Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).

This is an interventional treatment trial for Liver Cirrhosis Read More

Inclusion Criteria:

1. Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstrated with previous studies (positive viral load).
2. History of treatment with direct acting antivirals (AAD).
3. Demonstration of negative viral load at least 6 months after completing treatment with AAD, considered as sustained viral response (SVR).
4. Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
5. Verification of advanced liver fibrosis in a liver biopsy.
6. Patients with Child Pugh functional class A or B and in stable clinical conditions (without active variceal hemorrhage, ascites or refractory encephalopathy) with consumption of drugs at stable doses in at least 30 days.

7. Laboratory tests that confirm her condition and functional class, with results that, in the opinion of the main researcher, do not put the patient at risk:

   • Complete blood count, with hemoglobin values ≥ 10 g / dL, leukocytes ≥ 3,000 mL, platelets ≥ 50,000 mL
   • Creatinine <1.8 mg / dL

Exclusion Criteria:

1. Child Pugh functional class C (≥ 10 points)
2. Pregnancy and lactation.
3. History of known allergy or hypersensitivity to PFD.
4. Having participated in another clinical study in the 60 days prior to the start of this one.
5. Hospitalization within 30 days prior to the start of administration of the medication.
6. Co-existing liver pathology: alcohol cirrhosis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, amyloidosis, autoimmune hepatitis, and Primary Biliary Cholangitis).
7. Concomitant systemic infection including viral hepatitis B, HIV, as well as respiratory infections, urinary, digestive, cellulite, etc.
8. Serious concomitant conditions such as Heart Failure, Respiratory Failure and Chronic Kidney Failure.
9. Malignant neoplasms including hepatocellular carcinoma. Patients with basal cell carcinoma or those with malignancies with more than 5 years of inactivity may be considered for the study.
10. Decompensated diabetes mellitus (defined as that with fasting blood glucose values greater than 175 mg / dL and / or glycated hemoglobin greater than 8%).
11. Uncontrolled hypertension despite medications (defined as systolic values ≥ 150 and diastolic values ≥ 100 mmHg).
12. Patients with active alcohol intake in the last 6 months.
13. Use of drugs known as concomitant hepatoprotectors (ursodexosicolic acid, s-adenosyl-methionine, silymarin, among others).
14. Patients with treatment of CYP1A2 inhibitor drugs or other CYP isoenzymes such as: fluvoxamine, amiodarone, fluconazole, chloramphenicol, fluoxentine, paroxentine, ciprofloxacin, rifampin or propafenone, or other medicinal products that, in the opinion of the main investigator, may interfere with the study.
15. Any other clinical condition that in the opinion of the main investigator could compromise the safety and well-being of the patient or jeopardize the conduct of the study.