AZD7442 utilization for Pre-Exposure Prophylaxis Against COVID-19 in a French Early Access Program

Abstract

Abstract Background AZD7442, a combination of 2 neutralizing antibodies, has been shown to reduce symptomatic COVID-19 risk by 83% at 6 months among high-risk individuals in a Phase 3 trial (PROVENT). The French Health Authorities authorized AZD7442 use in immunocompromised patients through Early Access Program (EAP). Eligibility for EAP was serological anti-spike levels of < 260 BAU/ml and very high risk of severe COVID. This abstract aims to describe the AZD7442 eligible population in France and characterize AZD7442 uptake in the EAP. Methods This is a retrospective observational database analysis of the EAP data. Demographics, and clinical characteristics of participants are described. Results 27,782 patients were included in the EAP between 12/15/2021 and 11/30/2022. AZD7442 was mostly prescribed by onco-hematologists (24.2%), followed by nephrologists (19.9%), internal medicine specialists (15.6%), and rheumatologists (6.5%). 50% of participants were over 65 years, 54.7% were male. The majority (96.7%) had received at least three vaccine doses at inclusion. Most common comorbidities were cancer (34.9%), chronic kidney disease (23.7%), hypertension (23.2%), cardiovascular disease (19.4% >2CV factors), and diabetes (9.2%). 6 months follow-up data were available for 2106 patients. Conclusions In the EAP, health care professionals prioritized IC patients at the highest risk of severe COVID-19, consistent with the authorization granted in France. However, based on the approved criteria, HCP have the potential to broaden the use of AZD7442 among different IC groups which can lead to more equitable access. The large size of the EAP presents an opportunity to generate evidence regarding the effectiveness of AZD7442. Lack of follow up data highlights the need to enrich the EAP data to study relevant effectiveness endpoints as COVID-19 hospitalizations and mortality. An innovative observational comparative study is planned by combining EAP data and French National Claims database SNDS. Key messages • These findings could guide future efforts to implement COVID-19 prophylaxis measures. • The large size of the EAP presents an opportunity to generate evidence regarding the effectiveness of AZD7442.