| Objectives:To analyze the efficacy of peginterferon alpha treatment in 210 treatment-naive and NAs experienced HBeAg-Positivechronic hepatitis B patients and discuss whether peginterferon alpha and NAs combination therapy for the treatment of the HBeAg positive CHB patientsis better than that of peginterferon alpha monotherapy at different timing.Methods:Collecting the HBeAg positive CHB patients used peginterferon alpha as the antiviral treatment from January 2010 to December 2014 in outpatient and hospitalized patientsfrom the Infectious Disease Department in the first affiliated hospital of Kunming Medical University, the duration of peginterferon alpha therapy was 48 weeks.Patients were divided into treatment-naive patients (group A) and NAs experienced patients (group B, C, D, E).In group A, used by peginterferon alpha only were defined as group A1,peginterferon alpha and NAs combination therapy were divided into group A2. NAs experienced patients were divided into four groups(B, C, D, E) according to the timing of peginterferon alpha sequent or be added on NAs:The duration of NAs therapy before peginterferon alpha sequent or be added on was less than or equal to 24 weeks(group B), and sequential therapy were divided into group B1,adding peginterferon alpha combination therapy were divided into group B2.The duration of NAs therapy before peginterferon alpha sequent or be added on was more than 24 weeks, and the HBV-DNA was undetectable, HBeAg seroconversion hasn’t occurred after the NAs therapy(group C),and sequential therapy were divided into group Cl,adding peginterferon alpha combination therapy were divided into group C2.The duration of NAs therapy before peginterferon alpha sequent or be added on was more than 24 weeks, and the HBV-DNA was undetectable, HBeAg seroconversion has occurred after the NAs therapy(group D),and sequential therapy were divided into group Dl,adding peginterferon alpha combination therapy were divided into group D2.The duration of NAs therapy before peginterferon alpha sequent or be added on was more than 24 weeks, and the HBV-DNA was detectable (group E),and sequential therapy were divided into group El,adding peginterferon alpha combination therapy were divided into group E2.Collecting the baseline age, gender, nationality, history of hepatitis B, HBV-DNA loads,HBsAg quantitative, HBeAg quantitative, ALT level and ALT normalization rate, HV-DNA negative rate, HBeAg seroconversion rate, HBsAg seroconversion at week 12,24,the end of treatment and 24 weeks after end of treatment in each group.Database established by using EXCEL, and the statistical analysis by SPSS 17.0.Results:1.389 patients were involve into this study,179 patients were excluded from study because of losing follow-up and/or missing some important data,210 patients were enrolled in this study finally. The age ranged from 14 to 46 years old, mean age 33.1 years old, mainly were male (153 patients,72.9%), most of them were Han nationality (197 patients,93.8%),the history of hepatitis B of them ranged from 0.5 to 24 years,the mean was 7.68 years. The 72 patients in group A,66 patients in group B,31 patients in group C,23 patients in group D,18 patients in group E, of which,42 patients in group A1,30 patients in group A2,32 patients in group B1,34 patients in group B2,15 patients in group C1 group,16 patients in group C2,11 patients in group D1,12 patients in group D2,7 patients in group E1,11 patients in group E2.2. At the end of the treatment,169 (80.5%) of 210 patients had normal ALT,180 (85.7%) had negative HBV-DNA,106 (50.5%) had HBeAg seroconversion,33 (15.7%) had HBsAg seroconversion. Of which,87 (51.5%) of 169 patients were ALT normal because of peginterferon alpha therapy, and 97 (76.4%) patients of negatice HBV-DNA,75(41.9%) patients of HBeAg seroconversion, 33 (15.7%) of HBsAg seroconversion.3. At week 12 of treatment, A2 group had a significantly higher normal ALT rate than A1 group (53.3% vs 28.6%), and the difference was statistically significant (P= 0.034).At week 24 of treatment, B2 group had a significantly higher rate of normal ALT than 1B group (61.8% vs 37.5%), and the difference was statistically significant (P= 0.049).4. The ALT normal rate at the end of treatment:64 (64.9%) patients in group A,51 (77.3%) patients in group B, all of the patients in group C had ALT normal (100.0%),19 (82.6%) patients in group D,4 (22.2%) patients in group E.The ALT normal rate in group C was higher than that of group B, D, E group, and in group E was lower than that of group A, B, D, the difference was statistically significant (P< 0.05),otherwise, compared any two groups