Safety and efficacy of elexacaftor/tezacaftor/ivacaftor in adolescents and adults with cystic fibrosis and <i>F508del</i> -gating and <i>F508del</i> -residual function genotypes: Results from an open-label extension study
ELX/TEZ/IVA remained generally safe and well-tolerated with no new safety findings. Improvements in lung function, CFTR function, respiratory symptoms, and nutritional status after starting ELX/TEZ/IVA were maintained through 96 weeks of follow-up. These results demonstrate the safety and durable efficacy of ELX/TEZ/IVA in adolescents and adults with F/G or F/RF genotypes.
Authors
- Nina E. Suresh (ORCID: https://orcid.org/0000-0001-9663-6414)
- Deepika Polineni (ORCID: https://orcid.org/0000-0001-8551-3734)
- Kimberly McBennett (ORCID: https://orcid.org/0000-0001-9642-3814)
- Patrick R. Sosnay (ORCID: https://orcid.org/0000-0002-4798-6394)
- Pedro Mondéjar-López (ORCID: https://orcid.org/0000-0003-0145-0583)
- James F. Chmiel (ORCID: https://orcid.org/0000-0003-4495-4693)
- Mark T. Jennings (ORCID: https://orcid.org/0000-0001-6570-9481)
- Y. Zhang
- Philip Robinson (ORCID: https://orcid.org/0000-0001-6129-9075)
- Peter J. Barry
- Elke De Wachter
- Jennifer L Taylor-Cousar
- Isabelle Fajac
- Bonnie Ramsey
- on behalf of the 445-110 study group
- Edward F McKone
- Elizabeth Tullis
- Bradley S Quon
- Marcus A Mall
- Sivagurunathan Sutharsan
- Carla Colombo
Institutions
- Seattle Children's Hospital (US)
- St. Michael's Hospital (CA)
- Vrije Universiteit Brussel (BE)
- Washington University in St. Louis (US)
- Université Paris Cité (FR)
- University Hospitals of Cleveland (US)
- St. Paul's Hospital (CA)
- Riley Hospital for Children (US)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
- University of Manchester (GB)
- National Jewish Health (US)
- Ruhrlandklinik (DE)
- Sorbonne Paris Cité (FR)
- Manchester University NHS Foundation Trust (GB)
- St. Vincent's University Hospital (IE)
- Universitair Ziekenhuis Brussel (BE)
- German Centre for Cardiovascular Research (DE)
- St Michael's Hospital (GB)
- Murdoch Children's Research Institute (AU)
- Hospital Universitario Virgen de la Arrixaca (ES)
- Institute of Infection and Immunity (CA)
- Indiana University – Purdue University Indianapolis (US)
- Vertex Pharmaceuticals (United States) (US)
- Charité - Universitätsmedizin Berlin (DE)
- Manchester University (US)
- University of Colorado Denver (US)
Publication Details
- Journal
- Annals of the American Thoracic Society
- Published
- 2026-03-16
- DOI
- https://doi.org/10.1093/annalsats/aaoag053
- Primary Topic
- Cystic Fibrosis Research Advances
- Type
- article
- Field-Weighted Citation Impact
- 0.00