Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up

Virulence. 2021 Dec;12(1):1527-1537. doi: 10.1080/21505594.2021.1936769.

Abstract

We prospectively investigated the neurological development in infants born from mothers treated with telbivudine (LdT) in the third trimester for prevention of hepatitis B virus (HBV) mother-to-infant transmission. Mothers with high HBV load were assigned to either the LdT group (n = 81, 600 mg of LdT each day from gestational week 28 to delivery) or the Control group (n = 39, untreated). Their infants were followed for 36 months to assess physical and neurological developments with Gesell Developmental Schedule tools. At 12 months after birth, the mean scores in the LdT group for gross motor, fine motor, adaptive, linguistic, and personal social domains were similar to those in the Control group. At 36 months, infants in the LdT group had higher mean scores for gross motor than the Control group (98.42 ± 9.69 vs. 94.54 ± 7.48, P = 0.03). In the LdT group, the rates of normal development were higher for gross motor (96.30% vs. 82.05% P = 0.01) and lower for adaptive (74.07% vs. 92.31% P = 0.02). Multivariate regression analyses showed that exposure to LdT during pregnancy was independently associated with infant's development in gross motor (OR 6.49, 95% CI 1.37-30.20, P = 0.02) and adaptive (OR 0.18, 95% CI 0.05-0.71, P = 0.01) at 36 months. These results suggest that prenatal LdT exposure might affect neurological development in long-term observation.Abbreviations: LdT: telbivudine; HBV: hepatitis B virus; HBsAg: hepatitis B surface antigen; HBeAg: hepatitis Be antigen; HbsAb: hepatitis B surface antibody; ALT: alanine aminotransferase; NA: nucleoside/nucleotide analog; LAM: lamivudine; MTCT: mother-to-child transmission; GDS: Gesell Developmental Schedule; OR: odds ratio; CI: confidence interval; DQ: developmental quotient; RMB: renminbi; BMI: body mass Index; HBIG: hepatitis B immunoglobulin.

Keywords: Neurological development; chronic hepatitis B; pregnancy; safety; telbivudine.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents* / adverse effects
  • Antiviral Agents* / therapeutic use
  • Child Development
  • DNA, Viral
  • Female
  • Follow-Up Studies
  • Hepatitis B, Chronic* / drug therapy
  • Humans
  • Infant
  • Infectious Disease Transmission, Vertical* / prevention & control
  • Motor Skills
  • Nervous System* / drug effects
  • Nervous System* / growth & development
  • Pregnancy
  • Pregnancy Complications, Infectious* / drug therapy
  • Prenatal Exposure Delayed Effects / physiopathology*
  • Prospective Studies
  • Telbivudine / adverse effects*
  • Telbivudine / therapeutic use
  • Treatment Outcome

Substances

  • Antiviral Agents
  • DNA, Viral
  • Telbivudine

Grants and funding

This study was funded in part by the Beijing Municipal Science & Technology Commission [grant number Z151100004015122], in part by the Beijing Municipal Administration of Hospitals Clinical medicine Development of special funding support [grant number XMLX 201706 and XMLX 202127], in part by the National Science and Technology Major Project of China [grant number2017ZX10201201-001-006, grant number 2017ZX10201201-002-006], [grant number 2018ZX10715-005-003-005], in part by Beijing Science and Technology Commission [grant number D161100002716002], in part by the Digestive Medical Coordinated Development Center of Beijing Hospitals Authority [grant numberXXZ0302].