Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

Study Overview
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Brief Summary
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The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.

Detailed Description
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The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.

Official Title
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Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

Conditions
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Hepatitis C Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age - 18-64 years HCV genotype 1 HCV RNA >100,000 Liver biopsy within 5 years before enrollment Absolute neutrophil count of at least 1200 per cubic millimeter Platelet count of at least 90,000 per cubic millimeter Hemoglobin level of at least 12 g per deciliter Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms Exclusion Criteria: HCV genotypes other than genotype 1 Immunocompromised conditions including HIV, transplant or immunosuppressive drugs Decompensated liver disease or hepatocellular carcinoma Any other types of active cancer Active autoimmune disorders Major psychiatric disorders Active drug or alcohol use Pregnancy or lactation Patients with allergy to any of the drugs used in this study Drugs that may interact with boceprevir or telaprevir as listed in the package insert

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously treated<br>Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin | |
| Previously untreated<br>Records of patients who have never received anti-HCV treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic Response | Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment. | up to 96 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Comparison of rates and severity of adverse events between the two study arms | 24, 48, and 96 weeks post treatment | 
| Effect of baseline variables on treatment outcome | Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status. | 24, 48, and 96 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C infection, Hepatitis C Virus, HCV