PMID- 32266942
OWN - NLM
STAT- MEDLINE
DCOM- 20210702
LR  - 20240207
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 72
IP  - 10
DP  - 2021 May 18
TI  - Risk Factors for Adverse Events in Household Contacts Prescribed Preventive 
      Treatment for Drug-resistant Tuberculosis Exposure.
PG  - 1709-1715
LID - 10.1093/cid/ciaa327 [doi]
AB  - BACKGROUND: Completion of tuberculosis (TB) preventive treatment is important to 
      optimize efficacy; treatment-related adverse events (AEs) sometimes result in 
      discontinuation. This study describes the occurrence of AEs and their risk 
      factors during a 6-month, 2-drug, fluoroquinolone-based preventive treatment for 
      household contacts of patients with drug-resistant TB in Karachi, Pakistan. 
      METHODS: The primary outcome was development of any clinical AE during preventive 
      treatment. Adverse events were categorized using the AE grading tables of the 
      National Institutes of Health. Time-to-event analysis with Kaplan-Meier curves 
      and Cox proportional hazards models accounting for recurrence were used to 
      analyze associated risk factors. RESULTS: Of the 172 household contacts on 
      preventive treatment, 36 (21%) developed 64 AEs during 813 months of treatment. 
      The incidence of AEs over 6 months of treatment was 7.9 per 100 person-months; 16 
      per 100 person-months with a fluoroquinolone and ethionamide, and 4.4 per 100 
      person-months with a fluoroquinolone and ethambutol. There were 53 (83%) grade 1 
      and 11 grade 2 AEs, with no grade 3 or 4 AEs. In multivariable analysis, the risk 
      of AEs was higher in contacts prescribed ethionamide as compared to ethambutol 
      adjusting for age, sex, and body mass index (adjusted hazard ratio, 2.1 [95% 
      confidence interval CI, 1.2-3.6]). Overall, there was no notable difference in 
      treatment completion among the contacts who experienced an AE and those who did 
      not (crude odds ratio, 1.1 [95% CI, .52-2.5]). CONCLUSIONS: A 
      fluoroquinolone-based preventive treatment regimen for drug-resistant TB exposure 
      is well tolerated. Regimens with ethionamide are more likely to result in AEs.
CI  - (c) The Author(s) 2020. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail: 
      journals.permissions@oup.com.
FAU - Malik, Amyn A
AU  - Malik AA
AUID- ORCID: 0000-0003-4875-9916
AD  - Emory University Rollins School of Public Health, Atlanta, Georgia, USA.
AD  - Global Health Directorate, Indus Health Network, Karachi, Pakistan.
AD  - Interactive Research and Development Global, Singapore.
FAU - Becerra, Mercedes C
AU  - Becerra MC
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      Massachusetts, USA.
AD  - Division of Global Health Equity, Brigham and Women's Hospital, Boston, 
      Massachusetts, USA.
AD  - Partners In Health, Boston, Massachusetts, USA.
FAU - Lash, Timothy L
AU  - Lash TL
AD  - Emory University Rollins School of Public Health, Atlanta, Georgia, USA.
FAU - Cranmer, Lisa M
AU  - Cranmer LM
AD  - Emory University School of Medicine, Atlanta, Georgia, USA.
FAU - Omer, Saad B
AU  - Omer SB
AD  - Yale Institute for Global Health, New Haven, Connecticut, USA.
AD  - Yale School of Medicine, New Haven, Connecticut, USA.
AD  - Yale School of Public Health, New Haven, Connecticut, USA.
FAU - Fuad, Junaid
AU  - Fuad J
AD  - Global Health Directorate, Indus Health Network, Karachi, Pakistan.
FAU - Siddiqui, Sara
AU  - Siddiqui S
AD  - Global Health Directorate, Indus Health Network, Karachi, Pakistan.
FAU - Amanullah, Farhana
AU  - Amanullah F
AD  - Indus Hospital, Karachi, Pakistan.
FAU - Jaswal, Maria
AU  - Jaswal M
AD  - Global Health Directorate, Indus Health Network, Karachi, Pakistan.
FAU - Salahuddin, Naseem
AU  - Salahuddin N
AD  - Indus Hospital, Karachi, Pakistan.
FAU - Keshavjee, Salmaan
AU  - Keshavjee S
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      Massachusetts, USA.
AD  - Division of Global Health Equity, Brigham and Women's Hospital, Boston, 
      Massachusetts, USA.
AD  - Partners In Health, Boston, Massachusetts, USA.
FAU - Hussain, Hamidah
AU  - Hussain H
AD  - Interactive Research and Development Global, Singapore.
FAU - Gandhi, Neel R
AU  - Gandhi NR
AD  - Emory University Rollins School of Public Health, Atlanta, Georgia, USA.
LA  - eng
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
GR  - K23 AI143479/AI/NIAID NIH HHS/United States
GR  - K12 HD000850/HD/NICHD NIH HHS/United States
GR  - K24 AI114444/AI/NIAID NIH HHS/United States
GR  - U19 AI111211/AI/NIAID NIH HHS/United States
GR  - P30 AI050409/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antitubercular Agents)
RN  - 0 (Fluoroquinolones)
RN  - 8G167061QZ (Ethambutol)
SB  - IM
CIN - Clin Infect Dis. 2021 May 18;72(10):1716-1718. PMID: 32266941
MH  - Antitubercular Agents/adverse effects
MH  - Ethambutol
MH  - Fluoroquinolones/adverse effects
MH  - Humans
MH  - Pakistan
MH  - Risk Factors
MH  - *Tuberculosis, Multidrug-Resistant/drug therapy/epidemiology/prevention & control
PMC - PMC8315482
OTO - NOTNLM
OT  - TB
OT  - adverse events
OT  - drug-resistant tuberculosis infection
OT  - fluoroquinolone
OT  - preventive therapy
EDAT- 2020/04/09 06:00
MHDA- 2021/07/03 06:00
PMCR- 2021/04/08
CRDT- 2020/04/09 06:00
PHST- 2019/12/31 00:00 [received]
PHST- 2020/03/24 00:00 [accepted]
PHST- 2020/04/09 06:00 [pubmed]
PHST- 2021/07/03 06:00 [medline]
PHST- 2020/04/09 06:00 [entrez]
PHST- 2021/04/08 00:00 [pmc-release]
AID - 5817711 [pii]
AID - ciaa327 [pii]
AID - 10.1093/cid/ciaa327 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2021 May 18;72(10):1709-1715. doi: 10.1093/cid/ciaa327.