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.