19 October-30 November 2020
The 51st Union World Conference On Lung Health
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E-posters
EP02-Challenges for randomised controlled trials on TB treatment
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EP02-Challenges for randomised controlled trials on TB treatment
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All E-posters are accessible via the "E-posters" section of the conference platform until 30 November.

EP02-110-21-International multicentre controlled trial to evaluate 1200mg and 1800mg rifampicin daily in the reduction of treatment duration for pulmonary TB from six to four monthsThe current treatment for drug-sensitive pulmonary tuberculosis (TB) involves taking drugs daily for six months. RIFASHORT is an international multicentre controlled clinical trial which evaluates higher doses of rifampicin with the objective of reducing the treatment duration for drug-sensitive pulmonary TB from six months to four months.
Tulika Munshi

EP02-111-21-Documenting challenges faced and lessons learned from implementation of STREAM – the world’s largest recruited multidrug-resistant TB clinical trialMulticountry clinical trial implementation is complex – from different regulatory requirements and approval processes to variable research infrastructure and capacity across settings. Here, we document challenges faced and lessons learned from STREAM – the first large-scale, multicountry clinical trial for multidrug-resistant tuberculosis.
Meera Gurumurthy

EP02-112-21-A method for baseline adjudication of TB diagnosis in children in a therapeutic clinical trial: experience from SHINEDiagnosing non-severe pulmonary tuberculosis (TB) in children is challenging.  Results in children adjudicated as having TB (in the SHINE trial comparing four vs six months of standard therapy) will be essential. The approach to adjudicate TB or not TB can help overcome challenges in paediatric TB studies in the absence of gold standard diagnostic tests.
Genevieve H Wills

EP02-113-21-Sustainability of the ACT4 randomised trial to improve initiation of TB preventive treatmentThe ACT4 randomised trial found that a health systems' intervention in strengthening management of latent tuberculosis (TB) infection was effective at increasing TB preventive therapy initiation rates in households contacts. In this follow up study, the sustainability of the ACT4 intervention was evaluated over the nine months following the end of the trial.
Olivia Oxlade

EP02-114-21-Utility of colour vision testing in screening for ethambutol-associated ocular toxicity in children treated for TB in the SHINE trialEthambutol-associated ocular toxicity (EAOT) is reported in 0.05-0.7% of children treated for tuberculosis (TB). Using a child-friendly colour vision test as a screening tool, there was no evidence of clinically significant EAOT in children taking ethambutol.  Colour vision testing in children is feasible but may not be necessary for standard drug-sensitive TB treatment.
Eric Wobudeya

EP02-115-21-Adolescents in a TB clinical treatment trial: characteristics of an under represented populationAdolescents represent approximately 10% of the global tuberculosis (TB) burden yet they are historically under represented in clinical trials, potentially limiting their access to new treatments. We examined enrolment patterns for adolescents in a TB Trials Consortium and AIDS Clinical Trials Group Phase III and rifapentine-containing treatment shortening trial for pulmonary TB (NCT02410772).
Kimberley Hedges

EP02-116-21-Investigator reported barriers and facilitators to adolescent recruitment, enrolment and retention in TB Trials Consortium Study 31/ACTG A5349In a randomised, phase III treatment shortening trial for drug-susceptible pulmonary tuberculosis, we evaluated barriers and facilitators of adolescent participation in clinical trials. Using the capability, opportunity, motivation and behaviour model, we constructed interview guides, conducted interviews with principal investigators across two research consortia and analysed interview transcripts.
Joan Mangan

EP02-117-21-Exploring antagonism in anti-TB drugs using a hollow-fiber modelIsoniazid is part of the frontline anti-tuberculosis (TB) regimen. We have shown that its inclusion in a rifampicin/isoniazid dual therapy model increases the incidence of drug-tolerant, lipid-rich cells that stain as if respiring but with a compromised cell wall. This data is indicative of clearance antagonism occurring in TB chemotherapy.
Robert Hammond

