BEDAQUILINE AS A MANAGEMENT OF MULTIDRUG-RESISTANT TUBERCULOSIS (MDR-TB): A SYSTEMATIC REVIEW AND META ANALYSIS
DOI:
https://doi.org/10.53366/jimki.v10i2.554Keywords:
MDR-TB, Bedaquiline, Culture conversion, Relapse, DeathAbstract
ABSTRAK
Background: MDR TB is TB that is resistant to at least 2 types of first-line anti-tuberculosis drugs, namely isoniazid and rifampicin. Treatment requires a longer duration and is accompanied by worse side effects, high costs, and logistical constraints. Bedaquiline (BDQ) is a diarylquinoline compound which exhibits earlier culture conversion and minimal side effects, compared to other MDR TB drugs, making it possible to eliminate adherence problems in MDR TB patients. This meta-analysis aims to assess the effect of BDQ administration on MDR TB patients and other related aspects.
Methods: Systematic studies were carried out following the PRISMA rules using online databases, namely PubMed, ScienceDirect, and Cochrane. Studies assessing the effect of BDQ in MDR TB patients and compliance with inclusion criteria were included in this systematic review. The risk of bias of each inclusion study was assessed using the CONSORT, TREND and STROBE criteria. Meta-analysis with the fixed-effects method was then performed to obtain the combined Mean Difference (MD) of all inclusion studies along with the 95% Confidence Interval (CI).
Discussion: 17 studies involving 2454 patients were included in this systematic review. It was found that administration of BDQ in MDR TB patients increased the likelihood of conversion culture becoming negative with an RR of 1.39 (95% CI = 1.26-1.53 ; I2 = 29% ; p <0.00001), and decreased the likelihood of relapse with RR of 0.40 (95% CI = 0.21-0.75 ; I2 = 0% ; p = 0.004) significantly compared to the control group. As well as being able to reduce the death rate from MDR TB.
Conclusions: BDQ administration showed a positive effect on the possibility of earlier culture conversion, the possibility of relapse, and the mortality rate
References
1. M. Pai, M. A. Behr, D. Dowdy, K. Dheda, M. Divangahi , C. C. Boehme, A. Ginsberg, S. Swaminathan, M. Spigelman, H. Getahun, D. Menzies dan M. Raviglione, “Tuberculosis,” Nature Reviews Disease Primers, vol. 2, no. 1, p. 16076, 2016.
2. World Health Organization, “Global Tuberculosis Report 2021,” Word Health Organization, Geneva, 2021.
3. World Health Organization, “TB Country, Regional and Global Profiles,” 2021. [Online]. Available: www.worldhealthorg.shinyapps.io/tb_profiles. [Diakses 1 February 2022].
4. A. O. Abraham, A. U. Nasiru, A. K. Abdulazeez, O. O. Seun dan D. W. Ogonna, “Mechanism of Drug Resistance in Mycobacterium Tuberculosis,” American Journal of Biomedical Science & Research, vol. 7, no. 5, pp. 378-383, 2020.
5. N. Dookie, S. Rambaran, N. Padayatchi, S. Mahomed dan K. Naidoo, “Evolution of drug resistance in Mycobacterium tuberculosis: a review on the molecular determinants of resistance and implications for personalized care,” Journal of Antimicrobial Chemotherapy, vol. 73, no. 5, pp. 1138-1151, 2018.
6. K. Dheda, T. Gumbo, N. R. Gandhi, M. Murray, G. Theron, Z. Udwadia, G. B. Migliori dan R. Warren, “Global control of tuberculosis: from extensively drug-resistant to untreatable tuberculosis,” The Lancet Respiratory Medicine, vol. 2, no. 4, pp. 321-338, 2014.
.7 A. P. Khairani, P. Santoso dan E. P. Setiawati, “Role of Risk Factors in the Incidence of Multidrug-Resistant Tuberculosis,” International Journal of Integrated Health Science, vol. 5, no. 2, pp. 57-63, 2017.
8. K. J. Seung, S. Keshavjee dan M. L. Rich, “Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis,” Cold Spring Harbor Perspectives in Medicine, vol. 5, no. 9, p. a017863, 2015.
