Long-term safety of infants from mothers with chronic hepatitis B treated with tenofovir disoproxil in China.

Abstract

OBJECTIVE:

The physical and neuromental development of infants remains uncertain after fetal exposure to tenofovir disoproxil fumarate (TDF) for the prevention of mother-to-child transmission of HBV. We aimed to investigate the safety of TDF therapy during the third trimester of pregnancy.

DESIGN:

Infants from a previous randomised controlled trial were recruited for our long-term follow-up (LTFU) study. Mothers with chronic hepatitis B were randomised to receive TDF therapy or no treatment during the third trimester. Infants' physical growth or malformation, bone mineral density (BMD) and neurodevelopment, as assessed using Bayley-III assessment, were examined at 192 weeks of age.

RESULTS:

Of 180 eligible infants, 176/180 (98%) were enrolled and 145/176 (82%) completed the LTFU (control group: 75; TDF-treated group: 70). In the TDF-treated group, the mean duration of fetal exposure to TDF was 8.57±0.53 weeks. Congenital malformation rates were similar between the two groups at week 192. The mean body weight of boys in the control and TDF-treated groups was significantly higher (19.84±3.46 kg vs. 18.47±2.34 kg; p=0.03) and within the normal range (18.48±2.35 kg vs. 17.80±2.50 kg; p=0.07), respectively, when compared with the national standard. Other prespecified outcomes (head circumference, height, BMD, and cognitive, motor, social-emotional, and adaptive behaviour measurements) were all comparable between the groups.

CONCLUSION:

Infants with fetal exposure to TDF had normal physical growth, BMD and neurodevelopment at week 192. Our findings provide evidence on the long-term safety of infants after fetal exposure to maternal TDF therapy for preventing hepatitis B transmission.

TRIAL REGISTRATION NUMBER:

NCT01488526.

• Authors: Calvin Q Pan, Erhei Dai, Zhongping Duan, Guorong Han, Wenjing Zhao, Yuming Wang, Huaihong Zhang, Baoshen Zhu, Hongxiu Jiang, Shuqin Zhang, Xiaohu Zhang, Huaibin Zou, Xiuli Chen, Yu Chen
• Journal: Gut (Gut) Vol. 71 Issue 4 Pg. 798-806 (04 2022) ISSN: 1468-3288 [Electronic] England
• PMID: 33789963 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Antiviral Agents
• DNA, Viral
• Tenofovir

Topics

• Antiviral Agents (adverse effects)
• DNA, Viral
• Female
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (drug therapy, prevention & control)
• Humans
• Infant
• Infectious Disease Transmission, Vertical (prevention & control)
• Male
• Mothers
• Pregnancy
• Tenofovir (adverse effects)
• Treatment Outcome
• Viral Load