Shishu Zhu1, Yi Dong1, Limin Wang1, Weiwei Liu2, Pan Zhao3. 1. The Fifth Medical Center (formerly Beijing 302 Hospital), Chinese PLA General Hospital, Beijing 100039, China. 2. Medical Statistics Section, Academy of Military Medical Sciences, Beijing 100850, China. 3. The Fifth Medical Center (formerly Beijing 302 Hospital), Chinese PLA General Hospital, Beijing 100039, China; The First Affiliated Hospital of Xinxiang Medical University, Weihui, Henan 453100, China. Electronic address: doczhaopan@126.com.
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.
BACKGROUND & AIM: There is a paucity of data regarding antiviral therapy in hepatitis B virus (HBV)-infectedinfants 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-infectedinfants 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 infantsinfected 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.