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India has responded to the epidemic of multidrug-resistant tuberculosis (MDR-TB) with a number of strategies. The guidelines on notification1 and standards of care2 introduced by the Revised National Tuberculosis Control Programme (RNTCP) are important contributions towards the appropriate diagnosis and treatment of MDR-TB patients. However, these guidelines apply only to bacteriologically confirmed MDR-TB, while those patients without bacteriological confirmation are usually not treated.
We acknowledge that the diagnosis of MDR-TB patients is difficult; it is even more challenging in the absence of bacteriological confirmation of MDR-TB. The global TB community has recognised the need for ‘presumptive’ treatment of clinically diagnosed MDR-TB patients prior to receipt of bacteriological confirmation,3 and World Health Organization guidelines recommend initiating treatment with a presumptive MDR-TB regimen for patient groups with a high likelihood of MDR-TB, while awaiting the results of conventional drug susceptibility testing (DST).3 However, immunocompromised individuals, including those with human immunodeficiency virus (HIV) infection, children, and those unable to provide specimens/sputum, should be considered for treatment with similar presumptive regimens.
To date, few studies have reported on the treatment outcomes of patients initiated on presumptive treatment.4,5 Nevertheless, a considerable number of patients are at risk of remaining without a bacteriologically confirmed diagnosis of MDR-TB, as this may not be easily achieved in immunocompromised patients, including those with diabetes or cancer. These individuals are at higher risk of mortality from MDR-TB,5 as they often fail to receive timely and appropriate treatment. The presumptive use of a standard regimen in such patients is still not permitted in India's RNTCP.
The Médecins Sans Frontières (MSF) programme in Mumbai, India, has been providing treatment and care for HIV-infected MDR-TB patients since 2006. Of 174 patients enrolled in the clinic over the 10 years from 2006 to 2015, 36 (20%) did not have bacteriological confirmation of MDR-TB. These patients received presumptive treatment based on a clinical diagnosis of MDR-TB and their TB treatment history, including history of exposure to second-line anti-tuberculosis drugs and history of contact with a confirmed MDR-TB case. Of the 36 patients, 19 (53%) had a successful treatment outcome. These 36 patients would not have met the criteria for MDR-TB treatment in the RNTCP.
Early and appropriate treatment may prevent mortality in those with paucibacillary MDR-TB, in rapidly deteriorating MDR-TB patients (including those with TB meningitis due to an MDR strain), in children, and in those co-infected with HIV5 who might otherwise be made to wait for appropriate treatment due to the unavailability of bacteriological confirmation. Caution must nevertheless be exercised in providing presumptive treatment in such patients,3 due to possible pharmacological interactions and adverse events during treatment. A standardised treatment algorithm including an appropriate regimen and regular monitoring of clinical, radiological and/or laboratory evaluations would therefore be helpful.
We recommend the design and inclusion of standardised presumptive treatment algorithms in the RNTCP recommendations for immune-compromised individuals and children with a high likelihood of MDR-TB, but who fail to produce sputum/specimens for laboratory confirmation. Promoting presumptive treatment would assist in reducing the global burden of MDR-TB.
This research was supported through an operational research course that was jointly developed and run by the International Union Against Tuberculosis and Lung Disease (The Union) South-East Asia Regional Office, Delhi, India; the Centre for Operational Research, The Union, Paris France; and the Operational Research Unit (LUXOR), Médecins Sans Frontières (MSF), Brussels Operational Center, Luxembourg. This course is under the umbrella of the World Health Organization (WHO-TDR) SORT IT programme (Structured Operational Research and Training Initiative) for capacity building in low- and middle-income countries.
The authors wish to acknowledge the contributions of health care workers from the MSF clinic in Mumbai and the patients suffering from human immunodeficiency virus and multidrug-resistant tuberculosis and their families.
The authors also wish to thank Ewan Wilkinson for his critical feedback during the manuscript preparation.
Conflicts of interest: none declared.