A non-randomized pragmatic historically controlled trial evaluating the effectiveness and safety of a bedaquiline or a linezolid-based short regimen for rifampicin-resistant tuberculosis - 06/12/24
, Adriano Zacarias c, Rafael Terán c, Arlete Nindia d, Juan Espinosa-Pereiro a, b, Sandra Aixut a, c, Maria Eugenia Ramos e, Marcos José Nicolau e, Elena Sulleiro f, Maria Teresa Tórtola f, Adrián Sánchez-Montalvá a, b, g, 1, Israel Molina a, b, 1Summary |
Background |
Short all-oral regimens for Rifampicin-resistant tuberculosis (ShORRT) have been a turning point in the treatment of drug-resistant tuberculosis. Despite this, access to drugs, stockouts, or adverse effects may limit the use of the recommended regimens.
Methods |
Pragmatic non-randomized trial evaluating the efficacy and safety of a ShORRT strategy for the treatment of rifampicin-resistant Tuberculosis (RR-TB) at the Hospital Nossa Senhora da Paz (Angola). The strategy assigned participants to receive a bedaquiline (BDQ) or a linezolid-based (LZF) regimen supplemented with levofloxacin, clofazimine, and cycloserine for up to 9 months.
Results |
One hundred and twenty-one participants with pulmonary RR-TB were treated with the ShORRT strategy; 69 received the bedaquiline- and 52 the linezolid-based regimen. Overall, 98 (81%) participants had successful treatment outcomes, which was significantly higher compared to a 20-month historical injectable-based regimen (successful outcome rate including cure and treatment completed: 53.7%) (p < 0.001). No significant differences between treatment success rates (85.5% vs. 75.0%), treatment failure (0.0% vs. 1.9%), death (5.8% vs. 13.5%), or lost to follow-up (LTFU) (8.7% vs. 9.6%) were seen between the BDQ and the LZF-based regimen. Globally, 72 adverse events (AE) occurred in 36 (29.7%) participants. Eighteen (14.9%) of these were grade ≥3 and were more frequently observed in those receiving the LZD-based regimen (p = 0.02).
Conclusion |
The ShORRT strategy with a nine-month BDQ- or LZD-based regimen supports the efficacy of shorter all-oral regimens for the treatment of RR-TB and presents real-world data from schemes without bedaquiline, nitroimidazole, or injectables.
Le texte complet de cet article est disponible en PDF.Highlights |
• | The short all-oral strategy for RR-TB had better success rates than the old injectable-based treatment. |
• | No significant differences were found in outcomes between bedaquiline and linezolid regimens. |
• | Nearly 30% of participants experienced adverse events, which were more common early in treatment. |
Keywords : Tuberculosis, Drug-resistance, Pragmatic trial
Plan
Vol 89 - N° 6
Article 106291- décembre 2024 Retour au numéro
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