15 results on '"Souleymane, Mahamadou Bassirou"'
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2. High rate of adverse drug reactions with a novel tuberculosis re-treatment regimen combining triple doses of both isoniazid and rifampicin.
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Souleymane MB, Kadri S, Piubello A, Tsoumanis A, Soumana A, Issa H, Amoussa AK, Van Deun A, Lynen L, de Jong BC, and Decroo T
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- Humans, Male, Adult, Female, Rifampin adverse effects, Isoniazid adverse effects, Antitubercular Agents adverse effects, Drug Therapy, Combination, Treatment Outcome, Tuberculosis drug therapy, Drug-Related Side Effects and Adverse Reactions
- Abstract
Objectives: High-dose rifampicin (R) and isoniazid (H) are known to be safe but were not yet combined in a single regimen. The primary objective of the TRIple-DOse RE-treatment (TRIDORE) study is to determine whether a 6-month firstline regimen with triple dose of both R and H (intervention arm; 6R
3 H3 ZE) is non-inferior in terms of safety compared to a normal-dose regimen (6RHZE) in previously treated patients with R-susceptible (Rs) recurrent tuberculosis (TB)., Design/methods: TRIDORE is an ongoing pragmatic open-label multi-stage randomized clinical trial., Results: Between March 2021 and February 2022, 127 consenting patients were randomly assigned to either the intervention or control arm: 62 and 65 were treated with 6R3 H3 ZE and 6RHZE, respectively. Of 127, 111 (87.4%) were male and the median age (interquartile range) was 37 (30-48) years. The median body mass index at enrollment was 18.1 (16.3-19.7) kg/m2 . Drugrelated severe adverse events (AEs) (grade III-V) were significantly more frequent when 6R3 H3 ZE was used (5/62 vs 0/65, P = 0.03, difference weighted for site 8% [95% confidence interval: 1.0,14.3]). The Data and Safety Monitoring Board recommended publishing our interim safety data analysis., Conclusion: We show that the combination of triple-dose R with triple-dose H in a re-treatment regimen for patients with Rs-TB causes excess drug-related AEs., Competing Interests: Declarations of competing interest The authors have no competing interests to declare., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2023
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3. Definitive outcomes in patients with rifampicin-resistant tuberculosis treated in Niger from 2012 to 2019: A retrospective cohort study.
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Souleymane MB, Decroo T, Mamadou S, Soumana A, Lawan IM, Gagara-Issoufou A, Adehossi E, Ortuño-Gutiérrez N, Lynen L, Rigouts L, de Jong BC, Van Deun A, and Piubello A
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- Humans, Rifampin therapeutic use, Retrospective Studies, Niger, Treatment Outcome, Fluoroquinolones pharmacology, Fluoroquinolones therapeutic use, Antitubercular Agents therapeutic use, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
Background: Outcomes of retreatment for rifampicin-resistant tuberculosis (RR-TB) are rarely reported. We report 'definitive outcomes' after a cascade approach to RR-TB treatment. After a bacteriologically adverse outcome for the 9-months fluoroquinolone-based Short Treatment Regimen (STR), patients were retreated with a bedaquiline-based regimen (BDQ-regimen)., Methods: A Retrospective cohort study of RR-TB patients treated with the STR during 2012-2019 and retreated with a BDQ-regimen in case of failure or relapse was conducted. Definitive relapse-free cure took into account BDQ-regimen outcomes., Results: Of 367 patients treated with the STR, 20 (5.4%) experienced failure or relapse. Out of these 20 patients, 14 started a BDQ-regimen, of whom none experienced failure or relapse. Definitive end of treatment outcomes of STR after revising with third-line BDQ-regimen outcomes, 84.7% (311/367) were cured relapse-free, 10.6% (39/367) died during treatment and 3.0% (11/367) were lost to follow-up during treatment with either the STR or BDQ-regimen. Six patients (1.6%; 6/367) with STR failure/relapse died before starting a BDQ-regimen. No patient had definitive treatment failure or relapse and remained without treatment., Conclusions: If fluoroquinolone resistance is excluded or rare, it is beneficial to use fluoroquinolone as the core drug for a first RR-TB treatment regimen and to safeguard bedaquiline for those in need of retreatment., (© The Author(s) 2022. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)
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- 2023
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4. Safety, effectiveness, and adherence of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger: a study protocol of a pragmatic randomised clinical trial with stratified block randomisation.
