Conference Material
|AbstractSystematic and empirical treatment of tuberculosis in HIV advanced infected patients
Abstract
The STATIS trial compared the efficacy and safety of 2 strategies aiming to decrease mortality and invasive bacterial disease in late presenting HIV+ adults: initiation of TB treatment after extensive
TB screening vs systematic empirical TB treatment. Systematic empirical TB treatment was not superior to extensive TB screening.
BACKGROUND
In late presenting HIV+ adults, mortality following ART initiation is high with tuberculosis (TB) or invasive bacterial diseases (IBD) being major causes of mortality. We report the results of the STATIS open-label
randomized controlled trial (ANRS 12290) that compared the efficacy and safety of 2 strategies aiming to decrease mortality and IBD in late presenters.
METHODS
ART-naïve HIV-1 infected adults with CD4<100 cells/µl were randomly assigned to either ART + extensive TB screening (arm 1) or ART + systematic empirical TB treatment (arm 2). In arm 1, extensive TB screening included Xpert MTB/RIF on sputum, urine lipoarabinomannan (LAM) and chest X-ray at baseline and at any time during follow-up in case of TB symptoms. ART was initiated immediately in patients who did not start
TB treatment at baseline (arm 1 patients with negative TB screening) and 2 weeks after starting TB treatment in others (arm 1 patients with positive TB screening and arm 2 patients). The primary outcome was the
occurrence of death or IBD at week 24 (W24).
RESULTS
1047 participants were included (arm 1: 525; arm 2: 522). Baseline characteristics were: 58% male, mean age 36 years, body mass index 20.1 kg/m2, CD4 36 cells/µl, plasma HIV RNA 5.4 log10 copies/ml. At W24,
39 patients (3.8%) were lost to follow-up (arm 1: 21; arm 2: 18), while there were 69 deaths (arm 1: 36; arm 2: 33) and 29 IBD (arm 1: 14; arm 2: 15). The W24 hazard ratio of events between arm 2 vs. arm 1 was 0.93
(95%CI 0.61-1.42) for death or IBD, 0.92 (0.57-1.48) for death alone, 1.14 (0.54-2.40) for IBD alone and 2.70 (1.80-4.04) for grade 3-4 drug related toxicity.
CONCLUSIONS
We found that systematic TB treatment is not superior to extensive TB screening using Xpert MTB/RIF and urine LAM and targeted TB treatment to d
TB screening vs systematic empirical TB treatment. Systematic empirical TB treatment was not superior to extensive TB screening.
BACKGROUND
In late presenting HIV+ adults, mortality following ART initiation is high with tuberculosis (TB) or invasive bacterial diseases (IBD) being major causes of mortality. We report the results of the STATIS open-label
randomized controlled trial (ANRS 12290) that compared the efficacy and safety of 2 strategies aiming to decrease mortality and IBD in late presenters.
METHODS
ART-naïve HIV-1 infected adults with CD4<100 cells/µl were randomly assigned to either ART + extensive TB screening (arm 1) or ART + systematic empirical TB treatment (arm 2). In arm 1, extensive TB screening included Xpert MTB/RIF on sputum, urine lipoarabinomannan (LAM) and chest X-ray at baseline and at any time during follow-up in case of TB symptoms. ART was initiated immediately in patients who did not start
TB treatment at baseline (arm 1 patients with negative TB screening) and 2 weeks after starting TB treatment in others (arm 1 patients with positive TB screening and arm 2 patients). The primary outcome was the
occurrence of death or IBD at week 24 (W24).
RESULTS
1047 participants were included (arm 1: 525; arm 2: 522). Baseline characteristics were: 58% male, mean age 36 years, body mass index 20.1 kg/m2, CD4 36 cells/µl, plasma HIV RNA 5.4 log10 copies/ml. At W24,
39 patients (3.8%) were lost to follow-up (arm 1: 21; arm 2: 18), while there were 69 deaths (arm 1: 36; arm 2: 33) and 29 IBD (arm 1: 14; arm 2: 15). The W24 hazard ratio of events between arm 2 vs. arm 1 was 0.93
(95%CI 0.61-1.42) for death or IBD, 0.92 (0.57-1.48) for death alone, 1.14 (0.54-2.40) for IBD alone and 2.70 (1.80-4.04) for grade 3-4 drug related toxicity.
CONCLUSIONS
We found that systematic TB treatment is not superior to extensive TB screening using Xpert MTB/RIF and urine LAM and targeted TB treatment to d
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