Comparing The Efficacy Of Passive-active Immunoprophylaxis Using Different Doses Of Hepatitis B Immunoglobulin In Newborns Of HBsAg Positive Mothers

Objectives: HBV is a worldwide epidemic disease, which can transmit through blood,blood products, mother to child, broken skin, andmucous membranes and sexualcontact. Mother to child HBV transmission occurs in perinatal. the newborns ofHBsAg and HBeAg are positive mother, if we do not take any immune precautionary,85%~90%can become chronic HBV patients.30%~40%also can become chronicHBV patients, if the child of mother is HBsAg positive. All of these can become animportant source of HBV infection.This study sets up a long-term follow-up cohort,to research economic and efficient way to block perinatal transmission of HBV byassessing the efficacy of passive-active immunoprophylaxis with different doses ofhepatitis B immunoglobulin (HBIG) in newborns of HBsAg, putting forward the bestblocking strategy.(1) To explore economic and efficient way to block perinataltransmission of HBV by assessing the efficacy of passive-active immunoprophylaxiswith different doses of hepatitis B immunoglobulin (HBIG) in newborns of HBsAgpositive mothers in China, and analyzing the reasons of failure.(2) To study therelationship between serum HBeAg,HBsAg and HBVDNA concentration in HBsAgpositive mothers, and providing an effective basis for the blocking effect of differentdoses of hepatitis B immunoglobulin (HBIG).(3) To study the distribution of thegenotypes of HBsAg positive mothers in taixing and chuzhou of jiangsu province,and their effecting to block.Methods:(1) The newborns with HBsAg-positive mothers were randomly dividedinto100IU HBIG and200IU HBIG and received100IU and200IU HBIGrespectively within12hours after birth. Meanwhile all the newborns were received3doses of10ug yeast recombinant hepatitis B vaccine (HB vaccine) according to EPI procedure. Post-vaccination tests to detect HBsAg and anti-HBs were assessed at7months of age, analying the risk factors for blocking failure of HBV.(2) Quantitativemeasurement of serum HBV-DNA (with m2000) and HBeAg (with Architect i2000)were performed in900HBsAg positive mothers.(3) The nPCR was applied for thedetection of the genotypes and subgenotypes of900HBsAg positive mothers intaixing and chuzhou. Also using Real-time PCR(m2000) to detect HBV-DNA.Results:(1) The success rate of100IU and200IU group were98.9%and98.5%respectively. The difference of efficacy between the two groups was not significant,and the HBsAg positive rates between the two groups were also not significantlydifferent with analysis of mothers’HBeAg status.The level of anti-body has beendecreased from2.66±0.68to2.16±0.74l. The HBeAg positive, HBsAg>5000IU/mland HBVDNA>7LogIU/mL were identified as the only risk factors of blocking failureby Cox regression model, with risk ratio (RR) of17.42,11.78,25.71(95%confidenceinterval2.21~137.47,1.49~92.94,3.27~203.52). Other factors such as ALT, TB,body weight(mother and child) and so on have on significant (P>0.05).(2) There are298HBeAg-positive cases and601HBeAg-negative cases, which account for33.20%and66.78%in all901HBsAg-positive pregnant cases, respectively. AndHBV-DNA could be tested from99.67%HBeAg-positive pregnant cases（297in298cases）, among which HBV-DNA of74.83%（223in298cases） samples is no lessthan7LogIU/mL. Furthermore, HBV-DNA level in blood serum of HBeAg-positivepregnant cases shows positive correlation with titer of HBsAg (r=0.53, P<0.01).However, HBV-DNA could be tested in553cases(92.3%) among601HBeAg-negative pregnant cases, and HBV-DNA of0.5%samples is no less than7LogIU/mL. And HBV-DNA level in blood serum of HBeAg-negative pregnant caseshas no relativity with HBsAg(r=-0.05，P>0.05).(3)14.3%was genotype B, and2.4%was genotype B+C, and82.3%was genotype C,0.9%was genotype D in chuzhouregion;15.6%was genotype B, and3.0%was genotype B+C, and79.9%wasgenotype C,1.5%was genotype D in taixing region(P>0.05). The different genotypesof HBV which blocking success rate was no difference(P>0.05); HBeAg-positiverate of the different genotypes of infected persons have significant difference(P<0.05), and the typeB and B+C HBeAg positive rate were higher than typeC (P<0.05); Andthere were difference between B, B+C and type C on the mean level of HBV-DNA(P<0.05).Conclusion:(1) The passive-active immunoprophylaxis using100IU HBIG wassimilar to200IU HBIG to prevent HBV mother to infant infection. The HBeAgpositive, HBsAg>5000IU/ml and HBVDNA>7LogIU/mL were identified as the onlyrisk factors of blocking failure.(2) The relationship between serum HBsAg andHBVDNA concentration are the positive correlation in HBsAg positive mothers whenher HBeAg is positive, HBsAg can act as an indictor for HBV replicative status, theapplication is helpful for clinical practice.(3) The main HBsAg positive mothersinfection in taixing and chuzhou are genotype C. And different genotypes have noeffect to blocking.