Roger Chou, MD; Elizabeth C. Clark, MD, MPH; Mark Helfand, MD, MPH
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Acknowledgments: The authors thank Susan Wingenfeld and Kathryn Pyle Krages, AMLS, MA, for administrative support, and Heidi Nelson, MD, MPH, for reviewing the manuscript.
Grant Support: This study was conducted by the Oregon Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality, Contract #290-97-0018, Task Order No. 2, for the U.S. Preventive Services Task Force.
Potential Financial Conflicts of Interests: None disclosed.
Requests for Single Reprints: Reprints are available from the Agency for Healthcare Research and Quality Web site (www.preventiveservices.ahrq.gov) and through the Agency for Healthcare Research and Quality Publications Clearinghouse (telephone, 800-358-9295).
Current Author Addresses: Drs. Chou and Helfand: Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mailcode BICC, Portland, OR 97239.
Dr. Clark: University of Iowa College of Medicine, 200 Hawkins Drive, 01293-F PFP, Iowa City, IA 52242-1097.
Hepatitis C virus (HCV) is the most common bloodborne pathogen in the United States and is an important cause of patient morbidity and mortality, but it is unclear whether screening to identify asymptomatic infected persons is appropriate.
To synthesize the evidence on risks and benefits of screening for HCV infection.
MEDLINE (through February 2003), Cochrane Clinical Trials Registry (2002, Issue 2), reference lists, and experts.
Controlled studies of screening and antiviral therapy and observational studies on other interventions, risk factors, accuracy of antibody testing, work-up, harms of biopsy, and long-term outcomes.
Using preset criteria, the authors assessed the quality of included studies and abstracted information about settings, patients, interventions, and outcomes.
There are no published trials of screening for HCV infection. Approximately 2% of U.S. adults have HCV antibodies, with the majority having chronic infection. Risk factor assessment could identify adults at substantially higher risk. Antiviral treatment can result in a sustained virologic response rate of 54% to 56%, but no trials have been done specifically in asymptomatic patients likely to be identified by screening. Data are insufficient to determine whether treatment improves long-term outcomes. There are no data to estimate the benefit from counseling or immunizations. Although risks of biopsy and treatment appear minimal or self-limited, data on other adverse effects of screening, such as labeling or anxiety, are sparse.
Antiviral treatment can successfully eradicate HCV, but data on long-term outcomes in populations likely to be identified by screening are lacking. Although the yield from targeted screening, particularly in intravenous drug users, would be substantially higher than in the general population, data are inadequate to accurately weigh the overall benefits and risks of screening in otherwise healthy asymptomatic adults.
Table 1. Data from Large Observational Studies on Independent Risk Factors for Positive Status on Tests for Anti–Hepatitis C Virus Antibody
Table 2. Additional Studies on the Diagnostic Accuracy of Third-Generation Enzyme-Linked Immunosorbent Assays for Anti–Hepatitis C Virus Antibodies
Table 3. Randomized, Controlled Trials of Pegylated Interferon plus Ribavirin in Patients with Hepatitis C Virus Infection
Table 4. Sustained Virologic Response Rates with Different Antiviral Regimens for Hepatitis C Virus Infection
Table 5. Randomized, Controlled Trials with Long-Term Clinical Outcomes in Patients with Hepatitis C Virus Infection after Treatment with Interferon
Table 6. Differences in Baseline and 24-Week Scores on the 36-Item Short-Form Health Survey between Patients with Hepatitis C Virus Infection Who Had a Sustained Virologic Response Compared with Nonresponders
Table 7. Summary of Findings of Evidence Synthesis on Screening for Hepatitis C Virus Infection
Table 8. Estimated Yield of Screening for Hepatitis C Virus Infection in 2 Hypothetical Cohorts
Appendix Table. Results of Screening Tests for Hepatitis C Virus Infection and Usual Interpretation
Key questions (KQs).HCV
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Roger Chou, Elizabeth C. Clark, Mark Helfand. Screening for Hepatitis C Virus Infection: A Review of the Evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2004;140:465–479. doi: 10.7326/0003-4819-140-6-200403160-00014
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Published: Ann Intern Med. 2004;140(6):465-479.
Gastroenterology/Hepatology, Guidelines, Infectious Disease, Liver Disease, Prevention/Screening.
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