PMID- 31504347
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20240427
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 71
IP  - 3
DP  - 2020 Jul 27
TI  - Prospective International Study of Incidence and Predictors of Immune 
      Reconstitution Inflammatory Syndrome and Death in People Living With Human 
      Immunodeficiency Virus and Severe Lymphopenia.
PG  - 652-660
LID - 10.1093/cid/ciz877 [doi]
AB  - BACKGROUND: Patients living with human immunodeficiency virus (PLWH) with low CD4 
      counts are at high risk for immune reconstitution inflammatory syndrome (IRIS) 
      and death at antiretroviral therapy (ART) initiation. METHODS: We investigated 
      the clinical impact of IRIS in PLWH and CD4 counts <100 cells/muL starting ART in 
      an international, prospective study in the United States, Thailand, and Kenya. An 
      independent review committee adjudicated IRIS events. We assessed associations 
      between baseline biomarkers, IRIS, immune recovery at week 48, and death by week 
      48 with Cox models. RESULTS: We enrolled 506 participants (39.3% were women). 
      Median age was 37 years, and CD4 count was 29 cells/muL. Within 6 months of ART, 
      97 (19.2%) participants developed IRIS and 31 (6.5%) died. Participants with 
      lower hemoglobin at baseline were at higher IRIS risk (hazard ratio [HR], 1.2; P 
      = .004). IRIS was independently associated with increased risk of death after 
      adjustment for known risk factors (HR, 3.2; P = .031). Being female (P = .004) 
      and having a lower body mass index (BMI; P = .003), higher white blood cell count 
      (P = .005), and higher D-dimer levels (P = .044) were also significantly 
      associated with increased risk of death. Decision-tree analysis identified 
      hemoglobin <8.5 g/dL as predictive of IRIS and C-reactive protein (CRP) >106 
      mug/mL and BMI <15.6 kg/m2 as predictive of death. CONCLUSIONS: For PLWH with 
      severe immunosuppression initiating ART, baseline low BMI and hemoglobin and high 
      CRP and D-dimer levels may be clinically useful predictors of IRIS and death 
      risk.
CI  - Published by Oxford University Press for the Infectious Diseases Society of 
      America 2019.
FAU - Sereti, Irini
AU  - Sereti I
AD  - Division of Intramural Research, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Sheikh, Virginia
AU  - Sheikh V
AD  - Division of Intramural Research, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Shaffer, Douglas
AU  - Shaffer D
AD  - Walter Reed Army Institute of Research/US Army Medical Research 
      Directorate-Africa, Nairobi, Kenya.
AD  - Walter Reed Army Institute of Research, US Military Human Immunodeficiency Virus 
      Research Program, Silver Spring, Maryland, USA.
FAU - Phanuphak, Nittaya
AU  - Phanuphak N
AD  - South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research 
      Centre, Bangkok, Thailand.
FAU - Gabriel, Erin
AU  - Gabriel E
AD  - Department of Medical Epidemiology and Biostatistics, Karolinska Institute, 
      Stockholm, Sweden.
FAU - Wang, Jing
AU  - Wang J
AD  - Clinical Research Directorate/Clinical Monitoring Research Program, Leidos 
      Biomedical Research, Inc, National Cancer Institute Campus at Frederick, 
      Maryland, USA.
FAU - Nason, Martha C
AU  - Nason MC
AD  - Division of Clinical Research, National Institute of Allergy and Infectious 
      Diseases, Bethesda, Maryland, USA.
FAU - Roby, Gregg
AU  - Roby G
AD  - Division of Intramural Research, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Ngeno, Hellen
AU  - Ngeno H
AD  - Walter Reed Army Institute of Research/US Army Medical Research 
      Directorate-Africa, Nairobi, Kenya.
FAU - Kirui, Fredrick
AU  - Kirui F
AD  - Kenya Medical Research Institute/US Army Medical Research 
      Directorate-Africa-Kenya/ Henry Jackson Foundation Medical Research 
      International, Kericho Clinical Research Center, Kenya.
