Impact of Xpert MTB/RIF on Antiretroviral Therapy-Associated Tuberculosis and Mortality: A Pragmatic Randomized Controlled Trial.
BACKGROUND
GeneXpert® MTB/RIF (Xpert) is now widely distributed in high human immunodeficiency virus (HIV)/tuberculosis (TB)-burden countries. Yet, whether the test improves patient-important outcomes within HIV treatment programs in limited resource settings is unknown.


METHODS
To investigate whether use of Xpert for TB screening prior to initiation of antiretroviral treatment (ART) improves patient-important outcomes, in a pragmatic randomized controlled trial we assigned 424 patients to Xpert or fluorescence sputum smear microscopy (FM) at ART initiation. The primary endpoint was a composite of 3-month mortality and ART-associated TB.


RESULTS
There was no difference in overall TB diagnosis at ART initiation (20% [n = 43] Xpert vs 21% [n = 45] FM; P = .80), with most patients in both groups treated empirically. There was no difference in time to TB treatment initiation {5 days (interquartile range [IQR], 3-13) vs 8 days [IQR, 3-23; P = .26]} or loss to follow-up (32 [15%] vs 38 [18%]; P = 0.38). Although a nonsignificant reduction in mortality occurred in the Xpert group (11 [6%] vs 17 [10%]; 95% CI, -9% to 2%; P = .19), there was no difference in the composite outcome (9% [n = 17] Xpert vs 12% [n = 21] FM; difference -3%; 95% CI, -9% to 4%).


CONCLUSIONS
Among HIV-infected initiating ART, centralized TB screening with Xpert did not reduce the rate of ART-associated TB and mortality, compared with fluorescence microscopy.
University of Zimbabwe College of Health Sciences , Harare , Zimbabwe ; Biomedical Research and Training Institute , Zimbabwe.
L
L
Mupfumi
University of Zimbabwe College of Health Sciences , Harare , Zimbabwe ; Biomedical Research and Training Institute , Zimbabwe.
B
B
Makamure
Biomedical Research and Training Institute , Zimbabwe.
M
M
Chirehwa
Biomedical Research and Training Institute , Zimbabwe.
T
T
Sagonda
National Microbiology Reference Laboratory , Harare , Zimbabwe.
S
S
Zinyowera
University of Zimbabwe College of Health Sciences , Harare , Zimbabwe ; Biomedical Research and Training Institute , Zimbabwe.
P
P
Mason
Division of Pulmonary and Critical Care Medicine , San Francisco General Hospital, and Francis J. Curry International Tuberculosis Center, University of California , San Francisco, California.
J Z
JZ
Metcalfe
Biomedical Research and Training Institute , Zimbabwe.
R
R
Mutetwa
ART-associated TB; GeneXpert MTB/RIF; HIV; screening; tuberculosis