9. C. M. Rumende, “Risk Factors for Multidrug-resistant Tuberculosis,” Acta Medica Indonesiana, vol. 50, no. 1, pp. 1-2, 2018.
10. J. Heyckendorf, C. Lange dan J. Martensen, “Multidrug-Resistant Tuberculosis,” Academic Press, vol. 19, pp. 239-253, 2014.
11. J. v. d. Boogaard, G. S. Kibiki, E. R. Kisanga, M. J. Boeree dan R. E. Aarnoutse, “New Drugs against Tuberculosis: Problems, Progress, and Evaluation of Agents in Clinical Development,” American Society for Microbiology Antimicrobial Agents and Chemoteraphy, vol. 53, no. 3, pp. 849-862, 2009.
12. Kemenkes Republik Indonesia, “Manajemen Terpadu Pengendalian TB Resistan Obat (MTPTRO),” TBC Indonesia, 2021. [Online]. Available: https://tbindonesia.or.id/pustaka-tbc/informasi/teknis/tb-mdr/. [Diakses Januari 2022].
13. World Health Organization WHO, “Tuberculosis: Multidrug-resistant tuberculosis (MDR-TB),” WHO, Januari 2018. [Online]. Available: https://www.who.int/news-room/questions-and-answers/item/tuberculosis-multidrug-resistant-tuberculosis-(mdr-tb). [Diakses Januari 2022].
14. Kementerian Kesehatan Republik Indonesia , “Rencana Aksi Nasional Pengendalian Tuberkulosis Indonesia 2011-2014,” Kementerian Kesehatan RI, Jakarta, 2011.
15. Centers for Disease Control and Prevention CDC, “Drug-Resistant TB,” U.S. Department of Health & Human Services, Januari 2017. [Online]. Available: https://www.cdc.gov/tb/topic/drtb/default.htm. [Diakses Januari 2022].
16. World Health Organization WHO, WHO consolidated guidelines on tuberculosis Module, Geneva: WHO, 2020.
17. J. G. &. C. J. H. Jang, “Diagnosis and treatment of multidrug-resistant tuberculosis,” Journal of Yeungnam Medical Science, vol. 37, no. 4, p. 277–285, 2020.
18. R. D. Riley, K. G. Moons , K. I. E. Snell, J. Ensor, L. Hooft, D. G. Altman, J. Hayden, G. S. Collins dan t. P. A. Debray , “A guide to systematic review and meta-analysis of prognostic factor studies,” BMJ, vol. 364, p. k4597, 2019.
19. J. P. T. Higgins, S. G. Thompson, J. J. Deeks dan D. G. Altman, “Measuring inconsistency in meta-analyses,” BMJ, vol. 327, p. 557, 2003.
20. S. V. Patel, K. B. Nimavat, A. B. Patel, K. Mehta, K. Shringarpure dan L. K. Shukia, “Sputum Smear and Culture Conversion in Multidrug Resistance Tuberculosis Patients in Seven Districts of Central Gujarat, India: A Longitudinal Study,” Indian Journal of Community Medicine, vol. 43, pp. 117-119, 2018.
21. T. Y. Akalu, K. F. Muchie dan K. A. Gelaye, “Time to sputum culture conversion and its determinants among Multi-drug resistant Tuberculosis patients at public hospitals of the Amhara Regional State: A multicenter retrospective follow up study,” PLoS ONE, vol. 13, no. 6, 2018.
22. A. H. Diacon, A. Pym, M. Grobusch dan R. Patientia, “The Diarylquinoline TMC207 for Multidrug-Resistant Tuberculosis,” The New England Journal of Medicine, vol. 360, no. 23, 2009.
23. A. H. Diacon, P. R. Donald, A. Pym, M. Grobusch, R. F. Patientia, R. Mahanyele, N. Bantubani, R. Narasimooloo, T. De Marez, R. van Heeswijk, N. Lounis, P. Meyvisch, K. Andries dan D. F. McNeeley, “Randomized Pilot Trial of Eight Weeks of Bedaquiline (TMC207) Treatment for Multidrug-Resistant Tuberculosis: Long-Term Outcome, Tolerability, and Effect on Emergence of Drug Resistance,” Antimicrobial Agents and Chemotherapy, vol. 56, no. 6, pp. 3271-3276, 2012.
