Prevymis (letermovir) / Merck (MSD), AiCuris - LARVOL DELTA

Letermovir in ART-treated HIV-infected Persons (clinicaltrials.gov) - P=N/A | N=33 | Completed | Sponsor: Jean-Pierre Routy | Active, not recruiting ➔ Completed | N=60 ➔ 33 | Trial completion date: Dec 2025 ➔ Jul 2025

Enrollment change • Trial completion • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CD4

Insurance Barriers to High-Cost Anti-Infective Medications Post Allogeneic Hematopoietic Cell Transplant. (PubMed, Transplant Cell Ther) - "Medical records of patients who received high-cost medications (mold-active triazoles and letermovir [LTV]) during their first allo-HCT (1/1/20 - 5/1/22) were evaluated for insurance type, ancestry/ethnicity, and stem cell source...In the azole (n=287, voriconazole n=162, posaconazole n=64, isavuconazole n=61) and LTV (n=191) groups, the median age was 61 (range 19-81) and 61 years (range 22-81), respectively, with 44% female overall...Neither insurance type nor transplant characteristics predicted the level of barrier, suggesting that all patients should be assessed for financial toxicity. Pharmacists played an integral role in overcoming the insurance barriers for these high-cost medications, and work is ongoing to expand our understanding of the financial issues impacting our patients."

Journal • Reimbursement • US reimbursement • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

Generation of a panel of mutants that are resistant to standard of care therapies in a clinically relevant strain of Human cytomegalovirus for drug resistance profiling. (PubMed, Antiviral Res) - "This panel consists of WT and seven mutant viruses harboring mutations that confer resistance to ganciclovir, maribavir, cidofovir, and letermovir. We observed that mutant viruses demonstrated increased EC50 concentrations for SOC inhibition, and that host directed FLS-359 demonstrated broad-spectrum antiviral activity against known SOC drug-resistant mutants. This panel represents a much-needed comparatively innovative platform for screening the efficacy of new direct-acting antivirals and host-directed antivirals against HCMV variants refractive to therapeutic interventions."

Journal • Cytomegalovirus Infection • Infectious Disease

Prognostic Impact of Cytomegalovirus Reactivation After Transplantation From Cord Blood Compared to Other Donor Sources in Patients With Adult T-Cell Leukemia/Lymphoma in the Pre-Letermovir Era. (PubMed, Transpl Infect Dis) - "CMV-react was not associated with the outcomes in the U-CB group, while CMV-react correlates with worse OS and NRM in the MRD and URD groups, indicating the need for a more intensive strategy for late-phase complications in U-CB transplantation for ATL with and without CMV-react."

Journal • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Letermovir for CMV Prevention After Lung Transplantation (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Fernanda P Silveira, MD, MS | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Mar 2025 | Trial primary completion date: Jul 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Neutropenia • Pulmonary Disease • Respiratory Diseases • Transplantation

Recent Advances in Diagnostics and Therapeutics for Cytomegalovirus Management: Recent Advances in Kidney Transplantation (KSN 2025) - "Therapeutically, the emergence of newer agents such as letermovir and maribavir has expanded the available options for both prophylaxis and treatment. Collectively, these innovations reflect a shift toward precision medicine in CMV management. Continued research into viral-host interactions, immunologic monitoring, and optimized combination therapies will be essential to improving outcomes and reducing the disease burden in susceptible patient populations."

IO biomarker • Bone Marrow Transplantation • Cytomegalovirus Infection • Transplant Rejection • Transplantation

Letermovir reduces cytomegalovirus in HLA-matched and mismatched allogeneic hematopoietic cell transplant patients receiving post-transplant cyclophosphamide. (PubMed, Bone Marrow Transplant) - No abstract available

Journal • Cytomegalovirus Infection • Transplantation

Letermovir prophylaxis for cytomegalovirus infection in hematopoietic transplantation with post-transplant cyclophosphamide. (PubMed, Medicina (B Aires)) - "In summary, letermovir effectively prevented CMV infection in this high-risk population of allo-HCT recipients."

Journal • Retrospective data • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation

A novel strategy for the management of cytomegalovirus retinitis in immunocompromised patients using new anti-cytomegalovirus drugs. (PubMed, Front Med (Lausanne)) - "Weekly intravitreal injections of high-dose (6 mg) ganciclovir (IVG) were administered to those with macula involvement or aggressive lesions during the initial treatment. Both letermovir and maribavir demonstrated excellent tolerability with no adverse events observed. This novel therapeutic strategy provides safe and effective treatment option for CMVR, particularly promising for patients with complex systemic comorbidities."

Journal • Cytomegalovirus Infection • Genetic Disorders • Ocular Inflammation • Ophthalmology • Retinal Disorders

Real-world efficacy and safety of letermovir versus ganciclovir prophylaxis in adolescent patients undergoing allogenic hematopoietic stem cell transplantation: a single center observational study. (PubMed, Front Cell Infect Microbiol) - "In this single-center real-world study, letermovir exhibited a favourable efficacy and safety profile for CMV prophylaxis in adolescent patients undergoing HSCT. However, further prospective multi-center studies are warranted to validate our conclusion in adolescent patients."

Journal • Observational data • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Leukopenia • Transplantation

Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus. (PubMed, J Card Fail) - "Letermovir holds promise as an effective and safe alternative to valganciclovir for CMV prophylaxis in HT recipients."

Journal • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Leukopenia • Neutropenia • Transplant Rejection • Transplantation

Efficacy and Safety of Letermovir for Cytomegalovirus Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients. (PubMed, Drug Des Devel Ther) - "Letermovir is both effective and safe for CMV prophylaxis in pediatric patients following HCT, especially in patients with more risk factors of csCMVi. Grade II-IV GvHD increases the risk of csCMVi, while letermovir prophylaxis reduces the risk."

Journal • Aplastic Anemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Pediatrics • Transplantation

SUBSTANTIAL REDUCTION IN CHRONIC GRAFT-VERSUS-HOST DISEASE AND ADEQUATE IMMUNE RECONSTITUTION WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE IN UNRELATED DONOR TRANSPLANTATION: A COMPARATIVE CASE-CONTROL STUDY (EHA 2025) - "Study group included 61 consecutive patients who underwent MUD-HCT between 01/2021 and 09/2024 for myeloid malignancies with PTCy (50mg/kg on days +3 and +4) in addition to tacrolimus/mycophenolate mofetil (MMF) as GvHD prophylaxis. Conditioning regimen was busulfan/fludarabine/thiotepa...There was no difference in the CIN of CMV viremia between the PTCy and the control group for patients who received letermovir prophylaxis (20.6% vs. 24.0%, respectively, p=0.73)... We implemented PTCy for GvHD prophylaxis in the context of MUD-HCT and compared its efficacy to conventional non-PTCy-based strategies. The use of PTCy was not linked to delayed immune reconstitution or increased risk of viral reactivation. Moreover, PTCy was associated with substantial reduction in the occurrence of chronic GvHD, which translated to improved GRFS."

Clinical • Post-transplantation • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Oncology • Transplantation • CD4

REAL-WORLD EFFICACY AND SAFETY OF LETERMOVIR PROPHYLAXIS IN ADOLESCENT PATIENTS UNDERGOING ALLOGENIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: A SINGLE CENTER OBSERVATIONAL STUDY (EHA 2025) - "Aims: To compare the efficacy and safety of letermovir and ganciclovir for cytomegalovirus (CMV) prophylaxis in adolescent patients (aged 14-17 years) undergoing allogenic hematopoietic stem cell transplantation (HSCT). In this single-center real-world study, letermovir exhibited a favourable efficacy and safety profile for CMV prophylaxis in adolescent patients undergoing HSCT. However, further prospective multi-center studies are warranted to validate our conclusion in adolescent patients."

