PMID- 29749668
OWN - NLM
STAT- MEDLINE
DCOM- 20190918
LR  - 20190918
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 27
IP  - 7
DP  - 2018 Jul
TI  - 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.
PG  - 797-805
LID - 10.1002/pds.4552 [doi]
AB  - PURPOSE: Our aim was to explore a signal detection method for early 
      identification of potential adverse drug reactions (ADRs) in a patient cohort. 
      METHODS: 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. RESULTS: 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 patients had received simeprevir 
      and 6 photosensitivity reaction (4 during simeprevir treatment) had been reported 
      for an estimated IC of 1.90, 95% CI, 0.20-3.61. CONCLUSIONS: The 
      disproportionality method can help with early detection of potential ADRs in 
      patient cohorts. Detected associations need to be confirmed by a review of 
      clinical data.
CI  - Copyright (c) 2018 John Wiley & Sons, Ltd.
FAU - Feldman, Sarah F
AU  - Feldman SF
AUID- ORCID: 0000-0001-8264-5184
AD  - Assistance Publique-Hopitaux de Paris, Hopital Saint Antoine, Unite de Sante 
      Publique, Paris, France.
AD  - Sorbonne Universite, INSERM, Institut Pierre Louis d'epidemiologie et de Sante 
      Publique (IPLESP UMRS 1136), Paris, France.
FAU - Lapidus, Nathanael
AU  - Lapidus N
AD  - Assistance Publique-Hopitaux de Paris, Hopital Saint Antoine, Unite de Sante 
      Publique, Paris, France.
AD  - Sorbonne Universite, INSERM, Institut Pierre Louis d'epidemiologie et de Sante 
      Publique (IPLESP UMRS 1136), Paris, France.
FAU - Dorival, Celine
AU  - Dorival C
AD  - Sorbonne Universite, INSERM, Institut Pierre Louis d'epidemiologie et de Sante 
      Publique (IPLESP UMRS 1136), Paris, France.
FAU - Diallo, Alpha
AU  - Diallo A
AD  - ANRS (France REcherche Nord&sud Sida-hiv Hepatites), Clinical trial safety and 
      Public Health, Paris, France.
FAU - Amri, Imane
AU  - Amri I
AD  - ANRS (France REcherche Nord&sud Sida-hiv Hepatites), Clinical trial safety and 
      Public Health, Paris, France.
FAU - Fontaine, Helene
AU  - Fontaine H
AD  - Universite Paris Descartes; APHP, Unite d'Hepatologie, Hopital Cochin; INSERM 
      U-818 et USM20, Institut Pasteur, Paris, France.
FAU - Pol, Stanislas
AU  - Pol S
AD  - Universite Paris Descartes; APHP, Unite d'Hepatologie, Hopital Cochin; INSERM 
      U-818 et USM20, Institut Pasteur, Paris, France.
FAU - Carrat, Fabrice
AU  - Carrat F
AD  - Assistance Publique-Hopitaux de Paris, Hopital Saint Antoine, Unite de Sante 
      Publique, Paris, France.
AD  - Sorbonne Universite, INSERM, Institut Pierre Louis d'epidemiologie et de Sante 
      Publique (IPLESP UMRS 1136), Paris, France.
CN  - ANRS/AFEF HEPATHER study group
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180511
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Aged
MH  - Antiviral Agents/*adverse effects/*therapeutic use
MH  - Bayes Theorem
MH  - Cohort Studies
MH  - Female
MH  - France/epidemiology
MH  - Hepatitis C, Chronic/*drug therapy/epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pharmacovigilance
OTO - NOTNLM
OT  - Pharmacovigilance
OT  - adverse drug event
OT  - cohort studies
OT  - hepatitis C
OT  - pharmacoepidemiology
EDAT- 2018/05/12 06:00
MHDA- 2019/09/19 06:00
CRDT- 2018/05/12 06:00
PHST- 2017/07/06 00:00 [received]
PHST- 2018/01/11 00:00 [revised]
PHST- 2018/04/05 00:00 [accepted]
PHST- 2018/05/12 06:00 [pubmed]
PHST- 2019/09/19 06:00 [medline]
PHST- 2018/05/12 06:00 [entrez]
AID - 10.1002/pds.4552 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):797-805. doi: 10.1002/pds.4552. Epub 
      2018 May 11.