Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study.

ABSTRACT:

Background

Approval of drugs in chronic hepatitis C is supported by registration trials. These trials might have limited generalizability through use of strict eligibility criteria. We compared effectiveness and safety of real world hepatitis C patients eligible and ineligible for registration trials.

Methods

We performed a nationwide, multicenter, retrospective cohort study of chronic hepatitis C patients treated in the real world. We applied a combined set of inclusion and exclusion criteria of registration trials to our cohort to determine eligibility. We compared effectiveness and safety in eligible vs. ineligible patients, and performed sensitivity analyses with strict criteria. Further, we used log binomial regression to assess relative risks of criteria on outcomes.

SUBMITTER: Berden FA 

PROVIDER: S-EPMC5012685 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature