Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

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