Antivir Ther. 2020 Feb 12. doi: 10.3851/IMP3345. [Epub ahead of print]
Clinical efficacy and safety in telbivudine- or tenofovir-treated hepatitis B e antigen-positive pregnant women.
Deng H1, Liang S2, Xu M1, Zhuo L1, Gao H1, Chen K1, Shi Y1, Li H1, Jiao Q1, Lin L1, Lei Y1, Liu H1.
Author information
1
Department of Infectious Diseases Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.
2
Community Health Service Center of Lin He Street, Guangzhou, China.
Abstract
BACKGROUND:
Telbivudine (LdT) and tenofovir (TDF) are widely used in pregnant women to prevent vertical transmission; however, limited data are available on the differences in clinical efficacy and safety between the two drugs.
METHODS:
A total of 307 hepatitis B e antigen (HBeAg)-positive pregnant women with complete follow-up data were enrolled, the patients with alanine aminotransferase (ALT) levels < 1*ULN at baseline were enrolled to cohort 1 for treated from 28 ± 4 weeks gestation to delivery, while ALT levels > 1*ULN at baseline were enrolled to cohort 2 for treated from 28 ± 4 weeks gestation and continued after delivery. The clinical efficacy and safety was compared in LdT- and TDF-treated patients. In addition, 32 patients in cohort 1 were analyzed for nucleoside analogues (NAs)-related resistance mutations at baseline and after delivery.
RESULTS:
The results showed that HBV DNA levels were significantly lower at delivery than at baseline (P<0.001), but the decreases in HBV DNA, ALT, TBIL and TBA levels did not differ between the LdT- and TDF-treated patients at different time points (P>0.05) in the two cohorts. However, gastrointestinal adverse effects (vomiting), occurred more frequently in TDF-treated than LdT-treated patients (6.6% vs. 0.0%, P=0.001). The results of NAs-related resistance mutations analysis in cohort 1 revealed that short-term LdT or TDF treatment did not significantly change the NAs-related resistance mutations (P>0.05).
CONCLUSIONS:
This study revealed that the clinical efficacy in LdT- or TDF-treated HBeAg-positive Chinese pregnant women is similar, and gastrointestinal adverse effects occurred more frequently in TDF-treated patients.