BACKGROUND: Evaluate the efficacy and safety of telbivudine during the 2nd and 3rd trimester of pregnancy in intrauterine transmission of hepatitis B virus (HBV). Based on the principle of Cochrane systematic reviews, a database was constructed from Medline, EMBASE, Cochrane Library, the US National Science Digital Library (NSDL), the China Biological Medicine Database (CBM-disc), and contact with Chinese experts in the field from November 2006 to February 2013.
The Critical Appraisal Skills Programme (CASP) of Oxford, Cochrane Collaboration's tool, and Review Manager Version 5.0 (Rev-Man 5.0) for assessing the quality of clinical trials, risk of bias, and statistical analysis was used. We analyzed the effects and safety of telbivudine treatment on intrauterine mother-to-child transmission (MTCT) of HBV from HBsAg and HBV-DNA positive mothers. All newborns received an immune prophylaxis schedule consisting of simultaneous hepatitis B virus vaccine and hepatitis B immunoglobulin (HBIG) postpartum. Of 32 studies, 7 studies fulfilled the inclusion criteria in the study.
Either the Mantel-Haenszel or Inverse Variance fixed-effects model or Mantel-Haenszel or Inverse Variance random-effects model was applied for all analyses indicated by odds ratio (OR) and 95% confidence interval (CI). The meta-analysis based on new onset of HBsAg seropositivity of infants at 6-12 months postpartum revealed that the control group had an intrauterine transmission rate of 8.25-42.31%. This rate was reduced to 0-14.29% in the telbivudine treatment group (OR 0.09, 95% CI 0.04-0.22, including seven trials, p < 0.001). The rates of intrauterine transmission based on new onset of HBV DNA seropositivity of infants at 6-12 months postpartum were 8.25-19.23% in the control group and 0 - 3.57% in the treatment group (OR 0.07, 95% CI 0.02-0.22, p < 0.001, including only five trials, since two trials had no data on HBV DNA in infants). With the exception of CK elevations, adverse effect frequencies were similar in both groups.
Telbivudine is an effective and safe drug for preventing intrauterine transmission of HBV.