Bibliography
- Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
- World Health Organization. Global tuberculosis report 2015. WHO/HTM/TB/2015.22. Geneva: World Health Organization; 2015 [cited 2015 Oct 30]. Available at: http://www.who.int/tb/publications/global_report/en/.
- Keshavjee S, Gelmanova IY, Farmer PE, et al. Treatment of extensively drug-resistant tuberculosis in Tomsk, Russia: a retrospective cohort study. Lancet. 2008;372:1403–1409.
- Kim DH, Kim HJ, Park SK, et al. Treatment outcomes and long-term survival in patients with extensively drug-resistant tuberculosis. Am J Respir Crit Care Med. 2008;178:1075–1082.
- Kwon YS, Kim YH, Suh GY, et al. Treatment outcomes for HIV-uninfected patients with multidrug-resistant and extensively drug-resistant tuberculosis. Clin Infect Dis. 2008;47:496–502.
- Mitnick CD, Shin SS, Seung KJ, et al. Comprehensive treatment of extensively drug-resistant tuberculosis. N Engl J Med. 2008;359:563–574.
- Dheda K, Shean K, Zumla A, et al. Early treatment outcomes and HIV status of patients with extensively drug-resistant tuberculosis in South Africa: a retrospective cohort study. Lancet. 2010;375:1798–1807.
- Jacobson KR, Tierney DB, Jeon CY, et al. Treatment outcomes among patients with extensively drug-resistant tuberculosis: systematic review and meta-analysis. Clin Infect Dis. 2010;51:6–14.
- 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.
- Johnston JC, Shahidi NC, Sadatsafavi M, et al. Treatment outcomes of multidrug-resistant tuberculosis: a systematic review and meta-analysis. PLoS One. 2009;4:e6914.
- Kim DH, Kim HJ, Park SK, et al. Treatment outcomes and survival based on drug resistance patterns in multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010;182:113–119.
- Mitnick CD, Franke MF, Rich ML, et al. Aggressive regimens for multidrug-resistant tuberculosis decrease all-cause mortality. PLoS One. 2013;8:e58664.
- 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.
- Loveday M, Wallengren K, Brust J, et al. Community-based care vs. centralised hospitalisation for MDR-TB patients, KwaZulu-Natal, South Africa. Int J Tuberc Lung Dis. 2015;19:163–171.
- Garrido Mda S, Buhrer-Sekula S, Souza AB, et al. Multidrug-resistant tuberculosis in the Amazonas State, Brazil, 2000-2011. Int J Tuberc Lung Dis. 2015;19:531–536.
- Kwak N, Kim HR, Yoo CG, et al. Changes in treatment outcomes of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2015;19:525–530.
- 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.
- 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.
- Migliori GB, Sotgiu G, Gandhi NR, et al. Drug resistance beyond extensively drug-resistant tuberculosis: individual patient data meta-analysis. Eur Respir J. 2013;42:169–179.
- Zumla A, Nahid P, Cole ST. Advances in the development of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013;12:388–404.
- Kwon YS, Jeong BH, Koh WJ. Tuberculosis: clinical trials and new drug regimens. Curr Opin Pulm Med. 2014;20:280–286.
- Olaru ID, von Groote-Bidlingmaier F, Heyckendorf J, et al. Novel drugs against tuberculosis: a clinician’s perspective. Eur Respir J. 2015;45:1119–1131.
- Global alliance for TB drug development [Internet]. 2015. [cited 2015 Oct 27]. Available from: http://www.tballiance.org/downloads/Pipeline/TBA_Pipeline_Q3_2015.pdf.
- Global TB drug pipeline. Working Group On New TB Drugs. September 2015 [Internet]. 2015. [cited 2015 Oct 27]. Available from: http://www.newtbdrugs.org/pipeline.php.
- Kakkar AK, Dahiya N. Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. Tuberculosis (Edinb). 2014;94:357–362.
- Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science. 2005;307:223–227.
- Rustomjee R, Diacon AH, Allen J, et al. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis. Antimicrob Agents Chemother. 2008;52:2831–2835.
- Diacon AH, Pym A, Grobusch M, et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med. 2009;360:2397–2405.
•• This phase IIb randomized controlled trial was the first study that demonstrated the efficacy and safety of TMC207 for multidrung-resistant tuberculosis.
- Diacon AH, Donald PR, Pym A, et al. 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. Antimicrob Agents Chemother. 2012;56:3271–3276.
- Diacon AH, Pym A, Grobusch MP, et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014;371:723–732.
•• This phase IIb study is a proof-of-efficacy study of 24 weeks of bedaquiline in addition to background regimen in patients with multidrung-resistant tuberculosis.