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Souleymane MB, Decroo T, Soumana A, Maman Lawan I, Gagara-Issoufou A, Halidou-Moussa S, Ortuño-Gutiérrez N, Adehossi E, Mamadou S, Van Deun A, and Piubello A
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- Humans, Rifampin adverse effects, Linezolid adverse effects, Niger, Antitubercular Agents adverse effects, Randomized Controlled Trials as Topic, Tuberculosis, Pulmonary diagnosis, Tuberculosis, Multidrug-Resistant diagnosis, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
Background: Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence., Methods: A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm., Discussion: To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens., Trial Registration: Pan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022., (© 2022. The Author(s).)
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- 2022
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5. Treatment outcomes for multidrug- and rifampicin-resistant tuberculosis in Central and West Africa: a systematic review and meta-analysis.
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Toft AL, Dahl VN, Sifna A, Ige OM, Schwoebel V, Souleymane MB, Piubello A, and Wejse C
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- Humans, Antitubercular Agents therapeutic use, Antitubercular Agents pharmacology, Rifampin therapeutic use, Rifampin pharmacology, Directly Observed Therapy, Treatment Outcome, Tuberculosis, Multidrug-Resistant drug therapy, Tuberculosis, Multidrug-Resistant epidemiology, Mycobacterium tuberculosis
- Abstract
Objectives: We aimed to investigate published data on treatment outcomes of multidrug-resistant (MDR)/rifampicin-resistant tuberculosis (TB) in Central and West Africa because these, to the best of our knowledge, are sparsely available., Methods: Systematic review and meta-analysis., Results: A total of 14 studies were included, representing 4268 individuals in 14 of the 26 countries. Using a random-effects model meta-analysis, we observed a pooled success rate of 80.8% (95% confidence interval [CI] 56.0-93.3) for the Central African subgroup and 69.2% (95% CI 56.3-79.7) for the West African subgroup (P = 0.0522). The overall treatment success for all studies was 74.6% (95% CI 65.0-82.2). We found high heterogeneity among included studies (I
2 = 96.1%). The estimated proportion of successfully treated individuals with MDR/rifampicin-resistant TB was considerably higher than the global estimate provided by the World Health Organization (59%), reaching the 2015 World Health Organization target of at least 75% treatment success for MDR-TB., Conclusion: The use of shorter treatment regimens and the standardized treatment conditions, including directly observed therapy in these studies, could have contributed to a high treatment success. Yet, the available literature was not fully representative of the regions, possibly highlighting the sparse resources in many of these countries. The review was registered at PROSPERO (https://www.crd.york.ac.uk/prospero/) (CRD42022353163)., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)- Published
- 2022
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6. Country-specific lockdown measures in response to the COVID-19 pandemic and its impact on tuberculosis control: a global study.
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Migliori GB, Thong PM, Alffenaar JW, Denholm J, Tadolini M, Alyaquobi F, Al-Abri S, Blanc FX, Buonsenso D, Chakaya J, Cho JG, Codecasa LR, Danila E, Duarte R, Dukpa R, García-García JM, Gualano G, Kurhasani X, Manika K, Mello FCQ, Pahl K, Rendon A, Sotgiu G, Souleymane MB, Thomas TA, Tiberi S, Kunst H, Udwadia ZF, Goletti D, Centis R, D'Ambrosio L, and Silva DR
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- Communicable Disease Control, Humans, Pandemics prevention & control, COVID-19 epidemiology, COVID-19 prevention & control, Influenza, Human epidemiology, Tuberculosis
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The objective of this study was to describe country-specific lockdown measures and tuberculosis indicators collected during the first year of the COVID-19 pandemic. Data on lockdown/social restrictions (compulsory face masks and hand hygiene; international and local travel restrictions; restrictions to family visits, and school closures) were collected from 24 countries spanning five continents. The majority of the countries implemented multiple lockdowns with partial or full reopening. There was an overall decrease in active tuberculosis, drug-resistant tuberculosis, and latent tuberculosis cases. Although national lockdowns were effective in containing COVID-19 cases, several indicators of tuberculosis were affected during the pandemic.
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- 2022
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7. Gauging the impact of the COVID-19 pandemic on tuberculosis services: a global study.
