CARATTERIZZAZIONE MOLECOLARE DELLA FARMACO-RESISTENZA IN PAZIENTI NAIVE CON EPATITE CRONICA B TRATTATI CON ENTECAVIR

LONG-TREATMENT OF ENTECAVIR IN NUCLEOSIDE-NAÏVE PATIENTS WITH CHRONIC HEPATITIS B INFECTION The nucleoside analogue (NUC) entecavir (ETV) is a first line option for NUC-naïve patients with chronic hepatitis B, with a remarkable record of efficacy and safety in registration trials, but limited validation in field practice. Aim: to assess the outcome of ETV therapy in real life, previously untreated patients with chronic hepatitis B. Methods: 119 NUC-naïve patients with chronic hepatitis B (57 years, 75% HBeAg negative, 54% cirrhosis), consecutively recruited in A. M. Centro Migliavacca Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, were treated with ETV 0.5 mg for 36 months. Clinical, laboratory and virology (HBV DNA (LLQ < 12 IU/mL) surveillance was performed every 3 months while the RT resistance pattern was looked for by INNO-LiPA V2-3 at baseline and every 3 months. Results: serum HBV DNA became undetectable in 80% , 93% and 97% of the patients at week 48, 96 and 144, respectively, with time to virological response being significantly affected by baseline viremia (p<0.001). The 96-week cumulative probability of HBV DNA undetectable (< 12 IU/mL ) was 98% in patients without baseline mutations and 93% in patients with baseline mutations. No patient had to discontinue ETV for serious adverse events. Conclusions: ETV monotherapy efficiently suppresses HBV in the vast majority of real-life, NUC-naïve patients with chronic hepatitis B, independently on initial HBeAg status and cirrhosis.