Roger Chou, MD; Elizabeth C. Clark, MD, MPH; Mark Helfand, MD, MPH
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.
KQ 1 = Does screening for hepatitis C virus (HCV) infection reduce the risk or rates of harm and premature death and disability? KQ 2 = Can clinical or demographic characteristics identify a subgroup of asymptomatic patients at higher risk for HCV infection? KQ 3 = What are the test characteristics of HCV antibody testing? KQ 4 = What is the predictive value of a positive screening test result and what are the harms associated with screening for HCV infection? KQ 5a = What are the test characteristics of the work-up for active disease? KQ 5b = In patients found to be positive for HCV antibody, what proportion of patients would qualify for treatment? KQ 6 = What are the harms associated with the work-up for active HCV disease? KQ 7a = How well does antiviral treatment reduce the rate of viremia, improve aminotransferase levels, and improve histology? KQ 7b = How well does antiviral treatment improve health outcomes in asymptomatic patients with HCV infection? KQ 7c = How well do counseling and immunizations in asymptomatic patients with HCV infection improve clinical outcomes or prevent spread of disease? KQ 8 = What are the harms (including intolerance to treatment) associated with antiviral intervention? KQ 9 = Have improvements in intermediate outcomes (liver function tests, remission, histologic changes) been shown to reduce the risk or rate of harm from HCV infection? *Excluding pregnant women, HIV-positive persons, transplant recipients, and patients with renal failure.
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Chou R, Clark EC, Helfand M. 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.
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