Chronic Hepatitis c, Metabolic Syndrome
Conditions
Brief summary
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
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: 1. CBC , liver function test , lipid profile and CK every month till the end of therapy. 2. HgA1C and CRP at the end of therapy. 3. HCV-PCR test 3 months after the end of therapy. 4. Fibrosis using (FIB-4) 3 months after the end of therapy.
Interventions
DRUGSimvastatin 10mg
tablets
sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients age 18 to 70 years old. 2. Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR. 3. Clinically stable condition outpatients. 4. Platelet count ≥ 150,000/mm³. 5. INR ≤ 1.2. 6. Serum albumin ≥ 3.5 g/dl. 7. Total serum bilirubin ≤ 1.2 mg/dl.
Exclusion criteria
1. Inadequately controlled diabetes mellitus (HbA1c \> 9%) . 2. Total serum bilirubin \> 3mg/dl. 3. HCV-HIV co infection. 4. HBV-HCV co infection. 5. Any cause for chronic liver disease other than hepatitis C 6. Uncontrolled hypothyroidism. 7. Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI). 8. Extra-hepatic malignancy except after two years of disease-free interval. 9. Child's C cirrhotic patients. 10. Creatinine kinase \> 350 u/l
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVR 12 | 3 months after end of therapy | sustained virological response 3 months after the end of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic status marker | three months | fasting glucose test |
| inflammatory marker | three months | C-reactive protein(CRP). |
| Lipid marker | three months | lipid profile |
Other
| Measure | Time frame | Description |
|---|---|---|
| CHC related complications | 6 months | fibrosis and cirrhosis |
Countries
Egypt
Outcome results
None listed