Impact of BK Polyomavirus Plasma Viral Load in Kidney Transplant Outcomes

Alonso, Manuel; Villanego, Florentino; Orellana, Cristhian; Vigara, L.A.; Montiel, Natalia; Aguilera, Almudena; Amaro, Jose Manuel; García, Teresa Martín; Mazuecos, Auxiliadora

doi:10.1016/j.transproceed.2022.10.012

Cited by 6 publications

(4 citation statements)

References 8 publications

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“…While many complex factors can contribute to allograft failure, multiple studies have shown a strong correlation between BK viremia, BK virus-associated nephropathy, and kidney allograft failure, including BK viremia at high levels as an independent risk factor for graft failure. 20 There are no approved treatments for BK virus infection. The drugs that are most often used off-label to treat BK virus infection, leflunomide and cidofovir, have not shown clear antiviral benefit and moreover are associated with toxicities.…”

Section: Discussionmentioning

confidence: 99%

Posoleucel in Kidney Transplant Recipients with BK Viremia

Chandraker,

Regmi,

Gohh

et al. 2024

JASN

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Background: Kidney transplant recipients with BK virus infection are at risk of developing BK virus-associated nephropathy, allograft rejection, and subsequent graft loss. There are no approved treatments for BK virus infection. Posoleucel is an off-the-shelf, allogeneic, multivirus-specific T cell investigational therapy targeting BK virus, as well as five other opportunistic viruses: adenovirus, cytomegalovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. Methods: In this phase 2, double-blind study, kidney transplant recipients with BK viremia were randomized 1:1:1 to receive posoleucel weekly for 3 weeks then every 14 days (bi-weekly dosing) or every 28 days (monthly dosing), or placebo for 12 weeks. Participants were followed for 12 weeks after completing treatment. The primary objective was safety, the secondary objective was plasma BK viral load reduction. Results: 61 participants were randomized and dosed. Baseline characteristics were similar across groups. No deaths, graft-versus-host disease, or cytokine release syndrome occurred. The proportion of patients who had adverse events judged by the investigators to be treatment-related was slightly lower in recipients of posoleucel: 20% (4 of 20 patients) and 18% (4 of 22) in those infused on a bi-weekly and monthly schedule, respectively, and 26% (5 of 19) in placebo recipients. None of the grade 3-4 AEs or serious adverse events in any group were deemed treatment-related. No deaths, graft-versus-host disease, or cytokine release syndrome occurred. Three participants had allograft rejection, but none were deemed treatment-related by investigators. In posoleucel recipients, BK viremia reduction was associated with an increase in the circulating frequency of BK virus-specific T cells, and the presence and persistence of posoleucel was confirmed by T cell receptor sequencing. Conclusions: Posoleucel was generally safe, well tolerated, and associated with a larger reduction of BK viremia compared to placebo. Limitations of this study include the relatively short duration of follow-up and lack of power to detect significant differences in clinical outcomes.

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Section: Discussionmentioning

confidence: 99%

Posoleucel in Kidney Transplant Recipients with BK Viremia

Chandraker,

Regmi,

Gohh

et al. 2024

JASN

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“…Вирус-ассоциированные факторы Перестройки в области NCCR [30] Факторы, связанные с трансплантацией Использование тимоглобулина [31,32,33] Повышенное употребление стероидов [32,33,34] Длительность холодовой ишемии трансплантата [14] Высокая степень несоответствия антигена HLA [31,33,35] ABO-несовместимая трансплантация крови [36,37] Отсроченная функция аллотрансплантата [31,33,38] Стентирование мочеточника [39] Донор-ассоциированные факторы Трупный трансплантат [31,35,40,41] Присутствие вирусоспецифических антител к антигенам BKPyV [42][43][44] Пол (женский) [35] Реципиент-ассоциированные факторы Возраст (<17-18 и >55-60 лет) [31,33,35,45] Пол (мужской) [31,35,45,46] Раса (афроамериканец) [47] стициальный фиброз и атрофия канальцев наблюдались в 67% случаев, что коррелировало с ухудшением долгосрочных последствий. В исследовании B.J.…”

