Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

Inclusion Criteria:

• Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
• Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
• No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
• No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Exclusion Criteria:

• Patients with clinical contraindications to hepatic biopsy