Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics

GT=genotype

Inclusion Criteria:

- HCV Genotype-1, -2, -3 or -4 treatment naïve;

- HCV RNA ≥10,000 IU/mL at screening;

- HIV-1 infection [(approximately 200 subjects receiving HAART, approximately 100
subjects not receiving highly active antiretroviral therapy (HAART)];

- For subjects receiving HAART, HIV RNA must be below <40 copies/mL at screening and
<200 copies/mL for at least 8 weeks prior to screening;

- CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL
if not receiving HAART)

- Seronegative for Hepatitis B Surface Antigen (HBsAg)

- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI=weight (kg)/[height (m)]2 at
screening;

- Subjects with compensated cirrhosis are permitted, but the number of subjects will be
capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy
within 3 years prior to enrollment is required to demonstrate the absence of
cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan®
or FibroTest are acceptable if performed within 1 year prior to treatment in
countries where liver biopsy is not required prior to treatment and where
non-invasive imaging tests are approved for staging of liver disease

- Subjects with mild to moderate hemophilia as defined as:

1. Mild-factor level activity of 6-4% OR

2. Moderate defined as factor level activity of 1-5%

Exclusion Criteria:

- Any evidence of liver disease other than chronic HCV;

- Subjects infected with human immunodeficiency virus (HIV-2);

- Diagnosed or suspected hepatocellular carcinoma;

- Decompensated liver disease;

- Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic
infections within 12 weeks prior to study entry (AIDS-defining opportunistic
infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)

- Laboratory values: ANC <1.5 x 109 cells/L (<1.2 x 109 cells/L for Blacks), platelet
count <90 x 109 cells/L, hemoglobin <11 g/dL for females, hemoglobin <12 g/dL for
males;

- Subjects (receiving HAART) who had first initiated anti-retroviral therapy within
last 8 weeks prior to Day 1; however, if changes are required to a subject's HAART
regimen to meet the requirements of the protocol, these changes are allowed at the
screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a
repeat of HIV viral load has been confirmed, <40 copies/mL

- Subjects on Zidovudine (AZT), Didanosine (ddI), or Stavudine (d4T);

- Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements

- Subjects with severe hemophilia (defined as <1% factor activity level)