Tixagevimab-cilgavimab appears effective for pre-exposure prophylaxis against COVID-19 among kidney transplant recipients (KTRs) who have little or no antibody response after COVID-19 vaccination, according to investigators.
In a retrospective French study, investigators compared outcomes between 333 KTRs who received intramuscular tixagevimab-cilgavimab injections (150 mg each) for prophylaxis and 97 who did not because of patient refusal or a contraindication (such as a recent cardiovascular event). All had no COVID-19 vaccine response or a weak response, defined as an anti-spike antibody level of 7-264 BAU/mL after at least 3 doses of mRNA vaccines. During the study period, Omicron variants BA.1 and BA.2 predominated.
Symptomatic COVID-19 developed in a significantly smaller proportion of the group that received tixagevimab-cilgavimab compared with the group that did not (12.3% vs 43.3%), Lionel Couzi, MD, PhD, and colleagues from Pellegrin University Hospital in Bordeaux, France, reported in Kidney International. The group receiving these monoclonal antibodies had a significant 99% lower risk for symptomatic COVID-19.
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Overall hospitalization (1.2% vs 11.3%) and intensive care hospitalization rates (0.6% vs 6.2%) were also lower among the group who did and did not receive prophylaxis. Pre-exposure prophylaxis was significantly associated with a 95% lower risk for both hospitalization and an intensive care unit stay.
Death due to acute respiratory distress syndrome occurred in 1 and 2 patients in the prophylaxis and no prophylaxis groups, respectively. The risk of dying from COVID-19 acute respiratory distress syndrome was a significant 92% lower with tixagevimab-cilgavimab.
According to the investigators, 150 mg tixagevimab/150 mg cilgavimab may not provide full protection. The US FDA now recommends increasing the dose to 300 mg each with repeat dosing every 6 months.
“Although this study is inherently retrospective and not randomized, it reports an effectiveness of the preexposure prophylaxis by Evusheld™ in KTRs, during an Omicron wave dominated by BA.1 and BA.2 variants,” Dr Couzi’s team concluded.
References
Kaminski H, Gigan M, Vermorel A, et al. Covid-19 morbidity decreases with tixagevimab/cilgavimab preexposure prophylaxis in kidney transplant recipients non/low vaccine responders. Kidney Int. Published online July 20, 2022. doi:10.1016/j.kint.2022.07.008
FDA authorizes revisions to Evusheld dosing [release]. US Food and Drug Administration; Updated June 29, 2022. Accessed at https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing
