Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone (Eclipse 2)

Inclusion Criteria:

• Genotype 1 or 4 infected patients
• Age > 18 years

• Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:

  • Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or
  • Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
• Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)

Exclusion Criteria:

• Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
• Infection by HIV-1 and /or HIV-2
• Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
• Other liver disease (notably from alcoholic, metabolic or immunological origin)
• Body mass index (BMI) > 30kg/m2
• Relapse after previous response to pegylated IFN alpha and ribavirin therapy
• Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
• History of clinical autoimmune disease or active auto-immune disease
• History of severe asthma, presently on chronic medications
• Significant cardiac or pulmonary disease
• Prior solid organ or hematopoietic cell transplantation
• Dialyzed patient
• Inability to give informed consent