Combination PEG-INF a-2b therapy achieves higher HBsAg loss in HBV-infected children

Key takeaways:

• HBV-infected children treated with combination PEG-INF a-2b/nucleos(t)ide analogues achieved higher HBsAg loss rates vs. monotherapy.
• Higher HBsAg loss was observed among those aged younger than 7 years.

SAN DIEGO — Combination therapy with peginterferon alfa-2b and nucleos(t)ide analogues resulted in significantly higher hepatitis B surface antigen loss vs. monotherapy in children with HBV, especially among those aged younger than 7 years.

“Compared with adults, HBV-infected children face a higher risk for developing chronic HBV,” Hong Zhang, of the Public Health Clinical Center of Chengdu in China, told attendees at The Liver Meeting. “Multiple studies have highlighted significant progression in liver pathology among children with chronic HBV, making their clinical management especially challenging. ... Furthermore, the guideline and drug options specific to children remain quite limited compared to adults.”

In the prospective, multicenter, real-world Sprout Project study, Zhang and colleagues investigated the safety and efficacy of several antiviral strategies for the treatment of pediatric HBV, and also examined factors associated with HBsAg loss.

They enrolled 297 children aged 3 to 18 years (mean age, 7.9 years; 57.9% boys), all of whom were HBsAg positive and had received nucleos(t)ide analogue (NA) therapy alone (n = 6) or in combination with PEG-IFN a-2b (n = 291) for 96 weeks. Nearly two-thirds (63.6%) were treatment-naive.

According to interim results, HBsAg loss rates at week 48 were 24.7% in the total population and 26.6% among treatment-naive patients. In addition, hepatitis B e-antigen loss rates were 19.8% and 18.3%, respectively, among those who received combination therapy.

“No patients in the NA monotherapy group achieved any of above responses,” Zhang told attendees. “In other words, higher response rates were achieved in the PEG-INF a-2b combination therapy group.”

Zhang also noted that as treatment continued, the combination therapy group exhibited significant reductions in HBsAg, which reached 2.1 and 2.29 log₁₀ IU/mL in the total population and treatment-naive groups, respectively. However, elevated alanine aminotransferase levels were “observed during HBsAg decline.”

Results from subgroup analyses demonstrated higher rates of HBsAg loss among children aged 3 to 6 years vs. those aged 7 to 17 years in both the total (30.6% vs. 19.7%; P = .032) and treatment-naive (33.7% vs. 19.6%; P = .03) populations.

“HBV-infected children treated with PEG-INF a-2b combination therapy can achieve significantly higher HBsAg loss and HBeAg loss compared to the NA monotherapy,” Zhang said. “PEG-INF a-2b-based strategies used at an early age in pediatric patients can better pursue functional cure.”