- Mase S, Chorba T, Lobue PKC. Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (Sirturo) for the treatment of multidrug-resistant tuberculosis. MMWR Recomm Rep. 2013;62:1–12.
- World Health Organization. Interim guidance on the use of bedaquiline to treat MDR-TB. WHO/HTM/TB/2013.6. Geneva: World Health Organization; 2013 [cited 2015 Aug 14]. Available at http://www.who.int/tb/challenges/mdr/bedaquiline/en/.
- Svensson EM, Dooley KE, Karlsson MO. Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection. Antimicrob Agents Chemother. 2014;58:6406–6412.
- Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med. 2015;191:943–953.
• This is a phase IIa trial, early bactericidal activity study, of the combination of bedaquiline, pretomanid and pyrazinamide.
- Hartkoorn RC, Uplekar S, Cole ST. Cross-resistance between clofazimine and bedaquiline through upregulation of MmpL5 in Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2014;58:2979–2981.
- Andries K, Villellas C, Coeck N, et al. Acquired resistance of Mycobacterium tuberculosis to bedaquiline. PLoS One. 2014;9:e102135.
- Salfinger M, Migliori GB. Bedaquiline: 10 years later, the drug susceptibility testing protocol is still pending. Eur Respir J. 2015;45:317–321.
- Mukherjee T, Boshoff H. Nitroimidazoles for the treatment of TB: past, present and future. Future Med Chem. 2011;3:1427–1454.
- Matsumoto M, Hashizume H, Tomishige T, et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006;3:e466.
- Diacon AH, Dawson R, Hanekom M, et al. Early bactericidal activity of delamanid (OPC-67683) in smear-positive pulmonary tuberculosis patients. Int J Tuberc Lung Dis. 2011;15:949–954.
- Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012;366:2151–2160.
•• This study is the first phase IIb clinical trial demonstrating the efficacy of delamanid for the treatment of multidrung-resistant tuberculosis.
- Skripconoka V, Danilovits M, Pehme L, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J. 2013;41:1393–1400.
•• This is a subsequent open-label extension study demonstrating the efficacy of delamanid for 6 months in combination with an optimized background regimen in patients with both multidrug-resistant and extensively drug-resistant tuberculosis.
- Kwon YS, Jeong BH, Koh WJ. Delamanid when other anti-tuberculosis-treatment regimens failed due to resistance or tolerability. Expert Opin Pharmacother. 2015;16:253–261.
- Stover CK, Warrener P, VanDevanter DR, et al. A small-molecule nitroimidazopyran drug candidate for the treatment of tuberculosis. Nature. 2000;405:962–966.
- Singh R, Manjunatha U, Boshoff HI, et al. PA-824 kills nonreplicating Mycobacterium tuberculosis by intracellular NO release. Science. 2008;322:1392–1395.
- Tyagi S, Nuermberger E, Yoshimatsu T, et al. Bactericidal activity of the nitroimidazopyran PA-824 in a murine model of tuberculosis. Antimicrob Agents Chemother. 2005;49:2289–2293.
- Nuermberger E, Tyagi S, Tasneen R, et al. Powerful bactericidal and sterilizing activity of a regimen containing PA-824, moxifloxacin, and pyrazinamide in a murine model of tuberculosis. Antimicrob Agents Chemother. 2008;52:1522–1524.
- Dutta NK, Alsultan A, Gniadek TJ, et al. Potent rifamycin-sparing regimen cures guinea pig tuberculosis as rapidly as the standard regimen. Antimicrob Agents Chemother. 2013;57:3910–3916.
- Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet. 2012;380:986–993.
• This is a phase IIa early bactericidal activity study of new multi-drug combinations, including pretomanid, bedaquiline, pyrazinamide and moxifoloxacin.
- Dawson R, Diacon AH, Everitt D, et al. Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis. Lancet. 2015;385:1738–1747.
• This is a phase IIb study demonstrating the bactericidal activity of regimen consisting of pretomanide, moxifloxacin and pyrazinamide during the first 8 weeks of tuberculosis treatment.
- Dooley KE, Luetkemeyer AF, Park JG, et al. Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 with concomitant lopinavir-ritonavir, efavirenz, or rifampin. Antimicrob Agents Chemother. 2014;58:5245–5252.
- Kmentova I, Sutherland HS, Palmer BD, et al. Synthesis and structure-activity relationships of aza- and diazabiphenyl analogues of the antitubercular drug (6S)-2-nitro-6-{[4-(trifluoromethoxy)benzyl]oxy}-6,7-dihydro-5H-imidazo[2,1-b][1, 3]oxazine (PA-824). J Med Chem. 2010;53:8421–8439.
- Upton AM, Cho S, Yang TJ, et al. In vitro and in vivo activities of the nitroimidazole TBA-354 against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2015;59:136–144.
