Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
The purpose of this study is to determine the decline of virus in the blood and liver in
 patients treated with telaprevir, pegylated interferon and ribavirin.

 Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance
 the understanding of how the virus decays in the liver in response to treatment with
 anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA
 is an alternative procedure to core needle biopsy in its ability to repeatedly sample the
 liver with significantly reduced morbidity.
Inclusion Criteria:

 1. Male and female subjects, 18-65 years of age, inclusive.

 2. Cases will be genotype 1 (confirmed by standard testing). Enrollment of controls will
 not be restricted by genotype.

 3. All patients must show evidence of chronic hepatitis C, confirmed by detectable plasma
 HCV RNA. Chronic disease status must be confirmed by at least one of the following
 standard criteria:

 History of a remote risk factor, or Abnormal ALT levels for >6 months prior to
 screening period (Note: elevated ALT is not an inclusion criteria, if one of the other
 criteria for "chronic" hepatitis C is met), or Detectable HCV RNA for at least 6
 months before the screening period

 4. Liver biopsy obtained within 24 months of study enrollment demonstrating absence of
 cirrhosis (stage 0-3) for cases. Enrollment of controls will not be restricted by
 stage of fibrosis.

 5. Judged to be in good health on the basis of medical history and physical examination
 (including vital signs and ECG), with any chronic medical conditions under stable
 medical control.

 6. Screening Visit laboratory values must be within the following:

 -  Laboratory variable: acceptable range

 -  Absolute neutrophil count: 1200/cmm³

 -  Platelet count: 90,000/cmm³

 -  Hemoglobin: within normal range

 -  HbsAg (screening visit only): seronegative

 -  HIV1 and 2 Ab (screening visit only): seronegative

 In addition, all other hematology and clinical chemistry must be within normal limits
 or show no clinically significant abnormalities.

 7. Subjects (or their female partners) must be not pregnant, planning to become pregnant
 within the next 72 weeks, or they must be permanently sterile or otherwise of non
 childbearing potential. They must also not be breastfeeding. If of child-bearing
 potential, subjects must agree to use 2 effective methods of contraception from
 screening through 6 months after the last dose of RBV. Male subjects who have a female
 partner of childbearing potential must agree to use 2 effective methods of
 contraception from Screening through 7 months after the last dose of RBV unless
 vasectomized.

 8. Female subjects must have a negative pregnancy test at all visits (screening and
 predose Day 1) before the first dose of study drugs.

 9. Willing to refrain from the concomitant use of any medications, substances or foods.

 10. Able to read and understand the Informed Consent Form (ICF) and willing to sign the
 ICF and abide by the study requirements and restrictions.

 Exclusion Criteria:

 1. Received more than 4 weeks of any approved or investigational drug or drug regimen for
 the treatment of hepatitis C.

 2. Any medical contraindications to Peg-IFN alpa-2a or RBV therapy, including any of the
 following:

 1. Abnormal thyroid stimulating hormone (TSH) levels or poorly controlled thyroid
 function

 2. Evidence of clinically significant cardiac dysfunction;

 3. History of psychiatric disorders determined by the investigator to contraindicate
 the use of IFN-based therapy;

 4. Antinuclear antibody (ANA) titer 1:320;

 5. History of hemoglobinopathies.

 3. Patients coinfected with either human immunodeficiency virus (HIV) or hepatitis B
 virus (HBV).

 4. Decompensated liver disease as indicated by a history of ascites, hepatic
 encephalopathy, or bleeding esophageal varices.

 5. Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein (AFP) during
 screening must be less than 100 ng/mL.

 6. For cases, histologic evidence of hepatic cirrhosis on any liver biopsy

 o Most recent liver biopsy must be within 2 years prior to study screening.

 7. Has taken any of the prohibited medications within 28 days of initiation of therapy.

 8. A history of any illness that, in the opinion of the investigator, might confound the
 results of the study or pose an additional risk in administering study drug to the
 subject. This may include but is not limited to a history of relevant drug or food
 allergies, history of cardiovascular or central nervous system disease, history or
 presence of clinically significant illness, or history of mental illness that may
 affect compliance with study requirements.

 9. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by
 medical history) in the last 12 months.

 10. Participation in any investigational drug study within 90 days before drug
 administration or participation in more than 2 drug studies in the last 12 months
 (exclusive of the current study).

 11. For cases, hypersensitivity to tartrazine (known as yellow dye #5).

 12. Men whose female partners are pregnant