Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication.

Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Antiviral Agents; Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Patients with chronic HCV.

• Patients who need treatment for their elevated cholesterol:

• Total cholesterol >240 or

• LDL >160 without cardiac risk factors or

• LDL >130 with two cardiac risk factors (hypertension, smoker, family history of heart attach, or HDL <40 for men or <50 for women) or

• LDL >100 with diabetes or known coronary artery disease

Exclusion Criteria:

• Impaired mental ability preventing a subject from understanding the protocol or from completing the entire study.

• HCC

• A history of an adverse reaction to any HMG CoA reductase inhibitor.

• Patients who are on HCV treatment, who plan to initiate HCV treatment within 3 months, or who discontinued HCV treatment within the last 3 months.

• Patients whose aminotransferases are > 5 times the upper limit of normal.