Factors Associated with Tuberculosis and Rifampicin-Resistant Tuberculosis amongst Symptomatic Patients in India: A Retrospective Analysis.

BACKGROUND:Tuberculosis remains a major public health challenge for India. Various studies have documented different levels of TB and multi-drug resistant (MDR) TB among diverse groups of the population. In view of renewed targets set under the End TB strategy by 2035, there is an urgent need for TB diagnosis to be strengthened. Drawing on data from a recent, multisite study, we address key questions for TB diagnosis amongst symptomatics presenting for care: are there subgroups of patients that are more likely than others, to be positive for TB? In turn, amongst these positive cases, are there factors-apart from treatment history-that may be predictive for multi-drug resistance? METHODS:We used data from a multi-centric prospective demonstration study, conducted from March 2012 to December 2013 in 18 sub-district level TB programme units (TUs) in India and covering a population of 8.8 million. In place of standard diagnostic tests, upfront Xpert MTB/RIF testing was offered to all presumptive TB symptomatics. Here, using data from this study, we used logistic regression to identify association between risk factors and TB and Rifampicin-Resistant TB among symptomatics enrolled in the study. RESULTS:We find that male gender; history of TB treatment; and adult age compared with either children or the elderly are risk factors associated with high TB detection amongst symptomatics, across the TUs. While treatment history is found be a significant risk factor for rifampicin-resistant TB, elderly (65+ yrs) people have significantly lower risk than other age groups. However, pediatric TB cases have no less risk of rifampicin resistance as compared with adults (OR 1.23 (95% C.I. 0.85-1.76)). Similarly, risk of rifampicin resistance among both the genders was the same. These patterns applied across the study sites involved. Notably in Mumbai, amongst those patients with microbiological confirmation of TB, female patients showed a higher risk of having MDR-TB than male patients. CONCLUSION:Our results cast fresh light on the characteristics of symptomatics presenting for care who are most likely to be microbiologically positive for TB, and for rifampicin resistance. The challenges posed by TB control are complex and multifactorial: evidence from diverse sources, including retrospective studies such as that addressed here, can be invaluable in informing future strategies to accelerate declines in TB burden

Catching the Missing Million: Experiences in Enhancing TB & DR-TB Detection by Providing Upfront Xpert MTB/RIF Testing for People Living with HIV in India

<div><p>Background</p><p>A critical challenge in providing TB care to People Living with HIV (PLHIV) is establishing an accurate bacteriological diagnosis. Xpert MTB/RIF, a highly sensitive and specific rapid tool, offers a promising solution in addressing these challenges. This study presents results from PLHIV taking part in a large demonstration study across India wherein upfront Xpert MTB/RIF testing was offered to all presumptive PTB cases in public health facilities.</p><p>Method</p><p>The study covered a population of 8.8 million across 18 sub-district level tuberculosis units (TU), with one Xpert MTB/RIF platform established at each TU. All HIV-infected patients suspected of TB (both TB and Drug Resistant TB (DR-TB)) accessing public health facilities in study area were prospectively enrolled and provided upfront Xpert MTB/RIF testing.</p><p>Result</p><p>2,787 HIV-infected presumptive pulmonary TB cases were enrolled and 867 (31.1%, 95% Confidence Interval (CI) 29.4‒32.8) HIV-infected TB cases were diagnosed under the study. Overall 27.6% (CI 25.9–29.3) of HIV-infected presumptive PTB cases were positive by Xpert MTB/RIF, compared with 12.9% (CI 11.6–14.1) who had positive sputum smears. Upfront Xpert MTB/RIF testing of presumptive PTB and DR-TB cases resulted in diagnosis of 73 (9.5%, CI 7.6‒11.8) and 16 (11.2%, CI 6.7‒17.1) rifampicin resistance cases, respectively. Positive predictive value (PPV) for rifampicin resistance detection was high 97.7% (CI 89.3‒99.8), with no significant difference with or without prior history of TB treatment.</p><p>Conclusion</p><p>The study results strongly demonstrate limitations of using smear microscopy for TB diagnosis in PLHIV, leading to low TB and DR-TB detection which can potentially lead to either delayed or sub-optimal TB treatment. Our findings demonstrate the usefulness and feasibility of addressing this diagnostic gap with upfront of Xpert MTB/RIF testing, leading to overall strengthening of care and support package for PLHIV.</p></div

Demographic profile of the HIV-infected presumptive TB and DR-TB cases enrolled under the study.

<p>Demographic profile of the HIV-infected presumptive TB and DR-TB cases enrolled under the study.</p

Rifampicin resistant HIV-infected TB cases diagnosed under the study.

<p><i>Abbreviations—OR = Odds Ratio</i>, <i>CI = Confidence interval</i></p><p>Rifampicin resistant HIV-infected TB cases diagnosed under the study.</p

Predictors of TB positivity amongst all TB symptomatics.

<p>Owing to the size of the dataset, all associations shown as significant have p < 10⁻⁵, with the exception of Mumbai patients referred by ART centres (<i>p</i> = 0.01).</p

Study diagnostic algorithm.

<p>Study diagnostic algorithm.</p

Geographical location of study treatment units and the demographic classification assigned to each project treatment unit site.

<p>Geographical location of study treatment units and the demographic classification assigned to each project treatment unit site.</p

Enrolment of HIV infected presumptive TB and DR TB cases under the study and TB and Rifampicin resistant TB case detection by Xpert MTB/RIF.

<p>Enrolment of HIV infected presumptive TB and DR TB cases under the study and TB and Rifampicin resistant TB case detection by Xpert MTB/RIF.</p

Additional gain in detection of bacteriologically confirmed TB cases on Xpert MTB/RIF over smear microscopy.

<p>Additional gain in detection of bacteriologically confirmed TB cases on Xpert MTB/RIF over smear microscopy.</p

Demographic profile of study participants.

<p>Demographic profile of study participants.</p