Factors Associated with Unsuccessful Treatment of Bedaquiline and or Delamanid Based Regimens in Multidrug-Resistant Tuberculosis: A Review
Article Sidebar
Main Article Content
Page: 923-934
Abstract
Background: Multidrug-resistant tuberculosis (MDR-TB) is a serious health concern that is difficult to treat, requiring long and complex treatment with highly effective drugs. An all-oral regimen, bedaquiline and or delamanid have already shown low unsuccessful treatment in patients with MDR-TB. Method: We comprehensively reviewed factors associated with unsuccessful treatment (death, treatment failure, and loss to follow-up) related to all oral regimen containing bedaquiline and or delamanid in patients with MDR-TB. We conducted a scoping review under the PRISMA guideline for scoping review. Results: We included seven observational studies that met the inclusion criteria. Four studies reported the concomitant use of bedaquiline and delamanid. Unsuccessful treatment ranged from 7.8% to 36.6% in regimens containing bedaquiline, delamanid, or both at six months or after treatment completion. Low rates of treatment failure and loss to follow-up were reported in the included studies. Elderly, being underweight (BMI < 18.5 kg/m2), and hepatitis C coinfection among MDR-TB patients were associated with unsuccessful treatment in most studies. None studies reported pre-XDR and XDR-TB as risk factors for unsuccessful treatment. Conclusion: In MDR-TB patients receiving regimens containing bedaquiline and delamanid, age, BMI, and hepatitis C coinfection were associated with unsuccessful treatment.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
References
Auchynka, V., Kumar, A. M. V., Hurevich, H., Sereda, Y., Solodovnikova, V., Katovich, D., et al. 2021). Effectiveness and cardiovascular safety of delamanid-containing regimens in adults with multidrugresistant or extensively drug-resistant tuberculosis: A nationwide cohort study from Belarus, 2016-18. In Monaldi Archives for Chest Disease;91(1). https://doi.org/10.4081/MONALDI.2021.1647 DOI: https://doi.org/10.4081/monaldi.2021.1647
Behzadifar, M., Heydarvand, S., Behzadifar, M., & Bragazzi, N. L. (2019). Prevalence of Hepatitis C Virus in Tuberculosis Patients: A Systematic Review and Meta-Analysis. Ethiopian Journal of Health Sciences, 29(1), 945–956. https://doi.org/10.4314/ejhs.v29i1.17 DOI: https://doi.org/10.4314/ejhs.v29i1.17
Bonavida, V., Frame, M., Nguyen, K. H., Rajurkar, S., & Venketaraman, V. (2022). Mycobacterium tuberculosis: Implications of Ageing on Infection and Maintaining Protection in the Elderly. Vaccines, 10(11), 1892. https://doi.org/10.3390/vaccines10111892 DOI: https://doi.org/10.3390/vaccines10111892
Chen, X., Hashizume, H., Tomishige, T., Nakamura, I., Matsuba, M., Fujiwara, M., Kitamoto, R., Hanaki, E., Ohba, Y., & Matsumoto, M. (2017). Delamanid kills dormant mycobacteria in vitro and in a Guinea pig model of tuberculosis. Antimicrobial Agents and Chemotherapy, 61(6), 1–11. https://doi.org/10.1128/AAC.02402-16 DOI: https://doi.org/10.1128/AAC.02402-16
Gao, M., Gao, J., Xie, L., Wu, G., Chen, W., Chen, Y., et al. (2021). Early outcome and safety of bedaquiline-containing regimens for treatment of MDR- and XDR-TB in China: a multicentre study. Clinical Microbiology and Infection, 27(4), 597–602. https://doi.org/10.1016/j.cmi.2020.06.004 DOI: https://doi.org/10.1016/j.cmi.2020.06.004
Gour, A., Dogra, A., Sharma, S., Wazir, P., & Nandi, U. (2021). Effect of Disease State on the Pharmacokinetics of Bedaquiline in Renal-Impaired and Diabetic Rats. ACS Omega, 6(10), 6934–6941. https://doi.org/10.1021/acsomega.0c06165 DOI: https://doi.org/10.1021/acsomega.0c06165
Hewison, C., Khan, U., Bastard, M., Lachenal, N., Coutisson, S., Osso, E., et al. (2022). Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort. Clinical Infectious Diseases, 75(6), 1006–1013. https://doi.org/10.1093/cid/ciac019 DOI: https://doi.org/10.1093/cid/ciac019
