Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus

• Participants must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• HCV-Ab or HCV-RNA by PCR Positive for at least 6 months
• Serum positive for HCV-RNA by PCR assay
• Treatment naïve participants who have hepatitis C with genotype 1, 2, 3, or 4
• Body mass index >27
• Liver biopsy within 12 months with a pathology report confirming the histological diagnosis consistent with CHCand NASH or hepatic steatosis of >33%

• Compensated liver disease with minimum hematological, biochemical, and serologic criteria at the Enrollment Visit (WNL = within normal limits):

  • Hemoglobin values of \<12 gm/dL for females and \<13 gm/dL for males
  • WBC \<3,000/ mm3
  • Neutrophil count \< 1,500/mm3
  • Platelets \<65,000/ mm3
  • Direct bilirubin within 20% of ULN
  • Indirect bilirubin WNL
  • Albumin > 3 gm/dL
  • creatinine \< 20% of ULN
  • TSH WNL
  • Alpha fetoprotein value \< 100 ng/mL
• Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for six months following the last dose of study medication
• Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception

Exclusion Criteria:

• Women who are pregnant or breast-feeding
• Males whose female partner is pregnant
• No other Thiazolidinedione after liver biopsy and/or during the entire study
• Hepatitis C of non-genotype 1,2,3 or 4
• Previous anti-viral therapy for treatment of Hepatitis C
• Suspected hypersensitivity to interferon, PEG-interferon, ribavirin, Xenical

• Any other cause for liver disease other than chronic hepatitis C and NASH or steatosis, including but not limited to:

  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Co-infection with HBV
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Drug-related liver disease
• Any condition that would prevent the subject from having a liver biopsy
• Hemoglobinopathies (e.g., Beta Thalassemia)
• Evidence of advanced liver disease
• Patients with organ transplants other than cornea and hair transplant

• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:

  • Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
  • CNS trauma or preexisting/active seizure disorders uncontrolled with medication
  • Significant cardiovascular dysfunction within the past 12 months
  • Poorly controlled diabetes mellitus
  • Chronic pulmonary disease with documented pulmonary hypertension
  • Immunologically mediated disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis
• Any medical condition requiring, or likely to require chronic systemic administration of steroids
• Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within 2 years
• Active clinical gout
• Substance abuse
• Participants not willing to be counseled/abstain from alcohol
• Participants with clinically severe retinal abnormalities
• Any other condition that in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol
• Known positive HIV
• Inability/unwillingness to provide informed consent or abide by the requirements of the study