Status:

COMPLETED

An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C

Lead Sponsor:

Kaiser Permanente

Collaborating Sponsors:

OneFlorida Clinical Research Consortium

Patient-Centered Outcomes Research Institute

Conditions:

Hepatitis C, Chronic

Eligibility:

All Genders

18-88 years

Brief Summary

The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients wit...

Eligibility Criteria

Inclusion

  • HCV viral load
  • HCV genotype
  • HCV qualitative
  • HCV antibody
  • HCV drug
  • Continuously enrolled 12 months

Exclusion

  • Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.
  • The results will be examined for sensitivity to the following possible exclusion criteria:
  • Achieved SVR-12 prior to index date
  • HCV treatment experienced prior to index date
  • No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
  • No positive HCV test (genotype, viral load, or qualitative)
  • No recent positive HCV test (genotype, viral load or qualitative)

Key Trial Info

Start Date :

January 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2017

Estimated Enrollment :

33808 Patients enrolled

Trial Details

Trial ID

NCT03423641

Start Date

January 1 2011

End Date

December 31 2017

Last Update

August 7 2019

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