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

Fox, 1999, Studies on the treatment of tuberculosis undertaken by the British Medical Research Council Tuberculosis Units, 1946–1986, with relevant subsequent publications, Int J Tuberc Lung Dis, 3, S231 Floyd, 2018, The global tuberculosis epidemic and progress in care, prevention, and research: an overview in year 3 of the End TB era, Lancet Respir Med, 6, 299, 10.1016/S2213-2600(18)30057-2 Banda, 2000, Mortality rates and recurrent rates of tuberculosis in patients with smear-negative pulmonary tuberculosis and tuberculous pleural effusion who have completed treatment, Int J Tuberc Lung Dis, 4, 968 Hargreaves, 2001, ‘Smear-negative’ pulmonary tuberculosis in a DOTS programme: poor outcomes in an area of high HIV seroprevalence, Int J Tuberc Lung Dis, 5, 847 Dworkin, 2005, Factors that complicate the treatment of tuberculosis in HIV-infected patients, J Acquir Immune Defic Syndr, 39, 464, 10.1097/01.qai.0000152400.36723.85 Yee, 2003, Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis, Am J Respir Crit Care Med, 167, 1472, 10.1164/rccm.200206-626OC Rustomjee, 2008, A phase II study of the sterilising activities of ofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis, Int J Tuberc Lung Dis, 12, 128 Conde, 2009, Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial, Lancet, 373, 1183, 10.1016/S0140-6736(09)60333-0 Burman, 2006, Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis, Am J Respir Med Crit Care, 174, 331, 10.1164/rccm.200603-360OC Dorman, 2009, Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis, Am J Respir Crit Care Med, 180, 273, 10.1164/rccm.200901-0078OC Dawson, 2015, Lancet, 385, 1738, 10.1016/S0140-6736(14)62002-X Diacon, 2014, Multidrug-resistant tuberculosis and culture conversion with bedaquiline, N Engl J Med, 371, 723, 10.1056/NEJMoa1313865 Diacon, 2015, Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline, Am J Respir Crit Care Med, 191, 943, 10.1164/rccm.201410-1801OC 2014 Burger, 2018, Robust Bayesian nonlinear mixed-effects modeling of time to positivity in tuberculosis trials, Pharm Stat, 17, 615, 10.1002/pst.1877 Burger, 2018, Robust fit of Bayesian mixed effects regression models with application to colony forming unit count in tuberculosis research, Stat Med, 37, 544, 10.1002/sim.7529 Burger, 2015, A Bayesian nonlinear mixed-effects regression model for the characterization of early bactericidal activity of tuberculosis drugs, J Biopharm Stat, 25, 1247, 10.1080/10543406.2014.971170 Borisov, 2017, Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study, Eur Respir J, 49, 10.1183/13993003.00387-2017 Ndjeka, 2018, High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen, Eur Respir J, 52, 10.1183/13993003.01528-2018 Fregonese, 2018, Comparison of different treatments for isoniazid-resistant tuberculosis: an individual patient data meta-analysis, Lancet Respir Med, 6, 265, 10.1016/S2213-2600(18)30078-X Maartens, 2014, HIV infection: epidemiology, pathogenesis, treatment, and prevention, Lancet, 384, 258, 10.1016/S0140-6736(14)60164-1 Egelund, 2017, The pharmacological challenges of treating tuberculosis and HIV coinfections, Expert Rev Clin Pharmacol, 10, 213, 10.1080/17512433.2017.1259066 Manosuthi, 2016, Integrated therapy for HIV and tuberculosis, AIDS Res Ther, 13, 22, 10.1186/s12981-016-0106-y Bastos, 2014, Treatment outcomes of patients with multidrug-resistant and extensively drug-resistant tuberculosis according to drug susceptibility testing to first- and second-line drugs: an individual patient data meta-analysis, Clin Infect Dis, 59, 1364, 10.1093/cid/ciu619 Whitfield, 2015, A global perspective on pyrazinamide resistance: systematic review and meta-analysis, PLoS One, 10, 10.1371/journal.pone.0133869 Ingersoll, 2008, The impact of medication regimen factors on adherence to chronic treatment: a review of literature, J Behav Med, 31, 213, 10.1007/s10865-007-9147-y Schroeder, 2004, Interventions for improving adherence to treatment in patients with high blood pressure in ambulatory settings, Cochrane Database Syst Rev, 2 Pontali, 2017, Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence, Eur Respir J, 50, 10.1183/13993003.01462-2017 Tweed, 2018, Liver toxicity associated with tuberculosis chemotherapy in the REMoxTB study, BMC Med, 16, 46, 10.1186/s12916-018-1033-7