Presenting Authors: Fouad Boulbol, PharmD, Community Cancer Institute, Clovis, CA; Mohamed Karah Ali, PharmD, BCOP, Community Medical Centers, Clovis, CA
Co-Authors: Rebekah Faccinto, PharmD; Ngoc Nguyen, PharmD; Haifaa Abdulhaq, MD; Mohammed Bukari, MD; and Richard Ward, CCRC, Community Cancer Institute, Clovis, CA
BACKGROUND: Tixagevimab in combination with cilgavimab (Evusheld) was granted Emergency Use Authorization (EUA) by the FDA on December 8, 2021, to reduce the incidence of SARS-CoV-2 RT-PCR–positive symptomatic illness (COVID-19) in select patients. It was initially recommended for patients to receive tixagevimab 150 mg concurrently with cilgavimab 150 mg. On February 24, 2022, the FDA updated the EUA to increase the dose to tixagevimab 300 mg concurrently with cilgavimab 300 mg.
OBJECTIVE: This dose increase required patients to receive the updated dose. Despite this, many patients in our clinic did not receive their second dose, and this study will seek to evaluate why.
METHODS: In this institutional review board–approved retrospective, single-center study, we examined 25 patients who received a single dose of Evusheld from December 8, 2021, through February 24, 2022. It was later discovered that there were patients who did not receive their second dose. These patients were contacted to evaluate the reason why they did not receive their updated dose. Assessments on the patient’s education level, concerns of side effects, concerns of efficacy, concerns of lack of full FDA approval, transportation issues, as well as if the updated dose were explained appropriately.
RESULTS: Of the 19 evaluable patients, 74% were not at all concerned about the potential side effects, 63% were not concerned about efficacy, 68% were not concerned that the medication was not fully approved by the FDA, and 89% had no transportation issues to come to the clinic. In all, 63% of the patients stated that the necessity of the second dose was explained well or very well, whereas 32% of patients stated that it was not explained at all. Almost 90% of the patients who did not receive their second dose stated that lack of communication was the primary reason.
CONCLUSION: The majority of patients were interested in receiving the second dose of Evusheld. Although communications were sent out to providers and their team, only 42% of the patients received their second dose of Evusheld. During the COVID-19 pandemic, managing oncology patients presented unique challenges, and providing additional immune support was a significant concern. Our clinic is looking at improving its communication methods to ensure that such treatments reach patients effectively, and to also ensure that such omissions are not repeated in the future.
- World Health Organization. Coronavirus disease (COVID-19). www.who.int/health-topics/coronavirus#tab=tab_1
- Centers for Disease Control and Prevention. Long COVID or post-COVID conditions. www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html
- Mayo Clinic. U.S. Coronavirus Map: Tracking the Trends. www.mayoclinic.org/coronavirus-covid-19/map
- Clinicaltrials.gov. A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-Exposure Prophylaxis of COVID-19. NLM identifier: NCT04625725. Updated December 20, 2022. https://clinicaltrials.gov/study/NCT04625725
- US Food and Drug Administration. FDA authorizes revisions to Evusheld dosing. June 29, 2022. Accessed August 8, 2022. www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing
- Evusheld. Lexi-Drugs. Lexicomp online [database online]. Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com.