Key Questions:

1. What is the comparative effectiveness of antiviral treatment in improving morbidity and mortality in patients with HCV infection?

• How does the effectiveness of antiviral treatment vary according to patient subgroup characteristics, including but not limited to HCV genotype, age, race, sex, stage of disease or genetic markers?

2. What is the comparative effectiveness of antiviral treatments on intermediate outcomes, such as the rate of SVR or histologic changes in the liver?

• How does the comparative effectiveness of antiviral treatment for intermediate outcomes vary according to patient subgroup characteristics, including but not limited to HCV genotype, age, race, sex, stage of disease or genetic markers?

3. What are the comparative harms associated with antiviral treatments?

• Do these harms differ according to patient subgroup characteristics, including HCV genotype, age, race, sex, stage of disease, or genetic markers?

4. How well do improvements in intermediate outcomes (SVR, histologic changes) predict reduced morbidity and mortality in patients with HCV infection?
5. Are there clinically significant differences in intermediate and health outcomes of antiviral treatment managed by primary care providers versus subspecialists?

Patient population: Non-co-infected adults with HCV infection who have not had previous antiviral drug treatment

Subgroups include:

1. HCV genotype (e.g., genotype 1 or 4 vs. 2 or 3)
2. Race (e.g., black vs. non-black)
3. Sex
4. Stage of disease (e.g., cirrhosis or fibrosis)
5. Others (e.g., baseline viral load, weight) Exclusions: pregnant women, HIV co-infection, transplant recipients, and patients with renal failure

An estimated 2.7 million individuals in the U.S. are chronically infected with HCV (1). Due to the high proportion of persons who were infected in the 1960s and 1970s, the burden of HCV infection and its consequences (cirrhosis, hepatocellular cancer, premature death) are expected to increase in the coming decades (2). Expanded screening and effective interferon-free treatment regimens that can be safely prescribed in primary care settings have the potential to substantially reduce the public health burden of HCV infection over the coming years. The Project ECHO (Extension for Community Healthcare Outcomes) model tested in New Mexico, Arizona, and Utah demonstrated that with appropriate training, HCV infection treatment managed by a primary care clinician produced similar outcomes as treatment managed by an infectious disease or gastrointestinal subspecialists (3, 4). However, as most family physicians do not have direct experience prescribing antiviral medications for patients with HCV infection, they may feel ill-prepared to respond to the increasing demand for treatment. Updating AHRQ s 2012 evidence report on antiviral treatments for HCV infection (5) would provide crucial and timely guidance for primary care physicians.

1. Denniston MM, Jiles RB, Drobeniuc J, et al. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160(5):293 300.
2. Razavi H, Elkhoury AC, Elbasha E, et al. Chronic hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology. 2013;57(6):2164 2170.
3. Arora S, Thornton K, Murata G, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011;364(23):2199 2207.
4. Mitruka K, Thornton K, Cusick S, et al. Expanding primary care capacity to treat hepatitis C virus infection through an evidence-based care model. MMWR Morb Mortal Wkly Rep. 2014;63(18):393 398.
5. Chou R, Hartung D, Rahman B, Wasson N, Cottrell E, Fu R. Treatment for Hepatitis C Virus Infection in Adults. Comparative Effectiveness Review No. 76. (Prepared by Oregon Evidence-based Practice Center under Contract No. 290-2007-10057-I.) AHRQ Publication No. 12(13)-EHC113-EF. Rockville, MD: Agency for Healthcare Research and Quality. November 2012.

The updated evidence report will be used to inform a new AAFP clinical practice guideline for primary care physicians on antiviral treatment for HCV infection.

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

Medical Specialty Society

If you are you making a suggestion on behalf of an organization, please state the name of the organization

American Academy of Family Physicians (AAFP)

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

The AAFP has a long-standing relationship with AHRQ and the EHC program. The AAFP consistently uses evidence reports produced by this program to develop clinical practice guidelines.