Published online Feb 28, 2015. doi: 10.3748/wjg.v21.i8.2504
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
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.
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.