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India should speed up access to bedaquiline-based all-oral regimens, not procrastinate further

Udwadia, Zarir F1; Furin, Jennifer2

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doi: 10.4103/lungindia.lungindia_425_21
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We read with concern the Editorial by Jain[1] suggesting that India is moving too quickly when it comes to rolling out bedaquiline (BDQ)-based, all-oral regimens for drug-resistant forms of tuberculosis (DR-TB). India is home to the largest population of people living with DR-TB in the world,[2] and improving access to innovative diagnostic and therapeutic approaches is the only way the country will be able to move beyond its crippling TB problem. We would disagree with several of the authors’ claims and argue that India hasten to adopt all oral MDR regimes if it is to keep its pledge of eliminating TB by 2025.

Touting the efficacy of the so-called “Bangladesh” regimen, no mention is made however of the high rates of failure of this regimen if used in multidrug-resistant tuberculosis (MDR)-TB “hotspots” with high rates of additional resistance. Our study in Mumbai, where fluoroquinolone resistance is commonly encountered, showed that <5% of 559 patients were actually sensitive to all the drugs in the Bangladesh regimen when complete genotypic and phenotypic drug susceptibility tests were checked.[3] The paper also fails to mention more recent publications showing high rates of treatment success with new all-oral regimens. Indeed, a recent study by Khan etal. showed culture conversion rates of 83.8% (526/628) in patients receiving all oral BDQ or delamanid-based regimens in the end-TB observational study conducted in 15 high-burden countries across the globe.[4]

Oral regimens may also serve to dramatically shorten treatment of MDR-TB to just 6 months as in the on-going TB-PRACTECAL trial, the world’s first new all-oral trial. This study has stopped enrolling patients after initial clinical data showed the superiority of a regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin over current care.[5] The trial data have been shared with the World Health Organization (WHO), and such regimens could not only save thousands of lives but also vastly improve the quality of these lives.

The editorial by Jain[1] also glosses over the unacceptable rates of serious adverse events – including permanent hearing loss – as well as the trauma associated with injectable therapy use. Given that monitoring for hearing loss is virtually nonexistent in most parts of India, the use of injectable agents is far more dangerous than that of the new oral drugs, whose safety has been clearly demonstrated at all age groups and even when given in combination.[6]

Finally, the author relies on tired and ill-informed arguments regarding cost, which only take into account the up-front costs of medications. Conveniently ignored are the rights and perspectives of the affected community, who have stated a clear preference for injectable-free DR-TB treatment regimens.[7] The vast majority of practicing physicians would clearly choose BDQ (oral, WHO Group A) over amikacin (injectable, WHO Group C) if they were afflicted with DR-TB. Why then should we accept anything less for our patients?

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Conflicts of interest

Zarir F Udwadia was invited by WHO to be on their DR-TB guidelines group.


1. Jain NK WHO consolidated guidelines on tuberculosis 2020 moving toward fully oral regimen Should country act in hurry? Lung India 2021 38 303 06
2. WHO Global Tuberculosis Report 2020
3. Udwadia ZF, Tornheim JA, Ganatra S, DeLuca A, Rodrigues CS, Gupta A Few eligible for the newly recommended short course MDR-TB regimen at a large Mumbai private clinic BMC Infect Dis 2019 19 94
4. Khan PY, Franke MF, Hewison C, Seung KJ, Huerga H, Atwood S, et al. All-oral longer regimens are effective for the management of multidrug resistant tuberculosis in high burden settings Eur Respir J 2021 06 17 2004345
5. Pragmatic Clinical Trial for a more effective concise and less toxic MDR-TB treatment regimen. (TB-PRACTECAL) Identifier:NCT02589782
6. Das M, Mathur T, Ravi S, Meneguim AC, Iyer A, Mansoor H, et al. Challenging drug-resistant TB treatment journey for children, adolescents and their care-givers:A qualitative study PLoS One 2021 16 e0248408
7. Reuter A, Tisile P, von Delft D, Cox H, Cox V, Ditiu L, et al. The devil we know:Is the use of injectable agents for the treatment of MDR-TB justified? Int J Tuberc Lung Dis 2017 21 1114 26
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