of them, there was no statistically significant difference (P> 0.05). When compared the ALT normal rate of group A1 and A2 (88.1% vs 90.0%), B1 and B2 (81.3% vs 73.5%), D1 and D2 (81.8% vs 83.3%), E1 and E2 (28.6% vs 18.2%), there was no statistically significant difference (P> 0.05).5. The HBV-DNA negative rate at the end of treatment:63 (87.50%) patients in group A,59 (89.4%) patients in group B, and all of the patients from group C and group D had negative HBV-DNA (100.0%),4 (22.2%) patients in group E. The HBV-DNA negative rate of group E was significantly lower than that of group A and B, the difference was statistically significant (P< 0.05), there was no statistically significant difference (P> 0.05) between group A and group B.When compared the HBV-DNA negative rate of group A1 and A2 (85.7% vs 90.0%), B1 and B2 (84.4% vs 84.4%), E1 and E2 (28.6% vs 18.2%),there was no statistically significant difference (P> 0.05).6. The HBeAg seroconversion rate at the end of treatment:46 (63.9%) patients in group A,24 (36.4%) patients in group B,9 (29.0%) patients in group C,4 (22.2%) patients in group E. The HBeAg seroconversion rate of group A was higher than that of group B, C, E group, the difference was statistically significant (P< 0.05), otherwise, compared any two groups of them, there was no statistically significant difference (P> 0.05). When compared the HBeAg seroconversion rate of group Al and A2 (61.9% vs 66.7%), B1 and B2 (34.4% vs 38.2%),C1 and C2 (26.7% vs 31.3%), E1 and E2 (28.6% vs 18.2%), there was no statistically significant difference (P> 0.05).7. The HBsAg seroconversion rate at the end of treatments 1 (29.2%) patients in group A,6 (9.1%) patients in group B,2 (6.5%) patients in group C,4 (17.4%) patients in group D, there was no HBsAg seroconversion occurred in group E.The HBsAg seroconversion rate of group A was higher than that of group B andC,the difference was statistically significant (P< 0.05),otherwise, compared any two groups of them, there was no statistically significant difference (P> 0.05).When compared the HBsAg seroconversion rate of group Al and A2 (28.6% vs 30.0%), B1 and B2 (9.4% vs 8.8%),C1 and C2 (6.7% vs 6.3%),D1 and D2 (18.2% vs 16.7%),there was no statistically significant difference (P> 0.05).8. At 24 weeks after end of treatment, the ALT level dropped to normal had happened in 8 patients, HBeAg seroconversion had occurred in 4 patients, HBsAg seroconversion had occurred in 1 patients.9. Flu-like symptoms and bone marrow suppression were the most common adverse effects, severely adverse effects had not been seen in each group.Conclusions:1. The 48 weeks peginterferon alpha therapy can make treatment-naive and NAs experienced HBeAg positive CHB patients achieved a high normal ALT rate, HBV-DNA negative rate, HBeAg seroconversion rate and HBsAg seroconversion rate.2. Peginterferon alpha and NAs combination therapy may alleviated the early liver inflammation when using peginterferon alpha-based antiviral regimen to treat patients with CHB.3. Different timing of peginterferon alpha and NAs combination therapy were not superior to peginterferon alpha monotherapy in normal ALT rate, HBV-DNA negative rate, HBeAg seroconversion rate and HBsAg seroconversion rate.4. Choosing the peginterferon alpha advantage patients at baseline is very important for using peginterferon alpha-based antiviral treatment regimen for HBeAg positive CHB patients.5. Compared with the NAs experienced patients, treatment-naive patients can achieved higher higher HBeAg seroconversion rate and HBsAg loss or seroconversion rate when using peginterferon alpha-based antiviral treatment regimen.6. Sequented or added-on peginterferon alpha threapy can make part of NAs experienced patients whose NAs therapy duration was less than or equal to 24 weeks achieve HBeAg seroconversion and HBsAg seroconversion.7. Sequented or added-on peginterferon alpha threapy can make part of NAs experienced patients whose NAs therapy duration was more than 24 weeks and HBV-DNA had been undetectable and HBeAg seroconversion had not been occured achieve HBeAg seroconversion and HBsAg seroconversion.8. Sequented or added-on peginterferon alpha threapy can make part of NAs experienced patients whose NAs therapy duration was more than 24 weeks and HBV-DNA had been undetectable and HBeAg seroconversion had been occured achieve HBsAg seroconversion.9. Sequented or added-on peginterferon alpha threapy can make part of NAs experienced patients whose NAs therapy duration was more than 24 weeks and HBV-DNA was positive achieve HBsAg seroconversion. |
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