Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance (PEGLIST C)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 3

Conditions

Insulin Resistance

Chronic Hepatitis C

Treatments

Drug: Pioglitazone

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00927290

2008-006225-14

Details and patient eligibility

About

The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

Full description

In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years old or older
Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6
Naive Patient(never treated with antivirals for HCV)
HOMA score higher than 2.5
Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C

Exclusion criteria

Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke
Alcohol consumption exceeding 40 g / day
Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following : bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy
Hepatocellular carcinoma or any other neoplasm (except if in remission for > 5 years)
Other documented chronic liver disease
Insulin treated diabetes
HBV or HIV co-infection infection confirmed
Thrombocytopenia below 50 000/mm ³; neutropenia below 750/mm ³ or hemoglobin below 11 g / dL
Drug-induced steatosis(tamoxifen, glucocorticosteroids, amiodarone, tetracyclines).
Bone marrow or solid organ transplantation
Pregnancy or breastfeeding, or desire for pregnancy during the study period.
Patients under legal protection or unable to express their consent