Section: наименование характеристикаunclassified

“…Показано, что определение ДНК BKPyV в плазме крови и моче коррелирует с BKPyVассоциированной нефропатией, подтвержденной с помощью биопсии трансплантата, а постоянно высокий уровень виремии значительно снижает выживаемость аллотрансплантата [45,52]. У пациентов после ТГСК высокий уровень BKPyV-вирурии >7 lg геномных эквивалентов/мл связан с повышенным риском развития BKPyVассоциированного геморрагического цистита [15].…”

Section: современные возможности использования молекулярно-биологичес...unclassified

A systematic review. Current understanding of the infection caused by <i>Betapolyomavirus hominis</i>

Prilepskaya

Домонова

2023

jour

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Reactivation of Betapolyomavirus hominis (BKPyV) in kidney and hematopoietic stem cell recipients can lead to serious complications such as BKPyV-associated nephropathy followed by transplant rejection and BKPyV-associated hemorrhagic cystitis. Early diagnosis of the disease is hampering by the possible combination of infection of BKPyV with other post-transplant pathologies and the absence of specific symptoms. Replication of BKPyV is currently the only reliable prognostic sign of the development of long-term consequences, so patient management is basseting on monitoring the concentration of viral DNA. However, consistency between the results of determining the viral load and the development of post-transplant complications associated with BKPyV reactivation cannot be achieving without effective means of standardizing laboratory testing. This review covers the current understanding of the epidemiology; pathogenesis and the clinical features of the disease associated with BKPyV, and also considers in detail the current methods of laboratory diagnosis infection of BKPyV.

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“…Furthermore, its occurrence leads to graft loss in up to 50% of those affected [6]. It has been reported that male and old recipients, lymphopenia after kidney transplantation, and a maintenance therapy regimen involving corticosteroids can act as independent risk factors for BKVAN [7,8,16]. Intensive monitoring of BKV reactivation and the preemptive reduction of immunosuppression can improve graft survival in patients with BKVAN [12,17].…”

Section: Introductionmentioning

confidence: 99%

Evaluating the Efficiency of the Cobas 6800 System for BK Virus Detection in Plasma and Urine Samples

Song,

Kim,

Kwak

et al. 2023

Diagnostics

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We evaluated the overall performance of the Cobas 6800 BKV test in detecting BK virus (BKV). We examined the imprecision of the Cobas 6800 BKV test and compared the qualitative and quantitative results obtained from the Cobas 6800 BKV test and the Real-Q BKV quantification assay. We assessed 88 plasma and 26 urine samples collected between September and November 2022 from patients with BKV infection using the Real-Q BKV quantitative assay. The lognormal coefficient of variation indicated that the inter-assay precision of the Cobas 6800 BKV test ranged from 13.86 to 33.83%. A strong correlation was observed between the quantitative results obtained using the Cobas 6800 BKV test and the Real-Q BKV quantification assay for plasma samples. The Spearman’s rank correlation coefficients (ρ) for plasma, polymerase chain reaction (PCR) media-stabilized urine, and raw urine samples were 0.939, 0.874, and 0.888, respectively. Our analyses suggest that the Cobas 6800 BKV test is suitable for clinical applications owing to the strong correlation between the results obtained using this test and the Real-Q BKV quantification assay in plasma and urine samples. Furthermore, utilizing fresh raw urine samples can be a viable approach for the Cobas 6800 BKV test as it is less labor- and time-intensive.

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Impact of BK Polyomavirus Plasma Viral Load in Kidney Transplant Outcomes

Cited by 6 publications

References 8 publications

Posoleucel in Kidney Transplant Recipients with BK Viremia

Posoleucel in Kidney Transplant Recipients with BK Viremia

A systematic review. Current understanding of the infection caused by <i>Betapolyomavirus hominis</i>

Evaluating the Efficiency of the Cobas 6800 System for BK Virus Detection in Plasma and Urine Samples

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