Efficacy and safety of long term entecavir in chronic hepatitis B treatment naïve patients 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

ANNALS OF HEPATOLOGY

MEXICAN ASSOC HEPATOLOGY

Lugar: Mexico, DF.; Año: 2014

1665-2681

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.