Skip to content
2000
image of Bedaquiline Delivery Innovations: A Review on Advancing MDR-TB Treatment Strategies

Abstract

Multidrug-resistant tuberculosis (MDR-TB) poses a persistent challenge to global health, necessitating continuous efforts to enhance treatment efficacy. Bedaquiline, a cornerstone in MDR-TB management, presents biopharmaceutical challenges that impact its therapeutic potential. This review provides a comprehensive analysis of recent innovations in drug delivery strategies designed to optimize Bedaquiline's efficacy and improve MDR-TB treatment outcomes. Through a systematic examination of various delivery systems, including nanotechnology and formulation advancements, we explore their potential in addressing drug solubility and bioavailability challenges. Emphasizing the integration of Quality by Design (QbD) principles, this review aims to present a cohesive overview of evolving Bedaquiline delivery innovations, providing valuable insights for researchers and healthcare practitioners working towards advancing MDR-TB treatment strategies.

Loading

Article metrics loading...

/content/journals/raaidd/10.2174/0127724344318310241018113206
2024-10-25
2024-11-26
Loading full text...

Full text loading...

References

  1. Migliori G.B. Tiberi S. WHO drug-resistant TB guidelines 2022: What is new? Int. J. Tuberc. Lung Dis. 2022 26 7 590 591 10.5588/ijtld.22.0263 35768917
    [Google Scholar]
  2. Groenweghe E. Swensson L. Winans K.D. Griffin P. Haddad M.B. Brostrom R.J. Tuckey D. Lam C.K. Armitige L.Y. Seaworth B.J. Corriveau E.A. Outbreak of multidrug-resistant tuberculosis — Kansas. MMWR Morb. Mortal. Wkly. Rep. 2023 72 35 957 960 10.15585/mmwr.mm7235a4 37651293
    [Google Scholar]
  3. Xi Y. Zhang W. Qiao R.J. Tang J. Risk factors for multidrug-resistant tuberculosis: A worldwide systematic review and meta-analysis. PLoS One 2022 17 6 e0270003 10.1371/journal.pone.0270003 35709161
    [Google Scholar]
  4. Akalu T.Y. Clements A.C.A. Wolde H.F. Alene K.A. Economic burden of multidrug-resistant tuberculosis on patients and households: A global systematic review and meta-analysis. Sci. Rep. 2023 13 1 22361 10.1038/s41598‑023‑47094‑9 38102144
    [Google Scholar]
  5. Song Z. Liu C. He W. Pei S. Liu D. Cao X. Wang Y. He P. Zhao B. Ou X. Xia H. Wang S. Zhao Y. Insight into the drug-resistant characteristics and genetic diversity of multidrug-resistant Mycobacterium tuberculosis in China. Microbiol. Spectr. 2023 11 5 e01324-23 10.1128/spectrum.01324‑23 37732780
    [Google Scholar]
  6. Molla K.A. Reta M.A. Ayene Y.Y. Prevalence of multidrug-resistant tuberculosis in East Africa: A systematic review and meta-analysis. PLoS One 2022 17 6 e0270272 10.1371/journal.pone.0270272 35771884
    [Google Scholar]
  7. Mohamed M.A. Ali O.A. Osman A.M. Abatcha M.G. Ahmed A.A. Ali A.M. Dirie A.A. de Oliveira C.J.B. Osman A.Y. Wang S.H. Vieira R.F.C. Assessment of drug-susceptible and multidrug-resistant tuberculosis (MDR-TB) in the Central Region of Somalia: A 3-year retrospective study. PLOS Glob. Public Health 2023 3 9 e0002319 10.1371/journal.pgph.0002319 37676848
    [Google Scholar]
