Isoniazid-monoresistant tuberculosis in France: Risk factors, treatment outcomes and adverse events

Bachir, Marwa; Guglielmetti, Lorenzo; Tunesi, Simone; Billard-Pomarès, Typhaine; Chiesi, Sheila; Jaffré, Jérémy; Langris, Hugo; Pourcher, Valérie; Schramm, Frédéric; Robert, Jérôme; Bouchaud, Olivier; Carbonnelle, Étienne; Méchaï, F.; Nunes, Hérika Ferreira Batista; Pellan, Marine; Morin, A.-S.; Dumesnil, C.; Dumoulin, Jennifer; Roux, Alexandre; Jachym, M.; Dû, Damien Le; Marigot-Outtandy, Dhiba; Abgrall, Sophie; Chambrin, Véronique; Guillet, Carole; Fantin, Bruno; Galy, Adrien; Decousser, J.-W.; Lelièvre, Joël; Gallien, Sébastien; Nebbad-Lechani, B.; Deconinck, Laurène; Bulifon, Sophie; Fortineau, Nicolas; Wyplosz, Benjamin; Cohen, F.; Lemaître, Nadine; Crestani, Bruno; Grall, Nathalie; Pierre-Audigier, Catherine; Rioux, C.; Yazdanpanah, Yazdan; Jeunne, Claire Le; Morand, P; Roche, Nicolas; Pavie, Juliette; Loulergue, Pierre; Delcey, Véronique; Lecorché, Emmanuel; Munier, Anne‐Lise; Mougari, Faïza; Sellier, Pierre; Bille, Emmanuelle; Ferroni, Agnès; Guéry, Romain; Hummel, Aurélie; Lourenco, J; Aubry, Alexandra; Bonnet, Isabelle; Caumes, Éric; Londner, Cécile; Morel, Florence; Lacombe, Karine; Lalande, V.; Meynard, Jean-Luc; Véziris, Nicolas; Castro, N. De; Denis, Bernardino; Lafaurie, Margaux; Molina, Jean Michel; Canestri, Ana; Lassel, Ludovic; Pialoux, G.; Verdet, Charlotte; Nardi, Adines; Gominet, M.; Catherinot, Émilie

doi:10.1016/j.ijid.2021.03.093

Cited by 13 publications

(7 citation statements)

References 20 publications

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“…We found a low level of primary resistance to isoniazid and rifampicin detected by drug sensitivity testing on cultures at 3.7% for isoniazid resistance and 0.5% for rifampicin, which was lower than that reported in a recent French study [ 9 ]. For the 3 patients with isoniazid resistance detected at baseline in the PCR arm, treatment was adapted within the first week of treatment.…”

Section: Discussioncontrasting

confidence: 79%

Treatment With a Three-Drug Regimen for Pulmonary Tuberculosis Based on Rapid Molecular Detection of Isoniazid Resistance: A Noninferiority Randomized Trial (FAST-TB)

Castro

Méchaï

Bachelet

et al. 2022

Open Forum Infectious Diseases

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Background The rationale behind the use of ethambutol in the standard tuberculosis treatment is to prevent the emergence of resistance to rifampicin in case of primary resistance to isoniazid. We evaluated if early detection of isoniazid resistance using molecular testing allows to use an ethambutol-free regimen. Objective and Methods FAST-TB, a phase 4 French multicenter, open-label non-inferiority trial, compared two strategies: PCR-based detection of isoniazid and rifampicin resistance at baseline using Genotype® MTBDRplus v2.0® followed by ethambutol discontinuation if no resistance was detected (PCR arm), and a standard four-drug combination, pending phenotypic drug-susceptibility results (C arm). Adult patients with smear positive pulmonary tuberculosis were enrolled. The primary endpoint was the proportion of patients with treatment success defined as bacteriological and clinical cure at the end of treatment. A non-inferiority margin of 10% was used. Results 203 patients were randomized, 104 in the PCR arm and 99 in the C arm: 26.6% were female, median age was 37 [IQR: 28-51] years, 72.4% were born in Africa, and 5.4% were HIV-infected. Chest X-ray showed cavities in 64.5% of the cases. Overall, 169 patients met criteria of treatment success: 87/104 (83.7%) in the PCR arm and 82/99 (82.8%) in the C arm with a difference of +0.8% (90%IC: -7.9; 9.6), meeting the non-inferiority criteria in the intention-to-treat population (p = 0.02). Conclusion In a setting with low prevalence of primary isoniazid resistance, a three-drug combination with isoniazid, rifampicin, pyrazinamide based on rapid detection of isoniazid resistance using molecular testing was non-inferior to starting the recommended four-drug regimen.

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Section: Discussioncontrasting

confidence: 79%

Treatment With a Three-Drug Regimen for Pulmonary Tuberculosis Based on Rapid Molecular Detection of Isoniazid Resistance: A Noninferiority Randomized Trial (FAST-TB)

Castro

Méchaï

Bachelet

et al. 2022

Open Forum Infectious Diseases

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“…Additionally, Dean et al reported a prevalence that ranged from 10.7% to 27.2% from aggregated DR-TB data reported to WHO from routine surveillance and periodic surveys from the period from 2003 to 2017 and found that Isoniazid is the most critical drug used in the treatment of active TB, and also used for the preventive treatment of TB [42]. Isoniazid mono-resistance is the most common form of DR-TB in the world [39,43,44]. INH mono-resistance escalates the chances of poor treatment outcomes and a progression to MDR-TB [45][46][47].…”

