Long-term virological outcome in chronic hepatitis B patients with a partial virological response to entecavir

Abstract

Background/Aims: The clinical outcome of patients with a partial virological response (PVR) to entecavir (ETV), in particular nucloes(t)ide analogue (NA)-experienced patients, has not been thoroughly investigated. The aim of the present study was to assess long-term outcomes in NA-naive and NA-experienced chronic hepatitis B patients with a PVR to ETV. Methods: Chronic hepatitis B patients treated with ETV (0.5 mg/day) for at least 1 year were enrolled retrospectively. PVR was defined as a decrease in hepatitis B virus (HBV) DNA titer of more than 2 log10 IU/mL, yet with residual serum HBV DNA, as determined by real time-polymerase chain reaction, at week 48 of ETV therapy. Results: A total of 202 patients (127 NA-naive and 75 NA-experienced, male 70.8%, antigen positive 53.2%, baseline serum HBV DNA 6.2 ± 1.5 log10 IU/mL) were analyzed. Twenty-eight patients demonstrated a PVR. The PVR was associated with a high serum HBV DNA titer at baseline and at week 24. Virological response (< 60 IU/mL) was achieved in 46.2%, 61.5%, 77.6%, and 85% of patients with PVR at week 72, 96, 144, and 192, respectively. Resistance to antivirals developed in two NA-experienced patients. Failure of virological response (VR) in patients with PVR was associated with high levels of serum HBV DNA at week 48. Conclusions: Patients with PVR to ETV had favorable long-term virological outcomes. The low serum level of HBV DNA (< 200 IU/mL) at week 48 was associated with subsequent development of a VR in patients with PVR to ETV.