Document Detail

Efficacy and safety of long term entecavir in chronic hepatitis B treatment naïve patients in clinical practice.
MedLine Citation:
PMID:  24756007     Owner:  NLM     Status:  In-Data-Review    
Background and aims. Entecavir (ETV) is effective and safe in patients with chronic hepatitis B in the short term, but its long term efficacy and safety has not been established. Material and methods. We evaluated HBV DNA clearance, HBeAg/antiHBe and HBsAg/antiHBs seroconversion rates in HBeAg-positive and negative NUC naïve HBV patients treated with ETV for more than 6 months, and predictors of response. Results. A hundred and sixty nine consecutive patients were treated with ETV for a median of 181 weeks. 61% were HBeAg positive, 23% were cirrhotics, and mean HBV-DNA levels were 6,88 ± 1,74 log10 IU/mL. Overall, 156 (92%) patients became HBV DNA undetectable, 92 (88%) HBeAg positive and 64 (98%) HBeAg negative patients. Seventy four (71%) patients cleared HBeAg after a median of 48 weeks of treatment, 23 (14%) patients cleared HBsAg (19 HBeAg positive and 4 HBeAg negative, p 0.025) after a median of 96 weeks of treatment, and 22 (13%) patients developed protective titers of anti-HBs. At the end of the study, 35 (20%) patients had discontinued therapy: 33 HBeAg positive and 2 HBeAg negative; 9 of them (26%) developed virological relapse after a median of 48 weeks of stopping treatment. None of the patients had primary non response and one patient developed breakthrough. Two patients developed HCC, three underwent liver transplantation and 3 deaths were attributable to liver-related events. No serious adverse events were reported. Conclusion. Long term ETV treatment showed high virological response rates, and a favorable safety profile for NUC-naive HBeAg-positive and negative patients treated in clinical practice.
Ezequiel Ridruejo; Sebastián Marciano; Omar Galdame; María V Reggiardo; Alberto E Muñoz; Raúl Adrover; Daniel Cocozzella; Nora Fernandez; Claudio Estepo; Manuel Mendizabal; Gustavo A Romero; Diana Levi; Teresa Schroder; Silvia Paz; Hugo Fainboim; Oscar G Mandó; Adrián C Gadano; Marcelo O Silva
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of hepatology     Volume:  13     ISSN:  1665-2681     ISO Abbreviation:  Ann Hepatol     Publication Date:    2014 May-Jun
Date Detail:
Created Date:  2014-04-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101155885     Medline TA:  Ann Hepatol     Country:  Mexico    
Other Details:
Languages:  eng     Pagination:  327-36     Citation Subset:  IM    
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