Abstract
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Telbivudine During the Second and Third Trimester of Pregnancy Interrupts HBV Intrauterine Transmission: A Systematic Review and Meta-analysis
by Yong-Ping Lu, Xu-Jing Liang, Xiao-Min Xiao, Si-Min Huang, Zhi-Wei Liu, Jian Li, Berthold Hocher, You-Peng Chen
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Beckground: 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 (CBMdisc),
and contact with Chinese experts in the field from November 2006 to February 2013.
Methods: 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.
Results: 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.
Conclusions: Telbivudine is an effective and safe drug for preventing intrauterine transmission of HBV.
DOI: 10.7754/Clin.Lab.2013.130408
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