Sputum culture reversion in longer treatments with bedaquiline, delamanid, and repurposed drugs for drug-resistant tuberculosis
Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for...
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| Vydáno v: | Nature communications Ročník 15; číslo 1; s. 3927 - 7 |
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09.05.2024
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| Abstract | Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion.
In patients with drug-resistant tuberculosis who receive treatment with new and repurposed drugs, indicators of advanced disease and delayed conversion were associated with an increased risk of reversion. These factors may be targets for close monitoring. |
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| AbstractList | Abstract Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion. Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion.Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion. Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion. Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion. In patients with drug-resistant tuberculosis who receive treatment with new and repurposed drugs, indicators of advanced disease and delayed conversion were associated with an increased risk of reversion. These factors may be targets for close monitoring. Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion.In patients with drug-resistant tuberculosis who receive treatment with new and repurposed drugs, indicators of advanced disease and delayed conversion were associated with an increased risk of reversion. These factors may be targets for close monitoring. |
| ArticleNumber | 3927 |
| Author | Kho, Sooyeon Islam, Shirajul Zarli, Khin Salahuddin, Naseem Seung, Kwonjune J. Adnan, Sana Franke, Molly Khan, Uzma Rich, Michael L. Yeghiazaryan, Lusine Hewison, Catherine Zhizhilashvili, Dali Nikolenko, Elena Nikolaevna Shaimerdenova, Aiman Bastard, Mathieu Vargas, Zully Haydee Ruíz Huerga, Helena Gelin, Alain Khan, Palwasha Y. Ahmed, Saman Vilbrun, Stalz Charles Tamirat, Meseret Bekele, Amsalu Mitnick, Carole D. |
| Author_xml | – sequence: 1 givenname: Sooyeon surname: Kho fullname: Kho, Sooyeon organization: Division of Global Health Equity, Brigham and Women’s Hospital – sequence: 2 givenname: Kwonjune J. surname: Seung fullname: Seung, Kwonjune J. organization: Division of Global Health Equity, Brigham and Women’s Hospital, Partners in Health – sequence: 3 givenname: Helena surname: Huerga fullname: Huerga, Helena organization: Epicentre – sequence: 4 givenname: Mathieu surname: Bastard fullname: Bastard, Mathieu organization: Epicentre – sequence: 5 givenname: Palwasha Y. surname: Khan fullname: Khan, Palwasha Y. organization: Department of Clinical Research, London School of Hygiene & Tropical Medicine, Interactive Research and Development Global – sequence: 6 givenname: Carole D. surname: Mitnick fullname: Mitnick, Carole D. organization: Division of Global Health Equity, Brigham and Women’s Hospital, Partners in Health, Department of Global Health and Social Medicine, Harvard Medical School – sequence: 7 givenname: Michael L. surname: Rich fullname: Rich, Michael L. organization: Division of Global Health Equity, Brigham and Women’s Hospital, Partners in Health – sequence: 8 givenname: Shirajul surname: Islam fullname: Islam, Shirajul organization: Interactive Research and Development – sequence: 9 givenname: Dali surname: Zhizhilashvili fullname: Zhizhilashvili, Dali organization: Médecins sans Frontières – sequence: 10 givenname: Lusine surname: Yeghiazaryan fullname: Yeghiazaryan, Lusine organization: National Center for Pulmonology – sequence: 11 givenname: Elena Nikolaevna surname: Nikolenko fullname: Nikolenko, Elena Nikolaevna organization: Republican Research and Practical Centre for Pulmonology and Tuberculosis – sequence: 12 givenname: Khin surname: Zarli fullname: Zarli, Khin organization: Médecins sans Frontières – sequence: 13 givenname: Sana surname: Adnan fullname: Adnan, Sana organization: Indus Hospital and Health Network – sequence: 14 givenname: Naseem surname: