Chiang, Teresa PY, Alejo, Jennifer L., Mitchell, Jonathan, Kim, Jake D., Abedon, Aura T., Karaba, Andrew H., Thomas, Letitia, Levan, Macey L., Garonzik-Wang, Jacqueline M., Avery, Robin K., Pekosz, Andrew, Clarke, William A., Warren, Daniel S., Tobian, Aaron A. R., Massie, Allan B., Segev, Dorry L., and Werbel, William A.
American Journal of Transplantation. September, 2022, Vol. 22 Issue 9, p2254, 7 p.
Mitchell, Jonathan, Chiang, Teresa PY, Alejo, Jennifer L., Kim, Jake D., Chang, Amy, Abedon, Aura T., Avery, Robin K., Tobian, Aaron A. R., Levan, Macey L., Warren, Daniel S., Garonzik-Wang, Jacqueline M., Segev, Dorry L., Massie, Allan B., and Werbel, William A.
Chang, Amy, Chiang, Teresa PY., Kim, Jake D., Mitchell, Jonathan, Alejo, Jennifer L., Jefferis, Alexa A., Avery, Robin K., Tobian, Aaron A. R., Levan, Macey L., Warren, Daniel S., Garonzik-Wang, Jacqueline M., Massie, Allan B., Segev, Dorry L., and Werbel, William A.
Alejo, Jennifer L., Ruck, Jessica M., Chiang, Teresa P. Y., Abedon, Aura T., Kim, Jake D., Avery, Robin K., Tobian, Aaron A. R., Warren, Daniel S., Levan, Macey L., Massie, Allan B., Garonzik-Wang, Jacqueline M., Segev, Dorry L., and Werbel, William A.
Chang, Amy, Mitchell, Jonathan, Alejo, Jennifer L., Chiang, Teresa P.Y., Abedon, Aura T, Kim, Jake D., Avery, Robin K., Tobian, Aaron A.R., Levan, Macey L., Warren, Daniel S., Garonzik-Wang, Jacqueline M., Massie, Allan B., Segev, Dorry L., and Werbel, William A.
Alejo, Jennifer, Chiang, Teresa PY, Mitchell, Jonathan, Kim, Jake D, Abedon, Aura T, Avery, Robin K, Tobian, Aaron AR, Garonzik-Wang, Jacqueline M, Warren, Daniel S, Segev, Dorry L, Werbel, William A, and Bae, Sunjae
Chiang, Teresa Po-Yu, Alejo, Jennifer L, Mitchell, Jonathan, Kim, Jake D, Abedon, Aura T, Karaba, Andrew H, Thomas, Letitia, Levan, Macey L, Garonzik-Wang, Jacqueline M, Avery, Robin K, Pekosz, Andrew, Clarke, William A, Warren, Daniel S, Tobian, Aaron AR, Massie, Allan B, Segev, Dorry L, and Werbel, William A
Alejo, Jennifer, Chiang, Teresa PY, Zeiser, Laura Bowles, Kim, Jake D, Mitchell, Jonathan, Avery, Robin K, Tobian, Aaron AR, Massie, Allan B, Werbel, William A, and Segev, Dorry L
Chang, Amy, Chiang, Teresa PY, Alejo, Jennifer L, Mitchell, Jonathan, Kim, Jake D, Abedon, Aura T, Avery, Robin K, Tobian, Aaron AR, Massie, Allan B, Levan, Macey L, Warren, Daniel S, Garonzik-Wang, Jacqueline M, Segev, Dorry L, and Werbel, William A
Alejo, Jennifer L., Chiang, Teresa P.Y., Bowles Zeiser, Laura, Kim, Jake D., Mitchell, Jonathan, Avery, Robin K., Tobian, Aaron A. R., Abedon, Rivka R., Levan, Macey L., Warren, Daniel S., Garonzik-Wang, Jacqueline M., Massie, Allan B., Segev, Dorry L., and Werbel, William A.
Abedon, Aura T., Alejo, Jennifer L., Kim, Jake D., Thomas, Letitia, Mitchell, Jonathan, Chiang, Teresa P. Y., Avery, Robin K., Tobian, Aaron A. R., Levan, Macey L., Warren, Daniel S., Massie, Allan B., Garonzik-Wang, Jacqueline M., Segev, Dorry L., and Werbel, William A.
Abedon, Aura T., Alejo, Jennifer L., Kim, Jake D., Thomas, Letitia, Mitchell, Jonathan, Chiang, Teresa P.Y., Avery, Robin K., Tobian, Aaron A.R., Levan, Macey L., Warren, Daniel S., Massie, Allan B., Garonzik-Wang, Jacqueline M., Segev, Dorry L., and Werbel, William A.
Alejo, Jennifer L., Kim, Jake D., Chiang, Teresa P.Y., Avery, Robin K., Karaba, Andrew H., Jefferis, Alexa, Warren, Daniel S., Massie, Allan B., Tobian, Aaron A.R., Segev, Dorry L., and Werbel, William A.
Background Methods Results Conclusions 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.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.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%).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. [ABSTRACT FROM AUTHOR]
Abedon, Aura T., Teles, Mayan S., Alejo, Jennifer L., Kim, Jake D., Mitchell, Jonathan, Chiang, Teresa P. Y., Avery, Robin K., Tobian, Aaron A. R., Levan, Macey L., Warren, Daniel S., Massie, Allan B., Garonzik-Wang, Jacqueline M., Segev, Dorry L., and Werbel, William A.
Karaba AH, Kim JD, Chiang TP, Alejo JL, Abedon AT, Mitchell J, Chang A, Eby Y, Johnston TS, Aytenfisu T, Hussey C, Jefferis A, Fortune N, Abedon R, Thomas L, Warren DS, Sitaras I, Pekosz A, Avery RK, Massie AB, Clarke WA, Tobian AAR, Segev DL, and Werbel WA
MedRxiv : the preprint server for health sciences [medRxiv] 2022 May 26. Date of Electronic Publication: 2022 May 26.
Abstract
Neutralizing antibody responses are attenuated in many solid organ transplant recipients (SOTRs) despite SARS-CoV-2 vaccination. Pre-exposure prophylaxis (PrEP) with the monoclonal antibody combination Tixagevimab and Cilgavimab (T+C) might augment immunoprotection, yet activity against Omicron sublineages in vaccinated SOTRs is unknown. Vaccinated SOTRs who received 300+300mg T+C (either single dose or two 150+150mg doses) within a prospective observational cohort submitted pre- and post-injection samples between 1/10/2022-4/4/2022. Binding antibody (anti-receptor binding domain [RBD], Roche) and surrogate neutralization (%ACE2 inhibition; ≥20% connoting neutralizing inhibition, Meso Scale Discovery) were measured against variants including Omicron sublineages BA.1 and BA.2. Data were analyzed using the Wilcoxon matched-pairs signed-rank test and McNemar's test. Among 61 participants, median (IQR) anti-RBD increased from 424 (IQR <0.8-2322.5) to 3394.5 (IQR 1403.9-7002.5) U/ml post T+C (p<0.001). The proportion demonstrating vaccine strain neutralizing inhibition increased from 46% to 100% post-T+C (p<0.001). BA.1 neutralization was low and did not increase (8% to 16% of participants post-T+C, p=0.06). In contrast, BA.2 neutralization increased from 7% to 72% of participants post-T+C (p<0.001). T+C increased anti-RBD levels, yet BA.1 neutralizing activity was minimal. Encouragingly, BA.2 neutralization was augmented and in the current variant climate T+C PrEP may serve as a useful complement to vaccination in high-risk SOTRs.