The effect of atorvastatine on the viral load in patients with chronic hepatitis C

Completed

Conditions: chronic viral liver infection
viral hepatitis
10019654
10047438

Registration Number: NL-OMON30776

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 7

Inclusion Criteria

• age between 18 and 65 years
• All patients with hepatitis C (all genotypes)
• negative for hepatitis B and HIV
• ALAT < 2,5 x below the upper limit of normal
• serological evidence of hepatitis C infection with detectable HCV-RNA (with Bayer Versant HCV bDNA V3.0)
• failed current standard of care treatment with peginterferon and ribavirin
• WHO-score <=1
• fertile women must have a negative pregnancy test in the week before start of medication. Use of contraceptives during the whole study-period
• physically and mentaly able to attend outpatients clinics

Exclusion Criteria

• Hepatitis C patiënts naive for (peg)interferon and ribavirin treatment
• Alcohol abusus (> 20 grams per day) in the last year
• liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh B or C)
• concomittant treatment with hepatotoxic medication / interfering with CYP450 system: anti-fungal medication (voriconazol), antibiotics (gentamycine, azitromycine, claritromycine, erytromycine), immun-suppresives (cyclosporine), anti-arythmica (diltiazem, verapamil) and tuberculostatic drugs (rifampicine).
• current statin use
• active pregnancy or wish of pregnangy
• use of grapefruit juice
• metally not fit to participate in the study
• daily use of more than 2 grams of paracetamol
• history or signs of hypothyroidism
• renal dysfunction defined as a creatinin clearance below 60 ml/min
• a baseline CPK above 5 times the upper limit of normal

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. to which extend causes atorvastatin serious side effects like rhabdomyolysis<br /><br>and hepatotoxicity in patients chronically infected with hepatitis C? </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. does administration of atorvastatin in HCV infected patients lead to lower<br /><br>HCV-RNA viral load? 2. Is a decrease in LDL correlated to a decrease in HCV-RNA<br /><br>load?</p><br>