  8. Pai H. Ndjeka N. Mbuagbaw L. Kaniga K. Birmingham E. Mao G. Alquier L. Davis K. Bodard A. Williams A. Van Tongel M. Thoret-Bauchet F. Omar S.V. Bakare N. Bedaquiline safety, efficacy, utilization and emergence of resistance following treatment of multidrug-resistant tuberculosis patients in South Africa: A retrospective cohort analysis. BMC Infect. Dis. 2022 22 1 870 10.1186/s12879‑022‑07861‑x 36414938
    [Google Scholar]
  9. Jahan R.N. Khan Z. Akhtar M.S. Ansari M.D. Solanki P. Ahmad F.J. Aqil M. Sultana Y. Development of Bedaquiline-Loaded SNEDDS Using quality by design (QbD) approach to improve biopharmaceutical attributes for the management of multidrug-resistant Tuberculosis (MDR-TB). Antibiotics 2023 12 10 1510 10.3390/antibiotics12101510 37887211
    [Google Scholar]
  10. Diacon A.H. Dawson R. von Groote-Bidlingmaier F. Symons G. Venter A. Donald P.R. van Niekerk C. Everitt D. Winter H. Becker P. Mendel C.M. Spigelman M.K. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet 2012 380 9846 986 993 10.1016/S0140‑6736(12)61080‑0 22828481
    [Google Scholar]
  11. Diacon A.H. Pym A. Grobusch M.P. de los Rios J.M. Gotuzzo E. Vasilyeva I. Leimane V. Andries K. Bakare N. De Marez T. Haxaire-Theeuwes M. Lounis N. Meyvisch P. De Paepe E. van Heeswijk R.P.G. Dannemann B. TMC207-C208 Study Group Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N. Engl. J. Med. 2014 371 8 723 732 10.1056/NEJMoa1313865 25140958
    [Google Scholar]
  12. Ndjeka N Conradie F Schnippel K Hughes J Bantubani N Ferreira H Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: An interim cohort analysis. int j tuberc lung dis. 2015 19 979 985
    [Google Scholar]
  13. Olayanju O. Limberis J. Esmail A. Oelofse S. Gina P. Pietersen E. Fadul M. Warren R. Dheda K. Long-term bedaquiline-related treatment outcomes in patients with extensively drug-resistant tuberculosis from South Africa. Eur. Respir. J. 2018 51 5 1800544 10.1183/13993003.00544‑2018 29700106
    [Google Scholar]
  14. Esmail A. Oelofse S. Lombard C. Perumal R. Mbuthini L. Goolam Mahomed A. Variava E. Black J. Oluboyo P. Gwentshu N. Ngam E. Ackerman T. Marais L. Mottay L. Meier S. Pooran A. Tomasicchio M. Te Riele J. Derendinger B. Ndjeka N. Maartens G. Warren R. Martinson N. Dheda K. An all-oral 6-month regimen for multidrug-resistant tuberculosis: A multicenter, randomized controlled clinical trial (the next study). Am. J. Respir. Crit. Care Med. 2022 205 10 1214 1227 10.1164/rccm.202107‑1779OC 35175905
    [Google Scholar]
  15. Tweed C.D. Dawson R. Burger D.A. Conradie A. Crook A.M. Mendel C.M. Conradie F. Diacon A.H. Ntinginya N.E. Everitt D.E. Haraka F. Li M. van Niekerk C.H. Okwera A. Rassool M.S. Reither K. Sebe M.A. Staples S. Variava E. Spigelman M. Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: A multicentre, open-label, partially randomised, phase 2b trial. Lancet Respir. Med. 2019 7 12 1048 1058 10.1016/S2213‑2600(19)30366‑2 31732485
    [Google Scholar]
  16. Taune M Ustero P Hiashiri S Huang K Aia P Morris L Successful implementation of bedaquiline for multidrug-resistant TB treatment in remote Papua New Guinea public health action. 2019 9 S73 79
    [Google Scholar]
  17. Kempker R.R. Mikiashvili L. Zhao Y. Benkeser D. Barbakadze K. Bablishvili N. Avaliani Z. Peloquin C.A. Blumberg H.M. Kipiani M. Clinical outcomes among patients with drug-resistant tuberculosis receiving bedaquiline or delamanid containing regimens. Clin. Infect. Dis. 2019 ciz1107 10.1093/cid/ciz1107 31712809
