Ezequiel Ridruejo1, Sebastián Marciano2, Omar Galdame2, María V Reggiardo3, Alberto E Muñoz4, Raúl Adrover5, Daniel Cocozzella5, Nora Fernandez6, Claudio Estepo7, Manuel Mendizabal8, Gustavo A Romero4, Diana Levi4, Teresa Schroder7, Silvia Paz7, Hugo Fainboim7, Oscar G Mandó9, Adrián C Gadano2, Marcelo O Silva8. 1. Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC". Ciudad Autónoma de Buenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral. Pilar, Provincia de Buenos Aires, Argentina. 2. Hepatology and Liver Transplant Unit, Hospital Italiano. Ciudad Autónoma de Buenos Aires, Argentina. 3. Hepatology Unit, Hospital Provincial del Centenario/Sanatorio Americano. Rosario, Provincia de Santa Fe, Argentina. 4. Hepatology Unit, Hospital Dr. Carlos B. Udaondo. Ciudad Autónoma de Buenos Aires, Argentina. 5. Hepatology Unit, Centro de Hepatología. La Plata, Provincia de Buenos Aires, Argentina. 6. Hepatology Unit, Hospital Británico. Ciudad Autónoma de Buenos Aires, Argentina. 7. Hepatology Unit, Hospital Francisco J. Muñiz. Ciudad Autónoma de Buenos Aires, Argentina. 8. Hepatology and Liver Transplant Unit, Hospital Universitario Austral. Pilar, Provincia de Buenos Aires, Argentina. 9. Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC". Ciudad Autónoma de Buenos Aires, Argentina.
Abstract
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.
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.
Authors: Camila V Pereira; Cristiane Valle Tovo; Thiago K Grossmann; Henrique Mirenda; Bruna B Dal-Pupo; Paulo R L de Almeida; Angelo A de Mattos Journal: Mem Inst Oswaldo Cruz Date: 2016-04 Impact factor: 2.743