Bayer Versant bDNA 3.0 Quantification and TMA Detection of HCV RNA for the HALT-C Trial

Investigators:

Principal Investigator: David Gretch

Co- Principal Investigator: Chihiro Morishima

Outside Collaborators: Bayer Diagnostics, Emeryville, CA

Hypotheses/Aims

1. In untreated hepatitis C-infected nonresponders, HCV viremia at baseline and changes over time, as determined by the Bayer bDNA 3.0 test, may more accurately predict clinical outcomes compared to the Roche Monitor test.
2. In treated hepatitis C-infected nonresponders, the degree to which viral replication can be suppressed over time, as detected by the Bayer bDNA 3.0 test, may better predict outcome after 4 years of antiviral therapy compared to the Roche Monitor test.
3. Increased sensitivity of HCV RNA detection using the TMA assay may better predict which individuals will have subsequent virologic breakthrough or relapse, despite continued combination therapy, compared to the Roche Amplicor test.

Specific aims:

1. To compare the performance of Bayer bDNA 3.0 and Roche Monitor quantitative tests in measuring HCV RNA levels for the HALT-C Clinical Trial and correlate with both histologic and clinical outcomes.
2. To compare the performance of HCV RNA qualitative detection by Bayer TMA and Roche Amplicor at weeks 20 and 24, and correlate with virologic outcome (virologic breakthrough, relapse) in those treated with 48 weeks of combination therapy in the responder arm of the study.