Availability of drugs and resistance testing for BPaLM regimen for rifampicin-resistant tuberculosis in Europe.

Günther, Gunar; Guglielmetti, Lorenzo; Kherabi, Yousra; Duarte, Raquel; Lange, Christoph; Adamides, Tonia; Akkerman, Onno; Andersen, Aase Bengaard; Bakos, Ágnes; Bjarnason, Agnar; Bruchfeld, Judith; Chesov, Dumitru; Codecasa, Luigi Ruffo; Cirillo, Daniela; Danilovits, Manfred; Davidavičienė, Edita; Duarte, Raquel; De Souza Galvão, Maria Luiza; Garnier, Sandrine; Gjocaj, Majlinda; ... (2024). Availability of drugs and resistance testing for BPaLM regimen for rifampicin-resistant tuberculosis in Europe. (In Press). Clinical microbiology and infection Elsevier 10.1016/j.cmi.2024.03.009

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OBJECTIVES

Multidrug-resistant/Rifampicin-resistant tuberculosis (TB) is a major obstacle to successful TB control. The recommendation by the World Health Organization to use bedaquiline, pretomanid, linezolid and moxifloxacin (BPaL(M)) for 6 months, based on results of three trials with high efficacy and low toxicity, has revolutionized treatment options.

METHODS

In this study, representatives of the Tuberculosis Network European Trialsgroup (TBnet) in 44/54 countries of the WHO Europe region document the availability of the medicines and drug susceptibility testing (DST) of the BPaL(M) regimen through a structured questionnaire between September to November 2023.

RESULTS

24/44 (54.5%), 42/44 (95.5%), 43/44 (97.7%), and 43/44 (97.7%) had access to pretomanid, bedaquiline, linezolid, and moxifloxacin, respectively. Overall, 23/44 (52.3%) had access to all the drugs composing the BPaL(M) regimen. 7/44 (15.9%), 28/44 (63.6%), 34/44 (77.3%) and 36/44 (81.8%) had access to DST for pretomanid, bedaquiline, linezolid and moxifloxacin, respectively. DST was available for all medicines composing the BPaL(M) regimen in 6/44 (13.6%) countries.

CONCLUSION

Only in about half of the countries participating in the survey clinicians have access to all the BPaL(M) regimen drugs. In less than a fifth of countries, a complete DST is possible. Rapid scale up of DST capacity to prevent unnoticed spread of drug resistance and equal access to new regimens are urgently needed in Europe.

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