| Hepatitis B virus(HBV)infection is a major public health problem worldwide,especially in highly endemic are as like China.The epidemiological investigation during the population of our country in 2006 showed the carrying rate for hepatitis B surface antigen(HBs Ag)was about 7.18%,and the number of chronic hepatitis B(CHB)patients was about 30 million.The progressive chronic disease ending in acute hepatitis,liver failure,cirrhosis and hepatocellular carcinoma,which seriously threat public health.Most of antiviral therapies for CHB patients aim to achieve HBs Ag clearance.In our country,most of CHB patients were the results of mother to child transmission(MTCT)and infection amongst toddlers,and HBs Ag clearance was hard to become reality for these guys.During the patients who achieved HBs Ag spontaneous serological clearance,the cure rate was just about 0.5%~1.5%.Nucleos(t)ide analogues(NAs)is a kind of drugs which could inhibit HBV replication in different pathways,and further improve the liver function,postpone the progress of CHB.Some researches showed the HBs Ag clearance rate of NAs therapy and Interferon(IFN)is about 0%~3% and 3.0%~7.0%,respectively.Also,some scientists reported that the combination of NAs and IFN or the sequential IFN therapy after NAs could increase the HBs Ag clearance rate.Because of the side effect of IFN and the high price,the application of IFN was limited in clinical.Thus,it is importan t to find out the features of CHB patients who has high HBs Ag clearance rate after IFN therapy.Some reports showed that the CHB patients with low HBs Ag level w ere easier to achieve HBs Ag clearance.Therefore,the purpose of this study is to investigate th e curative effect,influencing factors and figure out the optimal course of IFN treatment on CHB patients with low HBs Ag level who intended to achieve HBs Ag clearance,and explore more evidences for the application of IFN.MethodsA total of 74 CHB patients with low HBs Ag levels(HBs Ag<3 000 IU/m L)who received pegylated or conventional IFN treatment for at least 24 weeks in our department from January 2012 to August 2014 were enrolled in this retrospective study.All patients were divided into response group,partial response group and non-response group depending on HBs Ag and HBe Ag status at the week 24,48 and 72 of IFN treatment.Non parametric tests,Chi-square tests and Logistic regression were used to analyze the baseline characteristics,HBV serum markers and other laboratory parameters before,during and after treatment to find out the influencing factors on the efficacy of IFN treatment.Results1.Twenty-five of 74 patients(33.8%)achieved response at the end of the treatment.and 19 of them(25.7%)achieved HBs Ag seroconversion,which accounts for 76%(19/25)of the total response patients.2.In the 24-week analysis,single factor analysis and multiple factors analysis showed that only 12-week's HBs Ag falling percentage was statistical difference(OR=1.058,95% CI=1.014~1.105,p =0.010).The decreased percentage of HBs Ag quantitation at week 12 could predict the efficacy at week 24 of the treatment,the area under the ROC curve was 0.860,cut-off value was 78.9,sensitivity was 88.9% and specificity was 81.5%.Positive predict value was 40% and negative predict value was 98.1%.3.In the 48-week analysis,single factor analysis showed that HBs Ag quantitation?12-and 24-week's HBs Ag falling percentage were statistical difference(p=0.049,0.006,0.008);multiple factors analysis showed that baseline level of HBV DNA and the decreased percentage of HBs Ag quantitation at week 24 could predict the efficacy at week 48(OR=9.116,95% CI=1.202~69.120,p=0.033;OR=1.089,95% CI=1.025~1.156,p=0.006),the area of the HBs Ag quantitation at week 24 under the ROC curve was 0.870,Cut-off value was 69.7,sensitivity was 100% and specificity was 72.2%.Positive predict value was 54.5% and negative predict value was 100%.4.There was a positive liner relationship between HBs Ag clearance rate and treatment duration within 48 weeks.Twenty-one of the 74(28.4%)patients achieved response at week 48,which accounts for 84.0 %(21/25)of the total response patients at the end of treatment.HBs Ag clearance rate could only be further improved with prolonged treatment of Peg-IFN.5.Pegylated IFN(Peg-IFN)had a better effect on HBs Ag clearance than ordinary IFN(41.9% vs 22.6%,p=0.084).But it was no statistical difference.Conclusions1.Clinical cure rate of IFN treatment is higher in patients with low HBs Ag levels(HBs Ag < 3 000 IU/m L)than those with high HBs Ag levels.2.The curative efficacy of Peg-IFN is a little better than ordinary IFN.3.The decreased level of HBs Ag quantitation at week 12 and 24 can predict the efficacy of subsequent treatment.4.For the common situation,48 weeks of IFN treatment is recommended.But if HBs Ag clearance did not achieved at week 48 by Peg-IFN treatment,it would be necessary to estimate the decrease of HBs Ag at that time before extend the treatment to week 72. |
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