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The slides used can be found here. The primary end points are to evaluate the effect of clofazimine when administrated orally in addition to background regimen compared to background regimen alone in producing higher cure rates at month 30 based on liquid culture media results in mycobacterial grown indicator tube MGIT. Presentation slides not available. Slides from this webinar can be found here. Yongge Liu, the Director of Diagnostics at Otsuka Novel Products, will discuss the development of this assay and the biomarker qualification process.

Patients will be randomized into one of two treatment arms. This presentation outlined the trials necessary to determine the efficacy of new TB drugs and regimens, the design differences between a single drug and a high impact regimen, and the pathway to FDA approval. XDR-TB; resistance to two injectables or ofloxacin; imprisonment in the past; 2nd line drugs treatment history low BMI and high bacillary load were independently associated with unfavourable outcomes.

On Thursday, April 20th, Dr. At this time, the V-QUIN Trial is only enrolling adults aged 15 years and above, with the hopes of enrolling children and adolescents at a later stage. The substudy will also assess the relationship between clofazimine plasma concentrations versus ECG parameters on Day -1 and Day to evaluate differences in study arms and analyze serial sputum colony buy viagra overnight during first 24 weeks of treatment.

The control arm will only receive the background regimen for the entire month treatment period. Enrollment will start on March 31 st and will end on March 28 th No presentation slides available. Presentation slides on Regulatory Requirements available here. However, there is less experience in using delamanid and bedaquiline together in the same MDR-TB treatment regimen due to concerns about the common effects on the QT interval.

On Thursday, December 14th, Dr. These results have been eagerly awaited and were first made public at the Union meeting in Guadalajara. The ACTG study, conducted in South Africa and Peru, is a trial of the safety, tolerability, and pharmacokinetics of bedaquiline and delamanid, alone and in combination, among participants taking multidrug treatment for drug-resistant pulmonary tuberculosis. Lorenzo Guglielmetti presented a webinar on the current evidence and practices for the combined use of delamanid and bedaquiline for the treatment of MDR-TB.

Presentation slides on Patient Recruitment, Enrollment, and Retention available here. The presentations for each of these discussions can be found below. Presentation slides on Sponsor Challenges available here. Based on a retrospective cohort study of outcomes of treatment of MDR-TB patients in programmes in Uzbekistan, Georgia, Armenia, Swaziland and Kenya, we aimed to identify patients at risk of unfavourable outcomes who may benefit of the new drugs.

Presentation slides on Challenges in Trial Implementation available here. WHO recommends adding bedaquiline or delamanid when a multidrug-resistant tuberculosis MDR-TB regimen with four effective drugs cannot be designed and delamanid in patients with high risk of poor outcomes. We will present novel methodological approaches, commonly used in other disciplines, that could be used to improve inference from MDR-TB treatment cohorts and identify the data gaps and challenges that must be overcome to implement them.

All regimens contain at least one of the newly approved anti-TB drugs, bedaquiline and delamanid. In our cohort, patients who may benefit of the new drugs represented up to two thirds of all MDR-TB patients.

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