Abstract
ObjectiveTo assess the performance of QuantiFERON-TB Gold In-Tube (QFT-GIT) test for active tuberculosis (TB) in HIV adults, and its variation over time in patients on antiretroviral therapy (ART) and/or isoniazide preventive therapy (IPT).MethodsTransversal study and cohort nested in the Temprano ANRS 12136 randomized controlled trial assessing benefits of initiating ART earlier than currently recommended by World Health Organization, with or without a 6-month IPT. Performance of QFT-GIT for detecting active TB at baseline in the first 50% participants, and 12-month incidence of conversion/reversion in the first 25% participants were assessed. QFT-GIT threshold for positivity was 0.35 IU/ml.ResultsAmong the 975 first participants (median baseline CD4 count 383/mm3, positive QFT-GIT test 35%), 2.7% had active TB at baseline. QFT-GIT sensitivity, specificity, positive and negative predictive value for active TB were 88.0%, 66.6%, 6.5% and 99.5%. For the 444 patients with a second test at 12 months, rates for conversion and reversion were 9.3% and 14%. Reversion was more frequent in patients without ART and younger patients. IPT and early ART were not associated with reversion/conversion.ConclusionA negative QFT-GIT could rule out active TB in HIV-infected adults not severely immunosuppressed, thus avoiding repeated TB testing and accelerating diagnosis and care for other diseases.Trial RegistrationClinicalTrials.gov NCT00495651.
Highlights
Tuberculosis (TB) disease and HIV infection are two epidemics with strong interactions in sub-Saharan Africa [1]
Two interventions can reduce the incidence of TB disease in HIV infected patients: antiretroviral treatment (ART) [2], and isoniazid preventive therapy (IPT) [3,4,5,6,7] The latter has been shown to be more effective in patients with proven asymptomatic TB infection [5,7]
We report the results of an ancillary study of Temprano, in which a group of participants in the trial had a QTF-GIT test at baseline and at Month-12
Summary
Tuberculosis (TB) disease and HIV infection are two epidemics with strong interactions in sub-Saharan Africa [1]. The purified protein derivative (PPD) skin test used to detect TB infection has several limitations. It utilizes a relatively non specific and complex mixture of antigens, it can be positive in patients who have been vaccinated with the BCG vaccine or exposed to non-tuberculous mycobacteria [8]. It can be negative in HIV-infected patients with low CD4 count, even if they are infected with TB [9]. Results may vary depending on the experience of readers [10,11], and the additional visit for reading the test after two days may be a challenge [12]
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