FAU - Pau, Alice
AU  - Pau A
AD  - Division of Intramural Research, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Mican, Joann M
AU  - Mican JM
AD  - Division of Intramural Research, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Rupert, Adam
AU  - Rupert A
AD  - Applied and Developmental Research Directorate, AIDS Monitoring Laboratory, 
      Leidos Biomedical Research, Inc, Frederick, Maryland, USA.
FAU - Bishop, Rachel
AU  - Bishop R
AD  - National Eye Institute, National Institutes of Health, Bethesda, Maryland, USA.
FAU - Agan, Brian
AU  - Agan B
AD  - Infectious Disease Clinical Research Program, Department of Preventive Medicine 
      and Biostatistics, Uniformed Services University of the Health Sciences, 
      Bethesda, Maryland, USA.
AD  - Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, 
      Maryland, USA.
FAU - Chomchey, Nitiya
AU  - Chomchey N
AD  - South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research 
      Centre, Bangkok, Thailand.
FAU - Teeratakulpisarn, Nipat
AU  - Teeratakulpisarn N
AD  - South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research 
      Centre, Bangkok, Thailand.
FAU - Tansuphaswadikul, Somsit
AU  - Tansuphaswadikul S
AD  - Bamrasnaradura Infectious Diseases Institute, Department of Medicine, Nonthaburi, 
      Thailand.
FAU - Langat, Deborah
AU  - Langat D
AD  - Kenya Medical Research Institute/US Army Medical Research 
      Directorate-Africa-Kenya/ Henry Jackson Foundation Medical Research 
      International, Kericho Clinical Research Center, Kenya.
AD  - Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, 
      Maryland, USA.
FAU - Kosgei, Josphat
AU  - Kosgei J
AD  - Kenya Medical Research Institute/US Army Medical Research 
      Directorate-Africa-Kenya/ Henry Jackson Foundation Medical Research 
      International, Kericho Clinical Research Center, Kenya.
AD  - Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, 
      Maryland, USA.
FAU - French, Martyn
AU  - French M
AD  - University of Western Australia, Medical School and School of Biomedical 
      Sciences, Nedlands, Australia.
FAU - Ananworanich, Jintanat
AU  - Ananworanich J
AD  - South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research 
      Centre, Bangkok, Thailand.
AD  - Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, 
      Maryland, USA.
AD  - US Military Human Immunodeficiency Virus Research Program, Walter Reed Army 
      Institute of Research, Silver Spring, Maryland, USA.
AD  - Department of Global Health, Amsterdam Medical Center, University of Amsterdam, 
      Amsterdam, The Netherlands.
FAU - Sawe, Fredrick
AU  - Sawe F
AD  - Kenya Medical Research Institute/US Army Medical Research 
      Directorate-Africa-Kenya/ Henry Jackson Foundation Medical Research 
      International, Kericho Clinical Research Center, Kenya.
AD  - Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, 
      Maryland, USA.
LA  - eng
GR  - HHSN261200800001C/RC/CCR NIH HHS/United States
GR  - HHSN261200800001E/CA/NCI NIH HHS/United States
GR  - Y01 AI005072/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, N.I.H., Intramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
SB  - IM
MH  - Adult
MH  - CD4 Lymphocyte Count
MH  - Female
MH  - HIV
MH  - *HIV Infections/complications/drug therapy
MH  - Humans
MH  - *Immune Reconstitution Inflammatory Syndrome/epidemiology
MH  - Incidence
MH  - Kenya
MH  - *Lymphopenia/epidemiology
MH  - Male
MH  - Prospective Studies
MH  - Thailand
PMC - PMC7384325
OTO - NOTNLM
OT  - AIDS
OT  - HIV
OT  - biomarkers
OT  - death
OT  - immune reconstitution inflammatory syndrome (IRIS)
EDAT- 2019/09/11 06:00
MHDA- 2021/04/28 06:00
PMCR- 2020/09/05
CRDT- 2019/09/11 06:00
PHST- 2019/05/03 00:00 [received]
PHST- 2019/09/03 00:00 [accepted]
PHST- 2019/09/11 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2019/09/11 06:00 [entrez]
PHST- 2020/09/05 00:00 [pmc-release]
AID - 5560189 [pii]
AID - ciz877 [pii]
AID - 10.1093/cid/ciz877 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2020 Jul 27;71(3):652-660. doi: 10.1093/cid/ciz877.