24. A. H. Diacon, A. Pym, M. P. Grobusch, J. M. de los Rios, E. Gotuzzo, I. Vasilyeva, V. Leimane, K. Andries, N. Bakare, T. De Marez, M. Haxaire-Theeuwes, N. Lounis, P. Meyvisch, E. De Paepe, R. P. van Heeswijk dan B. Dannemann, “Multidrug-Resistant Tuberculosis and Culture Conversion with Bedaquiline,” New England Journal of Medicine, vol. 371, no. 8, pp. 723-732, 2014.
25. L. Guglielmetti, M. Jaspard, D. L. Du dan M. Lachatre, “Long-term outcome and safety of prolonged bedaruillien treatment for multidrug-resistant tuberculosis,” European Resiprology Journal, vol. 49, 2016.
26. F. Conradie, A. H. Diacon , N. Ngubane, P. Howell, D. Everitt dan A. M. Crook , “Treatment of Highly Drug-Resistant Pulmonary Tuberculosis,” The New England Journal of Medicine, vol. 382, no. 10, 2020.
27. J. Li, G. Yang , Q. Cai, Y. Wang, Y. Xu dan R. Zhang, “Safety, efficacy, and serum concentration monitoring of bedaquiline in Chinese patients with multidrug-resistant tuberculosis,” Internatiopnal Journal of Infectious Disease, vol. 110, pp. 179-186, 2021 .
28. L. Fu, T. Weng, F. Sun, P. Zhang , H. Li, Y. Li dan Q. Yang , “Insignificant difference in culture conversion between bedaquilline-conatining and bedaquiolline-free all-oral short regimens for multidrug-resistant tuberculosis,” International Journal of Infectious Disease, vol. 111, pp. 138-147, 2021.
29. E. H. Lee, S. H. Yong, A. Y. Leem, S. H. Lee, S. Y. Kim dan K. S. Chung, “Improved Fluoroquinolone-Resistant and Extensively Drug-resistant Tuberculosis treatment Outcomes,” Open Forum Infectious Diseae , 2019.
30. Australian Government Department of Health, “health.gov.au,” Commonwealth of Australia, 2006. [Online]. Available: https://www1.health.gov.au/internet/publications/publishing.nsf/Content/mental-pubs-p-mono-toc~mental-pubs-p-mono-rel~mental-pubs-p-mono-rel-def. [Diakses 2022].
31. J. P. S. E. O. A. C. M. M. J. M. C. J. A. &. B. T. R. W. G. Millet, “Tuberculosis recurrence after completion treatment in a European city: reinfection or relapse?,” PloS one, vol. 8, no. 6, 2013.
32. P. Meyvisch, C. Kambili, K. Andries, N. Lounis, M. Theeuwes, B. Dannemann, A. Vandebosch, W. V. d. Elst, G. Molenberghs dan A. Alonso, “Evaluation of six months sputum culture conversion as a surrogate endpoint in a multidrug resistant-tuberculosis trial,” PLoS ONE, vol. 13, no. 7, 2018.
33. A. H. Diacon, A. Pym, M. P. Grobusch, J. M. d. l. Rios, E. Gotuzzo, M. Vasilyeva, V. Leimane, K. Andries dan N. Bakare, “Multidrug-Resistant Tuberculosis and Culture Conversion with Bedaquiline,” The new england journal of medicine, 2014.
34. A. H. Diacon, P. R. Donald, A. Pym, M. Grobusch, R. F. Patientia, R. Mahanyele, N. Bantubani, R. Narasimooloo, T. D. Marez, R. v. Heeswijk, N. Lounis, P. Meyvisch, K. Andries dan D. F. McNeeleyd, “Randomized Pilot Trial of Eight Weeks of Bedaquiline (TMC207) Treatment for Multidrug-Resistant Tuberculosis: Long-Term Outcome, Tolerability, and Effect on Emergence of Drug Resistance,” Antimicrobial Agents and Chemotherapy, vol. 56, no. 6, 2012.
