Treatment decisions and mortality in HIV-positive presumptive smear-negative TB in the Xpert® MTB/RIF era: a cohort study
Year: 2017
Type: article
Study design: Observational Study
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.
Source: BMC Infectious Diseases
Institutions: Amsterdam UMC Location University of Amsterdam, Infectious Diseases Institute, Amsterdam Institute for Global Health and Development, Makerere University, University of Amsterdam, University of Antwerp, Instituut voor Tropische Geneeskunde, University of Cambridge, Johns Hopkins University, Johns Hopkins Medicine
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,090
Funders: U.S. Department of Veterans Affairs, European Commission, Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Vlaamse Interuniversitaire Raad, National Institutes of Health, European Research Council, National Institute of Allergy and Infectious Diseases, Fogarty International Center, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases
OpenAlex ID: W2626521845
