Related Experiment Video
Updated: May 2, 2026
13:04
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
23.7K
HCV RNA quantification with different assays: implications for protease-inhibitor-based response-guided therapy
Bart Fevery1, Simone Susser, Oliver Lenz
1Janssen Infectious Disease BVBA, Beerse, Belgium.
Antiviral Therapy
|March 4, 2014
Summary
Response-guided therapy (RGT) for Hepatitis C Virus (HCV) requires undetectable viral load. Different assays impact RGT decisions, potentially lowering the number of patients qualifying for shorter treatment durations.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Response-guided therapy (RGT) for Hepatitis C Virus (HCV) shortens treatment based on viral load response.
- RGT necessitates HCV RNA levels below assay limits at weeks 4 and 12.
- Assay concordance and impact on treatment decisions were evaluated.
Purpose of the Study:
- To compare two HCV RNA assays for RGT assessment.
- To investigate the impact of assay differences on treatment decisions.
Main Methods:
- Analyzed 1,411 plasma samples from 290 HCV genotype-1 patients in the PILLAR study.
- Compared Roche High-Pure-System/COBAS® TaqMan® v2.0 assay (HPS) with Abbott realtime assay (ART).
- Assessed HCV RNA concentrations at baseline and weeks 4 and 12.
Main Results:
- Significant discordance between HPS and ART assays observed.
- ART showed lower undetectable HCV RNA rates at week 4 (49.4%) compared to HPS (75.5%).
- This led to different RGT assessments in 26.1% of cases, impacting eligibility for shorter treatment.
Conclusions:
- The Abbott realtime assay (ART) may result in fewer patients qualifying for shortened HCV treatment.
- Revised RGT criteria may be needed for ART to maximize benefits of shorter treatment durations.
- Further validation of assay performance for RGT is required.
