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临床试验/NCT03612973
NCT03612973已完成不适用

Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy

Assiut University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

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

时间窗: 1 year

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

次要结局

  • Changes and degree of improvement in insulin resistance in HCV patients after receiving direct acting antiviral therapy(1 year)
  • Effect of HCV treatment by direct acting antiviral therapy on lipid profile of chronic HCV patients(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa hanafy

principal investigator

Assiut University

研究点 (2)

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