Long‐term efficacy and safety of peginterferon in the treatment of children with HBeAg‐positive chronic hepatitis B

Abstract

Achieving ‘clinical cure’ in children with chronic hepatitis B (CHB) with safe and effective antiviral treatment is an unmet medical need. Peginterferon (PegIFN) has higher hepatitis B s antigen (HBsAg) clearance than nucleoside analogs (NUC). Currently, studies on interferon (IFN) in the treatment of Chinese children with CHB are relatively rare. This study aimed to further explore the efficacy of PegIFNα‐2a as an antiviral treatment in Chinese children and analyse the long‐term follow‐up after drug discontinuation. We enrolled 118 patients with CHB (2‐16 years old, 79 cases are males) treated with PegIFNα‐2a by the author in the Third People's Hospital of Kunming City from February 2009 to February 2015. The course of treatment was 52 weeks, with a follow‐up period of 104 weeks. All the patients completed at least 1 dose, of which 104 completed at least 36 weeks of treatment and 104 weeks of follow‐up. During treatment and follow‐up, indicators such as alanine aminotransferase (ALT), hepatitis B virus (HBV) DNA and HBV serological markers were monitored, and the efficacy and safety of PegIFNα‐2a in the treatment of CHB patients were observed. Hepatitis B e antigen (HBeAg) clearance and seroconversion rates were 53.8% and 49%, respectively, when the drug was discontinued; 72.1% and 72.1%, respectively, at the end of the follow‐up; and 98.2% and 98%, respectively, for sustained response. HBsAg clearance and seroconversion rates were 48.1% and 47.1%, respectively, when the drug was discontinued; 53.8% and 52.9%, respectively, at the end of the follow‐up; and 94% and 95.9%, respectively, for sustained response. The HBV DNA suppression rate was 89.4% when the drug was discontinued, 90.4% at the end of the follow‐up and 97.8% for sustained response. Two patients had virological relapse (2.3%) during follow‐up; however, no clinical relapse occurred. Multivariate regression analysis showed that genotype B, weight < 25 kg or between 25 and 45 kg, and reduction of HBsAg by more than 1 log following 24 weeks of treatment were independent predictors of HBsAg clearance at the end of follow‐up. Adverse events that occurred during treatment were similar to those reported in previous clinical studies on PegIFN. The results of this study showed that PegIFN was safe and effective in the treatment of children with CHB, and sustained response could be achieved after treatment. PegIFN treatment of children with CHB helps more achieve ‘clinical cure’.

Long‐term benefits of interferon‐α therapy in children with HBeAg‐positive immune‐active chronic hepatitis B

“…Thus, whether the HBeAg clearance rates in patients treated with IFN‐α differ from the spontaneous rates of HBeAg clearance during long‐term HBV infection requires further study. Furthermore, our recent study found that children with CHB treated with IFN‐α had a higher rate of HBsAg loss than adults during the 2‐year follow‐up period 17 . Despite this, the long‐term rate of HBsAg loss following IFN‐α treatment in children with CHB in the immune‐active phase has not been reported.…”

The efficacy of pegylated interferon and entecavir in HBeAg-positive children and adolescents with chronic hepatitis B

“…Tenofovir was only licensed for patients ≥ 12 years old currently. Due to less frequent injection and prolonged stability in vivo of peg-IFN compared with IFN, peg-IFN was approved for CHB pediatric patients by the United States of America and the European Union in 2017 and might replace the use of IFN- (5). ETV and peg-IFN, both of which are commonly used in pediatric patients at present, have distinctly different mechanisms in controlling the progress of CHB.…”

The efficacy of pegylated interferon alpha-2a and entecavir in HBeAg-positive children and adolescents with chronic hepatitis B

“…With the approval of peg-IFN α-2a for CHB paediatric patients(≥3 years old) by the United States of America and the European Union in 2017, peg-IFN α-2a has also recently been recommended in paediatric CHB patients by international guidelines. Due to the less frequent injection and prolonged stability in vivo of peg-IFN compared to IFN-ɑ, peg-IFN is promising to replace the use of IFN-ɑ [ 5 ]. ETV and peg-IFN, both of which are first-line drugs and are the most commonly used in paediatric patients, have distinctly different mechanisms in controlling the progression of CHB.…”