Hepatitis C Treatment: Inclusion Criteria by Key Question

Roger Chou; Daniel Hartung; Basmah Rahman; Ngoc Wasson; Erika Cottrell; Rongwei Fu

Appendix BHepatitis C Treatment: Inclusion Criteria by Key Question

Table

Excluded: Pregnant women, HIV co-infected, transplant recipients, patients with renal failure Mortality (all-cause or hepatic)

Publication Details

Copyright

Publisher

Agency for Healthcare Research and Quality (US), Rockville (MD)

NLM Citation

Chou R, Hartung D, Rahman B, et al. Treatment for Hepatitis C Virus Infection in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. (Comparative Effectiveness Reviews, No. 76.) Appendix B, Hepatitis C Treatment: Inclusion Criteria by Key Question.

	Inclusion Criteria
Populations	Asymptomatic adults with chronic hepatitis C virus infection who have not received antiviral drug treatment previously Subgroups include: HCV genotype, race, sex, stage of disease, viral load, weight, and others (e.g. genetic markers) Excluded: Pregnant women, HIV co-infected, transplant recipients, patients with renal failure
Interventions	KQ 1a and b: 1a. What is the comparative effectiveness of antiviral treatment in improving health outcomes in patients with HCV infection? 1b. How does the comparative effectiveness of antiviral treatment for health outcomes vary according to patient subgroup characteristics, including but not limited to HCV genotype, race, sex, disease severity or genetic markers? KQ 2a and b: 2. What is the comparative effectiveness of antiviral treatments in improving intermediate outcomes, such as the rate of viremia, aminotransaminase levels, and histologic changes? 2a. How does the comparative effectiveness of antiviral treatment for intermediate outcomes vary according to patient subgroup characteristics, including but not limited to HCV genotype, race, sex, disease severity or genetic markers? KQ 3a and b: 3a. What are the comparative harms (including intolerance to treatment) associated with antiviral treatment? 3b. Do these harms differ according to patient subgroup characteristics, including HCV genotype, race, sex, disease severity or genetic markers? KQ 4: Have improvements in intermediate outcomes (viremia, liver function tests, histologic changes) been shown to reduce the risk or rates of health outcomes from HCV infection?
Comparisons	KQ 1a and b: 1a. What is the comparative effectiveness of antiviral treatment in improving health outcomes in patients with HCV infection? 1b. How does the comparative effectiveness of antiviral treatment for health outcomes vary according to patient subgroup characteristics, including but not limited to HCV genotype, race, sex, disease severity or genetic markers? KQ 2a and b: 2a. What is the comparative effectiveness of antiviral treatments in improving intermediate outcomes, such as the rate of viremia, aminotransaminase levels, and histologic changes? 2b. How does the comparative effectiveness of antiviral treatment for intermediate outcomes vary according to patient subgroup characteristics, including but not limited to HCV genotype, race, sex, disease severity or genetic markers? KQ 3a and b: 3. What are the comparative harms (including intolerance to treatment) associated with antiviral treatment? 3a. Do these harms differ according to patient subgroup characteristics, including HCV genotype, race, sex, disease severity or genetic markers? KQ 4: Have improvements in intermediate outcomes (viremia, liver function tests, histologic changes) been shown to reduce the risk or rates of health outcomes from HCV infection?
Outcomes	Clinical outcomes Mortality (all-cause or hepatic) Cirrhosis Hepatic decompensation Hepatocellular carcinoma Need for liver transplantation Quality of life Harms from antiviral treatments (including withdrawals due to adverse events, neutropenia, anemia, psychological adverse events, flu-like symptoms, rash) Intermediate outcomes Sustained virological response Improvement in liver histology
Settings	All settings (including primary care and specialty settings) and locales, though focus on studies conducted in the U.S. and other developed countries.
Study designs	KQ 3a and b: 3a. What are the comparative harms (including intolerance to treatment) associated with antiviral treatment? 3b. Do these harms differ according to patient subgroup characteristics, including HCV genotype, race, sex, disease severity or genetic markers? KQ 4: Have improvements in intermediate outcomes (viremia, liver function tests, histologic changes) been shown to reduce the risk or rates of health outcomes from HCV infection?