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The Niger rifampicin-resistant tuberculosis treatment approach is safer than the WHO bedaquiline/linezolid-containing 9-month regimen

M B Souleymane(1) T Decroo(2) I M Lawan(1) A Soumana(3) R H Moussa(4) N O Gutiérrez(5) S Mamadou(6) B C de Jong(7) L Rigouts(7) A Van Deun(8) A Piubello(5)

1:Damien Foundation, Niamey, Niger; 2:Institute of Tropical Medicine, TB-HIV Unit, Antwerp, Belgium; 3:National Tuberculosis Programme, Coordination, Niamey, Niger; 4:Centre Hospitalier Regional de Tahoua, CAT, Tahoua, Niger; 5:Damien Foundation, Brussels, Belgium; 6:Université Abdou Moumouni de Niamey, Faculté des Science de la Santé, Niamey, Niger; 7:Institute of Tropical Medicine, Unit of Mycobacteriology, Antwerp, Belgium; 8:Independent Consultance, Leuven, Belgium

Bedaquiline (BDQ)/linezolid (LZD) all-oral short treatment regimens (AO+LZD-STR) are recommended for rifampicin-resistant tuberculosis (RR-TB) by WHO. The Niger RR-TB treatment strategy uses a second-line injectable drug (SLID)-STR, where the SLID is replaced by LZD when any grade of ototoxicity is identified on monthly audiometry. We compared both approaches through the SHOORT (SHOrt ORal Treatment) randomised clinical trial. Here we report the interim analysis for the occurrence of grade 3-4 adverse events (AE). Directly observed treatment and active drug safety and monitoring were applied throughout treatment duration. Monitoring procedures are adapted to fit the regimens (e.g. close monitoring of haemoglobin for patients taking LZD; monthly audiometry when a SLID is used). Between April 2021 and July 2022, 91 patients were enrolled. Baseline characteristics were similar for both arms. After excluding grade 3-4 AE that were attributed to a non-TB drug (n=1), 18 patients had at least one grade 3-4 AE: 5 of 46 (10.9%) treated with the Niger treatment strategy, and 13 of 45 (28.9%) treated with the all-oral STR (p=0.03). These 18 patients had 21 grade 3-4 AE (anaemia: 10, neurotoxicity: 6, hepatitis: 5, ototoxicity: 0). Ototoxicity and nephrotoxicity appeared during SLID-STR but none evolved to grade 3. Anaemia and neurotoxicity, including grade 3-4, were more frequent during treatment with the AO+LZD-STR. In conclusion, our interim data show that the Niger approach is associated with less grade 3-4 AE than the BDQ/LZD-containing all-oral STR. Findings need to be confirmed in the final analysis, expected by the end of 2023.

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