Study the Relationship Between Obesity and Hepatitis C Replication
Study the Relationship Between Obesity and Hepatitis C Replication
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.
Inclusion Criteria:

 -  Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not
 eligible)

 -  BMI greater than 25 Kg/m2

 -  HCV-infected subjects naïve to treatment: subjects who either have never been treated
 for HCV infection or who previously received HCV treatment ending more than 3 months
 prior to enrollment for not longer than 2 weeks

 -  Plasma HCV RNA concentration of >10,000 IU/mL at the screening evaluation

 Exclusion Criteria:

 -  Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids

 -  Women who are pregnant or breastfeeding

 -  History of diabetes mellitus requiring treatment other than diet

 -  Decompensated liver disease or other known causes of liver disease including, but not
 limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary
 cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver
 disease, or alpha-one antitrypsin deficiency

 -  Concurrent hepatitis B virus (HBV) infection

 -  Known immunodeficiency disease, autoimmune disorders or active gastrointestinal
 disease

 -  Abuse of alcohol or illicit drugs within 6 months before enrollment

 -  Use of an investigational drug within 4 weeks before the screening visit or during the
 screening period.

 -  Use of systemic immunosuppressants

 -  History of poorly controlled psychiatric disease or poorly controlled pulmonary
 disease