Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

Brooke Army Medical Center

Status and phase: Completed; Phase 4

Conditions: Hepatitis c

Treatments: Drug: pioglitazone (Actos); Drug: atorvastatin (Lipitor)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00926614

C.2008.153

Details and patient eligibility

About

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

Full description

The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.

This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• GT 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy

• Insulin resistance

• Compensated liver disease

  • WBC < 3,000/ mm3
  • Neutrophil count < 1,500/mm3
  • Platelets < 65,000/ mm3
  • Albumin > 3 gm/dL

Exclusion criteria

• Participants on metformin or other thiazolidinedione must have 3month wash-out period
• Women who are pregnant or breast-feeding
• Males with pregnant partners
• Co-infection with HAV, HBV, or HIV
• Ophthalmic abnormalities such as severe retinopathy
• Poorly controlled thyroid dysfunction
• Serum creatinine concentration > 1.5 times ULN
• Severe psychiatric or neuropsychiatric disorders
• History of alcoholism or drug addiction 1 year prior to screening
• Seizure disorders not controlled with medication
• Significant cardiovascular dysfunction within the past 12 months
• Chronic pulmonary disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Pioglitizone and Atorvastatin

Experimental group

Description:

Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin

Treatment:

Drug: atorvastatin (Lipitor)

Drug: pioglitazone (Actos)