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

Assiut University

Status and phase: Enrolling; Early Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: sofosbuvir and daclatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03882307

hhayam

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

group1 (naive)

No Intervention group

Description:

Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment

group2 (sustained responder)

Active Comparator group

Description:

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

Treatment:

Drug: sofosbuvir and daclatasvir