Hepatitis C Clinical Trial
Official title:
Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection
Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000
deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic
Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers,
was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009).
It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al
2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), (
Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals
(DAAs) have shown improved efficacy and tolerability compared with interferon
(IFN)-containing regimens, and they have become the standard of care for treatment of HCV
genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given
concentration of insulin produces a less-than-expected biological effect. The prevalence of
type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than
among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin
resistance and insulin resistance induces interferon resistance, steatosis and fibrosis
progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained
response rate, and increase the risk for the development of steatosis and fibrosis
progression, However, the impact of insulin resistance in other genotypes seems not achieve
enough importance to impair sustained response, probably due to the high sensitivity to
peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could
improve sustained response rate in patients with chronic HCV-1 infection when treated with
peginterferon plus ribavirin(Romero-Gómez,2006).
Objectives: we aim to determine the prevalence of insulin resistance among the patients with
chronic hepatitis C virus( HCV) infection and to explore the association between insulin
resistance and therapeutic response by comparing the insulin resistance among responders and
non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods:
The study is intended to include patients of chronic hepatitis C virus infection receiving
oral treatment for one year period. All patients will have clinical evaluation,
ultrasonographic examination, and laboratory investigations which include complete blood
count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and
determination of insulin resistance index.The patients will be selected according the
selection criteria determined by the National Committee for Control of Viral Hepatitis
(NCCVH).
n/a
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