Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital

Study Overview
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Brief Summary
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evaluation of glomerular filtration rate(eGFR)changes during HCV treatment with direct antiviral drugs according to 2018 guideline. TO estimate the frequency of renal impairment by direct antiviral drugs By detection of any changes in e GFR. Assessment The Renal safety during HCV treatment with direct antiviral drugs according to 2018 guideline. To clarify the importance of laboratory and other modalities in detection and estimation of frequency of renal impairment by direct antiviral drugs according to 2018 guideline.

Detailed Description
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Hepatitis C virus (HCV) has an estimated global prevalence of 2%-3% with 130-170 million people infected with HCV.(1) HCVcauses chronic inflammation of the liver leading to chronic hepatitis, which can advance to liver cirrhosis and hepatocellular carcinoma and significant extrahepatic complications.(2) Additionally, HCV has been shown to have a significant negative effect on apatient's overall quality of life, including decreased work hours and productivity and increased healthcare costs.(3) Cirrhosis and hepatocellular carcinoma related to HCV infection represent the most common indications for liver transplantation duo to poor treatment options.(4) Until recently, interferon-based treatments were thebackbone of HCV treatment options.(5) Unfortunately,therapy was only modestly effective and associatedwith significant side effects.(6) Therefore, research has focused on HCV eradication using oral antiviral therapy. Recent clinical studies have demonstrated efficacy using the nucleotide analogue inhibitor sofosbuvir(Sovaldi; Gilead Sciences, Inc., Foster City, CA) as the backbone in treatment of non transplant and post transplant recurrent HCV.(7) Both the ION-1 and ION-2 trials demonstrated nearly 99% efficacy in the treatment ofnontransplant, noncirrhotic HCV patientsusing sofosbuvir in a fixed-dose combination with theNS5A inhibitor ledipasvir (Harvoni, Gilead Sciences,Inc.), both with and without ribavirin.(8,9) The side effect profile of ledipasvir/sofosbuvir (LDV/SOF) hasbeen relatively mild and the drug has been well tolerated in trials, especially compared with previous interferon-based regimens. The ION trials report that LDV/SOF therapy was primarily complicated by headaches or fatigue inapproximately 10% of patients. Less frequently, patients experienced rashes, nausea, diarrhea, and insomnia.Serious side effects, such as nephrotoxicity, were not demonstrated by the ION-1 and ION-2 trials; however, these trials were conducted in a controlled clinical setting with rigorous exclusion criteria. Such trials are not always entirely reflective of the general patient population. Early data suggest possible risk of renal impairment during treatment with the use of direct antiviral drugs(10) this study is about renal safety and changes in eGFR in patients with chronic HCV undergoing direct acting antiviral therapy according to 2018 guideline.

Official Title
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Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital

Conditions
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Antiviral Drug

Intervention / Treatment
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* Drug: DAAs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic hepatitis C virus patients will be on direct antiviral therapy . Exclusion Criteria: patients with DM ,HTN ,CKD,Autoimmune Diseases Patients with kidney injury other than DAAs Patients with sever heart failure or malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic HCV will be on direct antiviral drugs<br>is defined as the presence of detectable viral replication for at least six months diagnosed by quantitative HCV RNA polymerase chain reaction (PCR) | Drug: DAAs<br>* Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks Daily simeprevir (150 mg) plus sofosbuvir (400 mg) 12 weeks Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) 12 weeks Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) 12weeks<br>* Other names: ledipasvir/sofosbuvir/daclatasvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate(eGFR) changes during HCV treatment | the frequency of renal impairment by evaluation of glomerular filtration rate(eGFR) changes during HCV treatment with direct antiviral drugs before and after the treatment using different equation for eGFR such as (MDRD, CKD_EPI,Cockroft) | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of direct anti Viral drugs on kidney function | the frequency of renal impairment by direct antiviral drugs by measurement of serum BUN and creatinine | 3 month |