A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F23%3A10462239" target="_blank" >RIV/00669806:_____/23:10462239 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11140/23:10462239

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=1XZrImO6oU" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=1XZrImO6oU</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1681/ASN.0000000000000090" target="_blank" >10.1681/ASN.0000000000000090</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients

Popis výsledku v původním jazyce

Background The optimal regimen for the prevention of cytomegalovirus (CMV) infection in kidney transplant recipients, primarily in terms of reducing indirect CMV effects, has not been defined.Methods This was an open-label, single-center, randomized clinical trial of valganciclovir prophylaxis vs preemptive therapy in 140 kidney transplant recipients recruited between June 2013 and May 2018. CMV-seronegative recipients with negative donors (D-R-) were excluded. Patients were randomized 1:1 to receive either valganciclovir prophylaxis, 900 mg, daily for 3 months (6 months in D+R-) (n=70) or preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests) for CMV DNAemia (&gt;=1000 IU/mL) detected by weekly CMV PCR for 4 months (n=70). The primary outcome was the incidence of acute rejection at 12 months, as confirmed by biopsy. Key secondary outcomes included subclinical rejection, CMV disease and DNAemia, and neutropenia.Results The incidence of acute rejection was numerically lower with valganciclovir prophylaxis than with preemptive therapy (13%, 9/70 vs 23%, 16/70, P=0.112 [HR, 0.52, 95% CI, 0.23-1.19]). Subclinical rejection at 3 months was lower in the prophylaxis group (13% vs 29%, P=0.027). Both regimens prevented CMV disease (4% vs 4%, P=0.974). Preemptive therapy resulted in higher rates of CMV DNAemia (44% vs 75%, P&lt;0.001) including episodes with higher viral load (&gt;=2000 IU/mL, P&lt;0.001) but lower valganciclovir exposure (P&lt;0.001) and neutropenia (P=0.019).Conclusion Among kidney transplant recipients, the use of valganciclovir prophylaxis, compared with preemptive therapy, did not result in a significantly lower incidence of acute rejection.

Název v anglickém jazyce

A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients

Popis výsledku anglicky

Background The optimal regimen for the prevention of cytomegalovirus (CMV) infection in kidney transplant recipients, primarily in terms of reducing indirect CMV effects, has not been defined.Methods This was an open-label, single-center, randomized clinical trial of valganciclovir prophylaxis vs preemptive therapy in 140 kidney transplant recipients recruited between June 2013 and May 2018. CMV-seronegative recipients with negative donors (D-R-) were excluded. Patients were randomized 1:1 to receive either valganciclovir prophylaxis, 900 mg, daily for 3 months (6 months in D+R-) (n=70) or preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests) for CMV DNAemia (&gt;=1000 IU/mL) detected by weekly CMV PCR for 4 months (n=70). The primary outcome was the incidence of acute rejection at 12 months, as confirmed by biopsy. Key secondary outcomes included subclinical rejection, CMV disease and DNAemia, and neutropenia.Results The incidence of acute rejection was numerically lower with valganciclovir prophylaxis than with preemptive therapy (13%, 9/70 vs 23%, 16/70, P=0.112 [HR, 0.52, 95% CI, 0.23-1.19]). Subclinical rejection at 3 months was lower in the prophylaxis group (13% vs 29%, P=0.027). Both regimens prevented CMV disease (4% vs 4%, P=0.974). Preemptive therapy resulted in higher rates of CMV DNAemia (44% vs 75%, P&lt;0.001) including episodes with higher viral load (&gt;=2000 IU/mL, P&lt;0.001) but lower valganciclovir exposure (P&lt;0.001) and neutropenia (P=0.019).Conclusion Among kidney transplant recipients, the use of valganciclovir prophylaxis, compared with preemptive therapy, did not result in a significantly lower incidence of acute rejection.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30217 - Urology and nephrology

Projekt

<a href="/cs/project/EF16_019%2F0000787" target="_blank" >EF16_019/0000787: Centrum výzkumu infekčních onemocnění</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of the American Society of Nephrology

ISSN

1046-6673

e-ISSN

1533-3450

Svazek periodika

34

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

15

Strana od-do

920-934

Kód UT WoS článku

000985661800021

EID výsledku v databázi Scopus

2-s2.0-85159254911