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Objective:To compare the efficacy and safety of telbivudine (LDT) and tenofovir disoproxil fumarate (TDF) treatment during the second and third trimester in pregnant women with high viral load of hepatitis B virus (HBV).Methods:Totally 506 pregnancy women with HBV infection who received antiviral therapy during the second and third trimester of pregnancy in the obstetrical clinic of The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine from January 1, 2016 to December 31, 2018 were retrospectively enrolled, and the anti-viral efficacy and safety in mothers and neonates were evaluated. Pregnancy women were divided into TDF group and LDT group according the medications. The efficacies including decline and negative rate of HBV DNA, the vertical transmission (VT) rate, the normalization rate of liver function in mothers between the two groups were compared. The safeties including birth weight of neonates, congenital deformities and the rates of preterm between the two groups were also compared. Chi-square test, independent sample t test or rank sum test were used for statistical analysis. Results:There were 239 pregnant women in the LDT group and 267 in the TDF group. The maternal HBV DNA levels before treatment in the LDT and TDF groups were (7.83±0.75) lg IU/mL and (7.82±0.66) lg IU/mL, respectively, while the maternal HBV DNA levels prior to delivery were 2.91(1.20) lg IU/mL and 2.83(1.01) lg IU/mL, respectively. The normalization rates of alanine aminotransferase (ALT) of chronic hepatitis B (CHB) pregnant women prior to delivery in TDF group and LDT group were 95.00%(38/40) and 98.18%(54/55), respectively. There were all no significant differences between the two groups ( t=0.097, U=1.040 and χ2=0.767, respectively, all P>0.05). For CHB pregnant women, the HBV DNA negative rate at one month postpartum in TDF group was 85.45%(47/55) and that in LDT group was 82.50%(33/40). The normalization rate of ALT in TDF group was 94.55%(52/55), and that in LDT group was 92.50%(37/40). There were no significant differences between the two groups ( χ2=0.152 and 0.164, respectively, P=0.697 and 0.687, respectively). The VT rates were 0(0/262) in TDF group and 0.43%(1/231) in LDT group, which had no significant difference between the two groups ( χ2=1.127, P=0.288). Two patients in LDT group who continued taking LDT 11 months postpartum switched to TDF because of HBV rt204 mutation, and no one had virus mutation in TDF group. No significant increased in creatine kinase in LDT group, and no significant abnormal calcium and phosphorus metabolism in the TDF group. The preterm rate was 7.87%(21/267) in TDF group and 4.18%(10/239) in LDT group, but there was no significant difference between the two groups ( χ2=2.970, P=0.085). However, the birth weight of neonates in TDF group ((3 204.72±490.50) g) was lower than that in LDT group ((3 374.31±467.50) g), and the difference was statistically significant ( t=3.780, P<0.01). During the course of treatment, no pregnant women discontinued treatment due to drug intolerance, and no infants presented with drug-related birth defects. Safeties for mothers and neonates were both good. Conclusions:Both LDT and TDF treatment could reduce the VT rate in pregnant women with high HBV viral load. The safety is good for both mothers and neonates. However, for CHB pregnant women who continue antiviral therapy postpartum, TDF is superior to LDT because of lower virus mutation, thus to reduce the risk of drug resistance.
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<p><b>OBJECTIVE</b>To compare the various combined immunization schemes available for treatment of babies born to mothers with high-load hepatitis B virus (HBV) infection.</p><p><b>METHODS</b>A total of 118 mothers with HBV infection status of hepatitis B surface antigen-positive (HBsAg+), hepatitis B e antigen-positive (HBeAg+) and HBV DNA load of more than 1.0 * 61og10 IU/mL were included in the study. All of the participants' babies received the main-passive immunization therapy according to the wishes of their families. For analysis,the infants were grouped according to the various dosages of the vaccine program (group A: hepatitis B immunoglobulin (HBIG) 200 IU and HBVac 20 mug intramuscular;group B:HBIG 200 IU and HBVac 10 mug intramuscular; group C HBIG 100 IU and HBVac 20 mug intramuscular injection) and times, and followed-up to 7 months of age.All results were statistically analyzed using SPSS software.</p><p><b>RESULTS</b>All of the infants produced anti-HBs after vaccination.After the HBIG injection schedule was completed in January, the mean concentrations of anti-HBs in groups A, B, and C were 263.56 ± 50.98,231.06 ± 74.07, and 99.23 ± 29.82 mIU/mL respectively;the concentrations were significantly different between groups A and C, and between groups B and C (P < 0.001). In July, the titers of anti-HBs in groups A, B, and C were 788.10 ± 281.96,428.39 ± 347.48, and 708.44 ± 315.69 mIU/mL respectively; the concentrations were significantly different between groups A and B, and between groups B and C (P < 0.05).</p><p><b>CONCLUSION</b>AdminisWation of the hepatitis B vaccine combined with HBIG at birth can achieve immune protection for babies born to highly viremic mothers. In January, the HBIG dosage of 200 IU was more reliable than 100 IU. The hepatitis B 20 tg dose vaccine was safe and effective.</p>