- Gumbo T, Louie A, Deziel MR, et al. Concentration-dependent Mycobacterium tuberculosis killing and prevention of resistance by rifampin. Antimicrob Agents Chemother. 2007;51:3781–3788.
- Rosenthal IM, Tasneen R, Peloquin CA, et al. Dose-ranging comparison of rifampin and rifapentine in two pathologically distinct murine models of tuberculosis. Antimicrob Agents Chemother. 2012;56:4331–4340.
- de Steenwinkel JE, Aarnoutse RE, de Knegt GJ, et al. Optimization of the rifampin dosage to improve the therapeutic efficacy in tuberculosis treatment using a murine model. Am J Respir Crit Care Med. 2013;187:1127–1134.
- Boeree MJ, Diacon AH, Dawson R, et al. A dose-ranging trial to optimize the dose of rifampin in the treatment of tuberculosis. Am J Respir Crit Care Med. 2015;191:1058–1065.
• This is a phase II multiple dose-ranging study to optimize the dose of rifampin for the treatment of tuberculosis.
- Munsiff SS, Kambili C, Ahuja SD. Rifapentine for the treatment of pulmonary tuberculosis. Clin Infect Dis. 2006;43:1468–1475.
- Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011;365:2155–2166.
- Vernon A, Burman W, Benator D, et al. Acquired rifamycin monoresistance in patients with HIV-related tuberculosis treated with once-weekly rifapentine and isoniazid. Tuberculosis Trials Consortium. Lancet. 1999;353:1843–1847.
- Benator D, Bhattacharya M, Bozeman L, et al. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet. 2002;360:528–534.
- Dorman SE, Goldberg S, Stout JE, et al. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis. 2012;206:1030–1040.
- Rosenthal IM, Zhang M, Williams KN, et al. Daily dosing of rifapentine cures tuberculosis in three months or less in the murine model. PLoS Med. 2007;4:e344.
- Mitchison DA. Pharmacokinetic/pharmacodynamic parameters and the choice of high-dosage rifamycins. Int J Tuberc Lung Dis. 2012;16:1186–1189.
- Dorman SE, Savic RM, Goldberg S, et al. Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial. Am J Respir Crit Care Med. 2015;191:333–343.
• This is a phase II multiple dose-ranging study to optimize the dose of daily rifapentine for pulmonary tuberculosis treatment.
- Cox H, Ford N. Linezolid for the treatment of complicated drug-resistant tuberculosis: a systematic review and meta-analysis. Int J Tuberc Lung Dis. 2012;16:447–454.
- Sotgiu G, Centis R, D’Ambrosio L, et al. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB and XDR-TB: systematic review and meta-analysis. Eur Respir J. 2012;40:1430–1442.
- Koh WJ, Kang YR, Jeon K, et al. Daily 300 mg dose of linezolid for multidrug-resistant and extensively drug-resistant tuberculosis: updated analysis of 51 patients. J Antimicrob Chemother. 2012;67:1503–1507.
- Jeong BH, Jeon K, Park HY, et al. Outcomes of pulmonary MDR-TB: impacts of fluoroquinolone resistance and linezolid treatment. J Antimicrob Chemother. 2015;70:3127–3133.
- 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.
•• This is a phase IIa prospective randomized trial demonstrating the efficacy and safety of linezolid for chronic extensive drug-resistant tuberculosis treatment.
- Lee M, Cho SN, Barry CE 3rd, et al. Linezolid for XDR-TB-final study outcomes. N Engl J Med. 2015;373:290–291.
- 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.
• This is a prospective, multicenter, randomized study demonstrating the efficacy, safety and tolerability of linezolid in patients with extensively drug-resistant tuberculosis.
- Chang KC, Yew WW, Cheung SW, et al. Can intermittent dosing optimize prolonged linezolid treatment of difficult multidrug-resistant tuberculosis? Antimicrob Agents Chemother. 2013;57:3445–3449.
- Bolhuis MS, van Altena R, van Soolingen D, et al. Clarithromycin increases linezolid exposure in multidrug-resistant tuberculosis patients. Eur Respir J. 2013;42:1614–1621.
- Yip PC, Kam KM, Lam ET, et al. In vitro activities of PNU-100480 and linezolid against drug-susceptible and drug-resistant Mycobacterium tuberculosis isolates. Int J Antimicrob Agents. 2013;42:96–97.
- Williams KN, Stover CK, Zhu T, et al. Promising antituberculosis activity of the oxazolidinone PNU-100480 relative to that of linezolid in a murine model. Antimicrob Agents Chemother. 2009;53:1314–1319.
- Williams KN, Brickner SJ, Stover CK, et al. Addition of PNU-100480 to first-line drugs shortens the time needed to cure murine tuberculosis. Am J Respir Crit Care Med. 2009;180:371–376.
