NEW YORK (Reuters Health) – Ribavirin added to pegylated interferon more than doubles the sustained viral response rate in children with chronic hepatitis C, a multicenter team reports in the February issue of Gastroenterology.
There may be 132,000 HCV antibody-positive children in the United States, with 7200 new cases annually, the researchers observe in the introduction to their paper.
“Recommendations for treatment of HCV infection in children have been derived from trials in adults, although the efficacy and safety of these therapies may be different in children,” write Dr. Kathleen B. Schwarz, with The Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues at 11 university medical centers.
They therefore conducted a randomized controlled trial of peginterferon and ribavirin, compared with peginterferon monotherapy, in children 5 to 17 years old with chronic hepatitis C.
By random assignment, 55 children received pegylated interferon alfa-2a (180 mcg/1.73 m² body surface area, subcutaneously weekly) and ribavirin (15 mg/kg orally in 2 doses daily), while 59 children were given peginterferon and placebo, for 48 weeks.
A sustained virologic response, defined as undetectable plasma levels of HCV RNA at least 24 weeks after stopping treatment, was documented in 29 children in the peginterferon-ribavirin group (53%) compared with 12 in the peginterferon-placebo group (21%), according to the report.
Almost all the children experienced headache, influenza-like symptoms and adverse GI effects, the researchers report. WBC and neutrophil counts dropped, along with hemoglobin levels, but returned to baseline when therapy ended. Dose reductions of peginterferon or ribavirin were common but did not affect sustained responses in either group.
As in other studies, subjects with HCV genotype 1 had lower sustained response rates than those with the other genotypes, the investigators found.
“These results indicate that children with chronic hepatitis C should not receive peginterferon monotherapy,” Dr. Schwarz and colleagues conclude. “The response rates in this trial were comparable to those in uncontrolled clinical trials of peginterferon and ribavirin in children and were similar to rates reported in adults.”
So, are children the same as adults? asks an editorialist. “‘Yes,’ in that they benefit from combined therapy for HCV,” writes Dr. Aymin Delgado–Borrego at the University of Miami Miller School of Medicine, Florida. “‘No,’ in some ways, including altered viral kinetics. ‘We don’t know’ in most ways. Efforts to accelerate trials in children will be essential to understand the key host differences between children and adults.”