    [Google Scholar]
  18. Padayatchi N Bionghi N Osman F Naidu N Ndjeka N Master I Treatment outcomes in patients with drug-resistant TB-HIV co-infection treated with bedaquiline and linezolid. int j tuberc lung dis. 2020 24 1024 1031
    [Google Scholar]
  19. Schnippel K. Ndjeka N. Maartens G. Meintjes G. Master I. Ismail N. Hughes J. Ferreira H. Padanilam X. Romero R. te Riele J. Conradie F. Effect of bedaquiline on mortality in South African patients with drug-resistant tuberculosis: A retrospective cohort study. Lancet Respir. Med. 2018 6 9 699 706 10.1016/S2213‑2600(18)30235‑2 30001994
    [Google Scholar]
  20. Wu S.H. Chan H.H. Hsiao H.C. Jou R. Primary bedaquiline resistance among cases of drug-resistant tuberculosis in Taiwan. Front. Microbiol. 2021 12 754249 10.3389/fmicb.2021.754249 34745058
    [Google Scholar]
  21. Xia H. Zheng Y. Zhao B. Van Den Hof S. Cobelens F. Zhao Y. Assessment of a 96-well plate assay of quantitative drug susceptibility testing for Mycobacterium Tuberculosis complex in China PLoS ONE 2017 12 e0169413
    [Google Scholar]
  22. Kaniga K. Hasan R. Jou R. Vasiliauskienė E. Chuchottaworn C. Ismail N. Metchock B. Miliauskas S. Viet Nhung N. Rodrigues C. Shin S. Simsek H. Smithtikarn S. Ngoc A.L.T. Boonyasopun J. Kazi M. Kim S. Kamolwat P. Musteikiene G. Sacopon C.A. Tahseen S. Vasiliauskaitė L. Wu M.H. Vally Omar S. Bedaquiline drug resistance emergence assessment in multidrug-resistant tuberculosis (MDR-TB): a 5-year prospective in vitro surveillance study of bedaquiline and other second-line drug susceptibility testing in MDR-TB isolates. J. Clin. Microbiol. 2022 60 1 e02919-20 10.1128/JCM.02919‑20 34705538
    [Google Scholar]
  23. Pardhi V.P. Pathak A. Jain K. Solid dispersions of bedaquiline fumarate to improve its pharmaceutical attributes: A comparative study between PEG and PVP. J. Drug Deliv. Sci. Technol. 2024 94 105461 10.1016/j.jddst.2024.105461
    [Google Scholar]
  24. Pardhi V.P. Suthar T. Sharma A. Jain K. Bedaquiline fumarate microemulsion: Formulation optimization, rheological characterization and in vitro studies. Nanomedicine (Lond.) 2022 17 21 1529 1546 10.2217/nnm‑2022‑0132 36416115
    [Google Scholar]
  25. Verma N. Arora V. Awasthi R. Chan Y. Jha N.K. Thapa K. Jawaid T. Kamal M. Gupta G. Liu G. Paudel K.R. Hansbro P.M. George Oliver B.G. Singh S.K. Chellappan D.K. Dureja H. Dua K. Recent developments, challenges and future prospects in advanced drug delivery systems in the management of tuberculosis. J. Drug Deliv. Sci. Technol. 2022 75 103690 10.1016/j.jddst.2022.103690
    [Google Scholar]
  26. Shang Y. Chen S. Shi W. Nie W. Jing W. Huo F. Xue Y. Dong L. Jiang G. Huang H. Chu N. Bedaquiline resistance pattern in clofazimine-resistant clinical isolates of tuberculosis patients. J. Glob. Antimicrob. Resist. 2023 33 294 300 10.1016/j.jgar.2023.04.003 37142094
    [Google Scholar]
  27. Dousa K.M. Kurz S.G. Bark C.M. Bonomo R.A. Furin J.J. Drug-resistant tuberculosis. Infect. Dis. Clin. North Am. 2020 34 4 863 886 10.1016/j.idc.2020.06.001 33011048
    [Google Scholar]
