, especially in hepatitis B e antigen (HBeAg)-positive patients.METHODS:
We retrospectively analysed data from 190 nucleos(t)ide-naive chronic hepatitis B patients treated with entecavir (0.5 mg/day) in 25 Spanish centres. Virological response (hepatitis B virus DNA <50 IU/ml by PCR), biochemical response (alanine aminotransferase ≤ 1 × upper limit of normal) and serological response were assessed at weeks 12, 24, 36 and 48.RESULTS:
The cohort was 73% male, 84% Caucasian, and 30% HBeAg-positive. Thirty-four per cent of the patients who underwent biopsy had advanced fibrosis/cirrhosis. At baseline, the median hepatitis B virus DNA was 5.94 (interquartile range=4.64-7.39) log10 IU/ml. At week 48, 83% of the patients (61% HBeAg-positive; 92% HBeAg-negative) achieved a virological response and 82% (78% HBeAg-positive; 83% HBeAg-negative) of those with elevated baseline alanine aminotransferase showed a biochemical response. Twenty-six per cent (14/54) of the HBeAg-positive patients lost HBeAg and 22% (12/54) achieved seroconversion to anti-HBe. A significant correlation was observed between virological response at week 12 and the rate of seroconversion to anti-HBe at week 48 (P=0.039). This correlation was also noted at weeks 24, 36 and 48 (P=0.003, 0.002 and 0.017, respectively). Three patients (2%) showed clearance of hepatitis B surface antigen. No resistance to entecavir was observed. Treatment with entecavir was generally well tolerated. No patients discontinued treatment due to adverse events.CONCLUSION:
Entecavir monotherapy in clinical practice was well tolerated and resulted in a rapid and significant reduction in viral load. A virological response at week 12 correlated significantly with the rate of seroconversion to anti-HBe at week 48.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Hepatite B Crônica
/
Guanina
Tipo de estudo:
Observational_studies
Limite:
Adult
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Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Eur J Gastroenterol Hepatol
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Espanha