(259) A Pilot Study to Evaluate The Impact of the The Patch Cap®/Patch App® on Adherence to Vitamins and Elexacaftor/Tezacaftor/Ivacaftor in Patients with Cystic Fibrosis

Background: Patients with cystic fibrosis (CF) require numerous daily medications to manage their disease. Adherence to vitamin therapy is challenging due to lack of perceived immediate effect. Elexacaftor/tezacaftor/ivacaftor improves pulmonary health but adds to the daily medication burden. The development of new technologies for remote monitoring presents an opportunity to enhance rates of medication adherence. The Patch Cap®/Patch App® has been shown to improve medication adherence. The Patch Cap® adheres to the underside of a prescription bottle cap and records when a medication is taken. The Patch App® captures data from the Patch Cap® and alerts the user at scheduled medication times/prompts them to record when a medication is taken. We conducted a 90-day prospective, unblinded, observational study to evaluate the efficacy of the Patch Cap®/Patch App® to improve adherence with vitamins and elexacaftor/tezacaftor/ivacaftor.

Methods: Eligible subjects were ≥12 years of age, on a daily multivitamin and elexacaftor/tezacaftor/ivacaftor for at least 6 months, and possessed a Bluetooth enabled smartphone or device. Instruction on application and utilization of the Patch Cap® and Patch App® was provided. Refill data and patient reported medication adherence were reported for the 90 days pre and post enrollment, and medication possession ratio (MPR) (low < 50%, moderate 50-80%, high >80%) was calculated. The Patch App® captured data from the Patch Cap® when the vitamin bottle was opened. Subjects entered dosing times for elexacaftor/tezacaftor/ivacaftor into the Patch App®. For categorical data, fishers exact test was used to compare the prospective cohort data against historical controls.

Results: We enrolled 12 subjects, median age 16.3 years (range 13.5-39.3 years) with 60.5 median days of Patch App® use. Patient reported adherence to elexacaftor/tezacaftor/ivacaftor pre-enrollment was 100% (high) and post enrollment 17% (moderate) and 83% (high). The MPR pre-enrollment was 8.3% (low), 25% (moderate), 66.7% (high) and post-enrollment 16.6% (low) and 83.3% (high), p = 0.0909. Patch App® recorded adherence to twice daily dosing of elexacaftor/tezacaftor/ivacaftor was 41.4% and average time between doses 10 hours 53 minutes (range 6:16-13:58). Adherence to morning and evening doses was 52% and 69.1% respectively with 77.7% days with at least one dose recorded. Patient reported adherence to vitamins pre-enrollment was 8% (low), 25% (moderate), 67% (high) and post enrollment 0%, 42%, 58%. The MPR pre-enrollment was 58.3% (low), 25% (moderate), 16.6% (high) and the post-enrollment 33.3%, 25%, 41.7%, p = 0.1591. Vitamin adherence using the PatchRx® cap was 46.6%.

Conclusions: Patient reported adherence to elexacaftor/tezacaftor/ivacaftor and vitamins was higher than suggested by MPR and data recorded through the Patch App®. Adherence improved based on MPR with use of the Patch App®, but did not reach statistical significance likely due to small sample size. Higher adherence to elexacaftor/tezacaftor/ivacaftor (based on percentage of days with any dose taken) vs vitamins is likely due to greater perceived benefit and specialty refill/cost savings programs. Adherence to twice a day of dosing of elexacaftor/tezacaftor/ivacaftor was lower than expected. This may due to subjects failing to enter dosing times into the Patch App® but it may also suggest that as a patients’ health improves on elexacaftor/tezacaftor/ivacaftor they may become less compliant with therapy.

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