https://doi.org/10.4081/monaldi.2022.2231
Comparison of efficacy of bedaquiline and moxifloxacin in drug resistant pulmonary tuberculosis. A prospective observational study
Submitted: February 12, 2022
Accepted: April 27, 2022
Published: May 4, 2022
Accepted: April 27, 2022
Abstract Views: 1489
PDF: 282
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Drug-resistant tuberculosis remains a major public health concern in many countries. We compared the efficacy and safety of bedaquiline plus optimized background regimen (Bdq+OBR) with high dose moxifloxacin and optimized background regimen (Mfx(h)+OBR) for the treatment of patients with multidrug-resistant tuberculosis with additional resistance to fluoroquinolones. In this prospective observational study, newly diagnosed cases of multidrug-resistant tuberculosis with additional resistance to fluoroquinolone were enrolled. They received either Bdq+OBR or Mfx(h)+OBR and were followed up for six months. The sputum culture conversion rate at the end of six months and the time to culture conversion in each group were studied. The safety profile of both regimens was also studied. The sputum culture conversion was achieved in 41 patients (100%) in the Bdq+OBR group and 36 patients (87.8%) in the Mfx(h)+OBR group at the end of 6 months. The mean time to culture conversion was found to be 3.10±0.8 months in the Bdq+OBR group and 3.32±0.9 months in the Mfx(h)+OBR group. Mortality was 6.8% in the Bdq+OBR group and 10.8 % in the Mfx(h)+OBR group at 6 months. Raised serum lipase and dark discolouration of skin were significantly more common in the Bdq+OBR group while vomiting and ototoxicity were more common in the Mfx(h)+OBR group. Bdq+OBR was associated with higher success of sputum culture conversion at 6 months and faster sputum culture conversion rate as compared to the Mfx(h)+OBR.
World Health Organization. Global Tuberculosis Report 2017. Available from: https://apps.who.int/iris/handle/10665/259366
World Health Organization. Global Tuberculosis Report 2021. Available from: https://www.who.int/publications/digital/global-tuberculosis-report-2021
Food and Drug Administration. Sirturo (bedaquiline) product insert. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf
Diacon A, Pym A, Grobusch M. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. New Engl J Med 2014;371:723–32.
DOI: https://doi.org/10.1056/NEJMoa1313865
World Health Organization. WHO consolidated guidelines on tuberculosis: Module 4: Treatment - Drug-resistant tuberculosis treatment. Available from: https://www.who.int/publications/i/item/9789240007048
Gumbo T, Louie A, Deziel MR, et al. Selection of a moxifloxacin dose that suppresses drug resistance in Mycobacterium tuberculosis, by use of an in vitro pharmacodynamic infection model and mathematical modeling. J Infect Dis 2004;190:1642–51.
DOI: https://doi.org/10.1086/424849
Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science 2005;307:223–7.
DOI: https://doi.org/10.1126/science.1106753
Borisov SE, Dheda K, Enwerem M, et al. Effectiveness and safety of bedaquiline containing regimes in the treatment of MDR- and XDR-TB: a multicentre study. Eur Respir J 2017;49:1700387.
DOI: https://doi.org/10.1183/13993003.00387-2017
Sarin R, Singla N, Vohra V, et al. Initial experience of bedaquiline implementation under the National TB Programme at NITRD, Delhi, India. Indian J Tuberc 2019;66:209-213.
DOI: https://doi.org/10.1016/j.ijtb.2019.02.009
Falagas ME, Rafailidis PI, Rosmarakis ES. Arrhythmias associated with fluoroquinolone therapy. Int J Antimicrob Agents 2007;29:374-9.
DOI: https://doi.org/10.1016/j.ijantimicag.2006.11.011
Yan LK, Zhang J, Ng MJ, Dang Q. Statistical characteristics of moxifloxacin-induced QTc effect. J Biopharm Stat 2010;20:497-507.
DOI: https://doi.org/10.1080/10543400903581945
Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med 2015;191:943–53.
DOI: https://doi.org/10.1164/rccm.201410-1801OC
Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012;366:2151-60.
DOI: https://doi.org/10.1056/NEJMoa1112433
Pontali E, Sotgiu G, Tiberi S, et al. Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence. Eur Respir J 2017;50:1701462.
DOI: https://doi.org/10.1183/13993003.01462-2017
Borisov S, Danila E, Maryandyshev A, et al. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report. Eur Respir J 2019;54:1901522.
DOI: https://doi.org/10.1183/13993003.01522-2019
Udwadia ZF, Ganatra S, Mullerpattan JB. Compassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India. Eur Respir J 2017;49:1601699.
DOI: https://doi.org/10.1183/13993003.01699-2016
Murashov MD, LaLone V, Rzeczycki PM, et al. The physicochemical basis of clofazimine-induced skin pigmentation. J Invest Dermatol 2018;138:697-703.
DOI: https://doi.org/10.1016/j.jid.2017.09.031
Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications, Int J Tuberc Lung Dis 1999;3:S231-79.
How to Cite
Desai, Govind, Gopal Purohit, Hemant Borana, Kunal Deokar, and Suresh Yogi. 2022. “Comparison of Efficacy of Bedaquiline and Moxifloxacin in Drug Resistant Pulmonary Tuberculosis. A Prospective Observational Study”. Monaldi Archives for Chest Disease 93 (1). https://doi.org/10.4081/monaldi.2022.2231.
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