Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR)
© 2023 Wiley Periodicals LLC..
BACKGROUND: Despite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R- liver transplant recipients (LTxRs), real-world effectiveness may be lower because of logistical concerns about feasibility of PET.
METHODS: We retrospectively assessed PET as standard clinical care at a single transplant center among 50 consecutive adult CMV D+R- LTxRs undergoing a first liver transplant between 4/4/2019 and 5/18/2021 and compared outcomes and adherence to those randomized to PET in the CAPSIL study (N = 100). The primary outcome was CMV disease and secondary outcomes were biopsy-confirmed acute allograft rejection, retransplant, invasive fungal infections, and death, all assessed by 1-year post-transplant. Exploratory outcomes included virologic parameters and measures of adherence to protocol-specified CMV qPCR monitoring.
RESULTS: Baseline characteristics were similar between groups. The cumulative incidence of CMV disease at 1-year post-transplant was 4/50 (8%) versus 9/100 (9%) in the real-world and CAPSIL cohorts, respectively, p = 1.0. The rate of breakthrough CMV disease during the 100-day PET period was low (2/50 [4%]) and similar to the PET cohort from the CAPSIL study (3/100 [3%]). All secondary and exploratory outcomes were not significantly different between the real-world and CAPSIL PET cohorts.
CONCLUSIONS: In this first reported study of real-world PET, the feasibility and effectiveness for CMV disease prevention and for other clinical outcomes in CMV D+R- LTxRs were similar to those reported with PET in a clinical trial. Additional studies to confirm feasibility and generalizability in other settings are warranted.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
|---|---|
| Enthalten in: |
Transplant infectious disease : an official journal of the Transplantation Society - 25(2023), 2 vom: 14. Apr., Seite e14015 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Doss, Kathleen M [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antiviral Agents |
|---|
| Anmerkungen: |
Date Completed 11.04.2023 Date Revised 11.04.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1111/tid.14015 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM352447915 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM352447915 | ||
| 003 | DE-627 | ||
| 005 | 20231226053741.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/tid.14015 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1174.xml |
| 035 | |a (DE-627)NLM352447915 | ||
| 035 | |a (NLM)36734631 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Doss, Kathleen M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR) |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 11.04.2023 | ||
| 500 | |a Date Revised 11.04.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND: Despite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R- liver transplant recipients (LTxRs), real-world effectiveness may be lower because of logistical concerns about feasibility of PET | ||
| 520 | |a METHODS: We retrospectively assessed PET as standard clinical care at a single transplant center among 50 consecutive adult CMV D+R- LTxRs undergoing a first liver transplant between 4/4/2019 and 5/18/2021 and compared outcomes and adherence to those randomized to PET in the CAPSIL study (N = 100). The primary outcome was CMV disease and secondary outcomes were biopsy-confirmed acute allograft rejection, retransplant, invasive fungal infections, and death, all assessed by 1-year post-transplant. Exploratory outcomes included virologic parameters and measures of adherence to protocol-specified CMV qPCR monitoring | ||
| 520 | |a RESULTS: Baseline characteristics were similar between groups. The cumulative incidence of CMV disease at 1-year post-transplant was 4/50 (8%) versus 9/100 (9%) in the real-world and CAPSIL cohorts, respectively, p = 1.0. The rate of breakthrough CMV disease during the 100-day PET period was low (2/50 [4%]) and similar to the PET cohort from the CAPSIL study (3/100 [3%]). All secondary and exploratory outcomes were not significantly different between the real-world and CAPSIL PET cohorts | ||
| 520 | |a CONCLUSIONS: In this first reported study of real-world PET, the feasibility and effectiveness for CMV disease prevention and for other clinical outcomes in CMV D+R- LTxRs were similar to those reported with PET in a clinical trial. Additional studies to confirm feasibility and generalizability in other settings are warranted | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a CMV | |
| 650 | 4 | |a preemptive therapy (PET) | |
| 650 | 4 | |a solid organ transplantation (SOT) | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a Ganciclovir |2 NLM | |
| 650 | 7 | |a P9G3CKZ4P5 |2 NLM | |
| 700 | 1 | |a Kling, Catherine E |e verfasserin |4 aut | |
| 700 | 1 | |a Heldman, Madeleine R |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Nina |e verfasserin |4 aut | |
| 700 | 1 | |a Wagener, Marilyn |e verfasserin |4 aut | |
| 700 | 1 | |a Rakita, Robert M |e verfasserin |4 aut | |
| 700 | 1 | |a Fisher, Cynthia E |e verfasserin |4 aut | |
| 700 | 1 | |a Limaye, Ajit P |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Transplant infectious disease : an official journal of the Transplantation Society |d 1999 |g 25(2023), 2 vom: 14. Apr., Seite e14015 |w (DE-627)NLM113005482 |x 1399-3062 |7 nnns |
| 773 | 1 | 8 | |g volume:25 |g year:2023 |g number:2 |g day:14 |g month:04 |g pages:e14015 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/tid.14015 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 25 |j 2023 |e 2 |b 14 |c 04 |h e14015 | ||