Effectivity Therapy and Adverse Drug Reaction of Short-Regimens for Multidrug-Resistant Tuberculosis: a Scoping Review

  • Yunilistianingsih - Yunilistianingsih Program Studi Farmasi Program Magister, Fakultas Matematika dan Ilmu Pengetahuan Alam Universitas Islam Indonesia
  • Vitarani Dwi Ananda Ningrum Universitas Islam Indonesia

Abstract

The increase in Multidrug-resistant Tuberculosis (MDR-TB) is a global problem that must be addressed immediately. Duration of treatment, adverse events (ADRs) and medical costs can affect adherence and treatment success. This literature review was conducted to review the effectiveness and ADRs of short-term regimens (STR) in MDR-TB patients.

We used PubMed, ScienceDirect, and Google Scholar to retrieve the relevant original articles on MDR-TB treatment with STR in English-language, published from 2018 through 2022. The keywords used in the search for articles are "multi-drug-resistant tuberculosis", "short regimens" or "short-term regimens", effectiveness, safety" or "adverse events".

Of the 13 articles obtained, the all-oral regimen proved promising for implementation in the treatment of MDR-TB. Based on sputum conversion, cure rate, and percentage of patients who completed treatment, the regimen with the highest therapeutic effectiveness was 6KmMfxPtoCfzHEZ/5MfxCfzEZ at 92.9%, and the lowest was 4KmMfxPtoCfzHEZ/5MfxCfzEZ at 63.6%. The all-oral regimen with or without Bedaquilin showed a better average therapeutic effectiveness (87.04%) than regimen containing injection (78.43%). Meanwhile, the serious ADRs that emerged were death, cardiotoxicity, hepatotoxicity and ototoxicity. Apart from monitoring the safety, research needs to be expanded to a larger population and wider sites, to find more effective regimens because Mycobacterium tuberculosis are easily resistant.

