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Interferon plus lamivudine therapy improves HBV clearance in children

Pediatric patients with chronic hepatitis B and immune-tolerant characteristics who underwent interferon therapy followed by treatment with Epivir had significantly improved the rates of undetectable serum HBV DNA, HBV e-antigen seroconversion and HBV surface antigen loss compared with control, according to a recently published study.

“In children, chronic hepatitis B (CHB) is characterized by its natural course, including immune-tolerant phase, immune-active state and inactive carrier,” Shishu Zhu, MD, from the Beijing 302 Hospital, and colleagues wrote. “Ideally, a child with CHB should be treated early to prevent the development of cirrhosis and HCC. Nevertheless, to date, no therapeutic interventions have been recommended by the guidelines for the pediatric immune-tolerant CHB, because of the scarcity of available data.

Of the 69 pediatric patients included in the open-label pilot study, Zhu and colleagues randomly assigned 46 patients to a treatment group and 23 patients to a control group. Patients in the treatment group received interferon monotherapy which was followed by Epivir (lamivudine, GlaxoSmithKline) depending on HBV DNA decline.

Among the treatment group, the rate of undetectable serum HBV DNA was 54.35% at 48 weeks, 67.39% at 72 weeks, and 73.91% at the 96-week study end. The rate of HBeAg seroconversion was 4.35% at 48 weeks and 32.61 % by study end. Similarly, the rate of HBsAg loss increased from 6.52% at 48 weeks to 21.74% by study end.

At the end of the study, seven patients achieved HBsAg seroconversion and four patients had serum HBsAg concentration lower than 10 IU/mL.

The researchers observed no significant difference in median alanine aminotransferase levels at study end between both groups. Multivariate analysis showed that ALT was an independent predictor of response at baseline (OR = 1.066; 95% CI, 1.01-1.124).

No patients experienced serious adverse events or ALT elevations higher than 10 times the upper limit of normal.

“Interestingly, individuals among the treatment group presented diverse features in the course of HBeAg and HBsAg clearance,” the researchers wrote. “Of the 10 patients who achieved HBsAg loss, five initially lost HBsAg and later HBeAg, two cleared HBeAg earlier than HBsAg, and three lost HBeAg and HBsAg simultaneously. This contributed to the higher rate of patients with HBsAg loss than that of patients with HBeAg seroconversion at week 48. However, the mechanism of HBsAg clearance prior to HBeAg loss was unclear.” – by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.