TB-PRACTECAL
Short All-Oral Regimens for Rifampicin-Resistant TB
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 552 patients with rifampicin-resistant tuberculosis, a 24-week regimen of bedaquiline, pretomanid, linezolid and moxifloxacin improved favourable outcome at 72 weeks compared with the 9–20-month standard of care.
N
301
Disegno
Open-label RCT
Esito
Favourable outcome at 72 weeks
Rilevanza
1
RisultatomITT: 89 % vs 52 % favourable (unfavourable 11 % vs 48 %; risk difference −37 pp, 96.6 % CI −53 to −22); noninferior, better safety with BPaLM.
Nyang'wa BT, et al. N Engl J Med. 2022;387(25):2331-2343. 10.1056/NEJMoa2117166
Discussione e critica
Generational shift in MDR-TB care: 6-month all-oral BPaLM replaces 18–24-month injectable-based regimens — now the WHO-preferred therapy for MDR-TB without fluoroquinolone resistance.