A prospective and open-label study for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus infection.

Abstract

BACKGROUND & AIMS:

In the Asia-Pacific region, perinatal transmission of the hepatitis B virus (HBV) is the primary cause of chronic hepatitis B infection. Despite the use of HBIG and HBV vaccination, HBV perinatal transmission (PT) occurs in 10-30% of infants born to highly viremic mothers. We evaluated the efficacy and safety of LTD use during late pregnancy in reducing HBV transmission in highly viremic HBeAg+mothers.

METHODS:

Two hundred and twenty-nine HBeAg+HBV DNA levels>1.0×10(7) copies/ml mothers received telbivudine 600 mg/day from week 20 to 32 of gestation (n=135) or served as untreated controls (n=94). All infants in both arms received 200 IU of HBIg within 12 h postpartum and recombinant HBV vaccine of 20 μg at 0, 1, and 6 months. HBsAg and HBV DNA results of infants at week 28 were used to determine perinatal transmission rate. All telbivudine treated subjects were registered in the Antiretroviral Pregnancy Registry.

RESULTS:

Telbivudine treatment was associated with a marked reduction in serum HBV DNA and hepatitis B e antigen (HBeAg) levels and normalization of elevated ALT levels before delivery. A striking decline of HBV DNA levels started from treatment onset to week 4, and sustained in a low level since week 12. Forty-four (33%) of the 135 telbivudine-treated mothers and none (0%) of the untreated controls had polymerase chain reaction-undetectable viremia (DNA<500 copies/ml) at delivery. Seven months after delivery, the incidence of perinatal transmission was lower in the infants that completed follow-up born to the telbivudine-treated mothers than to the controls (0% vs. 8%; p=0.002). HBV DNA levels were only detectable in HBsAg+infants. No significant differences in anti-HBs levels were observed during postnatal follow-up. No serious adverse events were noted in the telbivudine-treated mothers or their infants.

CONCLUSIONS:

Telbivudine used during pregnancy in CHB HBeAg+highly viremic mothers can safely reduce perinatal HBV transmission. Telbivudine was well-tolerated with no safety concerns in the telbivudine-treated mothers or their infants on short term follow up. These data support the use of telbivudine in this special population.

• Authors: Guo-Rong Han, Min-Kai Cao, Wei Zhao, Hong-Xiu Jiang, Cui-Min Wang, Shu-Fen Bai, Xin Yue, Gen-Ju Wang, Xun Tang, Zhi-Xun Fang
• Journal: Journal of hepatology (J Hepatol) Vol. 55 Issue 6 Pg. 1215-21 (Dec 2011) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 21703206 (Publication Type: Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B Antibodies
• Hepatitis B Surface Antigens
• Hepatitis B Vaccines
• Hepatitis B e Antigens
• Nucleosides
• Pyrimidinones
• Telbivudine
• Thymidine

Topics

• Adult
• Antiviral Agents (adverse effects, therapeutic use)
• DNA, Viral (blood)
• Female
• Hepatitis B Antibodies (administration & dosage)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B Vaccines (administration & dosage)
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (complications, drug therapy, prevention & control, transmission)
• Humans
• Infant
• Infant, Newborn
• Infectious Disease Transmission, Vertical (prevention & control)
• Male
• Nucleosides (adverse effects, therapeutic use)
• Pregnancy
• Pregnancy Complications, Infectious (drug therapy, virology)
• Prospective Studies
• Pyrimidinones (adverse effects, therapeutic use)
• Telbivudine
• Thymidine (analogs & derivatives)
• Treatment Outcome
• Young Adult