Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
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.
Hepatitis C Infection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection|
- Virologic Response [ Time Frame: up to 96 weeks post treatment ] [ Designated as safety issue: No ]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.
- Adverse events [ Time Frame: 24, 48, and 96 weeks post treatment ] [ Designated as safety issue: Yes ]Comparison of rates and severity of adverse events between the two study arms
- Effect of baseline variables on treatment outcome [ Time Frame: 24, 48, and 96 weeks post treatment ] [ Designated as safety issue: No ]Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin
Records of patients who have never received anti-HCV treatment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771653
|United States, Illinois|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62701|
|Principal Investigator:||Janak Koirala, MD, MPH||Southern Illinois University School of Medicine|