Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

NCT00403533 | Completed Phase 2

• 2 other identifiers: 2006-P-000138/1AASLD advanced hepato. grant
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Keywords

Hepatitis C; viral load; antiviral therapy; cholesterol; atorvastatin

Outcome Measures

Primary Outcomes (1)

• Paired comparison of pretreatment viral load to post-treatment 12 week viral load

Secondary Outcomes (1)

• Paired comparison of pretreatment viral load to post-treatment 4 week viral load

Interventions

20 mg of atorvastatin daily DRUG

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Ikeda M, Abe K, Yamada M, Dansako H, Naka K, Kato N. Different anti-HCV profiles of statins and their potential for combination therapy with interferon. Hepatology. 2006 Jul;44(1):117-25. doi: 10.1002/hep.21232.

  PMID: 16799963 BACKGROUND

• Kapadia SB, Chisari FV. Hepatitis C virus RNA replication is regulated by host geranylgeranylation and fatty acids. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2561-6. doi: 10.1073/pnas.0409834102. Epub 2005 Feb 7.

  PMID: 15699349 BACKGROUND

• Aizaki H, Lee KJ, Sung VM, Ishiko H, Lai MM. Characterization of the hepatitis C virus RNA replication complex associated with lipid rafts. Virology. 2004 Jul 1;324(2):450-61. doi: 10.1016/j.virol.2004.03.034.

  PMID: 15207630 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: February 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 23, 2006

Record last verified: 2006-11

Locations

US (1)