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Migliori GB, Thong PM, Alffenaar JW, Denholm J, Tadolini M, Alyaquobi F, Blanc FX, Buonsenso D, Cho JG, Codecasa LR, Danila E, Duarte R, García-García JM, Gualano G, Rendon A, Silva DR, Souleymane MB, Tham SM, Thomas TA, Tiberi S, Udwadia ZF, Goletti D, Centis R, D'Ambrosio L, Sotgiu G, and Ong CWM
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- Humans, Pandemics, SARS-CoV-2, COVID-19, Tuberculosis epidemiology, Tuberculosis therapy
- Abstract
Competing Interests: Conflict of interest: G.B. Migliori has nothing to disclose. Conflict of interest: P.M. Thong has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: J. Denholm has nothing to disclose. Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: F. Alyaquobi has nothing to disclose. Conflict of interest: F-X. Blanc has nothing to disclose. Conflict of interest: D. Buonsenso has nothing to disclose. Conflict of interest: J-G. Cho has nothing to disclose. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: E. Danila has nothing to disclose. Conflict of interest: R. Duarte has nothing to disclose. Conflict of interest: J-M. García-García has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: A. Rendon has nothing to disclose. Conflict of interest: D.R. Silva has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: S.M. Tham has nothing to disclose. Conflict of interest: T.A. Thomas has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: Z.F. Udwadia has nothing to disclose. Conflict of interest: D. Goletti has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: C.W.M. Ong reports grants from National Medical Research Council (CSAINV17nov014), personal fees (young investigator award) from Institut Merieux, during the conduct of the study; other (honorarium) from Qiagen, outside the submitted work.
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- 2021
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8. High rifampicin-resistant TB cure rates and prevention of severe ototoxicity after replacing the injectable by linezolid in early stage of hearing loss.
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Souleymane MB, Piubello A, Lawan IM, Hassane-Harouna S, Assao-Neino MM, Soumana A, Hamidou-Harouna Z, Gagara-Issoufou A, Ortuño-Gutiérrez N, Roggi A, Schwoebel V, Mamadou S, Lynen L, De Jong B, Van Deun A, and Decroo T
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- Antitubercular Agents adverse effects, Humans, Linezolid adverse effects, Retrospective Studies, Rifampin adverse effects, Treatment Outcome, Deafness drug therapy, Hearing Loss chemically induced, Hearing Loss prevention & control, Ototoxicity, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
The short treatment regimen (STR) achieves a >80% cure in rifampicin-resistant tuberculosis (RR-TB) patients. However, ototoxicity induced by the injectable is a concern. This is the first study to evaluate the replacement of injectables by linezolid in patients with audiometry abnormalities at baseline or during the treatment.We conducted a retrospective cohort study of all RR-TB patients started on the STR between 2016 and June, 2019, in Niger. Patients underwent audiometry every 2 months in 2016 and every month since 2017.Of 195 patients, 16.9% (33 out of 195) received linezolid from the start (n=17), or switched from injectables to linezolid during treatment (n=16), based on audiometry abnormalities. In 2016, two patients developed severe ototoxicity despite switching to linezolid. Since 2017, no patient developed severe hearing loss or complete deafness. Severe haematological toxicity was observed in 18.1% (six out of 33) of patients on linezolid, none of which was life threatening. The use of linezolid was associated with severe but manageable adverse events (hazard ratio 8.9, 95% CI 2.5-31.5; p=0.001). A total of 90.9% (30 out of 33) of patients on a linezolid-containing STR were cured, and none experienced treatment failure. Three died, but not due to adverse events.Baseline and monthly audiometry monitoring and using linezolid after detection of hearing abnormalities appears effective to prevent severe ototoxicity, while keeping high treatment success and manageable adverse events., Competing Interests: Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: I.M. Mamane-Lawan has nothing to disclose. Conflict of interest: S. Hassane-Harouna has nothing to disclose. Conflict of interest: M.M. Assao-Neino has nothing to disclose. Conflict of interest: A. Soumana has nothing to disclose. Conflict of interest: Z. Hamidou-Harouna has nothing to disclose. Conflict of interest: A. Gagara-Issoufou has nothing to disclose. Conflict of interest: N. Ortuño-Gutiérez has nothing to disclose. Conflict of interest: A. Roggi has nothing to disclose. Conflict of interest: V. Schwoebel has nothing to disclose. Conflict of interest: S. Mamadou has nothing to disclose. Conflict of interest: L. Lynen has nothing to disclose. Conflict of interest: B. De Jong has nothing to disclose. Conflict of interest: A. Van Deun has nothing to disclose. Conflict of interest: T. Decroo has nothing to disclose., (Copyright ©ERS 2021.)
