[Factors associated with response to lamivudine: retrospective study of 233 patients with chronic hepatitis B]

To identify factors associated with response to lamivudine in chronic hepatitis B patients.

Clinical data of 233 chronic hepatitis B patients treated with lamivudine 100mg daily (91 patients were switched to Adefovir 10mg daily or Adefovir 10mg in combination with lamivudine 100mg daily) were retrospective. HBV DNA level and serum HBV markers were detected by polymerase chain reaction and enzyme-linked immunosorbent assay. Kaplan-Meier, long-rank, t test were conducted to evaluate the data.

(1) The rates of HBV DNA loss, ALT normalization, viral breakthrough(VB), HBeAg loss and seroconversion were 63.4% , 83.8%, 30.9%, 30.9%, and 14.3%, respectively, in HBeAg(+) patients; and these were 84.6%, 81.3%, 14.3%, respectively in HBeAg(-) patients.(2) The rates of HBV DNA loss, HBeAg loss, HBeAg seroconversion, viral breakthrough (VB) were 55% and 66.7% (P more than 0.05), 55.0%, and 66.7% (P less than 0.05), 17.5% and 33.3% (P less than 0.05), 50% and 34.3% (P less than 0.05) in HBeAg(+) patients with baseline ALT less than 2.5 ULN and HBeAg(+) patients with baseline ALT is more than or equal to 2.5 ULN, respectively. (3) For HBeAg(+) patients, viral breakthrough rate was significantly lower in patients with baseline HBV DNA less than 10(6) copies/ml than that in patients with baseline HBV DNA more than 10(6) copies/ml patients (23.4% VS 46.3%, P less than 0.05) among HBeAg(+) patients. (4) The rate of HBV DNA loss, HBeAg loss, HBeAg seroconversion and viral breakthrough for the patients with IVR at week 24 were 76.3%, 72.3%, 40.8% and 28.9% compared to 47.6% (P less than 0.01), 46% (P less than 0.01), 12.7% (P less than 0.01) and 47.6% (P less than 0.05) for those without IVR. (4) For the 44 patients with viral breakthrough, 32 were switched to Adefovir monotherapy or adefovir in combination with lamivudine therapy, and 12 continued to receive lamivudine monotherapy. HBV DNA loss, HBeAg seroconversion were 40.6%, 21.9% for those switch/add group compare to 16.7%, 16.7% for the lamivudine monotherapy group. There were no significant differences in the background factors (sex, diagnosis, antiviral period, pre-tx ALT, pre-tx HBV DNA) between these two groups.

Both the baseline ALT and HBV DNA are associated with the efficacy of lamivudine in chronic hepatitis B patients. Patients with baseline ALT is more than or equal to 2.5*ULN and (or) HBV DNA level of less than 1*10(6) copies/ml have better efficacy and lower rate of breakthrough rate. IVR at week 24 is an important predictive factor of a favorable response to lamivudine therapy. For the patients with viral breakthrough, those switched to/added on Adefovir have a favorable result.