Clinical trial NCT00403533: Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
Official title: Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Hepatitis C
viral load
antiviral therapy
cholesterol
atorvastatin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from Massachusetts General Hospital.

The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator.

Each subject who consents will undergo phlebotomy of 10 cc of blood three times. Once prior to the initiation of atorvastatin to measure the patients viral load. In addition, patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects. Therefore patients who enroll in this study will undergo one additional phlebotomy. As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load.

Eligibility 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.

Primary outcomes:
measure: Paired comparison of pretreatment viral load to post-treatment 12 week viral load
Secondary outcomes:
measure: Paired comparison of pretreatment viral load to post-treatment 4 week viral load
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond T Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.