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- 2021
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9. Worldwide Effects of Coronavirus Disease Pandemic on Tuberculosis Services, January-April 2020.
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Migliori GB, Thong PM, Akkerman O, Alffenaar JW, Álvarez-Navascués F, Assao-Neino MM, Bernard PV, Biala JS, Blanc FX, Bogorodskaya EM, Borisov S, Buonsenso D, Calnan M, Castellotti PF, Centis R, Chakaya JM, Cho JG, Codecasa LR, D'Ambrosio L, Denholm J, Enwerem M, Ferrarese M, Galvão T, García-Clemente M, García-García JM, Gualano G, Gullón-Blanco JA, Inwentarz S, Ippolito G, Kunst H, Maryandyshev A, Melazzini M, de Queiroz Mello FC, Muñoz-Torrico M, Njungfiyini PB, Palmero DJ, Palmieri F, Piccioni P, Piubello A, Rendon A, Sabriá J, Saporiti M, Scognamiglio P, Sharma S, Silva DR, Souleymane MB, Spanevello A, Tabernero E, Tadolini M, Tchangou ME, Thornton ABY, Tiberi S, Udwadia ZF, Sotgiu G, Ong CWM, and Goletti D
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- Betacoronavirus, COVID-19, Humans, Pandemics, SARS-CoV-2, Tuberculosis epidemiology, Continuity of Patient Care trends, Coronavirus Infections epidemiology, Facilities and Services Utilization trends, Global Health trends, Pneumonia, Viral epidemiology, Tuberculosis therapy
- Abstract
Coronavirus disease has disrupted tuberculosis services globally. Data from 33 centers in 16 countries on 5 continents showed that attendance at tuberculosis centers was lower during the first 4 months of the pandemic in 2020 than for the same period in 2019. Resources are needed to ensure tuberculosis care continuity during the pandemic.
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- 2020
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10. High-Dose First-Line Treatment Regimen for Recurrent Rifampicin-Susceptible Tuberculosis.
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Decroo T, de Jong BC, Piubello A, Souleymane MB, Lynen L, and Van Deun A
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- Humans, Isoniazid, Pyrazinamide, Rifampin, Tuberculosis, Tuberculosis, Multidrug-Resistant
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- 2020
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11. Multidrug-resistant patients receiving treatment in Niger who are infected with M. tuberculosis Cameroon family convert faster in smear and culture than those with M. tuberculosis Ghana family.
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Ejo M, Hassane-Harouna S, Souleymane MB, Lempens P, Dockx J, Uwizeye C, De Rijk P, Decroo T, Diro E, Torrea G, Rigouts L, Piubello A, and de Jong BC
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- Bacteriological Techniques, Black People, Cameroon ethnology, Genotype, Ghana ethnology, Humans, Mycobacterium tuberculosis genetics, Mycobacterium tuberculosis pathogenicity, Niger epidemiology, Registries, Sputum microbiology, Time Factors, Treatment Outcome, Tuberculosis, Multidrug-Resistant diagnosis, Tuberculosis, Multidrug-Resistant ethnology, Tuberculosis, Multidrug-Resistant microbiology, Tuberculosis, Pulmonary diagnosis, Tuberculosis, Pulmonary ethnology, Tuberculosis, Pulmonary microbiology, Antitubercular Agents therapeutic use, Mycobacterium tuberculosis drug effects, Tuberculosis, Multidrug-Resistant drug therapy, Tuberculosis, Pulmonary drug therapy
- Abstract
In this study, we analyzed the M. tuberculosis complex (MTBc) population structure among multidrug-resistant TB (MDR-TB) patients in Niger and tested whether the Cameroon family displayed a slower response to MDR-TB treatment. We genotyped baseline clinical isolates that had been collected from pulmonary MDR-TB patients recruited consecutively between 2008 and 2016 in Niger. Spoligotyping was used to analyze the genetic diversity of mycobacterial lineages, and Kaplan Meier's analysis to compare treatment outcomes. A total of 222 MTBc isolates were genotyped; 204 (91,9%) were identified as the Euro-American L4 lineage, with the Ghana family (106, 47,4%) and the Cameroon family (63, 28,4%) being predominant. Patients infected by Cameroon family isolates 61(96,8%) showed faster conversion (log-rank p < 0.01) than those infected with Ghana family isolates (91,5%), and were more likely to experience favorable outcome (adjusted odds ratio [aOR] 4.4; 95%CI 1.1-17.9]; p = 0.015). We found no association between MTBc families and second-line drug resistance profiles (p > 0.05). Our findings show that MDR-TB in Niger is caused by major spoligotypes of the Euro-American L4; with more rapid smear and culture conversion in patients infected with the Cameroon family. These first insights may alert clinicians that slow conversion may be associated with the type of infecting strain., Competing Interests: Declaration of competing interest The authors stated that they have no competing interests., (Copyright © 2020. Published by Elsevier Ltd.)