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E-posters
EP01-Resisting the resistance
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EP01-Resisting the resistance
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EP01-100-21-Pharmacokinetics of anti-TB drugs in multidrug-resistant TB patients in IndiaA pharmacokinetic (PK) study of drugs used to treat multidrug-resistant (MDR) tuberculosis (TB) was undertaken in 350 adult MDR-TB patients treated according to the prevailing guidelines in India. Factors influencing drug PK and end of intensive phase status were also determined. Results of this study will be discussed.
Agibothu Kupparam Hemanth Kumar

EP01-101-21-Multidrug-resistant TB and its determinants of health service, community and social context in the state of São Paulo, BrazilThis study presents the social determinants of health in relation to the occurrence of multidrug-resistant tuberculosis, key information for disease control in regions with great social inequity. We emphasise the importance of socioeconomic, demographic and health system structure conditions for the spread of the disease.
Ricardo Arcêncio

EP01-102-21-Decentralised care for rifampicin-resistant TB in Western Cape, South Africa: a laboratory cohort studySouth Africa implemented a policy to decentralise rifampicin-resistant tuberculosis (RR-TB) care in 2011. We used laboratory data from the Western Cape province to assess patterns of RR-TB care and identify changes in hospitalisation rates, length of hospital stay and travel burden from 2012-2014. We compared Cape Town with more rural districts.
Helen Jenkins

EP01-103-21-Effectiveness, safety and feasibility of nine-month treatment regimen for rifampin-resistant TB in the PhilippinesThe short nine-month multidrug-resistant tuberculosis regimen had a high treatment success rate (74 percent) with a favourable safety profile in a prospective single-arm study conducted in the Philippines during 07/2015-12/2016. Nine-month treatment regimen operational research had a major impact on building national capacity and infrastructure for programmatic adoption of the new regimen in country.
Vivian Lofranco

EP01-104-21-Characterising multidrug-resistant tuberculosis transmission in rural KwaZulu-Natal: a prospective cohort studyThis study combined whole genome sequencing of 129 Mycobacterium tuberculosis (Mtb) isolates with demographic data from patients with multidrug-resistant TB in KwaZulu-Natal, South Africa. Transmission clusters based on genomic differences were identified. Relationships between demographic characteristics, Mtb lineage, rpoB mutation and transmission clustering were examined, aiming to elucidate drivers of Mtb transmission.
Cassandra Fairhead

EP01-105-21-Effectiveness and safety of use of bedaquiline and delamanid in combination for drug-resistant extrapulmonary TB in Mumbai, IndiaMédecins Sans Frontières has been providing treatment, including bedaquiline and/or delamanid, to patients with drug-resistant tuberculosis (TB) in Mumbai since 2015. Cases are referred with complex resistance profiles and extensive treatment history. This study aims to describe the effectiveness and safety of use of bedaquiline and delamanid for drug-resistant extrapulmonary TB.
Himani Mongia

EP01-106-21-Eliciting patient preferences for different attributes of a community-based model for management of multidrug-resistant TB in Uganda: a discrete choice experimentThe advent of all-oral regimens for the management of multidrug- resistant tuberculosis makes the implementation of home-based treatment a possibility for this group of patients. However, to be successful, options for home-based care should take into consideration patient preferences for different aspects of care.    
Stella Zawedde-Muyanja

EP01-107-21-Treatment of multidrug-resistant TB with modified shorter all-oral treatment regimen: Belarus operational research studyIn October 2018, Belarus started to use mSTR for multidrug-resistant tuberculosis under operational research conditions. By 1st May 2020, 415 patients were included in the study and, of them, 114 had final treatment outcomes with encouraging results (89% of treatment success).
Alena Skrahina

EP01-108-21-Patient’s perspective on drug-resistant TB medication: does it matter? Putting research into action to develop information, education and communication materialA qualitative study of drug-resistant tuberculosis (DR-TB) treatment from the perspective and experience of patient, family, healthcare worker and psychologist in six health facilities within three districts of Indonesia as a basis for developing DR-TB information, education and communication material based on the Health Belief Model and Transtheoretical Model.
Ferdiana Yunita

EP01-109-21-The role of clinical healthcare champions in driving drug-resistant TB policy implementation in South AfricaIn South Africa, champions have emerged as a driving force behind the implementation of decentralised management of drug-resistant tuberculosis (DR-TB). This study explored the typology of champions in the decentralisation of DR-TB management, strategies that champions used to implement policy and the contextual factors that enabled or hindered their agency.
Sacha Le Roux

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E-posters
EP09-Improved acceptability of TB regimens needed
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EP09-Improved acceptability of TB regimens needed
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All E-posters are accessible via the "E-posters" section of the conference platform until 30 November.

