PMID- 24367678
OWN - NLM
STAT- MEDLINE
DCOM- 20140728
LR  - 20211021
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 8
IP  - 12
DP  - 2013
TI  - Incidence of paradoxical tuberculosis-associated immune reconstitution 
      inflammatory syndrome and impact on patient outcome.
PG  - e84585
LID - 10.1371/journal.pone.0084585 [doi]
LID - e84585
AB  - OBJECTIVES AND DESIGN: We used data from a randomized trial of HIV-tuberculosis 
      co-infected patients in Mozambique to determine the incidence and predictors of 
      paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome 
      (IRIS) occurring within 12 weeks of starting antiretroviral therapy, and to 
      evaluate its association with patient outcome at 48 weeks. METHODS: 
      HIV-tuberculosis co-infected and antiretroviral therapy-naive adults with less 
      than 250 CD4/mm3 were randomized to a nevirapine or efavirenz-based 
      antiretroviral therapy initiated 4 to 6 weeks after starting tuberculosis 
      treatment, and were then followed for 48 weeks. Tuberculosis cases were diagnosed 
      using WHO guidelines, and tuberculosis-IRIS by case definitions of the 
      International Network for the Study of HIV-associated IRIS. RESULTS: The 573 
      HIV-tuberculosis co-infected patients who initiated antiretroviral therapy had a 
      median CD4 count of 92 cells/mm(3) and HIV-1 RNA of 5.6 log10 copies/mL. 
      Mortality at week 48 was 6.1% (35/573). Fifty-three (9.2%) patients presented a 
      tuberculosis-IRIS within 12 weeks of starting antiretroviral therapy. Being 
      female and having a low CD4 count, high HIV-1 RNA load, low body mass index and 
      smear-positive pulmonary tuberculosis were independently associated with 
      tuberculosis-IRIS. After adjustment for baseline body mass index, CD4 count and 
      hemoglobin, occurrence of tuberculosis-IRIS was independently associated with 
      48-week mortality (aOR 2.72 95%CI 1.14-6.54). Immunological and HIV-1 virological 
      responses and tuberculosis treatment outcomes were not different between patients 
      with and without tuberculosis-IRIS. CONCLUSION: In this large prospective cohort, 
      tuberculosis-IRIS occurrence within 12 weeks of starting antiretroviral therapy 
      was independently associated with the mortality of HIV-tuberculosis co-infected 
      patients at 48 weeks post antiretroviral therapy initiation.
FAU - Bonnet, Maryline
AU  - Bonnet M
AD  - Epicentre, Paris, France.
FAU - Baudin, Elisabeth
AU  - Baudin E
AD  - Epicentre, Paris, France.
FAU - Jani, Ilesh V
AU  - Jani IV
AD  - Instituto Nacional de Saude, Maputo, Mozambique.
FAU - Nunes, Elizabete
AU  - Nunes E
AD  - Hospital Central, Maputo, Mozambique.
FAU - Verhoustraten, Francois
AU  - Verhoustraten F
AD  - Medecins sans Frontieres, Geneva, Switzerland.
FAU - Calmy, Alexandra
AU  - Calmy A
AD  - Geneva University Hospital, Geneva, Switzerland.
FAU - Bastos, Rui
AU  - Bastos R
AD  - Hospital Central, Maputo, Mozambique.
FAU - Bhatt, Nilesh B
AU  - Bhatt NB
AD  - Instituto Nacional de Saude, Maputo, Mozambique.
FAU - Michon, Christophe
AU  - Michon C
AD  - Annecy Hospital, Annecy, France.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131218
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Anti-Retroviral Agents)
SB  - IM
EIN - PLoS One. 2014;9(1). doi:10.1371/annotation/15d01128-2495-4b95-8fe8-8702190fdb0e
MH  - AIDS-Related Opportunistic Infections/*drug therapy/*epidemiology
MH  - Adult
MH  - Anti-Retroviral Agents/*therapeutic use
MH  - Body Mass Index
MH  - CD4 Lymphocyte Count
MH  - Cohort Studies
MH  - Female
MH  - Humans
MH  - Immune Reconstitution Inflammatory Syndrome/*epidemiology
MH  - Incidence
MH  - Mortality
MH  - Mozambique/epidemiology
MH  - Outcome Assessment, Health Care
MH  - Prospective Studies
MH  - Tuberculosis/*epidemiology
PMC - PMC3867516
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2013/12/25 06:00
MHDA- 2014/07/30 06:00
PMCR- 2013/12/18
CRDT- 2013/12/25 06:00
PHST- 2013/09/04 00:00 [received]
PHST- 2013/11/17 00:00 [accepted]
PHST- 2013/12/25 06:00 [entrez]
PHST- 2013/12/25 06:00 [pubmed]
PHST- 2014/07/30 06:00 [medline]
PHST- 2013/12/18 00:00 [pmc-release]
AID - PONE-D-13-36287 [pii]
AID - 10.1371/journal.pone.0084585 [doi]
PST - epublish
SO  - PLoS One. 2013 Dec 18;8(12):e84585. doi: 10.1371/journal.pone.0084585. 
      eCollection 2013.