Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Study Overview
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Brief Summary
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The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination

Detailed Description
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Aim of the work To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through : Primary Outcome: Assessment of therapeutic SVR12 Seconadry Outcome 1. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP). 2- Evaluation of CHC related complications such as fibrosis and cirrhosis Patients will be followed up for the whole study period and will be subjected to assessment of the following: CBC , liver function test , lipid profile and CK every month till the end of therapy. HgA1C and CRP at the end of therapy. HCV-PCR test 3 months after the end of therapy. Fibrosis using (FIB-4) 3 months after the end of therapy.

Official Title
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Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Conditions
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Chronic Hepatitis c, Metabolic Syndrome

Intervention / Treatment
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* Drug: Simvastatin 10mg
* Drug: sofosbuvir plus daclatasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients age 18 to 70 years old. Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR. Clinically stable condition outpatients. Platelet count ≥ 150,000/mm³. INR ≤ 1.2. Serum albumin ≥ 3.5 g/dl. Total serum bilirubin ≤ 1.2 mg/dl. Exclusion Criteria: Inadequately controlled diabetes mellitus (HbA1c > 9%) . Total serum bilirubin > 3mg/dl. HCV-HIV co infection. HBV-HCV co infection. Any cause for chronic liver disease other than hepatitis C Uncontrolled hypothyroidism. Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI). Extra-hepatic malignancy except after two years of disease-free interval. Child's C cirrhotic patients. Creatinine kinase > 350 u/l

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks. | Drug: Simvastatin 10mg<br>* tablets<br>* Other names: simvastatin;Drug: sofosbuvir plus daclatasvir<br>* sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.<br>* Other names: Sovodac;|
| Active Comparator: Group II<br>sofosbuvir plus daclatasvir | Drug: sofosbuvir plus daclatasvir<br>* sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.<br>* Other names: Sovodac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR 12 | sustained virological response 3 months after the end of therapy | 3 months after end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid marker | lipid profile | three months | 
| Glycemic status marker | fasting glucose test | three months | 
| inflammatory marker | C-reactive protein(CRP). | three months |