Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Pre-exposure prophylaxis for COVID-19 with Tix-agevimab/Cilgavimab in kidney transplant recipients in the Kraken variant (XBB.1.5) era: A Single-center Experience

Version 1 : Received: 30 September 2023 / Approved: 30 September 2023 / Online: 2 October 2023 (11:22:50 CEST)

How to cite: Pinchera, B.; Carrano, R.; Salemi, F.; Piccione, A.; Schettino, E.; Romano, P.; Trucillo, E.; D'Agostino, A.; Sarno, M.; Zappulo, E.; Gentile, I. Pre-exposure prophylaxis for COVID-19 with Tix-agevimab/Cilgavimab in kidney transplant recipients in the Kraken variant (XBB.1.5) era: A Single-center Experience. Preprints 2023, 2023092171. https://doi.org/10.20944/preprints202309.2171.v1 Pinchera, B.; Carrano, R.; Salemi, F.; Piccione, A.; Schettino, E.; Romano, P.; Trucillo, E.; D'Agostino, A.; Sarno, M.; Zappulo, E.; Gentile, I. Pre-exposure prophylaxis for COVID-19 with Tix-agevimab/Cilgavimab in kidney transplant recipients in the Kraken variant (XBB.1.5) era: A Single-center Experience. Preprints 2023, 2023092171. https://doi.org/10.20944/preprints202309.2171.v1

Abstract

Pre-exposure prophylaxis for COVID-19 with Tixagevimab/Cilgavimab in immunocompromised patients has reduced the risk of breakthrough infection, disease, hospitalization, and COVID-19 related mortality. However, the advent of the Kraken variant (XBB.1.5) has limited the use of this monoclonal antibody, based on poor efficacy in in vitro studies The objective of the study was to evaluate the risk of breakthrough infection, symptomatic disease, hospitalization, intensive care admission and COVID-19 related death in kidney transplanted recipients receiving pre-exposure prophylaxis with Tixagevimab/Cilgavimab for COVID-19 in the era of the Kraken variant (XBB.1.5). In a prospective, observational study, we enrolled kidney transplant patients undergoing pre-exposure prophylaxis for COVID-19 with Tixagevimab/Cilgavimab at the Division of Infectious Diseases of Federico II University of Naples between February 2023 and August 2023. Each patient subsequently underwent a six-month follow-up with symptom monitoring and surveillance nasopharyngeal swab for SARS-CoV-2 RNA detection every 30 days, regardless of symptoms. Thirty-four kidney transplant patients were enrolled and in the follow-up period, only one tested positive for the nasopharyngeal swab for SARS-CoV-2 research with asymptomatic infection and virological recovery on the eighth day from the diagnosis of infection. Therefore, no patient developed disease and no patient needed hospitalization and no death occurred. No adverse drug reaction to Tixagevimab/Cilgavimab occurred. Our data, although derived from a limited and uncontrolled sample, show the potential of Tixagevimab/Cilgavimab as a valid and viable therapeutic strategy in pre-exposure prophylaxis for immunocompromised patients. These findings highlight the importance of conducting clinical studies on this topic.

Keywords

Tixagevimab/Cilgavimab, kidney transplantation, SARS-CoV-2, COVID-19, Kraken variant, XBB.1.5, pre-exposure prophylaxis, immunosuppressed patients

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

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