OBJECTIVETo evaluate the efficacy and safety of telbivudine treatment in pregnant patients with chronic hepatitis B to block mother-to-child transmission of hepatitis B virus (HBV).

METHODSMedline and the Chinese Biomedical Literature Database were searched for studies of HBV, mother-to-child transmission, and telbivudine. Of the 68 potentially relevant publications, eight randomized controlled trials (RCTs) conformed to the inclusion and exclusion criteria. Following data extraction, a meta-analysis was carried out with RevMan5.1 software.

RESULTSSeven of the eight RCTs were in Chinese, and the remaining study was in English but carried out at a Chinese site. The RCTs comprised a total of 678 subjects, including 352 cases and 326 controls. Infants born to telbivudine-treated mothers had a significantly lower rate of HBsAg positivity and HBV DNA positivity at birth than the control group of infants (odds ratio (OR) = 0.27, 95% confidence interval (CI): 0.17, 0.43, P less than 0.00001; OR = 0.14, 95% CI: 0.06, 0.32, P less than 0.00001). Infants born to telbivudine-treated mothers also had significantly lower rates of mother-to-child transmitted HBV at 6 months (OR = 0.06, 95% CI: 0.02, 0.22, P less than 0.00001; OR = 0.05, 95% CI: 0.01, 0.25, P = 0.0003) and 12 months (OR = 0.13, 95% CI: 0.03, 0.56, P = 0.007; OR = 0.08, 95% CI: 0.02, 0.37, P = 0.001) after birth. The pre-telbivudine treatment levels of HBV DNA were not significantly different between pregnant women in the telbivudine-treated group and the control group (OR = 0.12, 95% CI: 0.00, 0.24, P = 0.04), but the HBV DNA levels were significantly lower in the telbivudine-treated group of pregnant women prior to delivery (OR = -3.92, 95% CI: -4.90, -2.95, P less than 0.00001). There was no evidence of telbivudine treatment being associated with more adverse side effects or complications during pregnancy or in the infant (OR = 1.72, 95% CI: 0.68, 4.38, P = 0.25; OR=0.69, 95% CI: 0.04, 11.24, P = 0.80).

CONCLUSIONTelbivudine treatment effectively and safely prevents mother-to-child transmission of HBV from chronically infected mothers with a high degree of infectivity late in pregnancy.

Antiviral Agents ; adverse effects ; therapeutic use ; Female ; Hepatitis B virus ; drug effects ; Hepatitis B, Chronic ; prevention & control ; transmission ; Humans ; Infant ; Infectious Disease Transmission, Vertical ; prevention & control ; Mothers ; Pregnancy ; Pregnancy Complications, Infectious ; virology ; Randomized Controlled Trials as Topic ; Thymidine ; adverse effects ; analogs & derivatives ; therapeutic use