Treatment decisions and mortality in HIV-positive presumptive smear-negative TB in the Xpert™ MTB/RIF era: a cohort study.


Type
Article
Change log
Authors
Babirye, Juliet A 
Mbabazi, Olive 
Kakooza, Francis 
Colebunders, Robert 
Abstract

BACKGROUND: The Xpert™ MTB/RIF (XP) has a higher sensitivity than sputum smear microscopy (70% versus 35%) for TB diagnosis and has been endorsed by the WHO for TB high burden countries to increase case finding among HIV co-infected presumptive TB patients. Its impact on the diagnosis of smear-negative TB in a routine care setting is unclear. We determined the change in diagnosis, treatment and mortality of smear-negative presumptive TB with routine use of Xpert MTB/RIF (XP). METHODS: Prospective cohort study of HIV-positive smear-negative presumptive TB patients during a 12-month period after XP implementation in a well-staffed and trained integrated TB/HIV clinic in Kampala, Uganda. Prior to testing clinicians were asked to decide whether they would treat empirically prior to Xpert result; actual treatment was decided upon receipt of the XP result. We compared empirical and XP-informed treatment decisions and all-cause mortality in the first year. RESULTS: Of 411 smear-negative presumptive TB patients, 175 (43%) received an XP; their baseline characteristics did not differ. XP positivity was similar in patients with a pre-XP empirical diagnosis and those without (9/29 [17%] versus 14/142 [10%], P = 0.23). Despite XP testing high levels of empirical treatment prevailed (18%), although XP results did change who ultimately was treated for TB. When adjusted for CD4 count, empirical treatment was not associated with higher mortality compared to no or microbiologically confirmed treatment. CONCLUSIONS: XP usage was lower than expected. The lower sensitivity of XP in smear-negative HIV-positive patients led experienced clinicians to use XP as a "rule-in" rather than "rule-out" test, with the majority of patients still treated empirically.

Description
Keywords
Empirical treatment, HIV Infections/complications, Molecular diagnostic techniques/methods, Tuberculosis, pulmonary/diagnosis, Tuberculosis, pulmonary/epidemiology, Adult, CD4 Lymphocyte Count, Cohort Studies, Coinfection, Female, HIV Infections, Humans, Male, Microscopy, Molecular Diagnostic Techniques, Mycobacterium tuberculosis, Prospective Studies, Sensitivity and Specificity, Sputum, Tuberculosis, Uganda
Journal Title
BMC Infect Dis
Conference Name
Journal ISSN
1471-2334
1471-2334
Volume Title
17
Publisher
Springer Science and Business Media LLC