Tixagevimab/ Cilgavimab Outcomes Among Patients with Immunodeficiency

ABSTRACT

Rationale The FDA granted an emergency use authorization for tixagevimab/ cilgavimab in December 2021 for COVID-19 pre-exposure prophylaxis for individuals that are moderate to severely immunocompromised and has since recommended repeat dosing every 6 months. Given its novelty and resultant hesitation for use among some physicians and patients, our study aimed to observe safety and efficacy of tixagevimab/ cilgavimab, including against one of the newest variants, Omicron BA.5, among our patient population with immunodeficiencies 6 months post-administration via a telephone survey. We hypothesized that adverse outcomes would be minimal and COVID-19 incidence and severity would lessen following tixagevimab/cilgavimab administration. Methods: The Atrium Health Wake Forest Baptist Allergy, Asthma, and Immunology department recruited 15 patients with immunodeficiencies receiving immunoglobulin replacement and tixagevimab/ cilgavimab in March 2022 for a prospective cohort study. A telephone survey was conducted 6 months later regarding tixagevimab/ cilgavimab adverse effects and incidence/severity of COVID infection before and after administration. Results: Two patients experienced minor adverse effects (fatigue, bruising) following tixagevimab/ cilgavimab administration. No severe reactions were reported. Two patients required hospitalization for severe COVID-19 infection prior to tixagevimab/cilgavimab administration, whereas 0 patients required hospitalization for COVID-19 in the 6 months following administration. Four of 5 patients that had COVID-19 following administration had not yet received the bivalent Omicron booster vaccine and 2 had received no COVID-19 vaccines. Conclusions: Tixagevimab/ cilgavimab is associated with minor adverse effects and reduction of COVID-19 severity, albeit perhaps not associated with diminished incidence of newest COVID-19 strains, in a prospective, population-based cohort.