Kamara, R. F., Saunders, M. J., Sahr, F., Losa-Garcia, J. E., Foray, L., Davies, G., & Wingfield, T. (2022). Social and health factors associated with adverse treatment outcomes among people with multidrug-resistant tuberculosis in Sierra Leone: a national, retrospective cohort study. The Lancet Global Health, 10(4), e543–e554. https://doi.org/10.1016/S2214-109X(22)00004-3 DOI: https://doi.org/10.1016/S2214-109X(22)00004-3
Kang, H., Jo, K. W., Jeon, D., Yim, J. J., & Shim, T. S. (2020). Interim treatment outcomes in multidrug-resistant tuberculosis using bedaquiline and/or delamanid in South Korea. Respiratory Medicine, 167. https://doi.org/10.1016/j.rmed.2020.105956 DOI: https://doi.org/10.1016/j.rmed.2020.105956
Katrak, S., Lowenthal, P., Shen, R., True, L., Henry, L., & Barry, P. (2021). Bedaquiline for multidrug-resistant tuberculosis and QTc prolongation in California. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases, 23. https://doi.org/10.1016/j.jctube.2021.100216 DOI: https://doi.org/10.1016/j.jctube.2021.100216
Kempker, R. R., Mikiashvili, L., Zhao, Y., Benkeser, D., Barbakadze, K., Bablishvili, N., Avaliani, Z., Peloquin, C. A., Blumberg, H. M., & Kipiani, M. (2020). Clinical Outcomes among Patients with Drug-resistant Tuberculosis Receiving Bedaquiline- or Delamanid-Containing Regimens. Clinical Infectious Diseases, 71(9), 2336–2344. https://doi.org/10.1093/cid/ciz1107 DOI: https://doi.org/10.1093/cid/ciz1107
Kornfeld, H., Sahukar, S. B., Procter-Gray, E., Kumar, N. P., West, K., Kane, K., et al. (2020). Impact of Diabetes and Low Body Mass Index on Tuberculosis Treatment Outcomes. Clinical Infectious Diseases, 71(9), E392–E398. https://doi.org/10.1093/cid/ciaa054 DOI: https://doi.org/10.1093/cid/ciaa054
Lee, E. H., Yong, S. H., Leem, A. Y., Lee, S. H., Kim, S. Y., Chung, K. S., et al. (2019). Improved Fluoroquinolone-Resistant and Extensively Drug-Resistant Tuberculosis Treatment Outcomes. Open Forum Infectious Diseases, 6(4), 1–7. https://doi.org/10.1093/ofid/ofz118 DOI: https://doi.org/10.1093/ofid/ofz118
Lee, H. H., Jo, K. W., Yim, J. J., Jeon, D., Kang, H., & Shim, T. S. (2020). Interim treatment outcomes in multidrug-resistant tuberculosis patients treated sequentially with bedaquiline and delamanid. International Journal of Infectious Diseases, 98, 478–485. https://doi.org/10.1016/j.ijid.2020.07.001 DOI: https://doi.org/10.1016/j.ijid.2020.07.001
Li, J., Yang, G., Cai, Q., Wang, Y., Xu, Y., Zhang, R., Lang, Y., & Cai, X. (2021). Safety, efficacy, and serum concentration monitoring of bedaquiline in Chinese patients with multidrug-resistant tuberculosis. International Journal of Infectious Diseases; 110: 179–186). https://doi.org/10.1016/j.ijid.2021.07.038 DOI: https://doi.org/10.1016/j.ijid.2021.07.038
Lyu, X. L., Lin, T. T., Gao, J. T., Jia, H. Y., Zhu, C. Z., Li, Z. H., et al. (2021). The Activities and Secretion of Cytokines Caused by Delamanid on Macrophages Infected by Multidrug-Resistant Mycobacterium tuberculosis Strains. Frontiers in Immunology, 12. https://doi.org/10.3389/fimmu.2021.796677 DOI: https://doi.org/10.3389/fimmu.2021.796677
Maretbayeva, S. M., Rakisheva, A. S., Adenov, M. M., Yeraliyeva, L. T., Algozhin, Y. Z., Stambekova., et al. (2021). Culture conversion at six months in patients receiving bedaquiline- and delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. International Journal of Infectious Diseases, xxxx, 3–7. https://doi.org/10.1016/j.ijid.2021.03.075 DOI: https://doi.org/10.1016/j.ijid.2021.03.075
Mbuagbaw, L., Guglielmetti, L., Hewison, C., Bakare, N., Bastard, M., Caumes, E., et al. (2019). Outcomes of bedaquiline treatment in patients with multidrug-resistant tuberculosis. Emerging Infectious Diseases, 25(5), 936–943. https://doi.org/10.3201/eid2505.181823 DOI: https://doi.org/10.3201/eid2505.181823
Ministry of Health of Indonesia Republic. Technical Guide. Management of drug resistant
tuberculosis in Indonesia. 2020.
