Efficacy and safety of telbivudine for pregnant women with hepatitis Beantigen negative chronic hepatitis B / 中华传染病杂志

ABSTRACT

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.