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- 2020
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12. Standardised shorter regimens versus individualised longer regimens for rifampin- or multidrug-resistant tuberculosis.
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Abidi S, Achar J, Assao Neino MM, Bang D, Benedetti A, Brode S, Campbell JR, Casas EC, Conradie F, Dravniece G, du Cros P, Falzon D, Jaramillo E, Kuaban C, Lan Z, Lange C, Li PZ, Makhmudova M, Maug AKJ, Menzies D, Migliori GB, Miller A, Myrzaliev B, Ndjeka N, Noeske J, Parpieva N, Piubello A, Schwoebel V, Sikhondze W, Singla R, Souleymane MB, Trébucq A, Van Deun A, Viney K, Weyer K, Zhang BJ, and Ahmad Khan F
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- Antitubercular Agents therapeutic use, Humans, Microbial Sensitivity Tests, Rifampin, Treatment Outcome, Mycobacterium tuberculosis, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
We sought to compare the effectiveness of two World Health Organization (WHO)-recommended regimens for the treatment of rifampin- or multidrug-resistant (RR/MDR) tuberculosis (TB): a standardised regimen of 9-12 months (the "shorter regimen") and individualised regimens of ≥20 months ("longer regimens").We collected individual patient data from observational studies identified through systematic reviews and a public call for data. We included patients meeting WHO eligibility criteria for the shorter regimen: not previously treated with second-line drugs, and with fluoroquinolone- and second-line injectable agent-susceptible RR/MDR-TB. We used propensity score matched, mixed effects meta-regression to calculate adjusted odds ratios and adjusted risk differences (aRDs) for failure or relapse, death within 12 months of treatment initiation and loss to follow-up.We included 2625 out of 3378 (77.7%) individuals from nine studies of shorter regimens and 2717 out of 13 104 (20.7%) individuals from 53 studies of longer regimens. Treatment success was higher with the shorter regimen than with longer regimens (pooled proportions 80.0% versus 75.3%), due to less loss to follow-up with the former (aRD -0.15, 95% CI -0.17- -0.12). The risk difference for failure or relapse was slightly higher with the shorter regimen overall (aRD 0.02, 95% CI 0-0.05) and greater in magnitude with baseline resistance to pyrazinamide (aRD 0.12, 95% CI 0.07-0.16), prothionamide/ethionamide (aRD 0.07, 95% CI -0.01-0.16) or ethambutol (aRD 0.09, 95% CI 0.04-0.13).In patients meeting WHO criteria for its use, the standardised shorter regimen was associated with substantially less loss to follow-up during treatment compared with individualised longer regimens and with more failure or relapse in the presence of resistance to component medications. Our findings support the need to improve access to reliable drug susceptibility testing., Competing Interests: Conflict of interest: S. Abidi has nothing to disclose. Conflict of interest: J. Achar has nothing to disclose. Conflict of interest: M.M. Assao Neino has nothing to disclose. Conflict of interest: D. Bang has nothing to disclose. Conflict of interest: A. Benedetti has nothing to disclose. Conflict of interest: S. Brode reports grants from Insmed and the Canadian Institutes for Health Research, personal fees for educational presentations from Boehringer Ingelheim and AstraZeneca, outside the submitted work. Conflict of interest: J.R. Campbell has nothing to disclose. Conflict of interest: E. Casas has nothing to disclose. Conflict of interest: F. Conradie has nothing to disclose. Conflict of interest: G. Dravniece has nothing to disclose. Conflict of interest: P. du Cros reports he was previously a member of the steering committee and protocol writing committee for the PRACTECAL randomised controlled trial of three novel 6-month MDR-TB regimens; and has undertaken a paid consultancy between TB Alliance and Burnet Institute to investigate applicability of the TB-Nix regimen (a novel short MDR-TB regimen) to Papua New Guinea. Conflict of interest: D. Falzon has nothing to disclose. Conflict of interest: E. Jaramillo has nothing to disclose. Conflict of interest: C. Kuaban has nothing to disclose. Conflict of interest: Z. Lan has nothing to disclose. Conflict of interest: C. Lange reports personal fees for lectures from Chiesi, Gilead, Janssen, Lucane, Novartis, Oxoid, Berlin-Chemie and Thermo Fisher, outside the submitted work. Conflict of interest: P.Z. Li has nothing to disclose. Conflict