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

Southern Illinois University

Status: Completed

Conditions: Hepatitis C Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01771653

KOI-SIUSOM-12-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

Previously treated

Description:

Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin

Previously untreated

Description:

Records of patients who have never received anti-HCV treatment.