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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2021
  • participants needed
    40
  • sponsor
    Assiut University
Updated on 24 March 2021

Summary

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

Description

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-) 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-) which may stimulate T-regulatory cells.

Details
Condition Chronic viral hepatitis C
Treatment Sofosbuvir and Daclatasvir
Clinical Study IdentifierNCT03882307
SponsorAssiut University
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

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
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