Clinical • Observational data • Real-world • Real-world effectiveness • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Leukopenia • Transplantation

LONG TERM OUTCOME OF αßTCR/CD19 DEPLETED HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULTS WITH ACUTE LEUKEMIA. A SINGLE CENTER EXPERIENCE. (EHA 2025) - "Conditioning regimen consisted in Treosulfan 30gr/m2 (TREO30) increased to 36 gr/m2 (TREO36) since 2017, associated to Thiotepa 10 mg/Kg and Fludarabine 150 mg/m2...No CMV reactivations or diseases were noted in post letermovir era, while before letermovir CMV reactivation occurred in 30% of analyzed population... These data represent the longest reported follow up of αβTCR/CD19-based depletion haploidentical HSCT in a cohort of adult acute leukemia. This study confirms that this platform is an effective option to achieve deep disease complete remission and improvement in term of overall survival and disease free survival in patients who lack a matched donor or need urgently an allograft, especially if in CR at time of transplant. Moreover the toxicity profile is very tolerable in heavily pretreated population even with higher doses of treosulfan in combination with another alkylant drug."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Hepatology • Immunology • Leukemia • Oncology • Pediatrics • Transplant Rejection • Transplantation

PRE-TRANSPLANT MNGS-GUIDED LETERMOVIR PROPHYLAXIS REDUCES POST-HSCT CMV REACTIVATION: A PROSPECTIVE RISK STRATIFICATION STUDY (EHA 2025) - "Pre-transplant mNGS detection of CMV sequences identifies high-risk patients for breakthrough reactivation despite LET prophylaxis correlating with inferior survival. Risk stratification incorporating mNGS quantification conditioning intensity BMI and CMV history may optimize prophylactic strategies. These findings advocate for mNGS-based algorithms to guide precision CMV prevention in allo-HSCT."

Clinical • Pre-transplantation • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Hematological Malignancies • Infectious Disease • Oncology • Transplantation

THIOTEPA-BUSULFAN-FLUDARABINE CONDITIONING REGIMEN WITH ATG/PTCY-BASED GVHD PROPHYLAXIS AS PROMISING APPROACH FOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION IN ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: A SINGLE-CENTER, OPEN-LABEL, PROSPECTIVE STUDY (EHA 2025) - "GVHD prophylaxis included ATG (6 mg/kg) plus low-dose PTCy (50 mg/kg) combined with cyclosporine mycophenolate mofetil and a short course of methotrexate...All patients received letermovir for CMV prophylaxis. Four patients had CMV reactivation and 11 had EBV reactivation all of which resolved with ganciclovir foscarnet or rituximab... These data suggest that the TBF+ATG/PTCy regimen is feasible for haplo-HSCT in ALL with manageable transplant-related toxicity. We will further evaluate the regimen by expanding the patient cohort and extending follow-up which are essential for efficacy and safety analysis."

Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Dermatology • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Mucositis • Oncology • Pneumonia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • Transplantation

THE IMPACT OF LETERMOVIR PROPHYLAXIS IN MATCHED SIBLING DONOR HEMATOPOIETIC STEM CELL TRANSPLANTATION: SELECTING THE APPROPRIATE POPULATION FOR RATIONAL PROPHYLACTIC THERAPY (EHA 2025) - "In conclusions, for HSCT recipients from matched siblings, CMV prophylaxis strategies should be guided by risk stratification rather than solely relying on CMV serological status, which is valuable to optimize the prevention strategy. Further validation through larger clinical studies is needed."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Transplantation

G-CSF IMPROVES TREG SELECTION AND OUTCOMES OF HLA-HAPLOIDENTICAL HEMATOPOIETIC CELL TRANSPLANTATION WITH T CELL ADOPTIVE IMMUNOTHERAPY (EHA 2025) - "Immune reconstitution was good as viral reactivation occurred only in the early phase after transplant and did not cause any deaths (18 patients (58%) required treatment for HHV6 reactivation in the first month; 5 patients (16%) required treatment of CMV disease after Letermovir prophylaxis)... Treg selection from G-CSF stimulated donors allows for higher purity of Treg final product and its use, together with unstimulated donor Tcons, resulted in lower incidence of aGVHD, even in the absence of immunosuppression, maintaining a potent antileukemic effect. Our study supports the use of Stim-Tregs for immune-suppression free HLA-haploidentical HSCT with Treg-Tcon adoptive immunotherapy."

