BackgroundTo evaluate the efficacy and safety of treating HBV-positive mothers with telbivudine in early and middle pregnancy to prevent mother-to-infant HBV transmission.MethodsThe subject population comprised pregnant women with chronic hepatitis B (CHB; n = 188) from January 2013 to June 2015, with HBV DNA ≥1.0 × 107copies/mL and increased alanine aminotransferase levels. Groups A (n = 62) and B (n = 61) were treated with telbivudine starting at 12 weeks or 20–28 weeks after gestation, respectively. Telbivudine was discontinued at postpartum 12 weeks. Group C (n = 65) received no antiviral. All infants were vaccinated with hepatitis B immunoglobulin (200 IU) and HBV vaccine (20 with hepatitis B The maternal HBV DNA levels of the groups were compared. Mother-to-infant transmission of HBV was indicated by the presence of HBsAg in infants 7 months after birth.ResultsBefore treatment, the HBV DNA levels of the 3 groups were similar. Before delivery and 12 weeks after delivery, the HBV DNA levels of groups A and B were similar, but both were significantly lower than that of group C (P < 0.01, all). No infants in groups A and B were HBsAg-positive, but the infection rate of group C was 18.4% (P < 0.01). The HBV infection rate of infants was positively associated with the HBV DNA levels of the pregnant mothers.ConclusionAdministration of telbivudine to HBV-infected mothers, started during early and middle pregnancy, completely blocked mother-to-infant HBV transmission.Trial registrationThe study was registered retrospectively on Janurary 25 in 2016 at Chinese Clinical Trial Registry (ChiCTR-OPC-16007899).

To explore the association between serum cystatin C (Cys-C) and renal damage in patients with chronic hepatitis B. We retrospectively analyzed the clinical data of 425 patients with chronic hepatitis B virus (HBV) infection. Liver stiffness measured by FibroScan was used to diagnosis liver fibrosis. Cys-C levels were detected via latex-enhanced immunoturbidimetric assay. A total of 425 patients were enrolled. Among them, 217 were patients with CHB with an eGFR > 90 mL/min/1.73 m 2 and 208 with an eGFR ≤90 mL/min/1.73 m 2 . Cys-C levels significantly differed in patients with eGFR > 90 mL/min/1.73 m 2 compared with patients with eGFR ≤90 mL/min/1.73 m 2 (0.81 ± 0.05 vs 1.05 ± 0.06 mg/L, P < .001). Moreover, the Cys-C levels were 0.82 ± 0.04 mg/L in patients without liver fibrosis, 0.98 ± 0.05 mg/L in patients with mild liver fibrosis, 1.05 ± 0.08 mg/L in patients with advanced liver fibrosis, and 1.12 ± 0.07 mg/L in patients with liver cirrhosis ( P < .001). Multivariate analyses were conducted to explore the independent factors associated with a decreased eGFR. Multivariate analysis suggested that T2DM ( P = .032), liver fibrosis ( P = .013), and Cys-C level ( P = .035) were the independent factors associated with the decreased eGFR in patients with CHB. While age ( P = .020) and Cys-C level ( P = .001) were the independent factors associated with the decreased eGFR in patients with CHB-related fibrosis. The fibrosis group had significantly higher Cys-C levels than those without fibrosis. Routine monitoring of Cys-C levels is of positive significance in preventing the development of renal impairment of CHB patients.

To observe the efficacy of telbivudine in chronic hepatitis B (CHB) women with high viral load during pregnancy and the long-term effects on intelligence, growth, and development of the newborns. A total of 87 patients were included. Forty-two patients received telbivudine orally 600 mg per day and treatment initiated from 12 weeks after gestation until the 12th postpartum week. Forty-five patients were untreated according to principle of informed consent. All infants received injection of hepatitis B immune globulin (HBIG; 200 IU) and were vaccinated with recombinant HBV vaccine. Wechsler preschool intelligence scale was used to assess mental and neuropsychological developments of these children till they were 6 years old. Data including serum HBV DNA viral load, Apgar score, and scores of Wechsler preschool intelligence scale were analyzed and compared. Levels of both serum HBV DNA and ALT in patients who received telbivudine were significantly decreased at the 12th week after delivery, compared with baseline levels (P < .01). No significant changes were observed in patients not receiving telbivudine (P > .05). Serum HBV DNA and ALT levels at the 12th week after delivery in the telbivudine group were significantly lower than those of patients without telbivudine (P < .01). The serum HBsAg-positive rate in neonates 7 months of age was 0%, which was significantly lower than that in control group (11.11%) (P < .05). No statistical differences were observed between the 2 groups regarding maternal cesarean section rate, adverse pregnancy rate, postpartum bleeding rate, neonatal body mass, Apgar score, neonatal malformation incidence, or intelligence development of newborn. Telbivudine is effective to reduce the viral load in CHB mothers with high viral load and could lower the perinatal transmission rate. Both mental and physical development in neonates with exposure to telbivudine during perinatal period were similar to those without telbivudine exposure.