| Currently, the anti-virus therapy of CHB include nucleoside analogues and interferon(IFN). IFN has both higher HBe Ag seroconversion rate, stable treatment course and delayed response. Telbivudine has a relatively higher seroconversion rate than other nucleoside analogues, and some studies show that it has an immunoregulatory effect. Several studies indicated that patients received sequential treatment of telbivudine after using interferon can achieve better virological response than vice versa. Efficacy of sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with partial responses or poor responses to pegylated interferon is better than telbivudine monotherapy. It is worth noting that there is still no consensus about the optimized regimen for HBe Ag-positive CHB patients with poor response to IFN. In this study, we retrospectively analyzed efficacy of sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with partial responses or poor responses to pegylated interferon compared to the group of observation,then investigated the factors of influence and predictive indexes of the combined response and the optimized population fit for sequential use of telbivudine.The two parts are described below. 1.Efficacy of sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with partial responses to pegylated interferonObjective: To analyze the efficacy of sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with partial responses to pegylated interferonMethods: This study is a retrospective cohort study. The data of 58 HBe Ag-positive CHB patients with partial response to interferon monotherapy for 48-72 weeks were collected from the affiliated First Hospital of Fujian Medical University between January,2009 and December,2013. According to the subsequent treatments, the patients were divided into two groups,one group of sequential use of telbivudine and another group of observation,to compare the biochemicial, viological and serological responses, respectively. Statistical analysis was performed by SPSS 20.0. Chi-square test and independent Student's t test were applied for the categorical and continuous variables, respectively. Continuous variables were described as mean or median(range). Cox regression model was used to predict the factors related to clinical relapse. The Kaplan-Meier method with log-rank test was used to calculate cumulative combined response rates. A P value of two-tailed <0.05 was considered significant.Results:At week 12 and 24, the HBe Ag negative rates were both significantly higher in the group of sequential use of LDT than another(22.6%vs0.0%?29%vs3.7%,P<0.05). At week 48, 22.6% of patients in the group of sequential use of LDT achieved combined response, a rate significantly higher than those in another group(P<0.05). Among 31 patients in the group of sequential use of LDT,there were 11 patients of CK level increased. In two groups, none of the patients exhibited Serious Adverse Reaction like muscular soreness, myositis, peripheral neuropathy, hepatic dysfunction and so on.Conclutions: Sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with partial responses to pegylated interferon makes higher HBe Ag seroconversion and combined response rates in week 48,and sequential theraphy of telbivudine is safty.2.The factors of influence and the optimized population of sequential use of telbivudine in hepatitis B e antigen-positive chronic hepatitis B patients with poor responses to pegylatedInterferon Objective: To investigate the factors of influence and predictive indexes of the combined response and the optimized population fit for sequential use of telbivudine. Methods: This study is a retrospective study. The data of 87 HBe Ag-positive CHB patients with poor response to interferon monotherapy for 24-96 weeks were collected from the affiliated First Hospital of Fujian Medical University between January,2009 and December,2013. Statistical analysis was performed by SPSS 20.0. Cox regression model was used to predict the factors related to clinical relapse. A P value of two-tailed <0.05 was considered significant.Results: HBe Ag seroconversion or combined responseratesof 87 patients at 48,96,144,192 and 240 weeks is 17.24%,22.99%,27.59%,32.18%,33.33%, respectively. Cox proportional hazards analysis indicated that baseline HBs Ag, HBe Ag level and sex were significant predictors of HBe Ag seroconversion and combined response(P<0.05).Stratification analysis indicated that patients whose baseline HBs Ag level under 2500 IU/ml achieved higher HBe Ag seroconversion and combined response rates than above 2500 IU/ml did. Patients whose index of baseline HBs Ag combined HBe Ag is positive had significantly higher HBe Ag negative, HBe Ag seroconversion and combined response rates than the negative did.Conclutions: Serum HBs Ag level and the index of HBs Ag combined HBe Ag are useful for predicting the serological response of hepatitis B e antigen-positive chronic hepatitis B patients with poor responses to pegylated interferon who sequentially treat with telbivudine. Hepatitis B e antigen-positive chronic hepatitis B patients of positive index of HBs Ag combined HBe Ag(HBs Ag?2500 IU/ml and HBe Ag?6 s/co) is the optimized population fit for sequential use of telbivudine. |
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