Thursday, September 2, 2010

Pegylated Interferon plus Ribavirin Has High Sustained Response Rates in Children with Hepatitis C

Hepatitis C Research and News:

SUMMARY: Children with hepatitis C virus (HCV) infection who were treated with pegylated interferon plus ribavirin showed a high rate of sustained virological response, greater than that seen in most adult studies, according to a report in the June 2010 Journal of Hepatology. Nearly 60% of children with hard-to-treat HCV genotypes including 1 and 4 -- and more than 90% of those with easier-to-treat genotypes 2 or 3 -- achieved a cure.

By Liz Highleyman

Studies of combination interferon-based therapy for chronic hepatitis C usually focus on adults, who typically demonstrate sustained virological response (SVR) rates of just under 50% for HCV genotype 1 and 70%-80% for genotypes 2 or 3 using a standard regimen of pegylated interferon plus ribavirin for 48 or 24 weeks, respectively. Treatment of children with hepatitis C has not been as extensively studied.

In the present study, Etienne Sokal from Catholic University Louvain in Belgium and an international team of colleagues evaluated the safety and efficacy of pegylated interferon alfa-2a (Pegasys) plus ribavirin in previously untreated HCV antibody positive children with detectable HCV RNA viral load.

This prospective analysis included 18 children with HCV genotypes 2 or 3, who were treated for 24 weeks, and 47 children with harder-to-treat genotypes 1, 4, 5, or 6, who were treated for 48 weeks.

  • 83% of the genotype 2/3 children and 57% of the genotype 1/4/5/6 children achieved early virological response at week 12.
  • End-of-treatment response rates were 94% (at week 24) and 57% (at week 48), respectively.
  • Relapse rates were low, with 89% of easier-to-treat participants and 57% of hard-to-treat children achieving sustained response at 24 weeks after completion of therapy.
  • 10 participants overall (15%) stopped treatment prematurely -- 2 due to serious adverse events and 8 due to lack of virological response at week 24.
  • 15 children overall (23%) had their pegylated interferon or ribavirin doses adjusted -- 11 (17%) due to neutropenia and 3 (5%) due to anemia.
  • The most common treatment-related adverse events included:
--Fever and flu-like symptoms (54%);
--Abdominal pain (38%);
--Irritability, depression, or mood changes (34%);
--Dermatitis (29%);
--Vomiting (23%);
--Loss of appetite (22%).
  • Interferon-based treatment had no observed effect on the children's growth in height.
These results, the researchers concluded, show that children have an improved rate of sustained virological response compared with reference studies of adult chronic C patients treated with similar regimens.

Investigator affiliations: Université Catholique de Louvain, Cliniques universitaires St Luc, Bruxelles, Belgium; Paediatric Gastroenterology, Hospital de clinicas de Porto Alegre, Porto Alegre, Brazil; Unidade de Hepatologica Pediatrica, Hospital das clinicas da faculdade de medicina da universidade de Sao Paulo, Sao Paulo, Brazil; Department of Pediatrics, Stradinš University, Riga, Latvia; Department of Paediatrics, CLINTEC, Karolinska University Hospital, Huddinge, Stockholm, Sweden; Liver Unit, Birmingham Children's Hospital, Birmingham, UK.


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