of interest: M. Makhmudova has nothing to disclose. Conflict of interest: A.K.J. Maug has nothing to disclose. Conflict of interest: D. Menzies has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose. Conflict of interest: A. Miller reports that The Eli Lilly Foundation MDR-TB Partnership provided partial salary support in 2015–2016 through a grant to Salmaan Keshavjee, Harvard Medical School, although none of the work in the current paper or analysis was supported through that mechanism; the grant also paid for travel to a meeting in July of 2016. Conflict of interest: B. Myrzaliev has nothing to disclose. Conflict of interest: N. Ndjeka has nothing to disclose. Conflict of interest: J. Noeske has nothing to disclose. Conflict of interest: N. Parpieva has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: V. Schwoebel has nothing to disclose. Conflict of interest: W. Sikhondze has nothing to disclose. Conflict of interest: R. Singla has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: A. Trébucq has nothing to disclose. Conflict of interest: A. Van Deun has nothing to disclose. Conflict of interest: K. Viney has nothing to disclose. Conflict of interest: K. Weyer has nothing to disclose. Conflict of interest: B.J. Zhang has nothing to disclose. Conflict of interest: F. Ahmad Khan reports grants from the World Health Organization during the conduct of the study., (The content of this work is copyright of the authors or their employers. Design and branding are copyright ©ERS 2020.)
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- 2020
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13. Management of multidrug-resistant tuberculosis with shorter treatment regimen in Niger: Nationwide programmatic achievements.
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Piubello A, Souleymane MB, Hassane-Harouna S, Yacouba A, Lempens P, Assao-Neino MM, Maman-Lawan I, Attaher S, Moustapha B, Soumana A, Gagara-Issoufou A, Ortuño-Gutiérrez N, Roggi A, Gumusboga M, Hamidou-Harouna Z, Dockx J, Mamadou S, de Jong BC, Decroo T, and Van Deun A
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- Adolescent, Adult, Aged, Aged, 80 and over, Communicable Disease Control, Drug Resistance, Multiple, Bacterial genetics, Feasibility Studies, Female, Fluoroquinolones, Follow-Up Studies, Humans, Male, Middle Aged, Niger, Rifampin, Young Adult, Antitubercular Agents administration & dosage, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
Background: In Niger, the Shorter Treatment Regimen (STR) has been implemented nationwide for rifampicin resistant tuberculosis (RR-TB), since 2008. No previous publication has shown the results from countrywide programmatic implementation using few exclusion criteria, nor exhaustively assessed the effect of initial resistance to companion drugs on outcomes., Methods: The National Tuberculosis Programme and the Damien Foundation conducted a retrospective observational study to evaluate the management of RR-TB from 2008 to 2016. Baseline resistance to drugs was assessed phenotypically, complemented by screening the inhA, katG and pncA genes. Cured patients were followed-up for a period of one year after cure., Findings: Among 1044 patients tested for rifampicin resistance, mainly previously treated patients, 332 were diagnosed with pulmonary RR/TB, 288 were enrolled on treatment and 255 started on STR. Six patients received a modified STR. Among 249 patients on standardised STR, 207 (83·1%) were cured relapse-free, eight (3·2%) had failure, 23 (9·2%) died, seven (2·8%) were lost to follow-up and four (1·6%) relapsed. The risk of unfavourable outcome was higher in patients with initial resistance to fluoroquinolones (aOR 20·4, 95%CI:5·6-74·6) and very severely underweight (aOR 3·9, 95%CI:1·5-10·1). Successful outcome was not affected by initial resistance to companion drugs. Serious ototoxicity was reported in eight patients (3·2%)., Interpretation: A comprehensive nationwide approach to multidrug-resistant tuberculosis management using the STR was feasible and successful. Outcomes were not affected by initial resistance to companion drugs. Our study confirms the effectiveness and safety of the STR., Funding: Damien Foundation and Institute of Tropical Medicine-Antwerp., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
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- 2020
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14. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.