EP09-176-21-Risk factors for cycloserine neurotoxicity in patients treated for multidrug-resistant TBCycloserine has been re-classified as a category B drug by the World Health Organization. The neurotoxicity associated with cylcoserine has limited its use in treatment programmes. We systemically collected neurotoxicity data in patients in Cape Town treated with cycloserine, dosed as terizidone, for multidrug-resistant TB. We then evaluated factors, including cycloserine AUC, with neurotoxicity.
Richard Court

EP09-177-21-Hearing loss on second line injectable therapy for rifampin-resistant TB in a retrospective cohort in Worcester, South AfricaSecond line injectables (SLIs) remain a part of the drug-resistant TB regimen in many settings globally, even with SLI-induced ototoxicity rates remaining high. In this South African rifampin-resistant TB cohort, regimen adjustments due to hearing loss were common, further emphasising the need for access to SLI-sparing regimens.
Tara C Bouton

EP09-178-21-Treatment outcome of shorter regimen for multidrug-resistant TB in Pakistan 2018The National Tuberculosis (TB) Programme in Pakistan recommended a shorter regimen of nine-11 months in January 2018 under programmatic settings in all PMDT sites of the country. We compared treatment outcome of patients who were put on the shorter regimen, with those who were eligible for the shorter regimen but who were put on the longer one.
Abdul Ghafoor

EP09-179-21-From pilot to nationwide scale-up of shorter treatment regimen for drug-resistant TB treatment: lessons from NigeriaFollowing the adoption and rapid scale-up of GeneXpert as a primary tuberculosis (TB) diagnostic tool, limited bed spaces resulted in the challenge of a huge number of diagnosed drug-resistant TB (DR-TB) patients on treatment waiting lists. The CTB project facilitated nationwide scale-up of STR and NDs, including establishing aDSM for newly diagnosed DR-TB patients.
Sani Useni

EP09-180-21-Preferences for shorter regimens and child-friendly formulations for TB preventive treatment among families affected by TB in Lima, PeruFocus group discussions with families affected by tuberculosis (TB) in Lima, Peru, explored preferences for TB preventive treatment regimens, for both adult and child contacts, and sought to understand the drivers behind these preferences.
Courtney Yuen

EP09-182-21-Safety and efficacy of allogeneic γδ T cells for multidrug-resistant TB: an interim analysis of a prospective single centre, open labeled, non-randomised, controlled matched trialAnti-tuberculosis (TB) drugs for multidrug-resistant (MDR-TB) and rifampicin-resistant TB (RR-TB) currently encounter many obstacles and host-directed therapy approaches are now a focus for use as adjunct treatment options for shortening duration, limiting immunopathology, and improving outcomes. The safety and efficacy of γδT cells have been studied in our pilot trial, which is the first one worldwide.
Liang Fu

EP09-183-21-Interim outcomes of bedaquiline-containing regimen for the treatment of MDR/XDR-TB — a prospective cohort study from Hunan, ChinaChina introduced bedaquiline relatively late and little data exists on its use outside clinical trials. We conducted  a prospective cohort study to evaluate the effectiveness and safety of bedaquiline-containing regimen for 24 weeks intensive treatment of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis (MDR/XDR-TB) in Hunan province, China.
li shi

EP09-184-21-Treatment interruption patterns among patients on bedaquiline- containing regimen under programmatic conditionsThis was an observational study, including 275 consecutively enrolled tuberculosis (TB) patients, who received a bedaquiline-containing regimen under the national TB programme in India. The study analysed the reasons for interruptions of treatment and loss to follow-up and their effect on interim treatment outcomes during the first six months of treatment.
Rupak Singla

EP09-185-21-Incidence rate of linezolid adverse events among Myanmar adult MDR/RR-TB patients on individualised longer drug-resistant TB regimensLinezolid, a Group A drug, has evidences for significant treatment success but it also has common, serious adverse events such as myelosuppression and peripheral neuropathy. The study determined the incidence rate of linezolid adverse events and characterised the safety of linezolid among Myanmar adult multidrug-resistant and rifampicin-resistant tuberculosis (TB) patients who were on individualised, longer drug-resistant TB regimens.
Thandar Hmun

