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Safety of direct-acting antiviral medications for hepatitis C
Investigator (PI): McGlynn, Elizabeth
Performing Organization (PO): (Current): Kaiser Permanente, Division of Research / (510) 891-3400
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2019
Record Source/Award ID: PCORI/RI-RCR-1000
Funding: Total Award Amount: $560,583
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: The Patient-Centered Outcomes Research Institute (PCORI) is committed to advancing the capacity of PCORnet to fulfill the need for stakeholder-prioritized rapid-cycle research studies and projects. The PCORI Board of Governors approved funding for rapid-cycle research studies and projects using PCORnet's infrastructure to support stakeholder-prioritized rapid evidence generation. Research and projects that use PCORnet are funded to assess the feasibility of conducting future stakeholder-prioritized research and to complete small, rapid, observational research studies that address stakeholder-prioritized research questions. This 12-month rapid-cycle retrospective observational research study conducted by investigators using PCORnet infrastructure aims to evaluate whether patients with hepatitis C virus (HCV) who are prescribed newer direct-acting antiviral (DAA) medications experience higher rates of adverse events than HCV patients who are untreated. The outcomes of interest include hospitalization, acute myocardial infarction, neurological outcomes, acute kidney failure, acute liver failure, hepatic decompensation, multiple organ dysfunction syndrome, liver cancer, and death. The investigators will utilize data at sites within two PCORnet Clinical Data Research Networks, Kaiser Permanente and Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) and OneFlorida. A secondary aim of the study is to evaluate how well the PCORnet common data model characterizes the population with HCV, the severity of disease, medication prescribing and dispensing patterns, and adverse events.
MeSH Terms:
  • Acute Kidney Injury /therapy
  • Antiviral Agents /*pharmacology
  • /*therapeutic use
  • California
  • Florida
  • Hepacivirus
  • Hepatitis C /complications
  • /*drug therapy /virology
  • Hospitalization
  • Humans
  • Liver Failure, Acute /complications
  • /therapy
  • Liver Neoplasms /complications
  • /therapy
  • Myocardial Infarction /complications
  • /therapy
  • Nervous System Diseases /complications
  • /therapy
  • Observational Studies as Topic
  • Outcome Assessment, Health Care
  • Patient Safety
  • Retrospective Studies
Country: United States
State: California
Zip Code: 94612
UI: 20183379
Project Status: Completed