PMID- 31615610
OWN - NLM
STAT- MEDLINE
DCOM- 20200424
LR  - 20200424
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Linking)
VI  - 23
IP  - 9
DP  - 2019 Sep 1
TI  - Adverse events among people on delamanid for rifampicin-resistant tuberculosis in 
      a high HIV prevalence setting.
PG  - 1017-1023
LID - 10.5588/ijtld.18.0651 [doi]
AB  - SETTING: Patients with rifampicin-resistant tuberculosis (RR-TB) in the township 
      of Khayelitsha, South Africa, were offered delamanid (DLM) within a decentralised 
      RR-TB treatment programme.OBJECTIVE: To describe adverse events (AEs) among 
      HIV-positive and negative people receiving DLM for RR-TB in a programmatic 
      setting.DESIGN: Patients were followed up monthly for blood, electrocardiography 
      and clinical monitoring and AEs were assessed for severity grade, seriousness and 
      relationship to DLM.RESULTS: Fifty-eight patients (55% male; median age 35 years, 
      interquartile range [IQR] 28-42) started DLM; 46 (79%) were HIV-positive, median 
      CD4 count 173 cells/mm(3) (IQR 70-294). Fifty (86%) patients experienced >/=1 new or 
      worsening AE after starting DLM, most commonly vomiting, QTcB >450 ms and/or 
      myalgia. Serious and/or severe AEs were experienced by 22 (38%) patients; three 
      HIV-positive patients died (not related to DLM). HIV status was not significantly 
      associated with number (P = 0.089) or severity/seriousness (P = 0.11) of AEs 
      during exposure to DLM. Two (3%) patients had DLM withdrawn due to 
      AEs.CONCLUSION: AEs during RR-TB treatment, both before and during DLM exposure, 
      were common, with relatively few serious/severe AEs considered related to DLM and 
      no significant association with HIV status. Clinical and electrocardiography 
      monitoring should be prioritised in the first two months after starting DLM.
FAU - Hughes, J
AU  - Hughes J
AD  - Medecins Sans Frontieres (MSF), Khayelitsha, Cape Town.
FAU - Reuter, A
AU  - Reuter A
AD  - Medecins Sans Frontieres (MSF), Khayelitsha, Cape Town.
FAU - Chabalala, B
AU  - Chabalala B
AD  - Medecins Sans Frontieres (MSF), Khayelitsha, Cape Town.
FAU - Isaakidis, P
AU  - Isaakidis P
AD  - MSF, Southern Africa Medical Unit, Cape Town.
FAU - Cox, H
AU  - Cox H
AD  - Division of Medical Microbiology and the Institute of Infectious Disease and 
      Molecular Medicine, University of Cape Town, Cape Town, South Africa.
FAU - Mohr, E
AU  - Mohr E
AD  - Medecins Sans Frontieres (MSF), Khayelitsha, Cape Town.
LA  - eng
PT  - Journal Article
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
RN  - 0 (Nitroimidazoles)
RN  - 0 (OPC-67683)
RN  - 0 (Oxazoles)
RN  - VJT6J7R4TR (Rifampin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antitubercular Agents/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Infections/*epidemiology
MH  - Humans
MH  - Male
MH  - Nitroimidazoles/*administration & dosage/adverse effects
MH  - Oxazoles/*administration & dosage/adverse effects
MH  - Prevalence
MH  - Rifampin/administration & dosage
MH  - South Africa
MH  - Tuberculosis, Multidrug-Resistant/*drug therapy
MH  - Young Adult
EDAT- 2019/10/17 06:00
MHDA- 2020/04/25 06:00
CRDT- 2019/10/17 06:00
PHST- 2019/10/17 06:00 [entrez]
PHST- 2019/10/17 06:00 [pubmed]
PHST- 2020/04/25 06:00 [medline]
AID - 10.5588/ijtld.18.0651 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2019 Sep 1;23(9):1017-1023. doi: 10.5588/ijtld.18.0651.