  28. Desai G. Purohit G. Borana H. Deokar K. Yogi S. Comparison of efficacy of bedaquiline and moxifloxacin in drug resistant pulmonary tuberculosis. A prospective observational study. Monaldi Arch. Chest Dis. 2022 93 1 93 10.4081/monaldi.2022.2231 35535455
    [Google Scholar]
  29. Hoque M. Hossain M.S. Akram T. Das S.R. Advancing healthcare: Exploring recent innovations in drug delivery systems. Multidiscip. Res. J. 2023 4 5 50 55 10.54660/.IJMRGE.2023.4.5.50‑55
    [Google Scholar]
  30. Wal P. Wal A. Saxena B. Mishra S. Elossaily G.M. Arora R. Singh C. Sachdeva M. Anwer M.K. Gulati M. Behl T. Insights into the innovative approaches in fiber technology for drug delivery and pharmaceuticals. J. Drug Deliv. Sci. Technol. 2023 87 104877 10.1016/j.jddst.2023.104877
    [Google Scholar]
  31. Yang Y. Lockwood A. Topical ocular drug delivery systems: Innovations for an unmet need. Exp. Eye Res. 2022 218 109006 10.1016/j.exer.2022.109006 35248559
    [Google Scholar]
  32. De Matteis L. Jary D. Lucía A. García-Embid S. Serrano-Sevilla I. Pérez D. New active formulations against M. tuberculosis: Bedaquiline encapsulation in lipid nanoparticles and chitosan nanocapsules. Chem. Eng. J. 2018 340 181 191 10.1016/j.cej.2017.12.110
    [Google Scholar]
  33. Azger Dustachkeer V.N. Nirmal C.R. Rajadas S.E. Saadhali S.A. Kannayan S. Padmanaban V.P. Nanotheranostic management of drug-resistant tuberculosis. A Mechanistic Approach to Medicines for Tuberculosis Nanotherapy Academic Press 2021 149 173 10.1016/B978‑0‑12‑819985‑5.00004‑8
    [Google Scholar]
  34. Pardhi V.P. Jain K. Impact of binary/ternary solid dispersion utilizing poloxamer 188 and TPGS to improve pharmaceutical attributes of bedaquiline fumarate. J. Drug Deliv. Sci. Technol. 2021 62 102349 10.1016/j.jddst.2021.102349
    [Google Scholar]
  35. Goel D. Bedaquiline: A novel drug to combat multiple drug-resistant tuberculosis. J. Pharmacol. Pharmacother. 2014 5 1 76 78 10.4103/0976‑500X.124435 24554919
    [Google Scholar]
  36. Dahanayake M.H. Jayasundera A.C.A. Nano-based drug delivery optimization for tuberculosis treatment: A review. J. Microbiol. Methods 2021 181 106127 10.1016/j.mimet.2020.106127 33359155
    [Google Scholar]
  37. Suri S.S. Fenniri H. Singh B. Nanotechnology-based drug delivery systems. J. Occup. Med. Toxicol. 2007 2 1 16 10.1186/1745‑6673‑2‑16 18053152
    [Google Scholar]
  38. Gold K. Slay B. Knackstedt M. Gaharwar A.K. Antimicrobial activity of metal and metal‐oxide based nanoparticles. Adv. Ther. (Weinh.) 2018 1 3 1700033 10.1002/adtp.201700033
    [Google Scholar]
  39. Singh M. Mallick A.K. Banerjee M. Kumar R. Loss of outer membrane integrity in Gram-negative bacteria by silver nanoparticles loaded with Camellia sinensis leaf phytochemicals: Plausible mechanism of bacterial cell disintegration. Bull. Mater. Sci. 2016 39 7 1871 1878 10.1007/s12034‑016‑1317‑5
    [Google Scholar]
  40. Wypij M. Czarnecka J. Świecimska M. Dahm H. Rai M. Golinska P. Synthesis, characterization and evaluation of antimicrobial and cytotoxic activities of biogenic silver nanoparticles synthesized from Streptomyces xinghaiensis OF1 strain. World J. Microbiol. Biotechnol. 2018 34 2 23 10.1007/s11274‑017‑2406‑3 29305718
    [Google Scholar]
