November 10, 2013

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Liver Injury and Regeneration

Sam Lattimore1,*,Will Irving2,Sarah Collins1,Celia Penman1,Mary Ramsay1, On behalf of the collaboration for the sentinel surveillance of blood-borne virus testing

DOI: 10.1002/hep.26926

Copyright © 2013 American Association for the Study of Liver Diseases

Accepted manuscript online: 9 NOV 2013 04:08AM EST
Manuscript Accepted: 5 NOV 2013
Manuscript Revised: 21 OCT 2013
Manuscript Received: 31 JUL 2013

Keywords: Hepatitis C; epidemiology; surveillance; treatment; England

ABSTRACT

Background & Aims: To develop and validate an algorithm to monitor rates of, and response to, treatment of patients infected with hepatitis C virus (HCV) across England using routine laboratory HCV RNA testing data.

Methods: Hepatitis C testing activity between January 2002 and December011 was extracted from the local laboratory information systems of a sentinel network of 23 laboratories across England. An algorithm based on frequency of HCV RNA testing within a defined time period was designed to identify treated patients. Validation of the algorithm was undertaken for one centre by comparison with treatment data recorded in a clinical database managed by the Trent HCV study group.

Results: In total, 267,887 HCV-RNA test results from 100,640 individuals were extracted. Of these, 78.9% (79,360) tested positive for viral RNA, indicating an active infection, 20.8% (16,538) of whom had a repeat pattern of HCV-RNA testing suggestive of treatment-monitoring. Annual numbers of individuals treated increased rapidly from 468 in 2002, to 3,295 in 2009, but decreased to 3,110 in 2010. Approximately two thirds (63.3; 10,468) of those treated had results consistent with a sustained virological response, including 55.3% and 67.1% of those with a genotype-one and non-one virus, respectively. Validation against the Trent clinical database demonstrated that the algorithm was 95% sensitive and 93% specific in detecting treatment, and 100% sensitive and 93% specific for detecting treatment outcome.

Conclusions: Laboratory testing activity, collected through a sentinel surveillance programme has enabled the first country-wide analysis of treatment and response among HCV-infected individuals. Our approach provides a sensitive, robust, and sustainable method for monitoring service provision across England. (Hepatology 2013;)

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