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Testing Strategy To Identify Cases of Acute Hepatitis C Virus (HCV) Infection and To Project HCV Incidence Rates

Kimberly Page-Shafer,¹ Brandee L. Pappalardo,^2, Leslie H. Tobler,² Bruce H. Phelps,^3, Brian R. Edlin,^1,4 Andrew R. Moss,¹ Teresa L. Wright,^1,5, David J. Wright,⁶ Thomas R. O'Brien,⁷ Sally Caglioti,⁸ and Michael P. Busch^1,2,8*

University of California, San Francisco, California,¹ Blood Systems Research Institute, San Francisco, California,² Chiron Corporation, Emeryville, California,³ Center for the Study of Hepatitis C, Weill Medical College of Cornell University, New York, New York,⁴ San Francisco Veterans Administration Medical Center, San Francisco, California,⁵ Westat Inc., Rockville, Maryland,⁶ Viral Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, Maryland,⁷ Blood Systems, Inc., Scottsdale, Arizona⁸

Received 18 June 2007/ Returned for modification 25 August 2007/ Accepted 9 November 2007

Surveillance for hepatitis C virus (HCV) is limited by the challenge of differentiating between acute and chronic infections. In this study, we evaluate a cross-sectional testing strategy that identifies individuals with acute HCV infection and we estimate HCV incidence. Anti-HCV-negative persons from four populations with various risks, i.e., blood donors, Veterans Administration (VA) patients, young injection drug users (IDU), and older IDU, were screened for HCV RNA by minipool or individual sample nucleic acid testing (NAT). The number of detected viremic seronegative infections was combined with the duration of the preseroconversion NAT-positive window period (derived from analysis of frequent serial samples from plasma donors followed from NAT detection to seroconversion) to estimate annual HCV incidence rates. Projected incidence rates were compared to observed incidence rates. Projected HCV incidence rates per 100 person-years were 0.0042 (95% confidence interval [95% CI], 0.0025 to 0.007) for blood donors, 0.86 (95% CI, 0.02 to 0.71) for VA patients, 39.8 (95% CI, 25.9 to 53.7) for young IDU, and 53.7 (95% CI, 23.4 to 108.8) for older IDU. Projected rates were most similar to observed incidence rates for young IDU (33.4; 95% CI, 28.0 to 39.9). This study demonstrates the value of applying a cross-sectional screening strategy to detect acute HCV infections and to estimate HCV incidence.

Published ahead of print on 21 November 2007.

Present address: Abbott Laboratories, Abbott Park, IL.

Present address: Aviir, Inc., Palo Alto, CA.

Present address: Roche Diagnostics, Pleasanton, CA.