Nasiri, M. J., Zangiabadian, M., Arabpour, E., Amini, S., Khalili, F., Centis, R., et al. (2022). Delamanid-containing regimens and multidrug-resistant tuberculosis: A systematic review and meta-analysis. International Journal of Infectious Diseases. https://doi.org/10.1016/j.ijid.2022.02.043 DOI: https://doi.org/10.1016/j.ijid.2022.02.043
Notariza KR, Pradipta J. (2022). Impact of underweight on the unsuccessful treatment outcome among adults with drug-resistant tuberculosis: A systematic review. J Respirol Indones, 42:161-9 DOI: https://doi.org/10.36497/jri.v41i4.228
Olaru, I. D., Beliz Meier, M., Schumacher, S. G., Prodanovic, N., Kitchen, P. J., Mirzayev, F., & Denkinger, C. M. (2023). Co-administration of treatment for drug-resistant TB and hepatitis C. The International Journal of Tuberculosis and Lung Disease, 27(1), 66–68. https://doi.org/10.5588/ijtld.22.0403 DOI: https://doi.org/10.5588/ijtld.22.0403
Olayanju, O., Esmail, A., Limberis, J., & Dheda, K. (2020). A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis. European Respiratory Journal, 55(1). https://doi.org/10.1183/13993003.01181-2019 DOI: https://doi.org/10.1183/13993003.01181-2019
Padayatchi, N., Bionghi, N., Osman, F., Naidu, N., Ndjeka, N., Master, I., et al. (2020). Treatment outcomes in patients with drug-resistant TB-HIV coinfection treated with bedaquiline and linezolid. International Journal of Tuberculosis and Lung Disease, 24(10), 1024–1031. https://doi.org/10.5588/IJTLD.20.0048 DOI: https://doi.org/10.5588/ijtld.20.0048
Park, S., Lee, K. M., Kim, I., & Mok, J. (2018). The use of bedaquiline to treat patients with multidrug-resistant tuberculosis and end-stage renal disease: A case report. International Journal of Infectious Diseases, 76, 88–90. https://doi.org/10.1016/j.ijid.2018.09.009 DOI: https://doi.org/10.1016/j.ijid.2018.09.009
Pontali, E., Sotgiu, G., Tiberi, S., Tadolini, M., Visca, D., D’Ambrosio, L., et al. (2018). Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: A systematic review. In European Respiratory Journal (Vol. 52, Issue 1). European Respiratory Society. https://doi.org/10.1183/13993003.00934-2018 DOI: https://doi.org/10.1183/13993003.00934-2018
Primadana, V., Yovi, I., & Estiningsih, D. S. (2022). Bedaquiline Correlation to QT Interval Prolongation in DR-TB Patients. Jurnal Respirasi, 8(3), 140–146. https://doi.org/10.20473/jr.v8-I.3.2022.140-146 DOI: https://doi.org/10.20473/jr.v8-I.3.2022.140-146
Qiao, M., Li, S., Yuan, J., Ren, W., Shang, Y., Wang, W., Liu, R., Zhang, F., et al. (2022). Delamanid suppresses CXCL10 expression via regulation of JAK/STAT1 signaling and correlates with reduced inflammation in tuberculosis patients. Frontiers in Immunology, 13. https://doi.org/10.3389/fimmu.2022.923492 DOI: https://doi.org/10.3389/fimmu.2022.923492
Seung, K. J., Franke, M. F., Hewison, C., Huerga, H., Khan, U., & Mitnick, C. D. (2020). High prevalence of hepatitis C infection among multidrug-resistant tuberculosis patients. Journal of Hepatology. 72(5):1028–1029.https://doi.org/10.1016/j.jhep.2019.10.018 DOI: https://doi.org/10.1016/j.jhep.2019.10.018
Seung, K. J., Khan, P., Franke, M. F., Ahmed, S., Aiylchiev, S., Alam, M., Putri, F. A., et al. (2020). Culture conversion at 6 months in patients receiving delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. Clinical Infectious Diseases, 71(2), 415–418. https://doi.org/10.1093/cid/ciz1084 DOI: https://doi.org/10.1093/cid/ciz1084
Soeroto, A. Y., Nurhayati, R. D., Purwiga, A., Lestari, B. W., Pratiwi, C., Santoso, P., et al. (2022a). Factors associated with treatment outcome of MDR/RR-TB patients treated with shorter injectable based regimen in West Java Indonesia. PLoS ONE, 17(1 January). https://doi.org/10.1371/journal.pone.0263304 DOI: https://doi.org/10.1371/journal.pone.0263304