IO biomarker • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Mucositis • Myelodysplastic Syndrome • Oncology • Pneumonia • Respiratory Diseases • Stomatitis • T Acute Lymphoblastic Leukemia • Transplantation • CD34 • FOXP3 • IL2RA • IL7R • ISG20

LONG TERM FOLLOW UP OF THE BATMO PROTOCOL (BEST-ANTIMICROBIAL-THERAPY-TMO) AND COMPARISON WITH HYSTORICAL DATA (EHA 2025) - "The main features of this protocol are the lack of fluoroquinolones prophylaxis during neutropenic phase of allo-SCT the administration of posaconazole in high-risk patients (pts) and of letermovir in CMV-positive pts from day 0 to day +100. Sistematic use of posaconazole as fungal prophylaxis is effective in maintaining a low incidence of proven/possible IFD despite the increase of risk factors (e.g. more Haplo donors in Cohort B). Data on the antimicrobial susceptibility of BSI isolates MDR-colonizing bacteria and the use of new antimicrobials are currently under investigation."

Clinical • Acute Graft versus Host Disease • Febrile Neutropenia • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases

INCIDENCE AND RISK FACTORS FOR LATE CYTOMEGALOVIRUS (CMV) BLOOD INFECTIONS AFTER ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT (ALLOHCT) (EHA 2025) - "57% of patients received post-transplant cyclophosphamide (PTCY) for GVHD prophylaxis and 43% received letermovir at any time during their alloHCT...-10.4] 1.9 [0.6-6.4] GVHD Prophylaxis Cyclophosphamide containing 1 1 Methotrexate containing 3.1 [1.5-6.5] 1.4 [0.6-3.5] Other 7.9 [ .8- .0] 4... Multiple risk factors affect the incidence of CMV infection after day+90 of alloHCT. Some increase risk throughout the alloHCT process while others have time-limited effects. Consideration of these risk factors relative to the patient's alloHCT course can potentially predict the risk of CMV infection."

Clinical • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation

Successful BCMA-CAR T-cell salvage therapy in a patient with idiopathic inflammatory myositis relapsing after CD19-CAR T-cell therapy (EULAR 2025) - "The patient experienced a CMV-viremia under daratumumab, which was successfully treated with oral valganciclovir. Due to ongoing disease activity, plasma cell-targeting BCMA-CAR T-cell therapy was performed (Idecabtagene vicleucel, Bristol Myers Squibb). The patient experienced grade 1 cytokine release syndrome (CRS) on day 3, which resolved upon a single dose of the anti-interleukin-6 receptor monoclonal antibody tocilizumab. No neuro- or hematotoxicity were observed and, supported by a 100-day prophylaxis with letermovir, no CMV-reactivation occurred. BCMA-CAR T-cells expanded, cleared B cells in circulation and plasma cells in lymphoid tissue, reduced autoantibody levels, and re-induced stable drug-free remission with normalization of CK within three months. Learning points for clinical practice: These data demonstrate that (i) a switch of CAR T-cell target can restore drug-free remission after relapse of AID after the first CAR T-cell treatment, (ii) repeated..."

CAR T-Cell Therapy • Clinical • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Transplant Rejection • IL6R

Distinct impact of letermovir discontinuation on tacrolimus pharmacokinetics based on concomitant azole antifungal agent. (PubMed, Int J Hematol) - "Although some antifungal agents influence the pharmacokinetics of tacrolimus after the discontinuation of letermovir, the effect of posaconazole (PSCZ) has not been previously described...The fold-change in the C/D ratio (post-/pre-discontinuation) was significantly higher in the PSCZ group compared with the fluconazole group (median 1.23 vs 0.83, P = 0.003)...Furthermore, the tacrolimus C/D ratio could increase following letermovir discontinuation in patients receiving PSCZ. Careful monitoring of tacrolimus concentrations at letermovir discontinuation is crucial to avoid an unexpected reversal of tacrolimus concentrations and prevent adverse events."

Journal • PK/PD data • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Transplantation

Association of Cyclosporine Exposure Post-Allogeneic Hematopoietic Cell Transplant with Graft Failure and Relapse Risk in Hematological Malignancies. (PubMed, Transplant Cell Ther) - "This study underscores the importance of CsA monitoring to reduce the risks of GF and aGVHD without increasing relapse in hematological malignancies. However, higher CsA exposure requires careful management due to its association with CMV reactivation. These findings contribute to optimizing immunosuppression strategies in the context of contemporary GVHD prophylaxis."

Journal • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation

A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation