Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.

This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Inclusion Criteria:

• GT 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy

• Insulin resistance

• Compensated liver disease

  • WBC < 3,000/ mm3
  • Neutrophil count < 1,500/mm3
  • Platelets < 65,000/ mm3
  • Albumin > 3 gm/dL

Exclusion Criteria:

• Participants on metformin or other thiazolidinedione must have 3month wash-out period
• Women who are pregnant or breast-feeding
• Males with pregnant partners
• Co-infection with HAV, HBV, or HIV
• Ophthalmic abnormalities such as severe retinopathy
• Poorly controlled thyroid dysfunction
• Serum creatinine concentration > 1.5 times ULN
• Severe psychiatric or neuropsychiatric disorders
• History of alcoholism or drug addiction 1 year prior to screening
• Seizure disorders not controlled with medication
• Significant cardiovascular dysfunction within the past 12 months
• Chronic pulmonary disease