Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Hepatitis c; Metabolic Syndrome

Treatments: Drug: Simvastatin 10mg; Drug: sofosbuvir plus daclatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03490097

PHCL35

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group I

Experimental group

Description:

low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.

Treatment:

Drug: sofosbuvir plus daclatasvir

Drug: Simvastatin 10mg

Group II

Active Comparator group

Description:

sofosbuvir plus daclatasvir

Treatment:

Drug: sofosbuvir plus daclatasvir