A pilot study in patients with established advanced liver fibrosis using pirfenidone

Cirrhosis represents the third cause of mortality among Mexican people of productive age.1 Several drugs have been tested in the clinical scenario2,3 although conclusive evidence concerning drug efficacy has proven elusive. PFD is an orally bioavailable pyridone derivative (5-methyl-1-phenyl-2-(1H)-pyridone) that affects a variety of profibrogenic cytokines and its mechanism of action mostly resides in its anti-inflammatory and antifibrotic activity.4–6 Here we present data obtained from a pilot clinical trial evaluating the safety and efficacy of PFD in 15 patients with established advanced liver disease caused by hepatitis C virus chronic infection. This is the first report showing improvements in liver histology (that is, necrosis, inflammation, steatosis, fibrosis, and cell regeneration) 12 months after PFD therapy. Colour Doppler ultrasound guided liver biopsies were obtained at baseline and after 12 months of PFD treatment and evaluated for stage of fibrosis and grade of activity according to the modified …