Patient-reported outcomes after Tixagevimab and Cilgavimab pre-exposure prophylaxis among solid organ transplant recipients: Safety, effectiveness, and perceptions of risk.
Clin Transplant
; 37(4): e14913, 2023 04.
Article
in English
| MEDLINE | ID: covidwho-2192504
ABSTRACT
BACKGROUND:
Tixagevimab and Cilgavimab (T + C) is authorized for pre-exposure prophylaxis (PrEP) against Coronavirus Disease 2019 (COVID-19) in solid organ transplant recipients (SOTRs), yet patient-reported outcomes after injection are not well described. Furthermore, changes in risk tolerance after T + C PrEP have not been reported, of interest given uncertain activity against emerging Omicron sublineages.METHODS:
Within a national prospective observational study, SOTRs who reported receiving T + C were surveyed for 3 months to ascertain (1) local and systemic reactogenicity, (2) severe adverse events with focus on cardiovascular and alloimmune complications, and (3) breakthrough COVID-19, contextualized through (4) changes in attitudes regarding COVID-19 risk and behaviors.RESULTS:
At 7 days postinjection, the most common reactions were mild fatigue (29%), headache (20%), and pain at injection sites (18%). Severe adverse events were uncommon; over 3 months of follow-up, 4/392 (1%) reported acute rejection and one (.3%) reported a myocardial infarction. Breakthrough COVID-19 occurred in 9%, 16-129 days after receiving full dose (300/300 mg) T + C, including two non-ICU hospitalizations. Most surveyed SOTRs (65%) felt T + C PrEP was likely to reduce their COVID-19 risk, and 70% reported increased willingness to engage in social activities such as visiting friends. However, few felt safe to return to in-person work (20%) or cease public mask-wearing (15%).CONCLUSIONS:
In this prospective study of patient-reported outcomes, T + C was well tolerated with few serious events. Several COVID-19 breakthroughs were reported, notable as most SOTRs reported changes in risk tolerance after T + C. These results aid counseling of SOTRs regarding real-world safety and effectiveness of T + C.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Organ Transplantation
/
Pre-Exposure Prophylaxis
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Variants
Limits:
Humans
Language:
English
Journal:
Clin Transplant
Journal subject:
Transplantation
Year:
2023
Document Type:
Article
Affiliation country:
Ctr.14913
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