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. 2025 Jul;42(7):3419-3436.
doi: 10.1007/s12325-025-03210-x. Epub 2025 May 22.

Patient Number and Treatment Patterns in Cytomegalovirus Viremia and Disease Following Solid Organ and Hematopoietic Stem Cell Transplantation in Germany: Results of a Delphi Consensus Study

Daniel Teschner  1   2 , Jana Knop  3 , Christian Piehl  4 , Tino Schubert  5 , Oliver Witzke  6
Affiliations

Patient Number and Treatment Patterns in Cytomegalovirus Viremia and Disease Following Solid Organ and Hematopoietic Stem Cell Transplantation in Germany: Results of a Delphi Consensus Study

Daniel Teschner et al. Adv Ther. 2025 Jul.

Abstract

Introduction: Management of cytomegalovirus (CMV) viremia/disease in transplant recipients may be complicated by toxicities and resistance to conventional antivirals, adding to the overall healthcare burden. Despite advances in analyzing real-world data in current years, little is known about refractory and resistant CMV. This study therefore aimed to characterize treatment patterns and patient numbers with special focus on refractory and resistant CMV.

Methods: Two classical three-round Delphi consensus panels with German clinical experts in CMV following solid organ transplantations (SOT) and hematopoietic stem cell transplantations (HSCT) were held between October and December 2021 using online questionnaires. Consensus was defined as agreement of 75% of participants.

Results: Following SOT, experts agreed that on average 65% of SOT patients are not affected by CMV at all, while 35% of patients experience CMV viremia or disease. Of SOT patients treated with antiviral therapies, experts agreed that 90% respond to their first-line treatment and 10% do not. For HSCT, experts agreed that 62% of patients experience no CMV, while 38% of patients are diagnosed with either CMV viremia or CMV disease. It was further estimated that 23% HSCT patients receiving antiviral treatment do not respond to their first-line CMV treatment. Experts reached consensus on the reasons for non-response, suggesting that among non-responders, 55% were intolerant, while 45% of non-responders were refractory/resistant to first-line treatment.

Conclusion: Based on the current incidence of transplantations in Germany, experts estimated that 103 SOT and 225 HSCT patients need second-line CMV treatment annually.

Keywords: Cytomegalovirus; Hematopoietic stem-cell transplantation; Refractory and resistant cytomegalovirus; Solid organ transplantation.

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Conflict of interest statement

Declarations. Conflict of Interest: Daniel Teschner has received research grants from Gilead, honoraria from and served as a consultant to AbbVie, BioNTech, Gilead, iQone, Jazz, Mikrogen, MSD, Noscendo, Octapharma, Pfizer, Tillotts, and Takeda, honoraria from AstraZeneca, F2G, Janssen, Novartis, and Sanofi, and travel grants from AbbVie, Astellas, Celgene, Gilead, Jazz, Medac, MSD, and Tillotts. Jana Knop and Christian Piehl are employees of Takeda Pharma Vertrieb GmbH & Co. KG. Christian Piehl holds Takeda stocks. Tino Schubert is owner and employee of LinkCare GmbH, which received consulting honoraria from Takeda Pharma Vertrieb GmbH and Mallinckrodt Pharmaceuticals. Oliver Witzke received research grants for clinical studies, speaker’s fees, honoraria, and travel expenses from Alexion, Amgen, Astellas, Basilea, Biotest, Bristol Myers Squibb, Chiesi, Correvio, Gilead, Hexal, Janssen, Dr. F. Köhler Chemie, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda, Teva, and UCB, as well as an unrestricted grant from the Rudolf-Ackermann-Stiftung (Stiftung für Klinische Infektiologie). Ethical Approval: Participants were fully informed about the study’s objectives and the intent to publish the results. Consent was given voluntarily through signed contracts. Participant answers were anonymized, and no communication occurred between them during the study. Data protection adhered to GDPR regulations, with analyses conducted pseudonymously to ensure privacy. Ethical committee consultation was unnecessary as the study only involved physician responses, with no patient information and no interference with personal integrity.

Figures

Fig. 1
Fig. 1
Experts opinion on patient numbers of CMV viremia/disease in Germany based on 100 solid organ transplants. Checkmarks indicate consensus among experts. SOT solid organ transplantation, CMV cytomegalovirus, n number
Fig. 2
Fig. 2
Experts opinion on treatment patterns in CMV following SOT based on 100 solid organ transplants. Checkmarks indicate consensus among experts. SOT solid organ transplantation, CMV cytomegalovirus, PCR polymerase chain reaction, GCV ganciclovir, VGCV valganciclovir, FOS foscarnet, CDV cidofovir, LTM letermovir, n number
Fig. 3
Fig. 3
Experts opinion on patient numbers of CMV viremia/disease in German patients, based on 100 hematopoietic stem cell transplantations. Checkmarks indicate consensus among experts. These estimates reflect expert consensus and do not distinguish between patients receiving letermovir prophylaxis and those who are not. These data were gathered before the 2023 label extension, which allowed prolonged prophylaxis beyond 100 days post-transplant in high-risk patients. HSCT hematopoietic stem cell transplantation, CMV cytomegalovirus, n number
Fig. 4
Fig. 4
Experts opinion on treatment patterns in CMV following HSCT based on 100 hematopoietic stem cell transplantations. Checkmarks indicate consensus among experts. HSCT hematopoietic stem cell transplantation, CMV cytomegalovirus, PCR polymerase chain reaction, VGCV valganciclovir, LTM letermovir, GCV ganciclovir, FOS foscarnet, n number
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