Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis

European Respiratory Journal

Volumn 49, Issue 3, 2017, Pages

  Guglielmetti, Lorenzo ^a,b   Jaspard, Marie ^c   Le Dû, Damien ^a   Lachâtre, Marie ^d   Marigot Outtandy, Dhiba ^a,e   Bernard, Christine ^b,c   Veziris, Nicolas ^b,c   Robert, Jérôme ^b,c   Yazdanpanah, Yazdan ^d   Caumes, Eric ^c   Fréchet Jachym, Mathilde ^a  

^a Centre Hospitalier de Bligny   (France)

^b SORBONNE UNIVERSITÉ   (France)

^c PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^d BICHAT HOSPITAL   (France)

^e RAYMOND POINCARÉ HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; AMINOSALICYLIC ACID; BEDAQUILINE; CAPREOMYCIN; CLAVULANIC ACID; CLAVULANIC ACID PLUS IMIPENEM; CLAVULANIC ACID PLUS MEROPENEM; CLOFAZIMINE; CYCLOSERINE; ETHAMBUTOL; ETHIONAMIDE; IMIPENEM; LEVOFLOXACIN; LINEZOLID; MEROPENEM; MOXIFLOXACIN; PYRAZINAMIDE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; UNCLASSIFIED DRUG; QUINOLINE DERIVATIVE; TUBERCULOSTATIC AGENT;

ADULT; ANTIBIOTIC RESISTANCE; ARTICLE; CLINICAL ARTICLE; COHORT ANALYSIS; DISEASE SEVERITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; INCIDENCE; LUNG TUBERCULOSIS; MALE; MULTICENTER STUDY; MULTIDRUG RESISTANT TUBERCULOSIS; OBSERVATIONAL STUDY; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; QT PROLONGATION; RETROSPECTIVE STUDY; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT WITHDRAWAL; VESTIBULAR DISORDER; ADVERSE DRUG REACTION; CLINICAL TRIAL; FRANCE; KAPLAN MEIER METHOD; MICROBIOLOGY; MULTIVARIATE ANALYSIS; MYCOBACTERIUM TUBERCULOSIS; SPUTUM; STATISTICAL MODEL;

ADULT; ANTITUBERCULAR AGENTS; DIARYLQUINOLINES; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; FRANCE; HUMANS; KAPLAN-MEIER ESTIMATE; LOGISTIC MODELS; MALE; MULTIVARIATE ANALYSIS; MYCOBACTERIUM TUBERCULOSIS; RETROSPECTIVE STUDIES; SPUTUM; TREATMENT OUTCOME; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 85028613742     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.01799-2016     Document Type: Article

References (40)

