Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)
RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.
∙ RETRIAL-Mental Health:
• PWCF age 6 years and up (if age is \< 12 years old, the PWCF's caregiver will complete daily diaries and surveys; see Caregiver Participant Inclusion Criteria below)
• Eligible for VTD and intending to take it
• Experienced new or worsening mental health symptoms after initiating ETI, which led to one of the following changes in treatment to currently taking:
‣ No modulators
⁃ A modulator other than ETI
⁃ A flipped dose of ETI
⁃ A reduced dose of ETI
• Willing to delay first VTD dose for short period of time to complete the Baseline assessments
• Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links
• Is English-speaking.
∙ RETRIAL-LIVER:
• A person with CF age 6 years and up
• Eligible for VTD and intending to take it
• Experienced drug-induced liver injury (as defined by local care team) after initiating ETI, which led to one of the following changes in treatment to currently taking:
‣ no modulators; or
⁃ a modulator other than ETI; or
⁃ a reduced or altered dose of ETI;
• Willing to delay first VTD dose for short period of time to complete the Baseline assessments
• Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links
• Is English-speaking.
• Is a primary, daily caregiver of a person with CF under the age of 12 enrolled in the study
• Has access to smart device (phone, tablet, etc.) capable of receiving messages with survey links
• Is able to read and complete surveys and Daily Diary in English.