The Effect Of Administration Of NAs In CHB Patients On Their Offspring:the Mid-term Data Of The Real-world Cohort Study

Objective:China has a large population of hepatitis B.Due to the mother-to-child transmission of hepatitis B,the management of chronic hepatitis B patients at childbearing age is particularly important.This study aimed to observe nucleotide analogs(NAs)administered by parents of childbearing age with chronic hepatitis B(CHB)on the efficacy of blocking hepatitis B virus(HBV)infection and safety of their offspring in real-world settings.Methods:The data of 24 patients with CHB(pregnant or with pregnant spouses)who underwent the long-term oral administration of NAs more than 1 year and their 31 offspring were collected.The control group of chronic hepatitis B patients selected 800 males and 800females of the same age for physical examination in the First Hospital of Shanxi Medical University.The control group of offspring was national survey on physical growth and development of children under seven years of age in nine cities of China in 2015 and the national students’physical health survey in 2014.The growth,development,and HBV markers were analyzed and compared at birth and the time of following-up.The effect of long-term oral administration of NAs on the offspring of patients with CHB was observed.Results:1.In the present real-world cohort study,a total of 24 CHB patients at child-bearing age with administration of NAs underwent the observation,and there was no significant difference in the average height and weight between the obversed patients and those in healthy adults of the same age.2.In the present cohort study,there were 15 patients with oral administration of entecavir,9 with adefovir dipivoxil,and 1 with telbivudine,and the duration of medication before pregnancy or spouse’s pregnancy was 2-11 years with the average of 5.72±2.57years.The liver function of all patients before pregnancy or spouse’s pregnancy was normal;whereas the HBV DNA quantitative was negative except for one male patient was7.34*10~5 IU/mL.The childbearing age ranges from 23 to 36 years old with the average age of 29.5±3.5 years.3.Among the 31 offspring,there were 18 with their fathers being CHB patients,11with their mothers being CHB patients and 2 with their parents being CHB patients,and the liver function for all offspring was normal at the follow-up period;3 cases underwent the follow-up observation or provided the results of five markers of hepatitis B(HBsAg,HBsAb,HBeAg,HBeAb,HBcAb)at birth,while 2 cases with negative hepatitis B and 1with positive HBcAb(the titer 5.73c.o.l);7 cases finished the follow-up at 1 year of age,of which there was 1 with negative hepatitis B markers,6 with positive HBsAb(titer was200-955 mIU/ml);3 cases underwent the follow-up observation at 2 years of age,of which there were 2 with negative hepatitis B and 1 with positive HBsAb(titer was 65 mIU/ml);7cases receiving follow-up at 7-9 years old,of which there were 2 with continuous negative hepatitis B markers and 5 with positive HBsAb(titer was 5.9-540 mIU/ml).4.A total of 31 offspring with their age ranges from 20 days to 9 years old in this cohort received the follow-up.They were all full-term birth,with no significant difference in the height and weight at birth between these offspring and those of normal infants;there was no birth abnormality or defect,and the difference was not statistically significant in the height,weight between these offspring at the follow-up period and those in children of standard age,and the intelligence quotient(IQ)/emotional quotient(EQ)was unremarkable.There were 13 offspring whose mothers were CHB patients,11 of them were breast-fed and 2 were breast-fed.Conclusion:1.For patients at child-bearing age in present study,the administration of anti-hepatitis B virus(HBV)medications,including entecavir,adefovir dipivoxil,and telbivudine in this cohort,with hepatitis b vaccination,hepatitis B immune globulin(HBIG)injection for infants at birth could effectively block the vertical transmission of HBV;2.HBsAb turn positive in half a year-one year after birth and gradually reached the peak,and the continuous positive HBsAb could persist for 7-9 years even more;3.In the real-world mid-term follow-up,adverse effects of oral administration of NAs on growth,and development of offspring,including the development of EQ,and IQ,had not yet appe.