1. World Health Organization. Global Tuberculosis Report 2015. Geneva, World Health Organization, 2015.
2. Orenstein EW, Basu S, Shah NS, et al. Treatment outcomes among patients with multidrug-resistant tuberculosis: systematic review and meta-analysis. Lancet Infect Dis 2009; 9: 153–161.
3. Bonnet M, Bastard M, du Cros P, et al. Identification of patients who could benefit from bedaquiline or delamanid: a multisite MDR-TB cohort study. Int J Tuberc Lung Dis 2016; 20: 177–186.
4. Ahuja SD, Ashkin D, Avendano M, et al. Multidrug-resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patients. PLoS Med 2012; 9: e1001300.
5. Falzon D, Gandhi N, Migliori GB, et al. Resistance to fluoroquinolones and second-line injectable drugs: impact on multidrug-resistant TB outcomes. Eur Respir J 2013; 42: 156–168.
6. Pietersen E, Ignatius E, Streicher EM, et al. Long-term outcomes of patients with extensively drug-resistant tuberculosis in South Africa: a cohort study. Lancet 2014; 383: 1230–1239.
7. Diacon AH, Pym A, Grobusch MP, et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med 2014; 371: 723–732.
8. Pym AS, Diacon AH, Tang S-J, et al. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J 2016; 47: 564–574.
9. Guglielmetti L, Le Dû D, Jachym M, et al. Compassionate use of bedaquiline for the treatment of multidrug-resistant and extensively drug-resistant tuberculosis: interim analysis of a French cohort. Clin Infect Dis 2015; 60: 188–194.
10. Hewison C, Faqirzai J, Hayrapetian A, et al. Compassionate use of bedaquiline: interim outcomes from the Armenian National Tuberculosis Control Office [abstract]. Union World Conference, Cape Town, 2015; PC-719-04.
11. Ndjeka N, Conradie F, Schnippel K, et al. 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.
12. Henry B, Revest M, Dournon N, et al. Preliminary favorable outcome for medically and surgically managed extensively drug-resistant tuberculosis, France, 2009–2014. Emerg Infect Dis 2016; 22: 518–521.
13. Guglielmetti L, Le Dû D, Veziris N, et al. Is bedaquiline as effective as fluoroquinolones in the treatment of multidrug-resistant tuberculosis? Eur Respir J 2016; 48: 582–585.
14. Tiberi S, De Lorenzo S, Centis R, et al. Bedaquiline in MDR/XDR-TB cases: first experience on compassionate use. Eur Respir J 2014; 43: 289–292.
15. Pontali E, Sotgiu G, D’Ambrosio L, et al. Bedaquiline and multidrug-resistant tuberculosis: a systematic and critical analysis of the evidence. Eur Respir J 2016; 47: 394–402.
16. World Health Organization. Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. Geneva, World Health Organization, 2014.
17. Lewis JM, Hine P, Walker J, et al. First experience of effectiveness and safety of bedaquiline for 18 months within an optimised regimen for XDR-TB. Eur Respir J 2016; 47: 1581–1584.
18. Barrera L, Cooreman E, de Dieu Iragena J, et al. Policy Guidance on Drug-Susceptibility Testing (DST) of Second-Line Antituberculosis Drugs. Geneva, World Health Organization, 2008.
19. Aytemir K, Maarouf N, Gallagher MM, et al. Comparison of formulae for heart rate correction of QT interval in exercise electrocardiograms. Pacing Clin Electrophysiol 1999; 22: 1397–1401.
20. National Cancer Institute. Common Terminology Criteria for Adverse Events, version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE Date last accessed: March 15, 2016.
21. WHO-UMC. WHO-UMC system for standardised case causality assessment. http://who-umc.org/Graphics/24734.pdf Date last accessed: April 10, 2016.
22. Anderson LF, Tamne S, Watson JP, et al. Treatment outcome of multi-drug resistant tuberculosis in the United Kingdom: retrospective-prospective cohort study from 2004 to 2007. Euro Surveill 2013; 18: pii:20601.
23. Marks SM, Flood J, Seaworth B, et al. Treatment practices, outcomes, and costs of multidrug-resistant and extensively drug-resistant tuberculosis, United States, 2005–2007. Emerg Infect Dis 2014; 20: 812–821.
24. van Altena R, de Vries G, Haar CH, et al. Highly successful treatment outcome of multidrug-resistant tuberculosis in the Netherlands, 2000–2009. Int J Tuberc Lung Dis 2015; 19: 406–412.
25. Mitnick CD, Shin SS, Seung KJ, et al. Comprehensive treatment of extensively drug-resistant tuberculosis. N Engl J Med 2008; 359: 563–574.
26. Kim H-R, Hwang SS, Kim HJ, et al. Impact of extensive drug resistance on treatment outcomes in non-HIV-infected patients with multidrug-resistant tuberculosis. Clin Infect Dis 2007; 45: 1290–1295.
27. Mordant P, Henry B, Morel S, et al. Chirurgie et tuberculose multi/ultraresistante: une revue de la litterature rehabilite une intervention adjuvante a l’antibiotherapie chez des patients selectionnes. [Adjuvant surgical resection for multidrug-resistant tuberculosis: a review.] Rev Mal Respir 2014; 31: 511–524.
28. Lee M, Lee J, Carroll MW, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012; 367: 1508–1518.
29. Tang S, Yao L, Hao X, et al. Efficacy, safety and tolerability of linezolid for the treatment of XDR-TB: a study in China. Eur Respir J 2015; 45: 161–170.
30. Tang S, Yao L, Hao X, et al. Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China. Clin Infect Dis 2015; 60: 1361–1367.
31. Diacon AH, van der Merwe L, Barnard M, et al. Beta-lactams against tuberculosis – new trick for an old dog? N Engl J Med 2016; 375: 393–394.
32. Tiberi S, Sotgiu G, D’Ambrosio L, et al. Comparison of effectiveness and safety of imipenem/clavulanate- versus meropenem/clavulanate-containing regimens in the treatment of MDR- and XDR-TB. Eur Respir J 2016; 47: 1758–1766.
33. Aung KJM, Van Deun A, Declercq E, et al. Successful “9-month Bangladesh regimen” for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis 2014; 18: 1180–1187.
34. Bloemberg GV, Keller PM, Stucki D, et al. Acquired resistance to bedaquiline and delamanid in therapy for tuberculosis. N Engl J Med 2015; 373: 1986–1988.
35. Guglielmetti L, Le Dû D, Fréchet-Jachym M, et al. Preventing acquired resistance to bedaquiline and delamanid in multidrug-resistant tuberculosis treatment requires optimal management. Am J Respir Crit Care Med 2016; 3194: 1170–1171.
36. Fox GJ, Mitnick CD, Benedetti A, et al. Surgery as an adjunctive treatment for multidrug-resistant tuberculosis: an individual patient data meta-analysis. Clin Infect Dis 2016; 62: 887–895.
37. Bloss E, Kuksa L, Holtz TH, et al. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000–2004. Int J Tuberc Lung Dis 2010; 14: 275–281.
38. Bolhuis MS, Tiberi S, Sotgiu G, et al. Linezolid tolerability in multidrug-resistant tuberculosis: a retrospective study. Eur Respir J 2015; 46: 1205–1207.
39. Lachatre M, Rioux C, Du DL, et al. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect Dis 2016; 16: 294.
40. Tadolini M, Lingtsang RD, Tiberi S, et al. Report of the first case, concerns and challenges of treatment of severe XDR-TB with both delamanid and bedaquiline. Eur Respir J 2016; 48: 935–938.