Evaluation of the efficacy and safety of telbivudin in preventing mother-to-infant HBV transmission / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of telbivudine in preventing mother-to-infant HBV transmission in pregnant women who have positive HBsAg and HBeAg during the third trimester of pregnancy. METHODS: A total of 80 pregnant women, who had positive HBsAg and HBeAg with HBV DNA levels of ≥1 × 106 copies · mL-1 were divided into two groups the treatment group and the control group. Each group comprised 40 cases. The subjects in the treatment group received telbivudine 600 mg once daily from the 28th weeks of pregnancy till delivery. The subjects in the control group did not receive telbivudine or other anti-virus drugs. The adverse reactions of the subjects in the treatment group were observed, and the serum HBV DNA levels in the two groups were measured at the 28th weeks of pregnancy, upon delivery and 6 months after delivery, respectively. The infants in the two groups received IM HBIG 200 IU immediately after birth and 1 month after birth. And both of the groups received IM hepatitis B vaccine 10 μg immediately after birth as well as 1 month and 6 months after birth. The serum HBsAg and HBV DNA levels in all infants were measured at birth, 6 months, and 12 months after birth, respectively. RESULTS: There was no significant difference in serum HBV DNA levels between the treatment group and the control group at the 28th weeks of pregnancy. The serum HBV DNA level immediately after delivery in the treatment group [(3.48±0.90) × 10 copies · mL-1] was significantly decreased compared with the control group [(6.96±0.94) × 10 copies · mL-1](P<0.05). There was no significant difference in HBV DNA levels between the treatment group and the control group 6 months after delivery. The rates of mother-to-infant HBV transmission in 12-month-old infants in the treatment group and the control group were 97.5% and 75%, respectively. The difference was statistically significant(P<0.05). No adverse reaction was found in the treatment group, and abnormal development was not found in the infants of the two groups. CONCLUSION: Telbivudine appears to be effective and safe in preventing HBV mother-to-infant transmission and has no influence on infant development.