Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Chronic Hepatitis c
• Intervention / Treatment: Drug: Simvastatin 10mg; Drug: sofosbuvir plus daclatasvir

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kobri El koba Armed Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHC related complications	fibrosis and cirrhosis	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nagwa Ali Sabri, Professor, Professor of clinical pharmacy , ASU

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 23, 2018
• Study Completion (Actual): May 23, 2018

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Insulin Resistance; Hyperinsulinism; Hepatitis; Hepatitis A; Hepatitis C; Metabolic Syndrome; Hepatitis, Chronic; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sofosbuvir; Simvastatin
• Other Study ID Numbers: PHCL35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No