- Wallis RS, Jakubiec WM, Kumar V, et al. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010;202:745–751.
- Wallis RS, Jakubiec W, Kumar V, et al. Biomarker-assisted dose selection for safety and efficacy in early development of PNU-100480 for tuberculosis. Antimicrob Agents Chemother. 2011;55:567–574.
- Wallis RS, Dawson R, Friedrich SO, et al. Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis. PLoS One. 2014;9:e94462.
- Balasubramanian V, Solapure S, Iyer H, et al. Bactericidal activity and mechanism of action of AZD5847, a novel oxazolidinone for treatment of tuberculosis. Antimicrob Agents Chemother. 2014;58:495–502.
- Werngren J, Wijkander M, Perskvist N, et al. In vitro activity of AZD5847 against geographically diverse clinical isolates of Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2014;58:4222–4223.
- Balasubramanian V, Solapure S, Shandil R, et al. Pharmacokinetic and pharmacodynamic evaluation of AZD5847 in a mouse model of tuberculosis. Antimicrob Agents Chemother. 2014;58:4185–4190.
- Tahlan K, Wilson R, Kastrinsky DB, et al. SQ109 targets MmpL3, a membrane transporter of trehalose monomycolate involved in mycolic acid donation to the cell wall core of Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2012;56:1797–1809.
- Sacksteder KA, Protopopova M, Barry CE 3rd, et al. Discovery and development of SQ109: a new antitubercular drug with a novel mechanism of action. Future Microbiol. 2012;7:823–837.
- Reddy VM, Einck L, Andries K, et al. In vitro interactions between new antitubercular drug candidates SQ109 and TMC207. Antimicrob Agents Chemother. 2010;54:2840–2846.
- Reddy VM, Dubuisson T, Einck L, et al. SQ109 and PNU-100480 interact to kill Mycobacterium tuberculosis in vitro. J Antimicrob Chemother. 2012;67:1163–1166.
- Heinrich N, Dawson R, du Bois J, et al. Early phase evaluation of SQ109 alone and in combination with rifampicin in pulmonary TB patients. J Antimicrob Chemother. 2015;70:1558–1566.
- Makarov V, Manina G, Mikusova K, et al. Benzothiazinones kill Mycobacterium tuberculosis by blocking arabinan synthesis. Science. 2009;324:801–804.
- Pasca MR, Degiacomi G, Ribeiro AL, et al. Clinical isolates of Mycobacterium tuberculosis in four European hospitals are uniformly susceptible to benzothiazinones. Antimicrob Agents Chemother. 2010;54:1616–1618.
- Lechartier B, Hartkoorn RC, Cole ST. In vitro combination studies of benzothiazinone lead compound BTZ043 against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2012;56:5790–5793.
- Makarov V, Lechartier B, Zhang M, et al. Towards a new combination therapy for tuberculosis with next generation benzothiazinones. EMBO Mol Med. 2014;6:372–383.
- Lechartier B, Cole ST. Mode of action of clofazimine and combination therapy with benzothiazinones against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2015;59:4457–4463.
- Pethe K, Bifani P, Jang J, et al. Discovery of Q203, a potent clinical candidate for the treatment of tuberculosis. Nat Med. 2013;19:1157–1160.
- Kang S, Kim RY, Seo MJ, et al. Lead optimization of a novel series of imidazo[1,2-a]pyridine amides leading to a clinical candidate (Q203) as a multi- and extensively-drug-resistant anti-tuberculosis agent. J Med Chem. 2014;57:5293–5305.
- McIlleron H, Abdel-Rahman S, Dave JA, et al. Special populations and pharmacogenetic issues in tuberculosis drug development and clinical research. J Infect Dis. 2015;211(Suppl 3):S115–25.
- Nachman S, Ahmed A, Amanullah F, et al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis. 2015;15:711–720.
- Odone A, Houben RM, White RG, et al. The effect of diabetes and undernutrition trends on reaching 2035 global tuberculosis targets. Lancet Diabetes Endocrinol. 2014;2:754–764.
- Mitnick C, Bayona J, Palacios E, et al. Community-based therapy for multidrug-resistant tuberculosis in Lima, Peru. N Engl J Med. 2003;348:119–128.
- Putri FA, Burhan E, Nawas A, et al. Body mass index predictive of sputum culture conversion among MDR-TB patients in Indonesia. Int J Tuberc Lung Dis. 2014;18:564–570.
- Jeremiah K, Denti P, Chigutsa E, et al. Nutritional supplementation increases rifampin exposure among tuberculosis patients coinfected with HIV. Antimicrob Agents Chemother. 2014;58:3468–3474.