Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems. PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .
This is a randomized, two arm clinical trial. The investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers. Subject's screening for HCV Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Prednisone will be taken at a dose of 40 mg for up to 4 days
University of California at San Diego Hospitals
San Diego, California, United States
Agouza Hospital
Giza, Egypt
HCV RNA
Only in the Pioglitazone group
Time frame: 2 weeks
HCV RNA
Only in the Prednisone group
Time frame: Day 4
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.
Time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)
ALT and AST
Time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)
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