Early initiation of antiviral therapy contributes to a rapid and significant loss of serum HBsAg in infantile-onset hepatitis B

Abstract

Background & aim: There is a paucity of data regarding antiviral therapy in hepatitis B virus (HBV)-infected infants aged <1 year who have elevated alanine aminotransferase. This study aims to assess the efficacy and safety of antiviral therapy initiated in infancy.

Methods: A real-world cohort study was conducted from January 2010 to December 2017. HBV-infected infants under 1 year of age, with persistent elevation of alanine aminotransferase and high viral load, were recruited and divided into 2 groups. Group I included 18 infants whose parents chose to initiate antiviral therapy with lamivudine before 1 year of age. Group II included 11 infants whose parents chose to initiate antiviral therapy with interferon-α after 1 year of age and not to receive any antiviral therapies before 1 year of age. The main outcome measure was rate of serum HBV surface antigen (HBsAg) loss at month 12 of treatment.

Results: There were no statistical differences between Groups I and II regarding baseline characteristics. No infants in Group II developed spontaneous HBsAg loss before 1 year of age. In Group I, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were 39%, 67%, 78% and 83%, respectively. In Group II, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were 18%, 27%, 27% and 36%, respectively. Statistical differences existed in the cumulative rates of HBsAg loss between the 2 groups (log-rank test, p = 0.0023). No serious adverse events occurred in the study.

Conclusion: Early initiation of antiviral therapy for infantile-onset hepatitis B contributes to a rapid and significant loss of HBsAg. Further trials with larger cohorts are needed to verify our results.

Lay summary: Chronicity is a serious threat to infants infected with hepatitis B. However, no treatment measure has been recommended for infantile-onset hepatitis B in current guidelines. In order to evaluate the benefit and safety of antiviral therapy in infantile-onset hepatitis B, a real-world cohort study was conducted. Long-term follow-up results showed that early initiation of antiviral therapy with lamivudine safely led to a rapid and significant loss of serum hepatitis B surface antigen in the present subset of infants with alanine aminotransferase ≥2× upper limit of normal. Further trials with larger cohorts are needed.

Keywords: Antiviral therapy; Hepatitis B virus; Infant; Lamivudine; Real-word; Treatment guidelines.