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

Assiut University

Status: Completed

Conditions: Chronic Hepatitis c

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03612973

assuit 1234

Details and patient eligibility

About

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

Full description

Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity and recent estimates showed increase in its prevalence over the last decade to > 185 million infections worldwide. Prevalence HCV infection in Egypt is the highest in the world.Chronic viral hepatitis infection increases liver fibrosis and stiffness and is an important cause of liver cirrhosis. 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 .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections.Interferon (INF) based therapy was used in chronic HCV patient and investigators reported that it's effective in eradicating HCV RNA and improving liver fibrosis. However, It's associated with several side effects.Novel direct antiviral agents (DAA) for chronic hepatitis C have entered clinical practice. This therapeutics has minimal side effects and achieves sustained virological response (SVR) rates of above 90% of patients and they are shorter and simpler regimens.Liver fibrosis severity assessment is important when staging chronic HCV and it reflects impact of serological viral eradication on hepatic damage and fibrosis. Although liver biopsy is the gold standard procedure for fibrosis assessment, but non-invasive new approaches have been strongly recommended for evaluation of fibrosis, mainly in HCV. They have no complications and have good diagnostic accuracy. One of the most used non-invasive mechanical methods based on ultrasound is transient elastography (Fibro Scan). Although association of baseline metabolic characteristics with treatment outcome has not been fully assessed for DAAs, this group was reported to result in improved rates of SVR and to reduce the predictive ability of these factors except for the baseline low density lipoprotein. The highest prevalence of HCV was reported in Egypt, where genotype 4 is responsible for 91% of infections and DAAs represented main line of treatment in most centers.Although the changes in lipid metabolism after treatment with DAAs were reported for other genotypes. It was not fully studied in genotype 4 infected patients.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

non cirrhotic HCV patients

Active Comparator group

Description:

* 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

Treatment:

Diagnostic Test: lipid profile

Diagnostic Test: fibro scan

Diagnostic Test: fasting insulin

cirrhotic HCV patients

Active Comparator group

Description:

* 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

Treatment:

Diagnostic Test: lipid profile

Diagnostic Test: fibro scan

Diagnostic Test: fasting insulin