According to a follow-up of the Pediatric Study of Hepatitis C (PEDS-C) trial, children with hepatitis C (HCV) who were treated with peginterferon alpha (pegIFNα) display considerable changes in weight, height, body mass index (BMI), and body composition. The results of the trial are published in the August edition of Hepatology, and suggest that although the majority of growth-related side effects are reversible by ending the therapy, many children's height-for-age score had not returned to baseline two years after therapy cessation.
Around 240,000 children in the U.S. have the HCV antibody and almost 100,000 have chronic HCV according to Jonas, 2002.
Leading researcher Maureen Jonas, Director of the Center for Childhood Liver Disease and Medical Director of the Liver Transplant Program at Boston Children's Hospital in Massachusetts, said:
"While HCV in children is typically mild, some cases do progress to cirrhosis and liver cancer. Treatment of HCV with peginterferon and ribavirin is approved for young children and offers the most benefit while liver disease is mild. However, there are concerns about the potential side effects of peginterferon therapy in children, which is the focus of our current study."
For the Pediatric Study of Hepatitis C (PEDS-C), a multi-center trial of the safety of pegIFNα with and without ribavirin conducted from December 2004 until May 2006, researchers recruited children aged between 5 to 18 years with chronic HCV. The new study entailed following these children for an additional 2 years in order to establish whether the treatment had affected their height, weight, or BMI. The participants were divided into three groups based on the length of their pegIFNα therapy (24, 48 or 72 weeks).
Overall, the study included 107 children with an average age of 11 years, of which 55% were male and 82% were Caucasian. At baseline, all children displayed a normal height, weight, BMI, and body composition. During the treatment, the team observed that some patients showed a reduction of up to 0.5 per unit in height, weight, and BMI z scores (standard deviation scores), discovering that 33% of children in the 48-week treatment group had a reduction of ≥ 0.5 in their height-for-age z score.
The findings demonstrated that the average height-for-age z scores were slower to rebound compared with those in weight and BMI. The researchers state that 2 years after the therapy, most children in the 48 and 72-week peginterferon group displayed lower than average height z scores in baseline scores. The team points out that the children's physical activity and food intake had not changed during the study period.
Dr. Jonas concludes:
"Our findings demonstrate significant effects on weight, BMI, and body composition in children treated with pegIFNα that are reversible upon cessation of treatment. A reduction in linear growth persisted even after treatment was discontinued. Additional investigation of growth patterns is needed to determine long-term outcomes so that optimal timing of treatment can be determined for children with chronic HCV."