Efficacy and safety of telbivudine to prevent mother-to-child transmission of hepatitis B virus in middle- and late-stage pregnancy with high viral loads

Abstract

Objective: To observe the efficacy and safety of telbivudine on mother-infant blockade in pregnant women with hepatitis B virus (HBV) DNA.

Methods: A total of 141 pregnant women between 24 and 28 weeks of gestation and chronic HBV carriers with HBV DNA ≥10⁶ 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.

Results: 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).

Conclusion: 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.

Keywords: drug efficacy; fetus safety; hepatitis B virus; mother-to-infant transmission; telbivudine.