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
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis C, Chronic
Intervention: Pegylated Interferon Lambda-1a; Daclatasvir (DCV); Ribasphere (RBV)
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 453.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment
      with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
    

Eligibility criteria:

        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)