Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Ain Shams University100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Chronic Hepatitis c Metabolic Syndrome

Interventions

Simvastatin 10mgDRUG

tablets

sofosbuvir plus daclatasvirDRUG

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Kobri El koba Armed Forces Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

SVR 12

sustained virological response 3 months after the end of therapy

Time frame: 3 months after end of therapy

Secondary Outcomes

Lipid marker

lipid profile

Time frame: three months

Glycemic status marker

fasting glucose test

Time frame: three months

inflammatory marker

C-reactive protein(CRP).

Time frame: three months

Data from ClinicalTrials.gov

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