Evidence-Based Medicine
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 28, 2015; 21(8): 2504-2509
Published online Feb 28, 2015. doi: 10.3748/wjg.v21.i8.2504
Tenofovir rescue therapy in pregnant females with chronic hepatitis B
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
Author contributions: Cai HD designed the study; Hu YH, Liu M, Yi W and Cao YJ performed the study; Cai HD analyzed the data; Yi W and Cai HD wrote the manuscript.
Supported by Grants from Beijing Municipal Natural Science Foundation, No. D12110700390000.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Hao-Dong Cai, MD, Chief Physician, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, No. 8 Jingshun East Street, Beijing 100015, China. chddt@163.com
Telephone: +86-10-84322709 Fax: +86-10-84322708
Received: August 11, 2014
Peer-review started: August 12, 2014
First decision: August 27, 2014
Revised: August 31, 2014
Accepted: October 15, 2014
Article in press: October 15, 2014
Published online: February 28, 2015
Processing time: 200 Days and 17.7 Hours
Abstract

AIM: To evaluate the safety and efficacy of tenofovir monotherapy in pregnant females resistant to lamivudine or telbivudine. The effect of tenofovir on the fetus was also assessed.

METHODS: The clinical data of 17 females were reviewed in this study. Adverse events and pregnancy outcomes from January 1, 2011 to June 30, 2013 were evaluated in the Department of Gynecology and Obstetrics of Beijing Ditan Hospital, Capital Medical University, Beijing, China. These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated.

RESULTS: The median hepatitis B virus (HBV) DNA level in the pregnant females with LAM or LdT resistance was 5.9 (range, 4.2-7.2) log10 copies/mL before the initiation of TDF. Ten of these females had abnormal alanine aminotransferase (ALT) levels. The patients were treated with TDF for a median of 24 wk (range, 12-40 wk). Fourteen females (82.4%) had an HBV DNA level of < 500 copies/mL at the time of delivery. This decrease was statistically significant (P < 0.0001). Serum ALT levels were normalized in all subjects with an elevated serum ALT level at baseline (P = 0.0003). There were no significant changes in serum creatinine and phosphorus levels during TDF treatment. In addition, no adverse events related to TDF treatment were observed. Seventeen females delivered 17 live infants, and all infants had good Apgar scores. The mean birth weight was 3226.5 ± 331.7 g, and the mean length at birth was 50.4 ± 1.1 cm. The growth and development of the infants was normal at birth, and no infants had birth defects related to TDF treatment. Eleven infants completed HBV vaccination and had no evidence of vertical transmission.

CONCLUSION: The use of TDF in pregnant females with chronic HBV and LAM or LdT resistance was safe and effective.

Keywords: Pregnancy; Chronic hepatitis B; Tenofovir; Safety; Birth defects

Core tip: Tenofovir (TDF) is effective for treating chronic hepatitis B virus (HBV) patients with lamivudine (LAM) or telbivudine (LdT)-resistance. It is classified as category B during pregnancy. There are very few reports regarding the safety of TDF treatment in pregnant patients with LAM or LdT resistance. The present study reports the safety of TDF monotherapy in pregnant females with chronic HBV and LAM or LdT resistance. This study provides preliminary evidence regarding the efficacy and safety of TDF during pregnancy. It also sets an example for further studies exploring the safety profiles of nucleos(t)ide analogs in pregnant females.