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

Conditions: Chronic Hepatitis C Infection

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

study classification: safety/efficacy and pharmacokinetics/dynamics gt=genotype

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)