  41. Sánchez-López E. Gomes D. Esteruelas G. Bonilla L. Lopez-Machado A.L. Galindo R. Cano A. Espina M. Ettcheto M. Camins A. Silva A.M. Durazzo A. Santini A. Garcia M.L. Souto E.B. Metal-based nanoparticles as antimicrobial agents: An overview. Nanomaterials 2020 10 2 292 10.3390/nano10020292 32050443
    [Google Scholar]
  42. Geitani R. Ayoub Moubareck C. Touqui L. Karam Sarkis D. Cationic antimicrobial peptides: Alternatives and/or adjuvants to antibiotics active against methicillin-resistant Staphylococcus aureus and multidrug-resistant Pseudomonas aeruginosa. BMC Microbiol. 2019 19 1 54 10.1186/s12866‑019‑1416‑8 30849936
    [Google Scholar]
  43. Meng J. He G. Wang H. Jia M. Ma X. Da F. Wang N. Hou Z. Xue X. Li M. Zhou Y. Luo X. Reversion of antibiotic resistance by inhibiting mecA in clinical methicillin-resistant Staphylococci by antisense phosphorothioate oligonucleotide. J. Antibiot. (Tokyo) 2015 68 3 158 164 10.1038/ja.2014.132 25269464
    [Google Scholar]
  44. Becskei A. Tuning up transcription factors for therapy. Molecules 2020 25 8 1902 10.3390/molecules25081902 32326099
    [Google Scholar]
  45. Hibbitts A. O’Leary C. Emerging nanomedicine therapies to counter the rise of methicillin-resistant Staphylococcus aureus Materials 2018 11 2 321 10.3390/ma11020321 29473883
    [Google Scholar]
  46. Ur Rehman O. Fatima E. Ali A. Akram U. Nashwan A. Yunus F. Efficacy and safety of bedaquiline containing regimens in patients of drug-resistant tuberculosis: An updated systematic review and meta-analysis. J. Clin. Tuberc. Other Mycobact. Dis. 2024 34 100405 10.1016/j.jctube.2023.100405 38152568
    [Google Scholar]
  47. Ferreira A.P. Tobyn M. Multivariate analysis in the pharmaceutical industry: Enabling process understanding and improvement in the PAT and QbD era. Pharm. Dev. Technol. 2015 20 5 513 527 10.3109/10837450.2014.898656 24641280
    [Google Scholar]
  48. Mehta K. Guo T. van der Graaf P.H. van Hasselt J.G.C. Model‐based dose optimization framework for bedaquiline, pretomanid and linezolid for the treatment of drug‐resistant tuberculosis. Br. J. Clin. Pharmacol. 2024 90 2 463 474 10.1111/bcp.15925 37817504
    [Google Scholar]
  49. Padmapriyadarsini C. Devaleenal B. Ponnuraja C. Ramraj B. Singla R. Parmar M. Mattoo S. Mandal S. Randomised trial to evaluate the effectiveness and safety of varying doses of linezolid with bedaquiline and pretomanid in adults with pre-extensively drug-resistant or treatment intolerant/non-responsive multidrug-resistant pulmonary tuberculosis: Study protocol. BMJ Open 2022 12 8 e058606 10.1136/bmjopen‑2021‑058606 36038181
    [Google Scholar]
  50. Padmapriyadarsini C. Vohra V. Bhatnagar A. Solanki R. Sridhar R. Anande L. Muthuvijaylakshmi M. Rana M.B. Jeyadeepa B. Taneja G. Balaji S. Shah P. Saravanan N. Chavan V. Kumar H. Ponnuraja C. Livchits V. Bahl M. Alavadi U. Sachdeva K.S. Swaminathan S. Padmapriyadarsini C. Jeyadeepa B. Lakshana Akbar N. Arulraj E. Karthikeyan Muthukumar Tamizharasan Balaji S. Shivakumar S. Muthuvijayalakshmi M. Gayathri Ponnuraja C. Kumar H. Saravanan N. Sridhar R. Kumar R. Ramesh Vohra V. Rana M.B. Singla N. Myneedu V.P. Lawrence A. Kushwaha D. Shivam D.K. Sarin R. Bhatnagar A.K. Taneja G. Rawat A. Haniff M. Rahul Rai P. Saini S. Mathur