| Objective:PegIFNα-2a based ADV combination and/or extended treatment method according to the changes of HBV markers (HBV DNA, HBeAg, HBsAg). Observe the efficacy of this stepwise optimization strategy based on PegIFN α-2aMethod:A total of 78 adult HBeAg positive CHB patients who received optimized therapy based on PegIFNα-2a who were seen between 2008 and 2012 at Huashan hospital were screened for study inclusion. Each patients initiated PEGIFNa-2a therapy. At week 12-24, patients achieved early virological response (EVR defined as HBV DNA achieving 2 1g copies/ml reduction and HBV DNA less than 4 1g copies/ml at week 24) continued PegIFNa-2a therapy. Patients did not achieve EVR added on adeforvir to rescue. Then patients achieved 48w potential response (defined as 1.0≤ HBeAg≤ 10.0 s/co or HBeAg>10.0 s/co but HBsAg<1000 IU/ml at week 48) but did not get HBeAg seroconversion before 48 week continued PEGIFNα-2a or PEGIFNa-2a plus adefovir extended therapy, other patients withdrawed PEGIFNα-2a at week 48.All the patients received liver and kindney functions, blood routine test, electrolyte, zymography, coagulation fuction tests, HBV serologies test, HBsAg quantification, HBV DNA quantification, HAV, HCV, ,HEV, CMV, EBV, HIV test,autoantibodies, thyroid function,electrocardiogram,ultrasound tests and so on before receive antiviral therapy. All the patients exclude HAV, HCV, HEV, CMV, EBV infenction, alcoholic liver disease, autoimmune liver disease and drug induced liver disease. Monitoring blood routine test, liver and kindney function, electrolyte, HBC seologies, HBV and HBsAg quatification during treatment period. Aims to observe efficacy and predictive factors of this stepwise optimized therapy based on PEGIFNa-2a.Results (1) The HBeAg seroconversion rate and HBsAg clearance rate of patients who followed stepwise optimization therapy reached to 46.2% and 9% after 24-week post-treatment,the cumulative HBeAg seroconversion rate and HBsAg clearance rate was 68.7% and 21% at 120 week. (2) In Add-on ADV group (patients who did not get 12-24W ER), the HBeAg seroconversion rate and HBsAg reached to 36.8% and 5.3% after 24-week post-treatment,the cumulative HBeAg seroconversion rate and HBsAg clearance rate was 55.3% and 10.7% at 120 week. (3) For patients who fitted for extended optimization strategy in PegIFNα-2a group, the the HBeAg seroconversion rate after 24-week post-treatment was higher in per-protocal patients (85.7%) than those was protocol deviation (25%, P=0.046)Conclusion:PegIFNα-2a based on stepwise optimization strategy by using HBV DNA,HBeAg,HBsAg quantification during treatment period can typically enhance clinical efficacy for HBeAg positive chronic hepaties B patients.Predictors of PegIFNα-2a based on stepwise optimization strategy in HBeAg positive hepatitis B patientsObjective: PegIFNα-2a based ADV combination and/or extended treatment method according to the changes of HBV markers (HBV DNA, HBeAg, HBsAg). Observe the predictor factors of this stepwise optimization strategy based on PegIFNα-2aMethod:A total of 78 adult HBeAg positive CHB patients who received optimized therapy based on PegIFNα-2a who were seen between 2008 and 2012 at Huashan hospital were screened for study inclusion. We use logistic regression and receiver operating characteristic curves method to analysis predictors of different endpoints in this stepwise optimization strategy based on PegIFNα-2aResulst:(1) HBV DNA(OR=1.80, P= 0.018), HBsAg level(OR=13.52,P=0.003), and ALT>5xULN (OR=0.37, P=0.037)at baseline can predict 12-24W ER.The ROC area of HBV DNA at baseline was 0.695 and the cut-off value was 7.40 log10 copies/ml. The ROC area of HBsAg at baseline was 0.742 and the cut-off value was 4.0 log10 IU/ml. (2) The ALT>5xULN at baseline was an independent predict factor for 48 week HBeAg seroconversion in PegIFNa-2a group (OR=0.06, P=0.032).(3)In PegIFNa-2a group for patients who got 48W PR,follow extended optimization treatment is an independent predictor for HBeAg seroconversion 24 weeks post treatment.(4) In Add-on ADV group HBeAg level at 24 week can predict 48 week optimal response week optimal response (OR=12.6, P=0.005).The ROC area of HBeAg level at 24 week was 0.863 and the cut-off value was 35.0 s/co.Conclusion:In this stepwise optimization strategy HBV DNA, HBsAg, ALT>5 ×ULN at baseline can predict 12-24 week early response, ALT>5×ULN can predict 48 week HBeAg seroconversion in PEGIFNa-2a group, HBeAg level at 24 week can predict 48 week potential response in Add-on ADV groups. In PegIFNa-2a group for patients who got 48W PR,follow extended optimization treatment is an independent predictor for HBeAg seroconversion 24 weeks post treatment. |
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