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Borisov S, Danila E, Maryandyshev A, Dalcolmo M, Miliauskas S, Kuksa L, Manga S, Skrahina A, Diktanas S, Codecasa LR, Aleksa A, Bruchfeld J, Koleva A, Piubello A, Udwadia ZF, Akkerman OW, Belilovski E, Bernal E, Boeree MJ, Cadiñanos Loidi J, Cai Q, Cebrian Gallardo JJ, Dara M, Davidavičienė E, Forsman LD, De Los Rios J, Denholm J, Drakšienė J, Duarte R, Elamin SE, Escobar Salinas N, Ferrarese M, Filippov A, Garcia A, García-García JM, Gaudiesiute I, Gavazova B, Gayoso R, Gomez Rosso R, Gruslys V, Gualano G, Hoefsloot W, Jonsson J, Khimova E, Kunst H, Laniado-Laborín R, Li Y, Magis-Escurra C, Manfrin V, Marchese V, Martínez Robles E, Matteelli A, Mazza-Stalder J, Moschos C, Muñoz-Torrico M, Mustafa Hamdan H, Nakčerienė B, Nicod L, Nieto Marcos M, Palmero DJ, Palmieri F, Papavasileiou A, Payen MC, Pontarelli A, Quirós S, Rendon A, Saderi L, Šmite A, Solovic I, Souleymane MB, Tadolini M, van den Boom M, Vescovo M, Viggiani P, Yedilbayev A, Zablockis R, Zhurkin D, Zignol M, Visca D, Spanevello A, Caminero JA, Alffenaar JW, Tiberi S, Centis R, D'Ambrosio L, Pontali E, Sotgiu G, and Migliori GB
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Pharmacovigilance, Prospective Studies, Antitubercular Agents adverse effects, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new ( i.e. bedaquiline, delamanid) and repurposed ( i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care., Competing Interests: Conflict of interest: S. Borisov has nothing to disclose. Conflict of interest: E. Danila has nothing to disclose. Conflict of interest: A. Maryandyshev has nothing to disclose. Conflict of interest: M. Dalcolmo has nothing to disclose. Conflict of interest: S. Miliauskas has nothing to disclose. Conflict of interest: L. Kuksa reports personal fees for trial participation from Otsuka and Tibotec, personal fees for lectures from Johnson and Johnson Services Inc., outside the submitted work. Conflict of interest: S. Manga has nothing to disclose. Conflict of interest: A. Skrahina has nothing to disclose. Conflict of interest: S. Diktanas reports personal fees for trial participation from Otsuka, grants for meeting attendance from Janssen (Sirturo), outside the submitted work. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: A. Aleksa has nothing to disclose. Conflict of interest: J. Bruchfeld has nothing to disclose. Conflict of interest: A. Koleva has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: Z.F. Udwadia has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: E. Belilovski has nothing to disclose. Conflict of interest: E. Bernal has nothing to disclose. Conflict of interest: M.J. Boeree has nothing to disclose. Conflict of interest: J. Cadiñanos Loidi has nothing to disclose. Conflict of interest: Q. Cai has nothing to disclose. Conflict of interest: J.J. Cebrian Gallardo has nothing to disclose. Conflict of interest: M. Dara has nothing to disclose. Conflict of interest: E. Davidavičienė has nothing to disclose. Conflict of interest: L. Davies Forsman has nothing to disclose. Conflict of interest: J. De Los Rios has nothing to disclose. Conflict of interest: J. Denholm has nothing to disclose. Conflict of interest: J. Drakšienė has nothing to disclose. Conflict of interest: R. Duarte has nothing to disclose. Conflict of interest: S.E. Elamin has nothing to disclose. Conflict of interest: N. Escobar Salinas has nothing to disclose. Conflict of interest: M. Ferrarese has nothing to disclose. Conflict of interest: A. Filippov has nothing to disclose. Conflict of interest: A. Garcia has nothing to disclose. Conflict of interest: J.M. García-García has nothing to disclose. Conflict of interest: I. Gaudiesiute has nothing to disclose. Conflict of interest: B. Gavazova has nothing to disclose. Conflict of interest: R. Gayoso has nothing to disclose. Conflict of interest: R. Gomez Rosso has nothing to disclose. Conflict of interest: V. Gruslys has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: W. Hoefsloot has nothing to disclose. Conflict of interest: J. Jonsson has nothing to disclose. Conflict of interest: E. Khimova has nothing to disclose. Conflict of interest: H. Kunst has nothing to disclose. Conflict of interest: R. Laniado-Laborín has nothing to disclose. Conflict of interest: Y. Li has nothing to disclose. Conflict of interest: C. Magis-Escurra has nothing to disclose. Conflict of interest: V. Manfrin has nothing to disclose. Conflict of interest: V. Marchese has nothing to disclose. Conflict of interest: E. Martínez Robles has nothing to disclose. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: J. Mazza-Stalder has nothing to disclose. Conflict of interest: C. Moschos has nothing to disclose. Conflict of interest: M. Muñoz-Torrico has nothing to disclose. Conflict of interest: H. Mustafa Hamdan has nothing to disclose. Conflict of interest: B. Nakčerienė has nothing to disclose. Conflict of interest: L. Nicod has nothing to disclose. Conflict of interest: M. Nieto Marcos has nothing to disclose. Conflict of interest: D.J. Palmero has nothing to disclose. Conflict of interest: F. Palmieri has nothing to disclose. Conflict of interest: A. Papavasileiou has nothing to disclose. Conflict of interest: M-C. Payen has nothing to disclose. Conflict of interest: A. Pontarelli has nothing to disclose. Conflict of interest: S. Quirós has nothing to disclose. Conflict of interest: A. Rendon has nothing to disclose. Conflict of interest: L. Saderi has nothing to disclose. Conflict of interest: A. Šmite has nothing to disclose. Conflict of interest: I. Solovic has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: M. van den Boom has nothing to disclose. Conflict of interest: M. Vescovo has nothing to disclose. Conflict of interest: P. Viggiani has nothing to disclose. Conflict of interest: A. Yedilbayev has nothing to disclose. Conflict of interest: R. Zablockis has nothing to disclose. Conflict of interest: D. Zhurkin has nothing to disclose. Conflict of interest: M. Zignol has nothing to disclose. Conflict of interest: D. Visca has nothing to disclose. Conflict of interest: A. Spanevello has nothing to disclose. Conflict of interest: J.A. Caminero has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: E. Pontali has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose., (Copyright ©ERS 2019.)
- Published
- 2019
- Full Text
- View/download PDF
15. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study.
- Author
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Akkerman O, Aleksa A, Alffenaar JW, Al-Marzouqi NH, Arias-Guillén M, Belilovski E, Bernal E, Boeree MJ, Borisov SE, Bruchfeld J, Cadiñanos Loidi J, Cai Q, Caminero JA, Cebrian Gallardo JJ, Centis R, Codecasa LR, D'Ambrosio L, Dalcolmo M, Danila E, Dara M, Davidavičienė E, Davies Forsman L, De Los Rios Jefe J, Denholm J, Duarte R, Elamin SE, Ferrarese M, Filippov A, Ganatra S, Garcia A, García-García JM, Gayoso R, Giraldo Montoya AM, Gomez Rosso RG, Gualano G, Hoefsloot W, Ilievska-Poposka B, Jonsson J, Khimova E, Kuksa L, Kunst H, Laniado-Laborín R, Li Y, Magis-Escurra C, Manfrin V, Manga S, Marchese V, Martínez Robles E, Maryandyshev A, Matteelli A, Migliori GB, Mullerpattan JB, Munoz-Torrico M, Mustafa Hamdan H, Nieto Marcos M, Noordin NM, Palmero DJ, Palmieri F, Payen MC, Piubello A, Pontali E, Pontarelli A, Quirós S, Rendon A, Skrahina A, Šmite A, Solovic I, Sotgiu G, Souleymane MB, Spanevello A, Stošić M, Tadolini M, Tiberi S, Udwadia ZF, van den Boom M, Vescovo M, Viggiani P, Visca D, Zhurkin D, and Zignol M
- Subjects
- Diarylquinolines administration & dosage, Drug Therapy, Combination, Feasibility Studies, Female, Humans, Male, Nitroimidazoles administration & dosage, Oxazoles administration & dosage, Pilot Projects, Tuberculosis drug therapy, World Health Organization, Antitubercular Agents adverse effects, Diarylquinolines adverse effects, Nitroimidazoles adverse effects, Oxazoles adverse effects, Tuberculosis, Multidrug-Resistant drug therapy
- Abstract
The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019., (Copyright © 2019. Published by Elsevier Ltd.)
- Published
- 2019
- Full Text
- View/download PDF
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