An Analysis of Published Trials of Interferon Monotherapy in Children With Chronic Hepatitis C

Abstract

To date, there is no published large-scale, multicenter, prospective, placebo-controlled randomized trial of the use of IFN-alpha in children with CHC. The data in this review suggest that IFN-alpha in children with CHC does have reasonable efficacy and safety. This review highlights the need for a more systematic design of future pediatric CHC trials. Ideally, such trials would be large scale, prospective, and controlled, and would include HCV genotype and viral load, histology, quality of life measures, and systematic recording of adverse events and of effects of therapy on growth and development.

Recombinant alfa-interferon plus ribavirin therapy in children and adolescents with chronic hepatitis C

“…Response to alfa-interferon monotreatment correlated with genotypes similar to those in adulthood and genotype 1 yielded poor results with an average response rate of 27%. 5 Nongenotype-1-infected children responded in 70% of cases. Therefore, the magnitude of the improvement with combination therapy by doubling the response rate in genotype-1-infected children is important and may represent a major advance in the therapy of chronic hepatitis C in children.…”

Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics *

“…7,8 SVR rates in children with chronic HCV given interferon alfa-2b with ribavirin in these studies are higher than in those using interferon alone (46% vs. 36%, respectively). 6 The use of different patient populations and treatment regimens in the small, previously published pediatric clinical studies of interferon as monotherapy makes direct comparisons between these treatment regimens difficult.…”

“…Although our understanding about the natural history and pathobiology of HCV infection in children is incomplete, it has been associated with significant liver disease, including chronic hepatitis, cirrhosis, and hepatocellular carcinoma in this population. [1][2][3][4] Approximately 10% to 20% of adults 5 and 36% of children 6 treated with interferon alone achieve long-term virological remission. The addition of ribavirin to interferon-based regimens markedly improves virological responses in adults.…”

Longitudinal Long-term Follow-up Study of Children with Vertically Acquired Hepatitis C Virus Infection

“…HCV genotype 1b is less responsive to interferon therapy; better results have been obtained with genotypes 2 and 3 and in patients with a low viraemic load. 10,11 Data on the efficacy and safety of treatments, including interferon and ribavirin, in children are scarce. Combination therapy (interferon plus ribavirin) has been used in 11 children, with a sustained response in seven (64%) after 48 weeks' treatment.…”