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Updated: May 6, 2026
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Validation of a Simplified Laboratory-Based HCV Clearance Definition Using New York City Hepatitis C Program and
Christina S Hwang1, Martha P Montgomery, Diana I Diaz Munoz
1Author Affiliations: Bureau of Hepatitis, HIV and STI, New York City Department of Health and Mental Hygiene, New York City, New York (Mss Hwang, Diaz Munoz, and Bocour); and National Center for HIV, Viral Hepatitis, STD, and TB Prevention at US Centers for Disease Control and Prevention, Atlanta, Georgia (Drs Montgomery, Yin, and Teshale).
Insights
A validated laboratory definition for hepatitis C virus (HCV) clearance shows high agreement with clinical cure. This finding supports using public health surveillance data to monitor HCV elimination progress.
Area of Science:
- Public Health
- Virology
- Epidemiology
Background:
- Hepatitis C virus (HCV) clearance cascades are crucial for tracking elimination efforts.
- A validated laboratory-based definition for HCV clearance is needed.
Purpose of the Study:
- To compare the agreement between a laboratory-based definition of HCV clearance and a clinical cure definition.
Main Methods:
- Observational study using New York City's HCV surveillance and linkage-to-care program data.
- Included participants diagnosed with hepatitis C and enrolled in the program between July 2016 and June 2020.
- Assessed percent agreement between laboratory-based clearance and clinical cure definitions.
Main Results:
- The laboratory-based HCV clearance definition and clinical cure definition showed high concordance.
- Agreement was observed in 573 out of 591 participants (97%) with known treatment outcomes.
Conclusions:
- A laboratory-based HCV clearance definition derived from public health surveillance data is a reliable tool.
- This definition can effectively monitor progress toward hepatitis C elimination goals.
Context:
Laboratory-based hepatitis C virus (HCV) clearance cascades are an important tool for health departments to track progress toward HCV elimination, but a laboratory-based definition of HCV clearance has not yet been validated.
Objective:
To compare agreement between a laboratory-based HCV clearance definition with a clinical cure definition.
Design:
Observational.
Setting:
New York City Department of Health and Mental Hygiene HCV surveillance system data and New York City hepatitis C linkage-to-care program data.
Participants:
Linkage-to-care program participants who were diagnosed with hepatitis C and enrolled in the linkage-to-care program from July 1, 2016, through June 30, 2020.
Main Outcome Measure:
Percent agreement between a laboratory-based HCV clearance definition (surveillance system) and a clinical cure definition (program data).
Results:
Among 591 program participants with known treatment outcome, the laboratory-based HCV clearance definition and clinical cure definition were concordant in 573 cases (97%).
Conclusions:
A laboratory-based HCV clearance definition based on public health surveillance data can be a reliable source for monitoring HCV elimination.