K.K. Solanki R.N. Patel P.G. Prajapati V. Parmar B. Wadkar K. Shah P.L. Parmar S. Vyas P. Mistri K. Anade L. Chavan V. Bhui N.K. Tipre P. Shah D. Patwa S.K. Nhavakar A. Brito A. Keny K. Karanjkar V. Pal K. Godam K. Huje M. Ghadge S. Udmalle M. Posture V.V. Bansode J. Bhal M. Ranjan Pillai D. Semwal S. Livchits S.L.V. Alavadi U. Swamikan R. Nasubo D.N. Parmar M. Sahu S. Mukadi Y.D. Swaminathan S. for BEAT India Team Bedaquiline, delamanid, linezolid, and clofazimine for treatment of pre-extensively drug-resistant tuberculosis. Clin. Infect. Dis. 2023 76 3 e938 e946 10.1093/cid/ciac528 35767251
    [Google Scholar]
  51. Salinger D.H. Nedelman J.R. Mendel C. Spigelman M. Hermann D.J. Daily dosing for bedaquiline in patients with tuberculosis. Antimicrob. Agents Chemother. 2019 63 11 e00463-19 10.1128/AAC.00463‑19 31451504
    [Google Scholar]
  52. Shao G. Bao Z. Davies Forsman L. Paues J. Werngren J. Niward K. Schön T. Bruchfeld J. Alffenaar J.W. Hu Y. Population pharmacokinetics and model-based dosing evaluation of bedaquiline in multidrug-resistant tuberculosis patients. Front. Pharmacol. 2023 14 1022090 10.3389/fphar.2023.1022090 37050904
    [Google Scholar]
  53. Singh B. Singh C. Bedaquiline in drug-resistant tuberculosis: A mini-review. Curr. Mol. Pharmacol. 2023 16 3 243 253 10.2174/1874467215666220421130707 36919348
    [Google Scholar]
  54. Deshkar A.T. Shirure P.A. Deshkar A. Shirure P. Bedaquiline: A novel diarylquinoline for multidrug-resistant pulmonary tuberculosis. Cureus 2022 14 8 e28519 10.7759/cureus.28519 36185922
    [Google Scholar]
  55. Mehta K. Guo T. van der Graaf P.H. van Hasselt J.G.C. Predictions of bedaquiline and pretomanid target attainment in lung lesions of tuberculosis patients using translational minimal physiologically based pharmacokinetic modeling. Clin. Pharmacokinet. 2023 62 3 519 532 10.1007/s40262‑023‑01217‑7 36802057
    [Google Scholar]
  56. Tong E. Wu Q. Chen Y. Liu Z. Zhang M. Zhu Y. Wu K. Pan J. Jiang J. The efficacy and safety of bedaquiline in the treatment of pulmonary tuberculosis patients: A systematic review and meta-analysis. Antibiotics 2023 12 9 1389 10.3390/antibiotics12091389 37760686
    [Google Scholar]
  57. Sotgiu G. Centis R. D’ambrosio L. Migliori G.B. Tuberculosis treatment and drug regimens. Cold Spring Harb. Perspect. Med. 2015 5 5 a017822 a017822 10.1101/cshperspect.a017822 25573773
    [Google Scholar]
  58. Bezawada V. Mogili P. Rao Polagani S. Dodda S. Bioanalysis of bedaquiline in human plasma by liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic study. J. Mass Spectrom. Adv. Clin. Lab 2024 31 27 32 10.1016/j.jmsacl.2024.01.001 38375487
    [Google Scholar]
  59. Sarathy J.P. Gruber G. Dick T. Re-understanding the mechanisms of action of the Anti-Mycobacterial drug bedaquiline. Antibiotics 2019 8 4 261 10.3390/antibiotics8040261 31835707
    [Google Scholar]
  60. Nguyen T.V.A. Cao T.B.T. Akkerman O.W. Tiberi S. Vu D.H. Alffenaar J.W.C. Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis. Expert Rev. Clin. Pharmacol. 2016 9 8 1025 1037 10.1080/17512433.2016.1200462 27322153
    [Google Scholar]
  61. Khoshnood S. Goudarzi M. Taki E. Darbandi A. Kouhsari E. Heidary M. Motahar M. Moradi M. Bazyar H. Bedaquiline: Current status and future perspectives. J. Glob. Antimicrob. Resist. 2021 25 48 59 10.1016/j.jgar.2021.02.017 33684606
