Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

NCT03612973 | Completed

• 1 other identifier: assuit 1234
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

• Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy

  by using non-invasive measures (fibro scan) before and after end of treatment (12 weeks0

  1 year

Secondary Outcomes (2)

• Effect of HCV treatment by direct acting antiviral therapy on lipid profile of chronic HCV patients

  1 year

• Changes and degree of improvement in insulin resistance in HCV patients after receiving direct acting antiviral therapy

  1 year

Study Arms (2)

non cirrhotic HCV patients

ACTIVE COMPARATOR

* complete blood picture * Liver and renal function tests * Prothrombin time and concentration * HCV quantitative polymerase chain reaction * Hepatitis B surface Ag * lipid profile * fasting blood glucose level * fasting insulin level * homeostasis model for the assessment of insulin resistance (HOMA-IR) * fibrosis (FIB- 4) index * Aspartate aminotransferase (AST)/platelet ratio index (APRI) * Abdominal ultrasound to assess liver and spleen * Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks

Diagnostic Test: lipid profile; Diagnostic Test: fasting insulin; Diagnostic Test: fibro scan

cirrhotic HCV patients

ACTIVE COMPARATOR

* complete blood picture * Liver and renal function tests * Prothrombin time and concentration * HCV quantitative polymerase chain reaction * Hepatitis B surface Ag * lipid profile * fasting blood glucose level * fasting insulin level * homeostasis model for the assessment of insulin resistance (HOMA-IR) * Fibrosis (FIB- 4) index * Aspartate aminotransferase (AST)/platelet ratio index (APRI) * Abdominal ultrasound to assess liver and spleen * Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks

Diagnostic Test: lipid profile; Diagnostic Test: fasting insulin; Diagnostic Test: fibro scan

Interventions

lipid profile DIAGNOSTIC_TEST

Serum samples will be withdrawn after fasting 12 hours then performed on Siemens Dimension Max: Total cholesterol and triglyceride concentrations will be estimated using enzymatic methods ( Roche Diagnostics, Mannheim, Germany). High density lipoprotein cholesterol will be determined after precipitation with phosphotungstic acid/magnesium chloride. Low density lipoprotein(LDL) cholesterol will be measured directly with a commercially available direct LDL-C assay (LDL-C Plus assay; Roche Diagnostics)

cirrhotic HCV patients; non cirrhotic HCV patients

fasting insulin DIAGNOSTIC_TEST

serum samples used for doing the test by ELISA after fasting for 8 h

cirrhotic HCV patients; non cirrhotic HCV patients

fibro scan DIAGNOSTIC_TEST

liver stiffness by fibro scan before and after treatment

cirrhotic HCV patients; non cirrhotic HCV patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 ys.
• Disease status: patients with chronic hepatitis C infection, based on the presence of anti-HCV and detectable serum HCV-RNA for 6 months or more who had different grades of fibrosis (F) as estimated by fibroscan
• Treatment: treatment naïve patients who will receive direct acting antiviral drugs (Sofosbuvir and Daclatasvir ± ribavirin) for 12 weeks
• Negative hepatitis B virus surface Ag and HIV antibodies
• No history of hepatocellular carcinoma or development of hepatocellular carcinoma during the treatment period
• No other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease).

You may not qualify if:

• Diabetic patients.
• Patients using lipid lowering agents.
• HCV co-infection with hepatitis B virus(HBV) or human immunodeficiency virus(HIV)
• Presence of other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease).
• Patients with hepatocellular carcinoma

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: both study groups will be investigated at same time

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 2, 2018
• Study Start: June 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)