Table 3Study inclusion criteria

Populations
• Non-pregnant adult outpatients with chronic Hepatitis C infection
Subgroups include:
 • HIV-infected persons
 • Non-responders or relapsers (including re-treatment)
 • Based on gender, race, or age
 • Based on genotype
 • Based on viral load
 • Based on liver function test abnormalities
 • Based on degree of fibrosis, inflammation, or cirrhosis on liver biopsy
 • Based on other co-morbid conditions, including obesity, addiction, psychiatric illness
Treatments
• Pegylated interferon alfa-2a plus ribavirin
• Pegylated interferon alfa-2b plus ribavirin
Effectiveness outcomes
• Sustained virologic response (SVR)
• Normalization of liver enzyme abnormalities (sustained biochemical response, or SBR)
• Improvement in inflammation or fibrosis on liver biopsy
• Cirrhosis
• Hepatocellular carcinoma
• Need for liver transplant
• Quality of life
• Mortality
• Early virologic response (only for head-to-head trials)
Safety outcomes
• Overall adverse effects
• Withdrawals due to adverse effects
• Serious adverse events (including depression, suicidality)
• Specific adverse events (including myalgias, flu-like symptoms, fevers, chills, neutropenia, dose reduction)
Study designs
• For assessment of effectiveness in general, controlled clinical trials and good-quality systematic reviews were included.
• For assessment of effectiveness for cirrhosis, hepatocellular cancer, need for transplant, and mortality, controlled clinical trials and long-term observational studies were included.
• For assessment of safety, controlled clinical trials and observational studies were included.

From: Methods

Cover of Drug Class Review: Pegylated Interferons for Chronic Hepatitis C Infection
Drug Class Review: Pegylated Interferons for Chronic Hepatitis C Infection: Final Report [Internet].
Chou R, Carson S, Chan BKS, et al.
Portland (OR): Oregon Health & Science University; 2007 May.
Copyright © 2007, Oregon Health & Science University, Portland, Oregon.

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