Keywords: Tubercolosis MDR, Regimen jangka pendek, efektivitas terapi, KTD

References

[1] WHO, “Fact sheets.” Accessed: Nov. 18, 2022. [Online]. Available: https://www.who.int/indonesia/news/campaign/tb-day-2022/fact-sheets
[2] CDCTB, “MDRTB Factsheet,” Centers for Disease Control and Prevention. Accessed: Jan. 15, 2023. [Online]. Available: https://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm
[3] WHO, “Global tuberculosis report 2022.” Accessed: Jan. 15, 2023. [Online]. Available: https://www.who.int/publications-detail-redirect/9789240061729
[4] Kemenkes, “Dashboard TB,” TBC Indonesia. Accessed: Nov. 16, 2022. [Online]. Available: https://tbindonesia.or.id/pustaka-tbc/dashboard-tb/
[5] Kemenkes, “Petunjuk Teknis Penatalaksanaan Tuberkulosis Resistan Obat di Indonesia,” TBC Indonesia. Accessed: Nov. 09, 2022. [Online]. Available: https://tbindonesia.or.id/pustaka/pedoman/tb-ro/petunjuk-teknis-penatalaksanaan-tuberkulosis-resistan-obat-di-indonesia/
[6] D. Subchan and F. Kunoli, “Gambaran Kejadian Efek Samping Obat (ESO) Dengan Kejadian Putus Obat Pada Pasien Tb Paru Di RSUD Luwuk,” Poltekita J. Ilmu Kesehat., vol. 16, pp. 345–351, Nov. 2022, doi: 10.33860/jik.v16i3.1533.
[7] U. Ateba-Ngoa et al., “Implementation of multidrug-resistant tuberculosis (MDR-TB) treatment in Gabon: lessons learnt from the field,” Infection, vol. 47, no. 5, pp. 811–816, Oct. 2019, doi: 10.1007/s15010-019-01314-5.
[8] T. Avaliani et al., “Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019-2020,” Monaldi Arch. Chest Dis. Arch. Monaldi Mal. Torace, vol. 91, no. 1, Jan. 2021, doi: 10.4081/monaldi.2021.1679.
[9] L. Fu et al., “Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis,” Int. J. Infect. Dis. IJID Off. Publ. Int. Soc. Infect. Dis., vol. 111, pp. 138–147, Oct. 2021, doi: 10.1016/j.ijid.2021.08.055.
[10] V. S. Lofranco et al., “Effectiveness and Safety of 9-Month Treatment Regimen for Multidrug-Resistant Tuberculosis in the Philippines,” J. Tuberc. Res., vol. 10, no. 2, pp. 75–86, 2022.
[11] I. Tack et al., “Safety and Effectiveness of an All-Oral, Bedaquiline-Based, Shorter Treatment Regimen for Rifampicin-Resistant Tuberculosis in High Human Immunodeficiency Virus (HIV) Burden Rural South Africa: A Retrospective Cohort Analysis,” Clin. Infect. Dis. Off. Publ. Infect. Dis. Soc. Am., vol. 73, no. 9, pp. e3563–e3571, Nov. 2021, doi: 10.1093/cid/ciaa1894.
[12] A. Trébucq et al., “Treatment outcome with a short multidrug-resistant tuberculosis regimen in nine African countries,” Int. J. Tuberc. Lung Dis., vol. 22, no. 1, pp. 17–25, Jan. 2018, doi: 10.5588/ijtld.17.0498.
[13] C. Padmapriyadarsini et al., “Bedaquiline, Delamanid, Linezolid and Clofazimine for Treatment of Pre-extensively Drug-Resistant Tuberculosis,” Clin. Infect. Dis. Off. Publ. Infect. Dis. Soc. Am., p. ciac528, Jun. 2022, doi: 10.1093/cid/ciac528.
[14] T. M. P. Nguyen et al., “Effectiveness and safety of bedaquiline-based, modified all-oral 9-11-month treatment regimen for rifampicin-resistant tuberculosis in Vietnam,” Int. J. Infect. Dis. IJID Off. Publ. Int. Soc. Infect. Dis., vol. 126, pp. 148–154, Jan. 2023, doi: 10.1016/j.ijid.2022.11.007.
[15] F. Ciza et al., “Course of adverse events during short treatment regimen in patients with rifampicin-resistant tuberculosis in Burundi,” J. Clin. Med., vol. 9, no. 6, p. 1873, 2020.
[16] P. du Cros et al., “Outcomes with a shorter multidrug-resistant tuberculosis regimen from Karakalpakstan, Uzbekistan,” ERJ Open Res., vol. 7, no. 1, 2021.
[17] A. J. Nunn et al., “A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis,” N. Engl. J. Med., vol. 380, no. 13, pp. 1201–1213, Mar. 2019, doi: 10.1056/NEJMoa1811867.
[18] S. H. Harouna et al., “Short-course treatment outcomes and adverse events in adults and children-adolescents with MDR-TB in Niger,” Int. J. Tuberc. Lung Dis., vol. 23, no. 5, pp. 625–630, May 2019, doi: 10.5588/ijtld.17.0871.
[19] A. Piubello et al., “Management of multidrug-resistant tuberculosis with shorter treatment regimen in Niger: Nationwide programmatic achievements,” Respir. Med., vol. 161, p. 105844, Jan. 2020, doi: 10.1016/j.rmed.2019.105844.
[20] A. Van Deun et al., “World Health Organization 2018 treatment guidelines for rifampicin-resistant tuberculosis: uncertainty, potential risks and the way forward,” Int. J. Antimicrob. Agents, vol. 55, no. 1, p. 105822, Jan. 2020, doi: 10.1016/j.ijantimicag.2019.10.003.
[21] A. Van Deun et al., “Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis,” Am. J. Respir. Crit. Care Med., vol. 182, no. 5, pp. 684–692, Sep. 2010, doi: 10.1164/rccm.201001-0077OC.
[22] PubChem, “Gatifloxacin.” Accessed: Jan. 13, 2023. [Online]. Available: https://pubchem.ncbi.nlm.nih.gov/compound/5379
[23] A. Van Deun et al., “Gatifloxacin is superior to levofloxacin and moxifloxacin in shorter treatment regimens for multidrug-resistant TB,” Int. J. Tuberc. Lung Dis. Off. J. Int. Union Tuberc. Lung Dis., vol. 23, no. 9, pp. 965–971, Sep. 2019, doi: 10.5588/ijtld.19.0053.
[24] M. J. Kruger, M. Vanessa, and R. Vallie, “Clinical Guidelines & Standard Operating Procedure for the Implementation of the Short & Long DR-TB regimens for Adults, Adolescents and Children,” 2018.
[25] A. Berhan, Y. Berhan, and D. Yizengaw, “A meta-analysis of drug resistant tuberculosis in Sub-Saharan Africa: how strongly associated with previous treatment and HIV co-infection?,” Ethiop. J. Health Sci., vol. 23, no. 3, pp. 271–282, Nov. 2013, doi: 10.4314/ejhs.v23i3.10.
[26] I. G. Darmayani and P. Ascobat, “Profil Keamanan Obat Bedaquiline Terhadap Jantung | indonesiajournalchest”, Accessed: Jan. 13, 2023. [Online]. Available: https://indonesiajournalchest.com/index.php/IJC/issue/view/148
[27] L. V. I. Dewi, “the Faktor-Faktor yang Berpengaruh terhadap Adverse Drug Reaction pada penggunaan Obat Anti Tuberkulosis,” J. Farm. Indones., vol. 17, no. 2, Art. no. 2, Nov. 2020, doi: 10.31001/jfi.v17i2.903.
Published
2023-11-30