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Year : 2009  |  Volume : 6  |  Issue : 1  |  Page : 157-162
Efficacy and safety of telbivudine during pregnancy in a patient with HBeAg-Negative chronic Hepatitis B

Department of Gastroenterology, Apollo Hospitals, Chennai - 600 006, India

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Date of Web Publication19-Feb-2011


Managing chronic hepatitis B (CHB) during pregnancy remains a challenging task as there is no information on the consequences to the fetus. Telbivudine, an oral nucleoside analog (NA), is a potential therapeutic option during pregnancy, but clinical experience is lacking. We report on the safety and efficacy of telbivudine 600 mg/day administered to a 20-year-old Indian woman with hepatitis B e antigen negative CHB, who became pregnant during treatment. Telbivudine was continued with monitoring of maternal hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels during pregnancy and after delivery. The patient maintained polymerase chain reaction (PCR) undetectable HBV DNA and normal ALT levels with telbivudine throughout pregnancy. At birth, HBV DNA was undetectable by PCR in the newborn. No congenital abnormalities were noted. In conclusion, telbivudine therapy during pregnancy was effective in maintaining undetectable viremia, and no safety concerns were noted in the mother and child. Additional clinical studies are warranted.

Keywords: Chronic hepatitis B, hepatitis B virus, pregnancy, telbivudine

How to cite this article:
Mohan AT, Hariharan M. Efficacy and safety of telbivudine during pregnancy in a patient with HBeAg-Negative chronic Hepatitis B. Hep B Annual 2009;6:157-62

How to cite this URL:
Mohan AT, Hariharan M. Efficacy and safety of telbivudine during pregnancy in a patient with HBeAg-Negative chronic Hepatitis B. Hep B Annual [serial online] 2009 [cited 2023 Nov 29];6:157-62. Available from: https://www.hepatitisbannual.org/text.asp?2009/6/1/157/76912

   Introduction Top

Hepatitis B virus (HBV) infection remains a serious public health issue because of its potential for liver disease related sequelae. In areas of high endemicity, including India and the Asia-Pacific region, a large proportion of infected individuals acquire the disease perinatally or in early infancy from mothers who have chronic hepatitis B (CHB). [1] A positive correlation has been noted between high maternal serum HBV DNA levels (>10 9 copies/mL) and an increased risk for vaccination breakthrough, [2],[3],[4],[5] suggesting perinatal transmission as a major factor in the development of CHB in later life. [6] There is evidence that administering lamivudine to pregnant women who have HBV DNA levels >10 9 copies/mL reduces mother-to-infant transmission, [7],[8],[9] but limited data exist on the effects of therapy in early pregnancy [10] and in women who become pregnant whilst receiving treatment. In such a setting, the initiation of nucleoside analog (NA) therapy during pregnancy remains controversial due to the possible risks to the fetus. [11]

Telbivudine, an oral NA licensed for the treatment of patients with CHB has demonstrated superior efficacy to lamivudine in clinical trials of adults with hepatitis B e antigen (HBeAg) -positive and -negative CHB. [12],[13] Telbivudine is classified as a pregnancy category B drug by the US Food and Drug Administration (FDA) (i.e., it is not teratogenic and has shown no adverse effects in developing embryos and fetuses in preclinical studies); hence, it may be considered in the management of CHB during pregnancy. [14],[15] However, there are very limited published data on the safety and efficacy of telbivudine during pregnancy. We report here the efficacy of telbivudine in an Indian woman who conceived whilst receiving therapy for HBeAg-negative CHB.

   Case Report Top

A 20-year-old woman was found to have replicating HBV when she underwent a voluntary evaluation for CHB after her brother succumbed to HBV-induced acute liver failure. Laboratory studies revealed that she was HBeAg negative, with an HBV DNA level of 4.0433 Χ 10 4 copies/mL on real-time polymerase chain reaction (PCR)-based COBAS; AMPLICOR HBV MONITOR; assay (v 2.0) (Roche Diagnostics, Pleasanton, CA, USA), and had an alanine aminotransferase (ALT) level of 21 IU/L. She refused liver biopsy for disease confirmation. Therapy with an NA was suggested based on data from the REVEAL study that had shown an increased incidence of hepatocellular carcinoma in patients with viral loads between 0 and 300 copies/mL. [16],[17],[18] Treatment was initiated with telbivudine 600 mg/day. At 12 weeks of follow-up, the patient had undetectable viremia and an ALT level of 17 IU/L. However, she became pregnant 3 months later, whilst on therapy. Guidelines recommend continuing therapy with category B drugs in pregnant women who have CHB. [15],[19] The patient was counseled on the potential risks of such therapy; however, she decided to continue. She received telbivudine with monitoring of maternal HBV DNA and ALT levels. After parturition, the newborn was also assessed.

   Results Top

The patient had an uneventful pregnancy. As shown in [Table 1], PCR-undetectable HBV DNA and normal ALT levels were maintained throughout the pregnancy. Delivery was uncomplicated, and at birth HBV DNA was undetectable by PCR in the newborn, who was then immunized with HBV vaccine and hepatitis B immunoglobulin G. No congenital abnormalities were detected. The patient continued to receive telbivudine but was advised not to breastfeed.
Table 1: Effect of telbivudine monotherapy on virologic and biochemical parameters

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   Discussion Top

The treatment of patients with CHB during the last trimester of pregnancy with the NA lamivudine has been shown to reduce the mother-to-infant transmission of HBV. [7],[8] Current guidelines do recommend continuing treatment in women who become pregnant while receiving therapy with a category B drug, to prevent the rebound of HBV DNA and potentially life-threatening ALT flares associated withtreatment discontinuation. [15],[19] However ,Current guidelines do not provide fi rm recommendations on the use of NAs in pregnancy, as there are confl icting reports with regard to their effi cacy and adverse events. [20],[21]

