Chronic Hepatitis C Clinical Trial
Official title:
Pharmacogenomics Study on IL28B Genetic Variants for Prediction of Drug Response in Chinese Children With HCV Infection.
The aim of this study is to investigate the relationships between interleukin 28B genetic variants and the response to treatment of chronic hepatitis C in Chinese children.
Hepatitis C affects thousands of children throughout the world. Most children acquire the
virus through vertical transmission, although parenteral routes of acquisition are also
common. Affected children are usually asymptomatic and histological findings are mild with a
low risk of progression, about 5% develop significant liver disease in childhood.
The use of combination treatment with interferon-alpha and ribavirin were recommended in the
treatment of chronic hepatitis C in children, SVR in children with genotype 1 ranged from
44% to 59%. SVR in children with genotype 2 and 3 was more than 90%. But both interferon and
ribavirin have significant side effects which affect compliance, such as: repeated flu like
symptoms, leukopenia and anemia, moderate weight loss, behavioural problems, thyroid
dysfunction and transient deceleration of the growth rate. In addition, approximately 50% of
children infected with genotype 1 do not respond to therapy.
Recent work has highlighted that single nucleotide polymorphisms (SNPs) around the IL28B
gene have been identified as strong predictors of spontaneous and treatment-induced HCV
clearance in adults, especially Rs 12979860 and Rs 8099917. A recent article in Hepatology
also reported that interleukin (IL)-28B C/C genotype in the child was associated with
spontaneous clearance of hepatitis C virus (HCV) genotype 1 infection. All this reports show
that Genetic Variation in Interleukin-28B Locus is associated with the procession of CHC.
The aim of this study was to study the association between genetic variation in IL-28B and
the development of CHC in Chinese children, such as: HCV viral load, serum alanine
aminotransferase, histological change and the response to the treatment with
interferon-alpha and ribavirin.
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Observational Model: Case-Only, Time Perspective: Prospective
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