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Hepatitis C

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Insulin Sensitivity and Hepatic Steatosis in Hepatitis C

Specific Aims
Determine site and severity of insulin resistance (IR) in treatment-naïve patients with hepatitis C virus (HCV) infection (genotype 1) by stepped insulin-euglycemic clamp before and after anti-viral therapy compared to matched controls and those with nonalcoholic fatty liver disease (NAFLD).

Study Design
3 categories - 43 HCV patients, 15 NAFLD patients, 15 controls

Screening Visit: (all patients)
Oral glucose tolerance test (OGTT), ultrasound (done only in controls to rule out NAFLD), lifetime alcohol survey, review of medications.

Initial Assessment – Visit 1

Initial Assessment – Visit 2 (all patients)

Combination Antiviral Therapy (HCV patients only)

Follow-up Procedures: (HCV patients only)

Eligibility

Main Exclusion Criteria:

Costs for the Patient
Subjects will be paid for clamp procedure, liver biopsy, and periodic return visits to the General Clinical Research Center. The study will not cover costs of antiviral therapy, labs, or the procedures that are of a patient’s standard medical care.

Contact Persons
Please e-mail Dr. Charles Burant or call him at (734) 615-3481 if you have any questions.

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A Randomized, partially blind study to evaluate the safety, tolerability, and effect on virological response of treatment with the HCV protease inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in treatment-naïve patients with chronic hepatitis C genotype 1 virus infection

Primary Objective
To evaluate the safety, tolerability, and effect on virological response of a 12 and 24-week duration of RO5190591 in combination with Pegasys and Copegus compared to the combination of Pegasys and Copegus alone in treatment-naïve patients with chronic hepatitis C genotype 1 virus infection.

Study Design
A two part, Phase 2, randomized, partially-blind study comparing standard of care (SOC) (Pegasys plus Copegus) to RO5190591 plus Pegasys and Copegus.

Subjects will be randomized to one of the following treatment groups:

Part 1
A. RO5190591 300 mg q 8h + SOC
B. RO5190591 600 mg q 12h + SOC
C. RO5190591 900 mg q 12h + SOC
D. Placebo (300 mg q 8h, or 600 mg q 12h or 900 mg q 12h) + SOC (1:1:1)
or
Part 2
E. RO5190591 (300 mg q 8h or 600 mg q 12h or 900 mg q 12) + SOC
F. Placebo + SOC

Patients in groups A, B, C, or E who have undetectable HCV RNA by week 4 will stop treatment at week 24.
RO52190591 will be administered for 12 weeks only.

Main Inclusion Criteria

  1. HCV positive
  2. Genotype 1

Main Exclusion Criteria

  1. Prior treatment with interferon and ribaviron
  2. Hemoglobin (Hgb) concentration < 11 g/dL in females or < 12 g/dL in males
  3. Absolute neutrophil count (ANC) < 1.5 x 103 / μL
  4. Platelet count < 90 x 103 / μL
  5. Contraindications to use of PEG or RBV
  6. Decompensated liver disease, major comorbid medical or psychiatric conditions

Costs for the Patient
Study drug and costs of tests and evaluations associated with the study will be covered by the sponsor and provided free of charge to the patient.

Contact persons
R. Tess Bonham
Phone: 734-615-0158
Fax: 734-615-3855
e-mail: tbonham@umich.edu
or
Anna Lok, MD
Principal Investigator
e-mail: aslok@med.umich.edu

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