Hepatitis C, Chronic
Conditions
Keywords
hepatitis C virus therapy, interleukin-6, transforming growth factor -beta, sustained virological response
Brief 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 .
Detailed 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-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.
Interventions
oral tablets
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean difference in level of interleukin-6 and transforming growth factor beta after treatment | three months from the end of treatment | serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment |
Countries
Egypt
Contacts
Primary ContactSalwa Sayed Ahmed, proffessor
Backup ContactAliaa Mahmoud Ali, lecturer
Outcome results
None listed