Conceptual framework for outcomes research studies of hepatitis C: an analytical review

Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs hav...

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Bibliographic Details
Published in:Infection and drug resistance 2016-01, Vol.9 (Issue 1), p.101-117
Main Authors: Sbarigia, Urbano, Denee, Tom R, Turner, Norris G, Wan, George J, Morrison, Alan, Kaufman, Anna S, Rice, Gary, Dusheiko, Geoffrey M
Format: Article
Language:English
Subjects:
Alcohol
Antiviral agents
Antiviral agents/therapeutic use
Chronic infection
chronic/complications
Clinical outcomes
Clinical trials
combination
Disease control
Drug therapy
FDA approval
Genotype & phenotype
Health care access
Hepatitis
Hepatitis C
HIV
Human immunodeficiency virus
Humans
Infections
Interferon
Liver cancer
Liver diseases
Patients
Review
Ribavirin
Studies
Treatment outcome
Variables
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Summary:Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments.
ISSN:1178-6973
1178-6973
DOI:10.2147/IDR.S99329