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Humans , Infant , Hepatitis B , Hepatitis B Antibodies , Hepatitis B Vaccines , Hepatitis B e Antigens , Hepatitis B virus , Immunization , Immunoglobulins , Mothers , Serologic Tests , Vaccines, Combined , Viral LoadABSTRACT
Objective To evaluate the efficacy and safety of telbivudine for pregnant women with hepatitis Be antigen (HBeAg)negative chronic hepatitis B(CHB). Methods Sixty-two cases of HBeAg negative CHB pregnant women were collected from May 2007 to May 2012,and they were divided into telbivudine group (n=31 ,600 mg per day by oral administration)and compound glycyrrhizin group (n=31 ,120 mg per day by intravenous administration).All neonates were given intramuscular injection of 200 IU hepatitis Bimmune globalin at birth immediately and 15 days after birth,and 20 μg genetically engineered hepatitis B vaccine at 0,1 and 6 months after birth.The serum alanine aminotransferase (ALT)level and hepatitis B virus (HBV)DNA titer were monitored.The HBV DNA negative conversion rate,the rate of intrauterine infection,duration of pregnancy,delivery mode,neonate weight and disability rate were compared between groups.All categorical data were analyzed using the chi-square test and comparison between groups was analyzed by t test.Results In telbivudine group,the HBV DNA level before delivery ([0.20±0.11]lg copy/mL)and 6 weeks after delivery ([0.22±0.13]lg copy/mL) were lower than that before treatment [(6.24±0.75 )lg copy/mL]and the differences were statistically significant (t=303.128 and 301 .321 ,respectively;both P <0.01).The negative conversion rate of HBV DNA in telbivudine group was 28 cases before delivery,while in compound glycyrrhizin group,no one had HBV DNA negative conversion.And statistical significant differences were achieved between these two groups before delivery and 6 weeks after delivery (t = -20.285 and -8.721 ,respectively;both P <0.01).In telbivudine group,the ALT levels before delivery and 6 weeks after delivery were (13.08±5.87) U/L and (25.97 ± 17.48)U/L,respectively,which were significantly decreased compared with that before treatment (205.95± 95.69 )U/L.The differences were statistically significant (t = 93.128 and 81.321, respectively;both P <0.01).In compound glycyrrhizin group,the ALT level before delivery ([104.15 ± 69.15]U/L)was lower than that before treatment ([209.60 ± 102.24]U/L)and the difference was statistically significant (t = 9.281 ,P =0.032).However,the ALT level was fluctuant 6 weeks after delivery (150.26± 86.43)U/L,which was not significantly different from that before treatment (t =2.821 ,P =0.122).The ALT levels before delivery and 6 month after delivery were significantly different in both two groups (t=-2.559 and -3.158,respectively;both P <0.05 ).There were no statistically significant differences between these two groups in the rate of intrauterine infection, duration of pregnancy,delivery mode,neonate weight and disability rate.Conclusion The using of telbivudine for pregnant women with HBeAg negative CHB can effectively control the hepatitis activation and reduce the virus titer.
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Objective To study the effects of HBeAg in new born infants on the response to anti-hepatitis B immunoglobulin combined with hepatitis B vaccination.Methods Two hundred and eight infants who were born during January 2008 to January 2011 in the Department of Obstetrics in Second Affiliated Hospital of Southeast University,including 120 serum HBeAg positive infants without intrauterine infection,and 88 HBeAg negative infants as control group were recruited in the study.Infants in both groups were vaccinated with genetically engineered hepatitis B vaccine (CHO cell) 20 μg according to a standard vaccination regimen (i.e.0,1,6) and 200 IU doses of hepatitis B immunoglobulin immediately after birth and at day 15 respectively.Hepatitis B virus (HBV) serological markers and HBV DNA were measured at birth prior to immunization.HBsAg,HBeAgand hepatitis B surface antibody (anti-HBs) were detected at 1,7,and 12 months after birth to evaluate the effects of immune response.The date were analyzed by the chi-square test and groups were analyzed by t test.Results No statistical significances of anti-HBs were observed between the serum HBeAg positive group and the serum HBeAg negative group at the 1st,7th and the 12th month of birth (t=1.285,0.563 and-0.971,respectively; all P＞0.05).The anti-HBs titers in both groups at 1 month were higher than at birth (P＜0.05).At 7 months after birth,the anti-HBs titers in both groups were even higher than those at 1 month.At 12 months after birth,the anti-HBs titers in both groups were lower than those at 7 months,but still higher than those at 1 month(F=34.3959 and 64.908,respectively; both P＜0.01).Infants who were born with positive serum HBeAg were further divided into two subgroups according to the HBeAg titers,using the median HBeAg titer (47.495 S/CO) as the cut off point.Between the two subgroups,there were also no significant differences of anti-HBs at 1 month,7 months and 12 months (all P＞0.05).The HBeAg titers in HBeAg positive infants decreased gradually after birth.At 7 months,only 3 infants remained HBeAg positive.At 12 months,HBeAg turned negative in all of the 120 infants who were previously HBeAg positive,and no anti-HBe positivity were detected.Conclusion The production of anti-HBs after combined immunization with anti-hepatitis B immunoglobulin and hepatitis B vaccine in infants is independent of HBeAg serology at birth.