Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

Objective: Women of childbearing potential treated for chronic hepatitis B virus (HBV) infection may experience exacerbations during or after pregnancy. Infants may also acquire HBV infection through perinatal route. Currently, there is no antiviral agent approved for use in pregnancy. This makes it difficult to decide whether treatment should be withdrawn immediately or continued in women who become pregnant while on HBV antiviral therapy. The present study aims to establish the safety and, as a second measure, the efficacy of telbivudine in patients who became pregnant while they were on telbivudine treatment for chronic HBV infections and were maintained on the treatment throughout pregnancy.Materials and Methods: Between 2010 and 2013, twenty-one patients, who became pregnant while receiving telbivudine treatment for chronic HBV infection and continued the treatment, were evaluated retrospectively.Results: The mean age of the patients was 28.9 +/- 6.3 years (range: 18-41 years). All patients were hepatitis B envelope antigen-negative. The mean pre-treatment hepatic activity index was 9.4 +/- 1.6 (range: 7-13), and fibrosis and serum HBV, DNA measurements were 3.2 +/- 0.8 (range: 2-5) and 3.5x10(5)+/- 2.8x10(5) IU/mL, respectively. No drug-related side effects were seen in any of the patients. All infants had normal birth weights and no abnormalities were observed in any of them. At the end of week 28, none of the infants was hepatitis B surface antigen-positive.Conclusion: The use of telbivudine from the first trimester of pregnancy appears to be safe both for the mother and fetus and to be efficient in preventing mother-to-child transmission of HBV infection. However, randomized, controlled studies involving a higher number of subjects are needed.