A single‐center review of pre‐exposure prophylaxis with tixagevimab–cilgavimab in solid organ transplant recipients

Abstract

BackgroundCoronavirus disease 2019 (COVID‐19) continues to negatively impact solid organ transplant recipients (SOTr). Data on the use of tixagevimab–cilgavimab (tix‐cil) in vaccinated SOTr during circulation of Omicron and its subvariants are limited. Therefore, this single‐center review was conducted to evaluate tix‐cil efficacy in multiple organ transplant groups during a study period where Omicron B.1.1.529, BA.2.12.1, and BA.5 predominated.MethodsIn this single‐center retrospective study, we evaluated the incidence of COVID‐19 infection in adult SOTr who did or did not receive pre‐exposure prophylaxis (PrEP) with tix‐cil. SOTr were included if they were at least 18 years of age and met emergency use authorization criteria for tix‐cil use. The primary outcome analyzed was the incidence of COVID‐19 infection.ResultsNinety SOTr met inclusion criteria and comprised of two groups, tix‐cil PrEP (n = 45) and no tix‐cil PrEP (n = 45). Of SOTr who received tix‐cil PrEP, three (6.7%) developed COVID‐19 infection, compared to eight (17.8%) in the no tix‐cil PrEP group (p = .20). Of the 11 SOTr diagnosed with COVID‐19, 15 (82.2%) were fully vaccinated against COVID‐19 prior to transplantation. Moreover, 18.2% and 81.8% of the COVID‐19 cases observed were asymptomatic and mild‐to‐moderate, respectively.DiscussionOur study results, which included months when BA.5 was in increased circulation, suggest no significant difference in COVID‐19 infection with or without use of tix‐cil PrEP in our solid organ transplant groups. As the COVID‐19 pandemic continues to evolve, clinical utility of tix‐cil should be evaluated against new, emerging strains. image

Tixagevimab/cilgavimab prophylaxis against COVID-19 in solid organ transplant recipients: a systematic review and meta-analysis

“…Of these, eight studies were excluded for not meeting the inclusion criteria. Ultimately, seven retrospective studies [ 9 , 12 , 13 , 16 – 18 , 21 ], involving a total of 4,026 SOTRs, met the inclusion criteria and were examined in the meta-analysis. Most of the studies were conducted in the United States, with the kidney being the most commonly transplanted organ.…”

“…Across all seven studies [ 9 , 12 , 13 , 16 – 18 , 21 ] and a total of 3,538 SOTRs, the incidence of SARS-CoV-2 infection was compared between patients who received Tix/Cil preexposure prophylaxis and those who did not. Meta-analysis revealed a significant difference in the incidence of infection between these groups.…”

“…In four studies [ 9 , 16 – 18 ], encompassing 1,766 SOTRs, mortality rates were reported for patients who received Tix/Cil preexposure prophylaxis and those who did not. The meta-analysis revealed no significant difference in mortality rate between these groups (OR, 0.25; 95% CI, 0.06–1.06; P=0.06; I 2 =0%) ( Fig.…”

“…Monoclonal antibodies (mAbs) have shown promise in treating COVID-19 in SOTRs [ 8 ]. Tixagevimab/cilgavimab (Tix/Cil) is a mAb agent that neutralizes SARS-CoV-2 by binding to specific regions of the virus’s spike protein, preventing its attachment to the angiotensin-converting enzyme 2 receptor and subsequent infection [ 9 ]. This combination mAb agent is appropriate for early-stage COVID-19 in nonhospitalized individuals at risk of severe illness and is also effective for infection prevention and postexposure protection [ 10 ].…”

“…However, the U.S. Food and Drug Administration has withdrawn the emergency use authorization of Tix/Cil for treating high-risk patients with mild-to-moderate COVID-19 due to low efficacy against Omicron subvariants [ 11 ]. Real-world data indicate that Tix/Cil prophylaxis may effectively reduce mortality and hospitalization rates in SOTRs who become infected with the Omicron variant [ 9 , 12 , 13 ]. Two recent systematic reviews and meta-analyses have supported the effectiveness of preexposure prophylaxis with this drug combination in certain populations [ 14 , 15 ].…”