Salahuddin fullname: Salahuddin, Naseem organization: Indus Hospital and Health Network – sequence: 15 givenname: Saman surname: Ahmed fullname: Ahmed, Saman organization: Interactive Research and Development – sequence: 16 givenname: Zully Haydee Ruíz surname: Vargas fullname: Vargas, Zully Haydee Ruíz organization: Maria Auxiliadora Hospital – sequence: 17 givenname: Amsalu surname: Bekele fullname: Bekele, Amsalu organization: Department of Internal Medicine, Tikur Anbessa Specialized Hospital and Addis Ababa University, College of Health Sciences – sequence: 18 givenname: Aiman surname: Shaimerdenova fullname: Shaimerdenova, Aiman organization: Karaganda Regional Center of Phthisiopulmonology – sequence: 19 givenname: Meseret surname: Tamirat fullname: Tamirat, Meseret organization: Partners in Health, Lesotho – sequence: 20 givenname: Alain surname: Gelin fullname: Gelin, Alain organization: Zanmi Lasante – sequence: 21 givenname: Stalz Charles surname: Vilbrun fullname: Vilbrun, Stalz Charles organization: Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections (GHESKIO) – sequence: 22 givenname: Catherine surname: Hewison fullname: Hewison, Catherine organization: Medical Department, Médecins sans Frontières – sequence: 23 givenname: Uzma surname: Khan fullname: Khan, Uzma organization: Interactive Research and Development Global – sequence: 24 givenname: Molly orcidid: 0000-0002-4890-5728 surname: Franke fullname: Franke, Molly email: molly_franke@hms.harvard.edu organization: Partners in Health, Department of Global Health and Social Medicine, Harvard Medical School |
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| Cites_doi | 10.1056/NEJMc1603274 10.1186/s12879-019-4378-4 10.1016/j.jhep.2019.10.018 10.1093/cid/ciy727 10.1016/j.tube.2012.06.003 10.1371/journal.pone.0276457 10.1016/S2213-2600(15)00036-3 10.5588/ijtld.22.0613 10.5588/ijtld.21.0090 10.1093/cid/ciac019 10.5588/ijtld.22.0324 10.1016/j.meegid.2016.12.016 10.1183/13993003.00724-2015 10.1186/s12879-020-05350-7 10.1183/13993003.00462-2016 10.1093/ofid/ofaa653 10.1164/rccm.200801-132OC 10.1371/journal.pone.0193903 10.1371/journal.pone.0200539 10.7326/0003-4819-144-9-200605020-00008 10.1056/NEJMoa1313865 10.3201/eid2106.141873 10.1093/cid/cis1008 10.1016/j.jinf.2016.12.005 10.1016/j.jiph.2013.03.003 10.5588/ijtld.10.0221 10.1183/13993003.00804-2021 10.1164/rccm.202001-0135OC |
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Lung Dis.202125596591:STN:280:DC%2BB2c3jslCktg%3D%3D10.5588/ijtld.21.0090341831098259120 WHO. Definitions and Reporting Framework for Tuberculosis—2013 Revision: Updated December 2014 and January 2020https://www.who.int/publications/i/item/9789241505345 (2020). KhanUThe endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimensBMC Infect. Dis.20191910.1186/s12879-019-4378-4314297226701145 HoltzTHTime to sputum culture conversion in multidrug-resistant tuberculosis: predictors and relationship to treatment outcomeAnn. Intern. Med.200614465065910.7326/0003-4819-144-9-200605020-0000816670134 GüntherGTreatment outcomes in multidrug-resistant tuberculosisN. Engl. J. Med.20163751103110510.1056/NEJMc160327427626539 SeungKJHigh prevalence of hepatitis C infection among multidrug-resistant tuberculosis patientsJ. Hepatol.2020721028102910.1016/j.jhep.2019.10.01832147086 KurbatovaEVSputum culture conversion as a prognostic marker for end-of-treatment outcome in patients with multidrug-resistant tuberculosis: a secondary analysis of data from two observational cohort studiesLancet Respir. Med.2015320120910.1016/S2213-2600(15)00036-3257260854401426 KooHKPrediction of treatment failure and compliance in patients with tuberculosisBMC Infect. Dis.20202010.1186/s12879-020-05350-7328310447446045 ParmarMMUnacceptable treatment outcomes and associated factors among India’s initial cohorts of multidrug-resistant tuberculosis (MDR-TB) patients under the revised national TB control programme (2007-2011): Evidence leading to policy enhancementPLoS ONE201813e019390310.1371/journal.pone.0193903296415765894982 MitnickCDMultidrug-resistant tuberculosis treatment failure detection depends on monitoring