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What is the Risk and Burden of CMV in Adult Allogeneic HSCT?

Updated on 16/05/2019

CMV-seropositive allogeneic HSCT patients are at high risk for reactivation and associated mortality independent of CMV disease1,2

Any level of CMV has been associated with increased risk of mortality in the first year post transplant1

CMV viral load as a time-dependent risk factor for mortality 1 year after allogeneic HSCT (n=926)1,a

CMV viral load as a time-dependent risk factor for mortality 1 year after HSCT (n=926)^1,a graph

Adapted from Green ML, Leisenring W, Xie H, et al. 20161

  • Results from a large, retrospective, noninterventional cohort study of previously collected CMV viraemia and clinical outcome measures (n=1037)1

CI = confidence interval
a Viral load was a threshold variable. Data assessed using multivariable Cox proportional modelling.1

2.6 x risk increase image

Allogeneic HSCT patients with any positive viraemia have 2.6 times greater risk of overall mortality than patients with no viraemia up to 60 days after transplant1

Positive CMV serostatus pre-allogeneic HSCT is a strong predictor of CMV reactivation2

Donor-recipient CMV serostatus as a risk factor for CMV infection3

Donor-recipient CMV serostatus as a risk factor for CMV infection^3 graph
  • Results from a retrospective analysis of allogeneic HSCT patients (n=753)3
  • Primary end point was the incidence of CMV infection by 6 months post transplant3

CI = confidence interval; D = Donor; R = Recipient

15 x risk increase image

CMV-seropositive recipients have up to 15 times greater risk for CMV reactivation than CMV-seronegative recipients3

Positive CMV serostatus pre-allogeneic HSCT is a strong predictor of CMV reactivation2

Incidence of CMV reactivation in allogeneic HSCT patients who were CMV-seropositive or had a seropositive donor through 12 months post-transplant1

Incidence of CMV reactivation in HSCT patients who were CMV-seropositive or had a seropositive donor through 12 months post-transplant^1 graph

Adapted from Green ML, Leisenring W, Xie H, et al. 20161

  • Results from a large, retrospective, noninterventional cohort study of previously collected CMV viraemia and clinical outcome measures (n=1037)1
  • The aim of this study was to estimate the association between CMV viral load measured with the new international standard and non-relapse mortality and overall mortality during the first year after HSCT
  • Eligible patients were CMV seropositive or had a seropositive donor
>30% x CMV reactivation image

More than 30% of allogeneic HSCT patients who were
CMV-seropositive or had a seropositive donor had CMV reactivation within 1 month post transplant1

What are the main challenges with the current pre-emptive therapy approach?

The practice of initiating pre-emptive therapy (only upon emergence of a centre-specific CMV viraemia threshold) presents the following challenges:

  • Early CMV reactivation remains associated with increased transplant-related mortality in the current era.4
  • The presence of any CMV viraemia in the first 100 days post-allogeneic HSCT is associated with increased healthcare resource utilisation costs.5
  • Target-related toxicities such as myelosuppression with ganciclovir/valganciclovir and nephrotoxicity with foscarnet frequently require lengthy and costly hospitalisation.5
  • Neutropaenia has been reported in up to 30% of patients receiving ganciclovir,7 which can incur additional management costs arising from use of granulocyte colony-stimulating factor (G-CSF).6,7

(Not an actual patient.)

The burden of CMV in adult allogeneic HSCT recipients

Prescribing Information

Length: 04:21

Professor Karl Peggs, Consultant Haematologist, University College London Hospitals NHS Foundation Trust.

Hear Professor Peggs discuss the impact of cytomegalovirus (CMV) in patients undergoing allogeneic haematopoietic stem cell transplants. The prevalence of CMV reactivation, effect of viral load on survival outcomes and the unmet need of controlling CMV infection in this population are all discussed.

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References

  1. Green ML, Leisenring W, Xie H, et al. Cytomegalovirus viral load and mortality after haematopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective cohort study. Lancet Haematol. 2016;3:e119-e127.
  2. George B, Pati N, Gilroy N, et al. Pre-transplant cytomegalovirus (CMV) serostatus remains the most important determinant of CMV reactivation after allogeneic haematopoietic stem cell transplantation in the era of surveillance and preemptive therapy. Transpl Infect Dis. 2010;12(4):322-329.
  3. Walker CM, van Burik JA, De For TE, et al. Cytomegalovirus infection after allogeneic transplantation: comparison of cord blood with peripheral blood and marrow graft sources. Biol Blood Marrow Transplant. 2007;13(9):1106-1115.
  4. Teira P, Battiwalla M, Ramanathan M, et al. Early cytomegalovirus reactivation remains associated with increased transplant-related mortality in the current era: a CIBMTR analysis. Blood. 2016;127(20):2427-38.
  5. Jain NA, Lu K, Ito S, et al. The clinical and financial burden of pre-emptive management of cytomegalovirus disease after allogeneic stem cell transplantation-implications for preventative treatment approaches. Cytotherapy. 2014;16(7):927-33.
  6. Svahn BM, Remberger M, Alvin O, Karlsson H, et al. Increased costs after allogeneic haematopoietic SCT are associated with major complications and re-transplantation. Bone Marrow Transplant. 2012;47(5):706-15.
  7. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant recipients. Hematol Oncol Clin North Am. 2011;25(1):151–169.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-CYT-00018 | Date of Preparation: May 2019