Signal detection on a patient cohort: A disproportionality analysis of the ANRS CO22 HEPATHER cohort to identify associations between direct acting antivirals and adverse events in patients with hepatitis C virus chronic infection

Pharmacoepidemiology and Drug Safety
Sarah F FeldmanANRS/AFEF HEPATHER study group

Abstract

Our aim was to explore a signal detection method for early identification of potential adverse drug reactions (ADRs) in a patient cohort. ANRS CO22 HEPATHER is a French multicentre prospective observational cohort started in 2012. The cohort includes patients with chronic hepatitis C virus (HCV) infection with reports of all adverse events (AEs) occurring in patients exposed to HCV drugs. We applied a disproportionality method, which calculated a measure of association, the Bayesian information component (IC), for each drug-AE pair. Information components were continuously updated and a positive drug-AE association was detected when the lower limit of an IC 95% credible interval (95% CI) exceeded 0. We illustrate how the method could result in timely detection of photosensitivity reaction with simeprevir use. By August 28, 2016, 6600 patients with HCV infection had been treated or were undergoing current HCV treatment, and 3464 experienced at least one AE for a total of 12 720 reported AEs. We detected 52 positive drug-AE associations, including 44 that were known ADRs based on the summary of product characteristics. The association between simeprevir and photosensitivity reaction was detected on June 4, 2014. At this date, 68 ...Continue Reading

References

Aug 11, 1998·European Journal of Clinical Pharmacology·A BateR M De Freitas
Aug 24, 2000·Epidemiology·J M RobinsB Brumback
Nov 10, 2000·Lancet·I R Edwards, J K Aronson
May 10, 2002·Pharmacoepidemiology and Drug Safety·Eugène P van PuijenbroekAntoine C G Egberts
Jun 19, 2004·BMJ : British Medical Journal·David AtkinsUNKNOWN GRADE Working Group
Jul 3, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Andrew Bate
Feb 24, 2009·International Journal of Medical Informatics·Ronald K PearsonAlan M Hochberg
Feb 25, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Manfred Hauben, Jeffrey K Aronson
Feb 25, 2009·European Journal of Internal Medicine·H S RehanAshish Kumar Kakkar
Apr 11, 2009·Statistics in Medicine·Ismaïl AhmedPascale Tubert-Bitter
Aug 4, 2010·Pharmacoepidemiology and Drug Safety·Sebastian Schneeweiss
Oct 12, 2010·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·E MonteagudoV Summa
Oct 15, 2010·Pharmacoepidemiology and Drug Safety·Martijn J Schuemie
Sep 1, 2011·Statistical Methods in Medical Research·Ivan ZorychAndrew Bate
Dec 6, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Andrew BateManfred Hauben
Apr 11, 2013·Clinical Pharmacology and Therapeutics·R HarpazN H Shah
Nov 6, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·William DuMouchelDavid Madigan
Nov 6, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Patrick B RyanDavid Madigan
Jan 1, 2012·Pharmaceutics·Marc Suling, Iris Pigeot
Jan 17, 2014·The New England Journal of Medicine·Kris V KowdleyBarry Bernstein
Apr 15, 2014·The New England Journal of Medicine·Fred PoordadBarry Bernstein
Sep 6, 2014·Statistical Methods in Medical Research·Lan HuangRam Tiwari
Mar 10, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Antoni F Z WisniewskiG Niklas Norén
Jun 6, 2016·Journal of Hepatology·Audrey CoillyUNKNOWN ANRS C023 CUPILT study group
Sep 14, 2016·Journal of Hepatology·Stanislas PolUNKNOWN ANRS/AFEF HEPATHER study group
Jan 31, 2017·Liver International : Official Journal of the International Association for the Study of the Liver·Christophe HézodeStefan Zeuzem

❮ Previous
Next ❯

Citations

Feb 17, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Tchadine DjaogolUNKNOWN ANRS CO22 Hepather study group

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antivirals

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Antivirals (ASM)

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Related Papers

BMJ : British Medical Journal
Janus Christian JakobsenChristian Gluud
Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases
G Ippolito, G Antonelli
© 2022 Meta ULC. All rights reserved