Background: In Belgium elecaftor/tezacaftor/ivacaftor (ETI) is reimbursed since September 2022. Side effects (SE) are known from the literature but management guidelines are scarce.
Aims and objectives: In this single center retrospective study, SE and changes in treatments were recorded over 1 year. The aim was to identify treatment schedules for patients with physical SE (PhSE) or psychological SE (PsSE).
Methods: SE were recorded from 01/09/2022- 01/09/2023 and classified using the Common Terminology Criteria for Adverse Events (CTCAE). Psychotropic drug prescriptions were noted. Patients completed the short Mental Health Side-Effects Checklist (Graziano & Quittner).
Results: 120 pwCF started ETI of whom 32 (26,6%; 18 female; mean age 34.5 years, meanppFEV1 61%) reported a total of 53 SE: 47% were PhSE (e.g. rash), 31% were PsSE (e.g. anxiety) and 22% a combination of PsSE/PhSE. CTCAE classification resulted in 8 PsSE and 10 PhSE. Management included: 1. stopping ETI (n=4, 3 PsSE); 2. interruption and restart on full dose (n=7, all PhSE); 3. interruption and restart on lower dose (n=1, PsSE); 4. reduction in dose (n=9, 3 PhSE, 6 PsSE); 5. continuation of ETI (n=11, 7 PhSE, 4 PsSE). 13/32 patients were prescribed psychotropic medicines. Most prescriptions dated before ETI initation (n=8). Three patients consulted a psychiatrist.
Conclusions: A 1 year review of medical records of pwCF who started ETI resulted in a wide range of PhSE and PsSE followed by a variety of treatment adaptations. Psychotropic medicine prescription was mostly done by pulmonologists, indicating to an insufficient involvement of psychiatric consultants. Treatment optimization proved to be a multidisciplinary challenge for each individual patient.