AIM: To achieve an evidence-based conclusion regarding the
safety and efficacy of telbivudine during pregnancy.
METHODS: A pooled analysis of data from a
literature search reported 1739 pregnancy outcomes (1673 live births) from 1725
non-overlapping pregnant women treated with telbivudine. The prevalence of live
birth defects (3.6/1000) was similar to that of the non-antiviral controls
(3.0/1000) and not increased as compared with overall prevalence (14.5 to
60/1000). No target organ toxicity was identified. The prevalence of
spontaneous abortion in pregnant women treated with telbivudine (4.2/1000) was
not increased compared with the overall prevalence (16/1000). The
mother-to-child transmission rate was significantly reduced in pregnant women
treated with telbivudine (0.70%) compared to those treated with the
non-antiviral controls (11.9%; P <
0.0001) or compared to the historical rates of hepatitis B virus (HBV)-infected
population without antiviral treatment (10%-15%).
RESULTS: Cumulatively 489 pregnancy cases have been
reported in the telbivudine pharmacovigilance database (with a cut-off date 31
August 2014), of those, 308 had known pregnancy outcomes with 249 cases of live
births (239 cases of live birth without congenital anomaly and 10 cases of live
birth with congenital anomaly). In the latest antiretroviral pregnancy registry
report (1 January 1989 through 31 January 2015) of 27 patients exposed to
telbivudine during pregnancy (18, 6 and 3 during first, second and third
trimester, respectively) 19 live births were reported and there were no cases
of birth defects reported.
CONCLUSION: Telbivudine treatment during pregnancy
presents a favorable safety profile without increased rates of live birth
defects, spontaneous abortion or elective termination, or fetal/neonatal
toxicity. Exposure to telbivudine in the first, second and third trimester of
pregnancy has been shown to significantly reduce the risk of HBV transmission
from mother to child on the basis of standard immune prophylaxis procedure.
Core tip: The data
from literatures, pharmacovigilance reports on telbivudine exposure and
antiretroviral pregnancy registry during pregnancy in women with hepatitis B
virus (HBV) infection showed no increased rates of live birth defects,
spontaneous abortion or elective termination. No fetal/neonatal toxicity was
reported during telbivudine treatment. Telbivudine exposure in the second
and/or third trimesters of pregnancy has been shown to reduce the risk of HBV
transmission from mother to child if administered in addition to hepatitis B
immunoglobulin and HBV vaccination with a favorable safety profile.
Below: Analysis of the pregnancy outcomes from non-overlapping literature references. 11734 pregnancy outcomes from 1721 pregnancy mothers due to multiple births.
Full article at: http://goo.gl/9JIwAj
Teerha
Piratvisuth, Department of Medicine, NKC Institute of Gastroenterology and
Hepatology, Prince of Songkla University, Songkhla 90110, Thailand
Guo Rong Han,
Department of Gynecology and Obstetrics, the Second Affiliated Hospital of the
Southeast University, Nanjing 210003, Jiangsu Province, China
Stanislas Pol,
Département d’Hépatologie, Inserm USM20, Institut Pasteur, AP-HP, hôpital
Cochin, Université Paris Descartes, 75006 Paris, France
Yuhong Dong, Aldo
Trylesinski, Novartis Pharma AG, 4056 Basel, Switzerland
Author contributions: Piratvisuth T, Han GR, Pol S, Dong Y
and Trylesinski A contributed to the concept, inception, design, interpretation
of data, and critical revision of the manuscript; Dong Y collected the data and
performed the analysis; all authors approved the final version of the
manuscript, including the authorship list.
Correspondence to: Dr. Teerha Piratvisuth, MD, Department of
Medicine, NKC Institute of Gastroenterology and Hepatology, Prince of Songkla
University, 15 Equipment Acantholysis SOI Road, Hat Yai District, Songkhla
90110, Thailand.
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