Details

Autor(en) / Beteiligte

• Haley, Connie A
• Schechter, Marcos C
• Ashkin, David
• Peloquin, Charles A
• Peter Cegielski, J
• Andrino, Barbara B
• Burgos, Marcos
• Caloia, Lori A
• Chen, Lisa
• Colon-Semidey, Angel
• DeSilva, Malini B
• Dhanireddy, Shireesha
• Dorman, Susan E
• Dworkin, Felicia F
• Hammond-Epstein, Heidi
• Easton, Alice V
• Gaensbauer, James T
• Ghassemieh, Bijan
• Gomez, Maria E
• Horne, David
• Jasuja, Supriya
• Jones, Betsy A
• Kaplan, Leonard J
• Khan, Asharaf Edward
• Kracen, Elizabeth
• Labuda, Sarah
• Landers, Karen M
• Lardizabal, Alfred A
• Lasley, Maria T
• Letzer, David M
• Lopes, Vinicius K
• Lubelchek, Ronald J
• Patricia Macias, C
• Mihalyov, Aimee
• Misch, Elizabeth Ann
• Murray, Jason A
• Narita, Masahiro
• Nilsen, Diana M
• Ninneman, Megan J
• Ogawa, Lynne
• Oladele, Alawode
• Overman, Melissa
• Ray, Susan M
• Ritger, Kathleen A
• Rowlinson, Marie-Claire
• Sabuwala, Nadya
• Schiller, Thomas M
• Schwartz, Lawrence E
• Spitters, Christopher
• Thomson, Douglas B
• Tresgallo, Rene Rico
• Valois, Patrick
• Goswami, Neela D

Titel

Implementation of Bedaquiline, Pretomanid, and Linezolid in the United States: Experience Using a Novel All-Oral Treatment Regimen for Treatment of Rifampin-Resistant or Rifampin-Intolerant Tuberculosis Disease

Ist Teil von

• Clinical infectious diseases, 2023-10, Vol.77 (7), p.1053-1062

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2023

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract Background Rifampin-resistant tuberculosis is a leading cause of morbidity worldwide; only one-third of persons start treatment, and outcomes are often inadequate. Several trials demonstrate 90% efficacy using an all-oral, 6-month regimen of bedaquiline, pretomanid, and linezolid (BPaL), but significant toxicity occurred using 1200-mg linezolid. After US Food and Drug Administration approval in 2019, some US clinicians rapidly implemented BPaL using an initial 600-mg linezolid dose adjusted by serum drug concentrations and clinical monitoring. Methods Data from US patients treated with BPaL between 14 October 2019 and 30 April 2022 were compiled and analyzed by the BPaL Implementation Group (BIG), including baseline examination and laboratory, electrocardiographic, and clinical monitoring throughout treatment and follow-up. Linezolid dosing and clinical management was provider driven, and most patients had linezolid adjusted by therapeutic drug monitoring. Results Of 70 patients starting BPaL, 2 changed to rifampin-based therapy, 68 (97.1%) completed BPaL, and 2 of the 68 (2.9%) experienced relapse after completion. Using an initial 600-mg linezolid dose daily adjusted by therapeutic drug monitoring and careful clinical and laboratory monitoring for adverse effects, supportive care, and expert consultation throughout BPaL treatment, 3 patients (4.4%) with hematologic toxicity and 4 (5.9%) with neurotoxicity required a change in linezolid dose or frequency. The median BPaL duration was 6 months. Conclusions BPaL has transformed treatment for rifampin-resistant or intolerant tuberculosis. In this cohort, effective treatment required less than half the duration recommended in 2019 US guidelines for drug-resistant tuberculosis. Use of individualized linezolid dosing and monitoring likely enhanced safety and treatment completion. The BIG cohort demonstrates that early implementation of new tuberculosis treatments in the United States is feasible. An all-oral 6-month regimen of bedaquiline, pretomanid, and linezolid (BPaL) was implemented in the United States to treat rifampin-resistant and rifampin-intolerant tuberculosis. All patients safely completed treatment using close monitoring, linezolid serum drug levels, and early management of adverse events. Graphical Abstract Graphical Abstract This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/implementation-of-bpal-in-the-united-states-experience-using-a-novel-all-oral-treatment-regimen-for-treatment-of-rifampin-resistant-or-rifampin-intolerant-tb-disease-dee64faf-9909-4a26-ac3a-bf8078a7a4a3