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.
|Titolo:||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|
|Settore Scientifico Disciplinare:||Settore MED/09 - Medicina Interna|
|Data di pubblicazione:||ott-2011|
|Enti collegati al convegno:||American Association for the Study of Liver Diseases|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1002/hep.24666|
|Appare nelle tipologie:||01 - Articolo su periodico|