Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera

Study Overview
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Brief Summary
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Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma.. Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .

Detailed Description
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Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication . Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens. Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects. Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin . Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.

Official Title
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Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: sofosbuvir and daclatasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 70 years. HCV RNA positivity . Any Body Mass Index(BMI). Treatment-naive or treatment experienced. all fibrosis stages. Exclusion criteria: Direct serum bilirubin greater than 2 mg/dl. Serum albumin less than 2.8 g/dl. International normalization ratio (INR) greater than or equal to 1.7 Platelet count less than 50 000/mm3. Ascites or history of ascites. Hepatic encephalopathy or history of hepatic encephalopathy. Hepatocellular carcinoma. Serum creatinine greater than 2.5 mg/dl . Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group1 (naive)<br>Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment | |
| Active Comparator: group2 (sustained responder)<br>Assess serum level of interleukin-6 and transforming growth factor beta after three months from the end of treatment Sofosbuvir (SOF) (400 mg once per day) and daclatasvir (DCV)(60mg once per day) or simeprevir (SIM) (150 mg once per day) for 3 months treatment regimens | Drug: sofosbuvir and daclatasvir<br>* oral tablets<br>* Other names: Sovaldi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean difference in level of interleukin-6 and transforming growth factor beta after treatment | serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment | three months from the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transforming growth factor -beta, sustained virological response, hepatitis C virus therapy, interleukin-6