The neutralizing monoclonal antibody combination of tixagevimab/cilgavimab has been shown to reduce the risk of SARS-CoV-2 infection in unvaccinated individuals during the Alpha (B.1.1.7) and Delta (B.1.617.2) waves. However, data on the efficacy and safety of tixagevimab/cilgavimab in vaccinated solid organ transplant recipients during the Omicron wave is limited. To address this, we conducted a retrospective cohort study comparing 222 solid organ transplant recipients (SOTRs) who received tixagevimab/cilgavimab for pre-exposure prophylaxis and 222 vaccine-matched solid organ transplant recipients who did not receive tixagevimab/cilgavimab. Breakthrough SARS-CoV-2 infections occurred in 11 (5%) of SOTRs who received tixagevimab/cilgavimab and in 32 (14%) of SOTRs in the control group (p < .001). In the tixagevimab/cilgavimab group, SOTRs who received the 150–150 mg dose had a higher incidence of breakthrough infections compared to those who received the 300–300 mg dose (p = .025). Adverse events were uncommon, occurring in 4% of our cohort and most were mild. There was no significant change in serum creatinine or liver chemistries in kidney and liver transplant recipients, respectively. In conclusion, we found that tixagevimab/cilgavimab use is safe and associated with a lower risk of breakthrough SARS-CoV-2 infection in vaccinated solid organ transplant recipients during the Omicron wave.
Background.: In solid organ transplant recipients (SOTRs), studies investigating post–acute sequelae of SARS-CoV-2 infection (PASC) are limited, and risk factors for their development require further investigation. Methods.: In this cross-sectional study, we evaluated PASC symptoms among SOTRs followed at our institutions who had COVID-19 during the Omicron period from December 28, 2021, to November 4, 2022. Participants were surveyed using a newly published PASC score containing 13 symptoms experienced for ≥30 d. PASC was defined as a score of ≥12. Results.: Of 299 SOTRs invited, 93 completed the survey and were analyzed. The mean age was 58 y and 43% were women. Forty-six individuals (49%) reported experiencing ≥1 PASC symptom for ≥30 d, of whom 13 (14%) met the PASC definition. Multivariable analysis showed that female sex (adjusted odds ratio [aOR] = 0.32; 95% confidence interval [CI], 0.12-0.83), years from transplantation (aOR = 0.90 per additional year; 95% CI, 0.81-0.99), and tixagevimab-cilgavimab preexposure prophylaxis (aOR = 0.33; 95% CI, 0.12-0.84) were associated with significantly lower odds of developing ≥1 PASC symptom. Conclusions.: PASC symptoms are common in SOTRs infected during the Omicron period. PASC symptoms are less frequent in those with a longer time since transplant and in those who received tixagevimab-cilgavimab. New SARS-CoV-2 prevention and treatment strategies should also evaluate PASC symptoms as outcomes.
The neutralizing monoclonal antibody combination of tixagevimab/cilgavimab has been shown to reduce the risk of SARS-CoV-2 infection in unvaccinated individuals during the Alpha (B.1.1.7) and Delta (B.1.617.2) waves. However, data on efficacy and safety of tixagevimab/cilgavimab in vaccinated solid organ transplant recipients during the Omicron wave is limited. To address this, we conducted a retrospective cohort study comparing 222 solid organ transplant recipients who received tixagevimab/cilgavimab for pre-exposure prophylaxis and 222 age-matched vaccinated solid organ transplant recipients who did not receive tixagevimab/cilgavimab. Subjects were followed for a mean of 67 ± 18 days. Kaplan-Meier estimates of the 60-day incidence of breakthrough infection were 1.8% in the tixagevimab/cilgavimab group and 4.7% in the control group ( P = 0.045). Adverse events were uncommon, occurring in 4% of our cohort and most were mild. There was no significant change in serum creatinine or liver chemistries in kidney and liver transplant recipients respectively. In conclusion, we found that tixagevimab/cilgavimab use is safe and associated with a lower risk of breakthrough SARS-CoV-2 infection in vaccinated solid organ transplant recipients during the Omicron wave.
Immunoglobulin A (IgA) nephropathy is a common cause of kidney failure and can recur after kidney transplantation, increasing the risk of allograft loss. Effective treatments for recurrent IgA nephropathy in kidney transplant recipients are urgently needed. Iptacopan is a complement factor B inhibitor that received accelerated approval by the US Food and Drug Administration in August 2024 for the treatment of high-risk native IgA nephropathy based on trials that excluded transplant recipients. In this case series, we report our early experience with iptacopan in three individuals with biopsy-confirmed recurrent IgA nephropathy after kidney transplant. All received iptacopan for ≥3 months in combination with a short course of systemic corticosteroids. Two individuals demonstrated significant reductions in proteinuria and resolution of microscopic hematuria. One individual developed progressive graft dysfunction; repeat biopsy showed persistent active glomerulonephritis with codeposition of IgG, suggesting a more aggressive or atypical disease phenotype. These early data suggest that iptacopan, in combination with short-term corticosteroids, may offer therapeutic benefit in selected kidney transplant recipients with recurrent IgA nephropathy, warranting further investigation.