interval and microbiological methodEur. Respir. J.2016481160117010.1183/13993003.00462-2016275875525045442 KimDHTreatment outcomes and long-term survival in patients with extensively drug-resistant tuberculosisAm. J. Respir. Crit. Care Med.2008178107510821:CAS:528:DC%2BD1cXhsFSjsrrI10.1164/rccm.200801-132OC18703792 ShinSSTreatment outcomes in an integrated civilian and prison MDR-TB treatment program in RussiaInt. J. Tuberc. Lung Dis.2006104024081:STN:280:DC%2BD287ps1CgsQ%3D%3D16602404 LinhNNWorld Health Organization treatment outcome definitions for tuberculosis: 2021 updateEur. Respir. J.202158210080410.1183/13993003.00804-202134413124 WHO. WHO Consolidated Guidelines on Tuberculosis. Module 4: Treatment—Drug-resistant Tuberculosis Treatment, 2022 Updatehttps://www.who.int/publications/i/item/9789240063129 (2022). RichMLOutcomes of WHO-conforming, longer, all-oral multidrug-resistant TB regimens and analysis implicationsInt. J. Tuberc. Lung Dis.2023274514571:STN:280:DC%2BB2s3otVWhtA%3D%3D10.5588/ijtld.22.06133723159810237267 WHO. Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, 2016 Updatehttps://www.who.int/publications/i/item/9789241549639 (2016). GamminoVMBacteriologic monitoring of multidrug-resistant tuberculosis patients in five DOTS-Plus pilot projectsInt. J. Tuberc. Lung Dis.201115131513221:STN:280:DC%2BC387osFGrsA%3D%3D10.5588/ijtld.10.022122283887 KempkerRRAcquired drug resistance in mycobacterium tuberculosis and poor outcomes among patients with multidrug-resistant tuberculosisEmerg. Infect. Dis.20152199210011:CAS:528:DC%2BC2sXivVGksg%3D%3D10.3201/eid2106.141873259930364451915 ZhaoYImproved treatment outcomes with bedaquiline when substituted for second-line injectable agents in multidrug-resistant tuberculosis: a retrospective cohort studyClin. Infect. Dis.201968152215291:CAS:528:DC%2BB3cXnt1eksr4%3D10.1093/cid/ciy72730165431 RodriguezCASelection bias in multidrug-resistant tuberculosis cohort studies assessing sputum culture conversionPLoS ONE202217e02764571:CAS:528:DC%2BB38XivV2rsbnJ10.1371/journal.pone.0276457363556589648724 ArnoldADrug resistant TB: UK multicentre study (DRUMS): Treatment, management and outcomes in London and West Midlands 2008–2014J. Infect.20177426027110.1016/j.jinf.2016.12.00527998752 KurbatovaEVPredictors of poor outcomes among patients treated for multidrug-resistant tuberculosis at DOTS-plus projectsTuberculosis20129239740310.1016/j.tube.2012.06.00322789497 HewisonCSafety of treatment regimens containing bedaquiline and delamanid in the endTB cohortClin. Infect. Dis.202275100610131:CAS:528:DC%2BB3sXlsVCnt70%3D10.1093/cid/ciac019350286599522425 WHO. WHO Consolidated Guidelines on Drug-resistant Tuberculosis Treatmenthttps://www.who.int/publications/i/item/9789241550529 (2019). FrankeMFAggressive regimens for multidrug-resistant tuberculosis reduce recurrenceClin. Infect. Dis.20125677077610.1093/cid/cis1008232235913582355 CD Mitnick (48077_CR3) 2016; 48 I Kontsevaya (48077_CR9) 2017; 48 MM Parmar (48077_CR10) 2018; 13 JP Mathuria (48077_CR28) 2013; 6 TH Holtz (48077_CR6) 2006; 144 EV Kurbatova (48077_CR21) 2012; 92 48077_CR1 KJ Seung (48077_CR23) 2020; 72 ML Rich (48077_CR25) 2023; 27 RR Kempker (48077_CR27) 2015; 21 U Khan (48077_CR30) 2019; 19 P Meyvisch (48077_CR2) 2018; 13 SS Shin (48077_CR19) 2006; 10 A Arnold (48077_CR26) 2017; 74 EV Kurbatova (48077_CR4) 2015; 3 VM Gammino (48077_CR5) 2011; 15 C Zeng (48077_CR34) 2023; 27 CA Rodriguez (48077_CR32) 2022; 17 N Melikyan (48077_CR24) 2021; 8 48077_CR12 G Günther (48077_CR14) 2016; 375 48077_CR11 DH Kim (48077_CR20) 2008; 178 48077_CR33 HK Koo (48077_CR18) 2020; 20 A Diacon (48077_CR15) 2014; 371 AS Pym (48077_CR13) 2016; 47 V Sundaram (48077_CR8) 2002; 6 NN Linh (48077_CR7) 2021; 58 Y Zhao (48077_CR16) 2019; 68 C Hewison (48077_CR29) 2022; 75 MF Franke (48077_CR22) 2012; 56 CA Rodriguez (48077_CR31) 2021; 25 MF Franke (48077_CR17) 2021; 203 |
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| Title | Sputum culture reversion in longer treatments with bedaquiline, delamanid, and repurposed drugs for drug-resistant tuberculosis |
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