EP09-186-21-Real-time payment of Nikshay Poshan Yojana under direct benefit transfer scheme improved overall notification, treatment adherence and outcome of TB and DR-TB patients in Odisha, IndiaReal-time payment of Nikshay Poshan Yojana under a direct benefit transfer scheme improved the overall notification, treatment adherence and outcome of tuberculosis (TB) and drug-resistant TB patients in Odisha, India. The National TB Programme performance rank in the Odisha state went up from 27th to 15th during 2019.
Gayadhar Mallick

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SP-01-Strengthening evidence on optimal treatments for multidrug-resistant TB: approaches to studying timing and duration.
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SP-01-Strengthening evidence on optimal treatments for multidrug-resistant TB: approaches to studying timing and duration.
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Treatment for multidrug-resistant tuberculosis (MDR-TB) is characterised by prolonged duration and frequent toxicity. While injectable-free and shortened regimens represent enormous improvements, critical knowledge gaps remain about optimal treatment for MDR-TB. Among them are the comparative effectiveness of all-oral shortened regimens; the exposure-toxicity relationship in dynamic multidrug regimens; the optimal duration of treatment and of individual drugs and the choice and timing of endpoints used for each. This symposium will highlight challenges in the study of these questions, both in the clinical trial and observational study settings, and will offer practical approaches for improving valid inference.

11:00 - 11:05: Introduction

11:05 - 11:15: Follow-up duration in study of treatment of different durations: bias and implicationsA major concern about shortened regimens is possible increased recurrence (relapse and reinfection) after treatment completion. Documented, systematic post-treatment follow-up is critical to accurately assess efficacy of shortened regimens compared to longer control regimens.  Failure to systematically follow patients in observational or experimental studies can result in underestimated recurrence after shortened regimens. Follow-up time for equivalent durations after treatment completion (e.g. six months after a nine-month regimen and after an 18-month control) can result in the same overestimate, which can bias the effect estimate. For that reason, guidance recommends defining total follow-up duration from the point of randomisation, e.g. 24 months after randomisation. Effectively, this results in 15 months post-treatment follow-up for a nine-month regimen and six months for an 18-month regimen. This could overestimate recurrence in shortened regimens relative to controls and lead to bias. This talk will explore these biases and their implications for guidelines and programmatic decision making.
Gerry Davies

11:15 - 11:25: Short, long, or somewhere in between? Designing clinical trials to identify the optimal duration of therapyClinical development of new regimens for the treatment of tuberculosis (TB) involves not only the selection of the right drugs and doses, but also a choice of the optimal duration of therapy that maximises efficacy, while not exposing patients to a longer duration of potentially toxic drugs than necessary. Different approaches have been considered to generate evidence to support this choice with varying success. bedaquiline and delamanid have been evaluated in clinical trials and approved for the treatment of TB, but we are still learning the optimal duration of each. In this presentation, I will talk about the latest clinical trial designs that are being applied in drug-susceptible TB and drug-resistant TB randomised trials to efficiently identify optimal durations of new regimens. I will talk about the duration-randomised design which involves modelling of the duration-response relationship, proving a case study of how this has been applied in a planned TB trial.
Patrick Phillips

11:25 - 11:35: Does prolonged use of bedaquiline improve treatment outcomes? An application of methods to study optimal treatment duration using observational dataIn observational research, a common approach to studying the effect of treatment duration entails categorising patients according to the duration of their regimen (e.g. <15 months; 15-20 months, >20 months) and comparing the frequency of treatment success in patients with longer and shorter regimens. Results derived from this approach may be biased in favour of longer treatment because patients who survive longer can receive longer treatment. On the other hand, results may be biased against longer treatment if patients receive longer treatments due to a slower treatment response or treatment-emergent toxicities that then limit subsequent treatment options. To overcome these potential biases, we employ an alternative approach that emulates a randomised trial in which each individual is randomly assigned to a treatment duration. We provide an illustrative example in which we compare the effects of bedaquiline for 24 weeks, 48 weeks or the entire duration of treatment on end-of-treatment outcomes.
Molly Franke

