A recent randomized controlled, open-label study (S Wirth et al. Hepatology 2018; 68: 1681-94) examined the use of weekly peginterferon alfa-2a (PEG) in 161 children (3-18 yrs) with immune-active HBe-Ag-positive children. The two main groups were for those without advanced fibrosis: a PEG group (n=101) and a placebo group (n=50). A third group enrolled 10 patients with advanced fibrosis who all received PEG. The treatment period was 48 weeks with ongoing observation for an additional 24 weeks.
- The PEG group had HBeAg seroconversion of 8% at 48 weeks and 26% at 72 weeks; the placebo group had HBeAg seroconversion of 6% at both timepoints. At 72 weeks, the odds ratio was 5.43 for the PEG group and P=0.0043.
- HBsAg clearance rates were higher in the PEG group: 8.9% vs 0% in placebo group.
- The authors showed response (loss of HBeAg) by age and those <5 years had the highest response 43% (6 of 14). The rate of seroconversion was 30.2% in those <12 years compared with 20.8% in those ≥12 years.
- The authors showed response (loss of HBeAg) those with ALT values between 2-<5 had the highest response of 35% (15 of 43).
- Adverse events were frequent –among the 101 treated patients: 49 with pyrexia, 30 with headache, 19 with abdominal pain, 15 with influenza-like illness, 14 with vomiting, 61 with ALT >5 x ULN, 25 with ALT >10 x ULN, 19 with neutropenia (ANC <750), and two with self-limited increased thyroid-stimulating hormone. These were all much higher than in the placebo group
My take: This study does not answer the question about which treatment is optimal for hepatitis B in children–direct-acting antivirals (eg. entecavir, and tenofovir) or peginterferon. It does shows that weekly peginterferon alfa-2a was associated with HBeAg seroconversion in 26% of recipients at week 72. Although a high number of patients experienced adverse effects, there were no new safety signals identified.
Related blog posts:
- New Hepatitis B Treatment Guidelines
- More on Hepatitis B Treatment in Children | gutsandgrowth
- Update on Hepatitis B & C -Postgraduate Course
- Changing the Outcome for Hepatitis B
- Extended data with entecavir & annotated HBV management references
- “Immune-tolerant” — a misnomer for HBV infection | gutsandgrowth