Aim of the study was to assess the 3-year effectiveness and safety of Entecavir (ETV) in NUC-naïve patients treated in field practice. Methods: 418 consecutive NUC-naïve patients with chronic hepatitis B were recruited in 18 Liver Units in Italy and treated with ETV 0.5 mg for 38 months (0-45). At baseline, median age was 58 years, 76% males, 83% HBeAg negatives, 49% cirrhotics, 56% with concomitant diseases/medications. Median HBV DNA was 6.0 log IU/ml (range 1.5->9.0) and ALT were elevated in 85% of the patients. Liver function tests and HBV DNA, assessed by a sensitive assays, were performed every 3 months. Virological breakthrough was defined as > 1 log U increase of viremia, a “blip” was the occurrence of detectable viremia (<100 IU/ml) in a virological responder. Results Virological response rates, i.e undetectable HBV DNA, progressively increased over time, from 68% at month 6, to 85% at year 1, 94% at year 2 and 97% at year 3. While a virological breakthrough without drug-resistance occurred in <1% of the patients, a transient, short lasting, blip of viremia was observed in 4%. 35% of the HBeAg positive patients seroconverted to anti-HBe. ALT normalization rates progressively increased up to approximately 90%. No major safety issues were reported. Serum creatinine remained unchanged during treatment [from 0.90 (0.50-9.0) at baseline to 0.89 (0.52-2.0) mg/dl at year 3] as well as the proportion of patients with serum creatinine > 1.5 mg/dl (2% at baseline vs 2% at year 3). Less than 1% of the patients showed > 0.5 mg increase of serum creatinine and/or blood phosphorus levels below 2 mg/dl or significant proteinuria. Overall, 6% of the patients died, 3% were transplanted, 5% changed antiviral therapy (PEG or ETV+TDF), 1% stopped ETV for HBsAg clearance and 5% were lost to follow-up. In conclusion, ETV suppressed HBV replication in most NUC-naïve patients in field practice up to 3 years, with a favourable safety profile.
Entecavir monotherapy in 418 NUC-naïve patients with chronic hepatitis B from field practice : high efficacy and favorable safety profile over 3 years of treatment / P. Lampertico, M. Viganò, R.M. Soffredini, F. Facchetti, E. Minola, O. Fracassetti, F. Suter, S. Zaltron, A. Vavassori, G. Carosi, E. Angeli, G.A. Gubertini, C.F. Magni, A. Testa, G. Antonucci, M. Vinci, G. Pinzello, E. Fatta, S.R. Fargion, P. Del Poggio, B. Coco, M.R. Brunetto, M. Andreoletti, A. Colli, M. Fasano, T. Santantonio, G. Colloredo, L. Pasulo, S. Fagiuoli, A.E. Colombo, G.A. Bellati, F. Fumagalli Maldini, M. Milanese, M. Pozzi, N.M. Terreni, G. Spinzi, M. Quagliuolo, G. Lunghi, M. Colombo. - In: HEPATOLOGY. - ISSN 0270-9139. - 54:suppl. 1(2011 Oct), pp. 1043A-1043A. ((Intervento presentato al 62. convegno Annual meeting of the American association for the study of liver diseases : the liver meeting tenutosi a San Francisco (CA) nel 2011.
Entecavir monotherapy in 418 NUC-naïve patients with chronic hepatitis B from field practice : high efficacy and favorable safety profile over 3 years of treatment
P. Lampertico;M. Viganò;R.M. Soffredini;F. Facchetti;S.R. Fargion;M. Colombo
2011
Abstract
Aim of the study was to assess the 3-year effectiveness and safety of Entecavir (ETV) in NUC-naïve patients treated in field practice. Methods: 418 consecutive NUC-naïve patients with chronic hepatitis B were recruited in 18 Liver Units in Italy and treated with ETV 0.5 mg for 38 months (0-45). At baseline, median age was 58 years, 76% males, 83% HBeAg negatives, 49% cirrhotics, 56% with concomitant diseases/medications. Median HBV DNA was 6.0 log IU/ml (range 1.5->9.0) and ALT were elevated in 85% of the patients. Liver function tests and HBV DNA, assessed by a sensitive assays, were performed every 3 months. Virological breakthrough was defined as > 1 log U increase of viremia, a “blip” was the occurrence of detectable viremia (<100 IU/ml) in a virological responder. Results Virological response rates, i.e undetectable HBV DNA, progressively increased over time, from 68% at month 6, to 85% at year 1, 94% at year 2 and 97% at year 3. While a virological breakthrough without drug-resistance occurred in <1% of the patients, a transient, short lasting, blip of viremia was observed in 4%. 35% of the HBeAg positive patients seroconverted to anti-HBe. ALT normalization rates progressively increased up to approximately 90%. No major safety issues were reported. Serum creatinine remained unchanged during treatment [from 0.90 (0.50-9.0) at baseline to 0.89 (0.52-2.0) mg/dl at year 3] as well as the proportion of patients with serum creatinine > 1.5 mg/dl (2% at baseline vs 2% at year 3). Less than 1% of the patients showed > 0.5 mg increase of serum creatinine and/or blood phosphorus levels below 2 mg/dl or significant proteinuria. Overall, 6% of the patients died, 3% were transplanted, 5% changed antiviral therapy (PEG or ETV+TDF), 1% stopped ETV for HBsAg clearance and 5% were lost to follow-up. In conclusion, ETV suppressed HBV replication in most NUC-naïve patients in field practice up to 3 years, with a favourable safety profile.
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