11:35 - 11:45: Methodological challenges in analysis and reporting of sputum culture conversion endpoints in observational treatment cohortsIn observational multidrug-resistant tuberculosis treatment cohorts, time-to-sputum culture conversion (SCC) or SCC at specified time-points since treatment initiation (e.g. six months), are commonly used as interim endpoints for end-of-treatment outcome. While World Health Organization definitions for SCC exist, there is substantial heterogeneity in how these definitions are operationalised given varying data collection practices, monitoring schedules and laboratory procedures across cohorts. We will discuss the potential for selection bias due to the use of prolonged periods to establish patients’ baseline culture in SCC cohorts. We will describe the current state defining baseline sputum culture in the literature and recommend best practices for avoiding or resolving this bias.
Carly Rodriguez

11:45 - 11:55: How best to analyse and report adverse events occurring during multidrug-resistant TB treatment?Is the new regimen safe? This is a priority question in the evaluation of new multidrug-resistant TB regimens. Adverse events reporting is critical to evaluate regimen safety. However, drawing conclusions from observational adverse event data is challenging in the context of dynamic regimens. Important considerations include causality attribution in the context of regimens with multiple drug stops and stops; determining the dates of event onset and drug exposure; and adverse event recurrences. In this talk, we will detail methodological challenges to the analyses and reporting of adverse event data and provide illustrative examples using data from the End TB observational study. 
Mathieu Bastard

11:55 - 12:20: Q&A session

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SP-10-High-dose rifapentine with or without moxifloxacin for shortening treatment of TB: TB Trials Consortium study 31/ACTG A5349 phase III clinical trial results
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SP-10-High-dose rifapentine with or without moxifloxacin for shortening treatment of TB: TB Trials Consortium study 31/ACTG A5349 phase III clinical trial results
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Study 31/A5349 is a phase III randomised controlled non-inferiority trial to evaluate the efficacy and safety of two, four-month regimens with high-dose rifapentine with or without moxifloxacin for the treatment of drug-sensitive tuberculosis (TB). The trial is a collaboration between the TB Trials Consortium (TBTC) and the Adult AIDS Clinical Trials Group (ACTG).  In this symposium, we will present the trial design and results of the primary 12-month analysis. In addition, presentations will discuss safety of the short regimens, selected secondary and sensitivity analyses, local medical and community perspectives, plus lessons learned and next steps.

16:30 - 16:35: Introduction

16:35 - 16:45: The design and primary efficacy results of Study 31/A5349In this talk the design and the efficacy results for Study 31/A5349, a randomised, open-label, controlled phase 3 trial, will be presented. The trial’s primary efficacy endpoint is tuberculosis (TB) disease-free survival at 12 months after study treatment assignment. A total of 2,516 participants, from 33 sites in 13 countries, were enrolled. The proportion of participants, who are culture-negative at eight weeks, and time to stable sputum culture conversion (on solid and liquid media) will also be reported.
Susan Dorman

16:45 - 16:55: Safety of high-dose rifapentine regimensThis talk will review safety data of the two high-dose rifapentine regimens. The proportion of participants with grade 3 or higher adverse events during study drug treatment will be described. Rates of discontinuation of assigned treatment for a reason other than microbiological ineligibility, will be reported. All-cause mortality, including all deaths from any cause during treatment or follow-up up, will be described with primary cause of death reported by the regimen. The presentation will also include suggestions for safety monitoring and patient management for the short regimen in programmatic settings.
Ekaterina Kurbatova

16:55 - 17:05: Secondary efficacy and safety analyses of short regimen performance by disease phenotypes and patient subgroupsKnown risk factors for relapse and treatment failure include extensive cavitation, higher smear grade, low BMI and a compromised immune system because of HIV infection or uncontrolled diabetes. This talk will review results of secondary analyses that further explore the efficacy and safety of the short regimens, highlighting particular groups of patients that experienced the most benefit.
Payam Nahid

17:05 - 17:15: Perspectives on shortened TB regimens: local medical and community viewsThis talk will focus on local medical and community perspectives considering the promise, value-add and possible challenges and solutions to implementation of short tuberculosis regimens. These will be considered in a specific country setting, contextualising the findings.
Grace Muzanye