    [Google Scholar]
  62. Vanino E. Granozzi B. Akkerman O.W. Munoz-Torrico M. Palmieri F. Seaworth B. Tiberi S. Tadolini M. Update of drug-resistant tuberculosis treatment guidelines: A turning point. Int. J. Infect. Dis. 2023 130 Suppl. 1 S12 S15 10.1016/j.ijid.2023.03.013 36918080
    [Google Scholar]
  63. Kim J. Choi J. Kang H. Ahn J. Hutchings J. Niekerk C. Kim J. Jeon Y. Nam K. Kim T.H. Shin B.S. Shin S. Safety, tolerability, pharmacokinetics, and metabolism of telacebec (Q203) for the treatment of tuberculosis: A randomized, placebo-controlled, multiple ascending dose phase 1B trial. Antimicrob. Agents Chemother. 2023 67 1 e01123-22 10.1128/aac.01123‑22 36507677
    [Google Scholar]
  64. Mirnejad R. Asadi A. Khoshnood S. Mirzaei H. Heidary M. Fattorini L. Ghodousi A. Darban-Sarokhalil D. Clofazimine: A useful antibiotic for drug-resistant tuberculosis. Biomed. Pharmacother. 2018 105 1353 1359 10.1016/j.biopha.2018.06.023 30021373
    [Google Scholar]
  65. Guglielmetti L. Chiesi S. Eimer J. Dominguez J. Masini T. Varaine F. Veziris N. Ader F. Robert J. Bedaquiline and delamanid for drug-resistant tuberculosis: A clinician’s perspective. Future Microbiol. 2020 15 9 779 799 10.2217/fmb‑2019‑0309 32700565
    [Google Scholar]
  66. Guglielmetti L. Jaspard M. Le Dû D. Lachâtre M. Marigot-Outtandy D. Bernard C. Veziris N. Robert J. Yazdanpanah Y. Caumes E. Fréchet-Jachym M. French MDR-TB Management Group Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis. Eur. Respir. J. 2017 49 3 1601799 10.1183/13993003.01799‑2016 28182570
    [Google Scholar]
  67. Chahine E.B. Karaoui L.R. Mansour H. Bedaquiline. Ann. Pharmacother. 2014 48 1 107 115 10.1177/1060028013504087 24259600
    [Google Scholar]
  68. Chesov E. Chesov D. Maurer F.P. Andres S. Utpatel C. Barilar I. Donica A. Reimann M. Niemann S. Lange C. Crudu V. Heyckendorf J. Merker M. Emergence of bedaquiline resistance in a high tuberculosis burden country. Eur. Respir. J. 2022 59 3 2100621 10.1183/13993003.00621‑2021 34503982
    [Google Scholar]
  69. Perrin C. Athersuch K. Elder G. Martin M. Alsalhani A. Recently developed drugs for the treatment of drug-resistant tuberculosis: A research and development case study. BMJ Glob. Health 2022 7 4 e007490 10.1136/bmjgh‑2021‑007490 35440441
    [Google Scholar]
  70. Gupta R Wells CD Hittel N Hafkin J Geiter LJ Delamanid in the treatment of multidrug-resistant tuberculosis. int j tuberc lung dis. 2016 20 33 37
    [Google Scholar]
  71. Dooley K.E. Park J.G. Swindells S. Allen R. Haas D.W. Cramer Y. Aweeka F. Wiggins I. Gupta A. Lizak P. Qasba S. van Heeswijk R. Flexner C. ACTG 5267 Study Team Safety, tolerability, and pharmacokinetic interactions of the antituberculous agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS clinical trials group study A5267. J. Acquir. Immune Defic. Syndr. 2012 59 5 455 462 10.1097/QAI.0b013e3182410503 22126739
    [Google Scholar]
  72. Svensson E.M. Murray S. Karlsson M.O. Dooley K.E. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug. J. Antimicrob. Chemother. 2015 70 4 1106 1114 10.1093/jac/dku504 25535219
    [Google Scholar]