There are currently only two drugs licensed for the therapy of patients with CHB during pregnancy - lamivudine and telbivudine. Clinical experience with lamivudine in the third trimester is more extensive than that with telbivudine; however, telbivudine has demonstrated superior efficacy in randomized phase III trials in patients with HBeAg-positive and -negative disease. [12],[13],[22]

We demonstrated that continuing telbivudine therapy during pregnancy is effective in maintaining undetectable viremia and prevents perinatal transmission. However, there is a need for larger clinical studies to further evaluate the safety and efficacy of telbivudine in pregnant women. In the absence of such studies, clinicians are encouraged to participate in an ongoing safety registry sponsored by the Centers for Disease Control and Prevention, the FDA, and the National Institutes of Health ( http://www.apregistry.com/who.htm ).

   Acknowledgment Top

The authors wish to thank Kathleen Covino, PhD, for her editorial support in the preparation of this manuscript, which was supported by Novartis Pharma AG.

   References Top

1.Leung N. Chronic hepatitis B in Asian women of childbearing age. Hepatol Int 2009;3:24-31.  Back to cited text no. 1
2.del Canho R, Grosheide PM, Schalm SW, de Vries RR, Heijtink RA. Failure of neonatal hepatitis B vaccination: The role of HBV-DNA levels in hepatitis B carrier mothers and HLA antigens in neonates. J Hepatol 1994;20:483-6.  Back to cited text no. 2
3.del Canho R, Grosheide PM, Mazel JA, Heijtink RA, Hop WC, Gerards LJ, et al. Ten-year neonatal hepatitis B vaccination program, The Netherlands, 1982-1992: Protective efficacy and long-term immunogenicity. Vaccine 1997;15:1624-30.  Back to cited text no. 3
4.Ip HM, Lelie PN, Wong VC, Kuhns MC, Reesink HW. Prevention of hepatitis B virus carrier state in infants according to maternal serum levels of HBV DNA. Lancet 1989;1:406-10.  Back to cited text no. 4
5.Ngui SL, Andrews NJ, Underhill GS, Heptonstall J, Teo CG. Failed postnatal immunoprophylaxis for hepatitis B: Characteristics of maternal hepatitis B virus as risk factors. Clin Infect Dis 1998;27:100-6.  Back to cited text no. 5
6.Stevens CE, Beasley RP, Tsui J, Lee WC. Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med 1975;292:771-4.  Back to cited text no. 6
7.van Zonneveld M, van Nunen AB, Niesters HG, de Man RA, Schalm SW, Janssen HL. Lamivudine treatment during pregnancy to prevent perinatal transmission of hepatitis B virus infection. J Viral Hepat 2003;10:294-7.  Back to cited text no. 7
8.Xu WM, Cui YT, Wang L, Yang H, Liang ZQ, Li XM, et al. Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: A multicentre, randomized, double-blind, placebo-controlled study. J Viral Hepat 2009;16:94-103.  Back to cited text no. 8
9.Yang S, Liu M, Wang L. Lamivudine effects to the hepatitis B viral positive pregnant woman during perinatal vertical transmission. J Chinese Gynecol Obstet 2008;43:329-31.  Back to cited text no. 9
10.Hung JH, Chu CJ, Sung PL, Chen CY, Chao KC, Yang MJ, et al. Lamivudine therapy in the treatment of chronic hepatitis B with acute exacerbation during pregnancy. J Chin Med Assoc 2008;71:155-8.  Back to cited text no. 10
11.Fiore S, Savasi V. Threatment of viral hepatitis in pregnancy. Expert Opin Pharmacother 2009;10:2801-9.  Back to cited text no. 11
12.Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007;357:2576-88.  Back to cited text no. 12
13.Liaw YF, Gane E, Leung N, Zeuzem S, Wang Y, Lai CL, et al. 2-Year GLOBE trial results: Telbivudine is superior to lamivudine in patients with chronic hepatitis B. Gastroenterology 2009;136:486-95.  Back to cited text no. 13
14.Novartis Pharmaceuticals Corporation. Tyzeka® (telbivudine) prescribing information. Available from: http://www.pharma.us.novartis.com/product/pi/pdf/tyzeka.pdf. last updated on Apr 2009]. [last accessed on 2009 Nov 15].  Back to cited text no. 14
15.Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: A 2008 update. Hepatol Int 2008;2:263-83.  Back to cited text no. 15
16.Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73.  Back to cited text no. 16
17.Chen CJ, Iloeje UH, Yang HI. Long-term outcomes in hepatitis B: The REVEAL-HBV study. Clin Liver Dis 2007;11:797-816.  Back to cited text no. 17
18.Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ, et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-86.  Back to cited text no. 18
19.Keeffe EB, Dieterich DT, Han SH, Jacobson IM, Martin P, Schiff ER, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin Gastroenterol Hepatol 2008;6:1315-41.  Back to cited text no. 19
20.Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39.   Back to cited text no. 20
21.Lok AS, McMahon BJ. Chronic hepatitis B: Update 2009. Hepatology 2009;50:661-2.  Back to cited text no. 21
22.Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, et al. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology 2008;47:447-54.  Back to cited text no. 22

Correspondence Address:
Arumugam T Mohan
Sabari, W-6, I.C.C., Annanagar West Ext., Chennai - 600 101
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Source of Support: Novartis Pharma AG, Conflict of Interest: None

DOI: 10.4103/0972-9747.76912

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