Soeroto, A. Y., Pratiwi, C., Santoso, P., & Lestari, B. W. (2021). Factors affecting outcome of longer regimen multidrug-resistant tuberculosis treatment in West Java Indonesia: A retrospective cohort study. PLoS ONE, 16(2 February), 1–13. https://doi.org/10.1371/journal.pone.0246284 DOI: https://doi.org/10.1371/journal.pone.0246284
Svensson, E. M., Dosne, A. G., & Karlsson, M. O. (2016). Population Pharmacokinetics of Bedaquiline and Metabolite M2 in Patients with Drug-Resistant Tuberculosis: The Effect of Time-Varying Weight and Albumin. CPT: Pharmacometrics and Systems Pharmacology, 5(12), 682–691. https://doi.org/10.1002/psp4.12147 DOI: https://doi.org/10.1002/psp4.12147
Tanneau, L., Karlsson, M. O., Diacon, A. H., Shenje, J., de Los Rios, J., Wiesner, L., et al. (2022). Population Pharmacokinetics of Delamanid and its Main Metabolite DM-6705 in Drug-Resistant Tuberculosis Patients Receiving Delamanid Alone or Coadministered with Bedaquiline. Clinical Pharmacokinetics, 61(8), 1177–1185. https://doi.org/10.1007/s40262-022-01133-2 DOI: https://doi.org/10.1007/s40262-022-01133-2
Tricco, A. C., Lillie, E., Zarin, W., O’Brien, K. K., Colquhoun, H., Levac, D., et al. (2018). PRISMA extension for scoping reviews (PRISMA-ScR): Checklist and explanation. Annals of Internal Medicine. 169(7): 467–473. American College of Physicians. https://doi.org/10.7326/M18-0850 DOI: https://doi.org/10.7326/M18-0850
Vambe, D., Kay, A. W., Furin, J., Howard, A. A., Dlamini, T., Dlamini, N., et al. (2020). Bedaquiline and delamanid result in low rates of unfavourable outcomes among TB patients in Eswatini. International Journal of Tuberculosis and Lung Disease, 24(10), 1095–1102. https://doi.org/10.5588/IJTLD.20.0082 DOI: https://doi.org/10.5588/ijtld.20.0082
van Deun, A., Decroo, T., Piubello, A., de Jong, B. C., Lynen, L., & Rieder, H. L. (2018). Principles for constructing a tuberculosis treatment regimen: The role and definition of core and companion drugs. In International Journal of Tuberculosis and Lung Disease (Vol. 22, Issue 3, pp. 239–245). International Union against Tubercul. and Lung Dis. https://doi.org/10.5588/ijtld.17.0660 DOI: https://doi.org/10.5588/ijtld.17.0660
Wang, X., Mallikaarjun, S., & Gibiansky, E. (2021). Population pharmacokinetic analysis of delamanid in patients with pulmonary multidrug-resistant tuberculosis. Antimicrobial Agents and Chemotherapy, 65(1). https://doi.org/10.1128/AAC.01202-20 DOI: https://doi.org/10.1128/AAC.01202-20
World Health Organization (2020). Consolidated Guidelines on Tuberculosis Treatment. World Health Organization
World Health Organization. (2020). Global tuberculosis report 2020. World Health Organization.
Yang, T. W., Park, H. O., Jang, H. N., Yang, J. H., Kim, S. H., Moon, S. H., Byun, J. H., Lee, C. E., Kim, J. W., & Kang, D. H. (2017). Side effects associated with the treatment of multidrug-resistant tuberculosis at a tuberculosis referral hospital in South Korea. Medicine (United States), 96(28). https://doi.org/10.1097/MD.0000000000007482 DOI: https://doi.org/10.1097/MD.0000000000007482
Yu, M. C., Chiang, C. Y., Lee, J. J., Chien, S. T., Lin, C. J., Lee, S. W., Lin, C. bin, Yang, W. T., Wu, Y. H., & Huang, Y. W. (2018). Treatment outcomes of multidrug-resistant tuberculosis in Taiwan: Tackling loss to follow-up. Clinical Infectious Diseases, 67(2), 202–210. https://doi.org/10.1093/cid/ciy066. DOI: https://doi.org/10.1093/cid/ciy066
Yudhawati R, Prasanta N. (2020). The role of N-Acetyl Cysteine in pulmonary tuberculosis. Jurnal Respirasi, 6:27-34 DOI: https://doi.org/10.20473/jr.v6-I.1.2020.27-34
Yuengling KA, Padayatchi N, Wolf A, Mathema B, Brown T, Horsburgh CR, et al. (2018). Effect of antiretroviral therapy on treatment outcomes in a prospective study of extensively drug resistant tuberculosis (XDR-TB) HIV co-infection treatment in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 79:474-80 DOI: https://doi.org/10.1097/QAI.0000000000001833