17:15 - 17:25: Lessons learned and next stepsThis talk will discuss lessons about inclusion of adolescents and HIV-positive individuals with CD4 count threshold of 100 cell/mm3, adherence, regional differences, a novel 'possible poor treatment response' process for endpoint ascertainment, and the value of standardised laboratory techniques. Relevant future actions will be considered.
Richard Chaisson

17:25 - 17:50: Q&A session

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OA-17-Safety first: side effects of old and new drugs
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OA-17-Safety first: side effects of old and new drugs
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12:30 - 12:35: Introduction


12:35 - 12:43: OA-17-605-22-Audiometry outcomes during and after drug-resistant TB treatment with a kanamycin-containing drug-regimen: drug-resistant TB patients assessed in three rural districts of Masvingo Zimbabwe The abstract focuses on the ototoxic effects of a kanamycin-containing regimen on drug-resistant (DR-TB) patients managed in rural Zimbabwe without previous access to audiometry monitoring. Results show the importance of screening for drug side-effects during, as well as after, stopping the drug.

Cordelia Kunzekwenyika

12:43 - 12:51: OA-17-606-22-Validation study comparing tablet-based and conventional audiometry results in stage 2 of the STREAM trial Due to limited access to conventional audiometry testing in many high TB burden countries, tablet-based audiometry was used to monitor and evaluate for changes in hearing among multidrug-resistant tuberculosis trial participants. This validation study investigates the accuracy of tablet-based audiometry compared to conventional audiometry in stage 2 of the STREAM Trial.

Ishmael Qawiy

12:51 - 12:59: OA-17-607-22-Safety and efficacy of a shorter TB treatment: time to sputum culture positivity as a surrogate marker of bacterial load in an radomised control study of high-dose rifampicin and pyrazinamide Tuberculosis (TB) treatment is long, posing a risk of poor treatment adherence. In this randomised phase II study, we aim to investigate a strategy to shorten TB treatment by exploring safety, drug exposure and efficacy of a high-dose rifampicin/pyrazinamide regimen on early bactericidal activity using time to sputum culture positivity (TTP).

David Ekqvist

12:59 - 13:07: OA-17-608-22-Predictive analyses of QT prolongation from ECG monitoring in STREAM stage 1 The STREAM stage 1 trial investigated a short nine-month regimen for the treatment of multidrug-resistant tuberculosis, which included high-dose moxifloxacin and clofazimine, both of which can lead to QT prolongation. We analysed whether assessment of QT interval early on in treatment could be used to identify patients requiring more intensive QT monitoring.

Gareth Hughes

13:07 - 13:15: OA-17-609-22-A study to determine the frequency of QT interval prolongation in people treated with bedaquiline for drug-resistant TB Bedaquiline (BDQ) is a recent addition to the drug-resistant tuberculosis (DR-TB) armamentarium. There is a black-box warning of arrhythmias and sudden death associated with BDQ therapy. This retrospective study aimed to determine the incidence of QTc prolongation and cardiac events in patients receiving BDQ DR-TB therapy under routine conditions.

Sharon Isralls

13:15 - 13:23: OA-17-610-22-Pretomanid added to bedaquiline and linezolid for patients with extensively-drug resistant TB and multidrug-resistant TB treatment failure or intolerance: a comparison of prospective cohorts The Nix-TB study, evaluating the treatment of 109 patients with highly resistant TB with the oral 3-drug regimen (bedaquiline, pretomanid and linezolid; BPaL) for six-nine months, is compared to a cohort of contemporaneous patients, in South Africa, receiving regimens that included bedaquiline and linezolid, but not pretomanid.

Suzette Oelofse

13:23 - 13:31: OA-17-611-22-Moxifloxacin pharmacokinetics and cardiac safety in children with multidrug-resistant TB In this work, we characterise moxifloxacin pharmacokinetics and the exposure-response relationship with QT-interval prolongation in children 0-17 years. These results are from two observational pharmacokinetic and safety studies and provide important information regarding moxifloxacin use in young (<7 years) children and insight on optimal dosing.

Kendra K Radtke

13:31 - 13:50: Q&A


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