35. F. Conradie, A. H. Diacon, N. Nguban, P. Howell, D. Everitt, A. M. Crook, C. M. Mendel, E. Egizi, J. Moreira dan J. Timm, “Treatment of Highly Drug-Resistant Pulmonary Tuberculosis,” The New England Journal of Medicine, vol. 382, no. 10, 2020.
36. L. Guglielmetti, M. Jaspard, D. L. Dû, M. Lachâtre, D. Marigot-Outtandy, C. Bernard, N. Veziris, J. Robert, Y. Yazdanpanah, E. Caumes dan M. Fréchet-Jachym, “Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis,” European Respiratory Journal, vol. 49, 2017.
37. K. Chung-Delgado, S. Guillen-Bravo, A. Revilla-Montag dan A. Bernabe-Ortiz, “Mortality among MDR-TB Cases: Comparison with Drug-Susceptible Tuberculosis and Associated Factors,” PLOS ONE, vol. 10, no. 3, p. e0119332, 2015.
38. M.-G. Wang, S.-Q. Wu dan J.-Q. He, “Efficacy of bedaquiline in the treatment of drug-resistant tuberculosis: a systematic review and meta-analysis,” BMC Infectious Diseases, vol. 21, no. 1, p. 970, 2021.
39 J. Jones, V. Mudaly, J. Voget, T. Naledi, G. Maartens dan K. Cohen, “Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases,” BMC Infectious Diseases, vol. 19, no. 1, p. 544, 2019.
40. A. S. Pym, A. H. Diacon, S.-J. Tang, F. Conradie, M. Danilovits, C. Chuchottaworn, I. Vasilyeva, K. Andries, N. Bakare, T. De Marez, M. Haxaire-Theeuwes, N. Lounis, P. Meyvisch, B. Van Baelen, R. P. van Heeswijk dan B. Dannemann , “Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis,” European Respiratory Journal, vol. 47, no. 2, pp. 564-574, 2016.
41. H. Kang, K.-W. Jo, D. Jeon, J.-J. Yim dan T. S. Shim, “Interim treatment outcomes in multidrug-resistant tuberculosis using bedaquiline and/or delamanid in South Korea,” Respiratory Medicine, vol. 167, p. 105956, 2020.
42. S. Koirala, S. Borisov, E. Danila, A. Mariandyshev, B. Shrestha, N. Lukhele, M. Dalcolmo, S. Shakya, S. Miliauskas, L. Kuksa, S. Manga, A. Aleksa, J. Denholm, H. Khadka, A. Skrahina, S. Diktanas, M. Ferrarese, J. Bruchfeld, A. Koleva, A. Piubella, G. S. Koirala, Z. Udwadia, D. Palmero, M. Munoz-Torrico, R. GC, G. Gualano, V. Grecu, I. Motta, A. Papavasileiou, Y. Li, W. Hoefsloot, H. Kunst, J. Mazza-Stalder, M. Payen, O. Akkerman, E. Bernal, V. Manfrin, A. Mattelli, H. Mustafa Hamdan, M. Nieto Marcos, J. Cadiñanos Loidi, J. Cebrian Gallardo, R. Duarte, N. Escobar Salinas, R. Gomez Rosso, R. Laniado-Laborín, E. Martínez Robles, S. Quirós Fernandez, A. Rendon, I. Solovic, M. Tadolini, P. Viggiani, E. Belilovski, M. Boeree, Q. Cai, E. Davidavičienė, L. Forsman, J. De Los Rios, J. Drakšienė, A. Duga, S. Elamin, A. Filippov, A. Garcia, I. Gaudiesiute, B. Gavazova, R. Gayoso, V. Gruslys, J. Jonsson, E. Khimova, G. Madonsela, C. Magis-Escurra, V. Marchese, M. Matei, C. Moschos, B. Nakčerienė, L. Nicod, F. Palmieri, A. Pontarelli, A. Šmite, M. Souleymane, M. Vescovo, R. Zablockis, D. Zhurkin, J. Alffenaar, J. Caminero, L. Codecasa, J. García-García, S. Esposito, L. Saderi, A. Spanevello, D. Visca, S. Tiberi, E. Pontali, R. Centis, L. D'Ambrosio, M. van den Boom, G. Sotgiu dan G. Migliori, “Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort,” Pulmonology, vol. 27, no. 5, pp. 403-412, 2021.
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