Safety Observation Of TDF Blocking Mother-to-child Transmission Of Hepatitis B Virus At Different Periods Of Withdrawal

BackgroundChronic Hepatitis B Virus（HBV）infection is a global infectious disease affecting human life safety.The key mode of transmission is mother-to-child transmission（MTCT）,also known as vertical transmission.Tenofovir Disoproxil Fumarate（TDF）is currently recommended for anti-viral treatment during pregnancy in pregnant women with a high hepatitis B virus load.Not only can HBV DNA levels be reduced,but mother-to-child transmission rates can also be more effectively reduced.However,the time of withdrawal is still controversial,and the safety of TDF needs to be further explored to provide theoretical support for pregnant women undergoing antiviral therapy during pregnancy.MethodsThe clinical data of 181 pregnant women with HBs Ag positive HBV DNA>2.0×10^5 IU/ml who received tenofovir dipivoxil（TDF）for mother-to-child blockade were retrospectively analyzed in our hospital from January 2016 to August 2020.According to different time of drug withdrawal,they were divided into discontinuation group,intrapartum drug withdrawal group and postpartum drug withdrawal group,the levels of HBV DNA and ALT in the three groups were observed at the time of delivery and 12 months after the cessation of antiviral therapy,as well as the child 1 years old or so second liver two half-and-half situation,etc.The safety of TDF in pregnant women and infants blocking mother-to-child transmission was observed,and the best time for pregnant women to stop medication was studied to prevent mother-to-child transmission of hepatitis B virus（MTCT）.According to the data type and research design,the corresponding statistical description and analysis methods were used.ResultFrom January 2016 to August 2020,181 cases of mother-to-child transmission blocking with TDF received in the outpatient department of our hospital,including 49cases in the discontinuation group,78 cases in the prenatal withdrawal group,and 54cases in the postpartum withdrawal group.Fifty-one cases of children aged around 1year were negative for HBs Ag detection.ALT levels detected at the time of delivery and 12 months postpartum were not statistically significant（P=0.145>0.05 at the time of delivery,P=0.231>0.05 at 12 months postpartum）,and ALT abnormalities at the time of delivery and 12 months postpartum were not statistically significant in the three groups（P>0.05）.HBV DNA levels of pregnant women in the discontinuation group,the intrapartum discontinuation group and the postpartum discontinuation group decreased at delivery,and the difference of HBV DNA levels between them at delivery was statistically significant（P<0.05）,and HBV DNA levels in the discontinuation group were detected at delivery>5log₁₀IU/ml.After pair comparison,there were differences in HBV DNA levels between the postpartum discontinued group and discontinuation group（adjusted P<0.001）,and there were differences in HBV DNA levels between the postpartum discontinued group and the discontinuation group（adjusted P=0.002<0.05）.There was no difference in HBV DNA levels between the discontinued group at the time of delivery and the discontinued group after delivery（P=0.085>0.05 after adjustment）.At the time of delivery,there was a statistically significant difference in the mean duration of TDF administration before delivery between the discontinuation group,the intrapartum discontinuation group and the postpartum discontinuation group（P<0.001）,and there was a statistically significant difference in the mean duration of TDF administration before delivery between the discontinuation group and the intrapartum discontinuation group and the postpartum discontinuation group（P<0.001）.There was no significant difference in the mean duration of TDF administration before delivery between the discontinuation group at the time of delivery and the discontinuation group after delivery（P=0.678）.Duration of TDF affects HBV DNA levels during childbirth.At 12 months postpartum,there was no significant difference in the number of ALT detected in discontinuation group,intrapartum discontinuation group and postpartum discontinuation group（X²=5.579,P=0.061）.There were statistically significant differences in the number of HBV DNA detected in the three groups（X²=10.097,P=0.006）.The postpartum discontinuation group was different from the discontinuation group and the intrapartum discontinuation group,respectively,while there was no difference between the discontinuation group and the intrapartum discontinuation group.At the age of 1,the proportion of children undergoing two-and-a-half tests for hepatitis B was 14.3%（7/49）,25.9%（21/81）,and 42.6%（23/54）,respectively.There was statistically significant difference between the three groups（X²=10.506,P=0.005）.There was significant difference between the postpartum group and the discontinuation group.There was no difference between discontinuation group and postpartum drug withdrawal group.The detection rate of postpartum drug withdrawal group was higher than that of discontinuation group and intrapartum drug withdrawal group.Conclusion1.Pregnant women taking TDF for maternal-infant interception did not increase the risk of postpartum hepatitis activity,regardless of prenatal discontinuation,intrapartum,or postpartum discontinuation,and continued postpartum discontinuation did not reduce the abnormal rate of ALT.2.The duration of treatment with TDF affected the HBV DNA level at the time of delivery.The average HBV DNA level in the group of discontinuation group was higher than 10^5IU/m L,and increasing the duration of treatment before delivery was beneficial to reduce the mother-to-child transmission rate.3.The detection rate of laboratory indicators of pregnant women and children in the postpartum drug withdrawal group was higher.From the side,the compliance of pregnant women in the postpartum drug withdrawal group was higher,and improving the compliance of pregnant women was conducive to the late health management of mother-to-child blocking of hepatitis B.