Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For asymptomatic adults (excludes HIV-positive persons, transplant recipients and patients with renal failure) and asymptomatic pregnant women:

Does screening for hepatitis C virus (HCV) infection reduce the risk or rates of harm and premature death and disability?

What are the test characteristics of the work-up for active disease?

What are the harms associated with the work-up for active HCV disease? Are there additional data on the adverse effects of screening, such as anxiety, labeling and impact on partner relationships?

In patients found to be positive for HCV antibody, what proportion of patients would qualify for treatment?

How well does antiviral treatment reduce the rate of viremia, improve aminotransferase levels, and improve histology?

How well does antiviral treatment improve health outcomes in asymptomatic patients with HCV infection?

Are there data to support and estimate the benefit from counseling or immunization?

Have improvements in intermediate outcomes (liver function tests, remission, histologic changes) been shown to reduce the risk or rate of harm from HCV infection?

In Pregnancy:

Does routine screening during pregnancy reduce the risk or rates of harm to the mother, fetus or newborn?

What interventions would decrease the transmission of HCV before or during delivery?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

There are several possible comparisons including, but not limited to:

Drug treatments: Treatment consists of a combination of peginterferon and ribavirin. The addition of ribavirin may not improve treatment outcomes;

Treatment by genotypes: Among the three most common genotypes, treatment strategies vary in the amount of agent used and initial duration of treatment; and,

Comparison of counseling strategies or administering appropriate immunizations on improvements in clinical outcomes or prevention of the spread of the disease.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Populations for HCV Screening Include:

Asymptomatic adults and children with liver disease, asymptomatic pregnant women and high risk adults with high risk defined by:

• Persons who have ever injected illegal drugs, including those who injected only once many years ago
• Recipients of clotting factor concentrates made before 1987
• Recipients of blood transfusions or solid organ transplants before July 1992
• Patients who have ever received long-term hemodialysis treatment
• Persons with known exposures to HCV, such as healthcare workers after needlesticks involving HCV-positive blood; recipients of blood or organs from a donor who later tested HCV-positive;
• All persons with HIV infection
• Patients with signs or symptoms of liver disease (e.g., abnormal liver enzyme tests)
• Children born to HCV-positive mothers (to avoid detecting maternal antibody, these children should not be tested before age 18 months)

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

High risk - see above

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Benefits include, but are not limited to:

Intermediate health outcomes such as improved liver function tests, remission, histologic changes; behavior changes that reduce the spread of the diease; and,

Improvements in long-term health outcomes such as decreased morbidity and mortality from cirrhosis, hepatocellular cancer; reduction in transplants; reduction in deaths related to HCV; reduction in the spread of the disease; reduction in vertical transmission rates from infected mother to newborn.

Describe any health-related risks, side effects, or harms that you are concerned about.

Harms include, but are not limited to:

Adverse effects of screening such as harms associated with the work up for active HCV disease, labeling, anxiety, impact on partner relationships; and,

Adverse effects of treatment such as intolerance to treatment.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Infectious diseases, including HIV/AIDS
• Pregnancy, including preterm birth

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Hepatitis C virus (HCV) is primarily a chronic disease. While there were an estimated 3,200 acute HCV cases in the United States in 2006, there are at least 3.2 million chronic cases of HCV infection in the United States. In addition to approximately 8,000-10,000 deaths per year, HCV is the primary cause for chronic liver disease and the primary reason for liver transplantation. The incidence of HCV infection has dropped over 90% since the early 1990s mainly due to a decrease in the incidence of HCV among injection drug users and improved blood-supply screening.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

The U.S. Preventive Services Task Force last released its recommendation on screening for HCV in adults in 2004. Its goals is to update all its topics every 5 years, in accordance with National Guidelines Clearinghouse protocol.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

There are inconsistent recommendations for screening and treatment of HCV, for example, whether to target screening to high risk adults or to screen all adults.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

The U.S. Preventive Services Task Force will use this report to update its recommendation on screening for HCV in adults and pregnant women.

Describe the timeframe in which an answer to your question is needed.

The U.S. Preventive Services Task Force would like to update its recommendation on screening for HCV as soon as possible. Its current recommendation is over 5 years old.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

The U.S. Preventive Services Task Force will use this report to update its recommendation on screening for HCV in adults and pregnant women.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

AHRQ supports the U.S. Preventive Services Task Force