  73. Healan A.M. Griffiss J.M. Proskin H.M. O’Riordan M.A. Gray W.A. Salata R.A. Blumer J.L. Impact of Rifabutin or Rifampin on bedaquiline safety, tolerability, and pharmacokinetics assessed in a randomized clinical trial with healthy adult volunteers. Antimicrob. Agents Chemother. 2017 62 1 e00855 e17 29061739
    [Google Scholar]
  74. Conradie F. Diacon A.H. Ngubane N. Howell P. Everitt D. Crook A.M. Mendel C.M. Egizi E. Moreira J. Timm J. McHugh T.D. Wills G.H. Bateson A. Hunt R. Van Niekerk C. Li M. Olugbosi M. Spigelman M. Nix-TB Trial Team Treatment of highly drug-resistant pulmonary tuberculosis. N. Engl. J. Med. 2020 382 10 893 902 10.1056/NEJMoa1901814 32130813
    [Google Scholar]
  75. Dooley K.E. Rosenkranz S.L. Conradie F. Moran L. Hafner R. von Groote-Bidlingmaier F. Lama J.R. Shenje J. De Los Rios J. Comins K. Morganroth J. Diacon A.H. Cramer Y.S. Donahue K. Maartens G. Alli O. Gottesman J. Guevara M. Hikuam C. Hovind L. Karlsson M. McClaren J. McIlleron H. Murtaugh W. Rolls B. Shahkolahi A. Stone L. Tegha G. Tenai J. Upton C. Wimbish C. AIDS Clinical Trials Group (ACTG) A5343 DELIBERATE Study Team QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial. Lancet Infect. Dis. 2021 21 7 975 983 10.1016/S1473‑3099(20)30770‑2 33587897
    [Google Scholar]
  76. Conradie F. Bagdasaryan T.R. Borisov S. Howell P. Mikiashvili L. Ngubane N. Samoilova A. Skornykova S. Tudor E. Variava E. Yablonskiy P. Everitt D. Wills G.H. Sun E. Olugbosi M. Egizi E. Li M. Holsta A. Timm J. Bateson A. Crook A.M. Fabiane S.M. Hunt R. McHugh T.D. Tweed C.D. Foraida S. Mendel C.M. Spigelman M. ZeNix Trial Team Bedaquiline–pretomanid–linezolid regimens for drug-resistant tuberculosis. N. Engl. J. Med. 2022 387 9 810 823 10.1056/NEJMoa2119430 36053506
    [Google Scholar]
  77. Crisafulli S. Khan Z. Karatas Y. Tuccori M. Trifirò G. An overview of methodological flaws of real-world studies investigating drug safety in the post-marketing setting. Expert Opin. Drug Saf. 2023 22 5 373 380 10.1080/14740338.2023.2219892 37243676
    [Google Scholar]
  78. Colombo S. Beck-Broichsitter M. Bøtker J.P. Malmsten M. Rantanen J. Bohr A. Transforming nanomedicine manufacturing toward quality by design and microfluidics. Adv. Drug Deliv. Rev. 2018 128 115 131 10.1016/j.addr.2018.04.004 29626549
    [Google Scholar]
  79. Ginsberg A. The TB Alliance: Overcoming challenges to chart the future course of TB drug development. Future Med. Chem. 2011 3 10 1247 1252 10.4155/fmc.11.82 21859299
    [Google Scholar]
  80. Zumla A. Petersen E. Nyirenda T. Chakaya J. Tackling the tuberculosis epidemic in sub-Saharan Africa – unique opportunities arising from the second European Developing Countries Clinical Trials Partnership (EDCTP) programme 2015-2024. Int. J. Infect. Dis. 2015 32 46 49 10.1016/j.ijid.2014.12.039 25809755
    [Google Scholar]
  81. Gotham D. McKenna L. Frick M. Lessem E. Public investments in the clinical development of bedaquiline. PLoS ONE. 2020 15 e0239118 10.1371/journal.pone.0239118
    [Google Scholar]
/content/journals/raaidd/10.2174/0127724344318310241018113206
Loading
/content/journals/raaidd/10.2174/0127724344318310241018113206
Loading

Data & Media loading...

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test