Abstract | BACKGROUND: 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.
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Authors | María Buti, Rosa Maria Morillas, Martín Prieto, Moisés Diago, Juan Pérez, Ricard Solà, Lucía Bonet, Antonio Palau, Milagros Testillano, Javier García-Samaniego, Manuel Rodríguez, ORIENTE Study Group |
Journal | European journal of gastroenterology & hepatology
(Eur J Gastroenterol Hepatol)
Vol. 24
Issue 5
Pg. 535-42
(May 2012)
ISSN: 1473-5687 [Electronic] England |
PMID | 22382708
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- DNA, Viral
- Hepatitis B Surface Antigens
- Hepatitis B e Antigens
- entecavir
- Guanine
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Topics |
- Adult
- Antiviral Agents
(adverse effects, therapeutic use)
- DNA, Viral
(blood)
- Drug Evaluation
(methods)
- Female
- Guanine
(adverse effects, analogs & derivatives, therapeutic use)
- Hepatitis B Surface Antigens
(blood)
- Hepatitis B e Antigens
(blood)
- Hepatitis B virus
(genetics, isolation & purification)
- Hepatitis B, Chronic
(drug therapy, virology)
- Humans
- Male
- Middle Aged
- Retrospective Studies
- Treatment Outcome
- Viral Load
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