Section: Discussionmentioning

confidence: 99%

First and Second-Line Anti-Tuberculosis Drug-Resistance Patterns in Pulmonary Tuberculosis Patients in Zambia

et al. 2023

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Background: Drug-resistant tuberculosis has continued to be a serious global health threat defined by complexity as well as higher morbidity and mortality wherever it occurs, Zambia included. However, the paucity of information on drug-susceptibility patterns of both first-line and second-line anti-tuberculosis (anti-TB) drugs, including the new and repurposed drugs used in the management of drug-resistant tuberculosis in Zambia, was the major thrust for conducting this study. Methods: A total of 132 bacteriologically confirmed TB isolates were collected from patients with pulmonary TB during the period from April 2020 to December 2021 in Southern and Eastern Provinces of Zambia. Drug-resistance profiles were determined according to four first-line and five second-line anti-TB drugs. Standard mycobacteriological methods were used to isolate and determine phenotypic drug susceptibility. Data on the participants’ social–demographic characteristics were obtained using a pre-test checklist. Results: Overall, the prevalence of resistance to one or more anti-TB drugs was 23.5% (31/132, 95% CI: 16.5–31.6%). A total of 9.8% (13/132, 95% CI: 5.3–16.2%) of the patients had multidrug-resistant TB and 1.2% were new cases, while 25.5% had a history of being previously treated for TB. Among those with mono-resistant TB strains, isoniazid (INH) resistance was the highest at 9.8% (13/132, 95% CI: 5.3–16.2%). Two (2/31) (6.5%) XDR-TB and one (1/31) (3.2%) pre-XDR-TB cases were identified among the MDR-TB patients. Previously treated patients were 40 times more likely (OR; 40.3, 95% CI: 11.1–146.5%) to have drug-resistant TB than those who had no history of being treated for TB. Conclusion: This study has established a high rate of multidrug-resistant TB and has further identified both pre-XDR- and XDR-TB. There is a need to intensify surveillance of MDR- and XDR-TB to inform future guidelines for effective treatment and monitoring.

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“…Studies conducted in different settings indicated that isoniazid mono-resistant TB is a problem in different countries [4][5][6][7][8]. The incidence of isoniazid mono-resistant TB is increasing and it is higher than RR-TB globally [9].…”

Section: Introductionmentioning

confidence: 99%

Poor treatment outcome and associated risk factors among patients with isoniazid mono-resistant tuberculosis: A systematic review and meta-analysis

et al. 2023

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Background To date, isoniazid mono-resistant tuberculosis (TB) is becoming an emerging global public health problem. It is associated with poor treatment outcome. Different studies have assessed the treatment outcome of isoniazid mono-resistant TB cases, however, the findings are inconsistent and there is limited global comprehensive report. Thus, this study aimed to assess the poor treatment outcome and its associated risk factors among patients with isoniazid mono-resistant TB. Methods Studies that reported the treatment outcomes and associated factors among isoniazid mono-resistant TB were searched from electronic databases and other sources. We used Joana Briggs Institute critical appraisal tool to assess the study’s quality. We assessed publication bias through visual inspection of the funnel plot and confirmed by Egger’s regression test. We used STATA version 17 for statistical analysis. Results Among 347 studies identified from the whole search, data were extracted from 25 studies reported from 47 countries. The pooled successful and poor treatment outcomes were 78% (95%CI; 74%-83%) and 22% (95%CI; 17%-26%), respectively. Specifically, complete, cure, treatment failure, mortality, loss to follow-up and relapse rates were 34%(95%CI; 17%-52%), 62% (95%CI; 50%-73%), 5% (95%CI; 3%-7%), 6% (95%CI; 4%-8%), 12% (95%CI; 8%-17%), and 1.7% (95%CI; 0.4%-3.1%), respectively. Higher prevalence of pooled poor treatment outcome was found in the South East Asian Region (estimate; 40%, 95%C; 34%-45%), and African Region (estimate; 33%, 95%CI; 24%-42%). Previous TB treatment (OR; 1.74, 95%CI; 1.15–2.33), having cancer (OR; 3.53, 95%CI; 1.43–5.62), and being initially smear positive (OR; 1.26, 95%CI; 1.08–1.43) were associated with poor treatment outcome. While those patients who took rifampicin in the continuation phase (OR; 0.22, 95%CI; 0.04–0.41), had extrapulmonary TB (OR; 0.70, 95%CI; 0.55–0.85), and took second-line injectable drugs (OR; 0.54, 95%CI; 0.33–0.75) had reduced risk of poor treatment outcome. Conclusion Isoniazid mono-resistant TB patients had high poor treatment outcome. Thus, determination of isoniazid resistance pattern for all bacteriologically confirmed TB cases is critical for successful treatment outcome. PROSPERO registration number: CRD42022372367

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Isoniazid-monoresistant tuberculosis in France: Risk factors, treatment outcomes and adverse events

Cited by 13 publications

References 20 publications

Treatment With a Three-Drug Regimen for Pulmonary Tuberculosis Based on Rapid Molecular Detection of Isoniazid Resistance: A Noninferiority Randomized Trial (FAST-TB)

Treatment With a Three-Drug Regimen for Pulmonary Tuberculosis Based on Rapid Molecular Detection of Isoniazid Resistance: A Noninferiority Randomized Trial (FAST-TB)

First and Second-Line Anti-Tuberculosis Drug-Resistance Patterns in Pulmonary Tuberculosis Patients in Zambia

Poor treatment outcome and associated risk factors among patients with isoniazid mono-resistant tuberculosis: A systematic review and meta-analysis

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