Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China.
Department of Infectious Diseases, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.
J Med Virol. 2019 Dec;91(12):2153-2157. doi: 10.1002/jmv.25566. Epub 2019 Aug 29.
To observe the efficacy and safety of telbivudine on mother-infant blockade in pregnant women with hepatitis B virus (HBV) DNA.
A total of 141 pregnant women between 24 and 28 weeks of gestation and chronic HBV carriers with HBV DNA ≥10 copies/mL were enrolled, 105 in the treatment group and 36 in the control group. The treatment group was given telbivudine 600 mg/d oral, and the control group did not use antiviral drugs. Hepatitis B immunoglobulin 200 IU intramuscular injection and hepatitis B vaccine (HBVac) 10 μg subcutaneous injection were given to the infants in both groups within 12 hours after birth, and 10 μg of HBVac was subcutaneously injected when the infants were 1-month and 6-month old. Safety endpoints including HBV DNA quantification, liver function, CK were observed before treatment, 4 weeks after treatment, before delivery, and 24 weeks after delivery.
There was no difference in HBV DNA levels between the two groups before treatment and 6 months after delivery (P > .05). The HBV DNA level in the treatment group was significantly lower than that in the control group before delivery (P < .05). Between the two groups, the HBV positive rate was statistically different between the two groups (P < .05), and the difference of serum HBsAg of infants had statistical significance (P < .05), but the safety of the telbivudine group was not significantly different from that of the control group (P > .05).
The application of telbivudine antiviral therapy in the middle and late stage of pregnancy of HBV high-load pregnant women can significantly reduce the HBV DNA level before delivery, reduce the mother-to-child transmission rate of HBV, and have excellent security.
观察替比夫定治疗孕妇乙型肝炎病毒（HBV）DNA 载量对母婴阻断的疗效及安全性。
选择妊娠 24~28 周 HBV 载量≥10⁶copies/ml 的慢性 HBV 携带者 141 例，分为治疗组 105 例和对照组 36 例。治疗组给予替比夫定 600mg/d 口服，对照组未用抗病毒药物。两组新生儿均于出生后 12h 内肌内注射乙肝免疫球蛋白 200IU，皮下注射乙肝疫苗（HBVac）10μg，于 1 个月和 6 个月龄时再次分别肌内注射 HBVac 10μg。观察两组治疗前、治疗 4 周后、分娩前、分娩后 24 周时 HBV-DNA 定量、肝功能、CK 等安全性指标。
两组治疗前及分娩后 6 个月时 HBV-DNA 水平比较差异均无统计学意义（P＞.05），治疗组分娩前 HBV-DNA 水平明显低于对照组（P＜.05）。两组 HBV 阳性率比较差异有统计学意义（P＜.05），新生儿血清 HBsAg 比较差异有统计学意义（P＜.05），但替比夫定组安全性与对照组比较差异无统计学意义（P＞.05）。
替比夫定抗病毒治疗用于 HBV 高载量孕妇中晚期妊娠，可显著降低分娩前 HBV-DNA 水平，降低 HBV 母婴传播率，安全性良好。
