20 May Pre-Emptive Therapy of CMV in Allogeneic Hematopoietic Cell Transplant
MedicalResearch.com Interview with:
Roy F. Chemaly, MD, MPH F.A.C.P., F.I.D.S.A.
Department of Infectious Diseases
Infection Control and Employee Health
Division of Internal Medicine
MD Anderson Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: CytomegalovirusCMV infection is a common cause of morbidity and mortality in allo-HCT recipients. Evidence suggests that CMV infection has not only an enormous clinical burden, but a substantial economic burden as well.
We conducted this study at MD Anderson to determine the economic and clinical burden of preemptive therapy (PET) for CMV infection. Between 2012 and 2015, 100 consecutive patients hospitalized at our institution for allo-HCT who experienced reactivation of CMV and were treated pre-emptively, were enrolled.
The majority of patients were men (55%), who had underlying leukemia (73%), and underwent matched unrelated donor transplant (59%). At the time of hospitalization, most patients had acute GvHD (62%), and were on steroids (58%) within 30 days of CMV reactivation which occurred at a median of 32 days post-HCT (2 -174). A total of 192 episodes of PET occurred in the 100 allo-HCT recipients within 1 year post-HCT. PET consisted of ganciclovir (41%), foscarnet (40%), and valganciclovir (38%). IVIG was also used as adjunct therapy in 20% of episodes.
Progression to Cytomegalovirus disease occurred in 4 patients (4%) and mainly affected the GI tract. Mean length of stay for patients treated with ganciclovir or foscarnet was 32 days (2-141) and 41 days (1-177), respectively. The average direct cost per patient admitted for PET was $126,038 ($7,866-$641,841) and the mean cost of CMV antiviral drug per hospitalization was $6,096 for IVIG, $2,410 for foscarnet, $836 for ganciclovir, and $780 for valganciclovir.
Serious side effects from PET were observed in 35% of patients on ganciclovir and 12% of patients on foscarnet. Total direct cost per encounter was significantly higher in patients who had serious side effects from foscarnet. All-cause mortality was 59% at 1 year post-transplant.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Until very recently, PET has been the most common strategy for managing CMV reactivation and/or disease. However, with this approach, we wait until after infection has occurred to start therapy which is associated not only with serious side effects such as myelosuppression and nephrotoxicity, but also with high costs from hospital readmissions, treatment with toxic drugs, and management of side effects associated with those drugs.
The study findings underscore the significant impact of CMV reactivation and preemptive therapy in terms of economic and clinical burden in allo-HCT patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Whether prophylactic strategy with an effective and well tolerated agent such as the recently FDA-approved letermovir decreases the burden in allo-HCT needs to be determined in future studies.
Disclosures: Chimerix Inc., grants, and personal fees; Merck & Co. Inc., grants, and personal fees; Novartis, grant; Astellas, personal fees; Oxford Immunotec, grants, and personal fees; Shire, grants.
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Clinical & Economic Burden of Pre-Emptive Therapy (PET) of Cytomegalovirus (CMV) Infection in Hospitalized Allogeneic Hematopoietic Cell Transplant (Allo-HCT) Recipients: The MD Anderson Cancer Center Experience
Shashank S. Ghantoji,Jonathan Schelfhout, Lynn El Haddad, Yadira Lobo, Ying Jiang, R. Gabriella Rondon, Elizabeth J. Shpall, Katy Rezvani, Amanda Olson, Roy F. Chemaly
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Clinical & Economic Burden of Pre-Emptive Therapy (PET) of Cytomegalovirus (CMV) Infection in Hospitalized Allogeneic Hematopoietic Cell Transplant (allo-HCT) Recipients: The MD Anderson Cancer Center Experience