Livtencity (maribavir) / Takeda, GSK - LARVOL DELTA

Maribavir Treatment in Resistant/Refractory Cytomegalovirus Infection Among Kidney Transplant Recipients: A Real-World Experience (ERA 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Cytomegalovirus Infection • Infectious Disease • Transplantation

Challenges in the Management of Refractory Cytomegalovirus Infection in a Heart Transplant Recipient (ISHLT 2025) - "He was treated with basiliximab, steroids, tacrolimus and mycophenolate (MMF). Valganciclovir (VGCV) prophylaxis due to CMV D-R missmatch was discontinued at 3 months, developing CMV disease with gastrointestinal symptoms and thrombotic microangiopathy (TMA)...Due to worsening renal function secondary to foscarnet, ganciclovir was restarted and then replaced by maribavir due to pancytopenia...Everolimus was withdrawn due to pleural effusion. Treatment with foscarnet and eculizumab improved TMA...The role and efficacy of maribavir and letermovir in HT needs to be further established. CMV-specific T lymphocyte infusions offers a promising therapeutic option, warranting further investigation."

Clinical • Cardiomyopathy • Cardiovascular • Cytomegalovirus Infection • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Pneumonia • Respiratory Diseases • Transplantation

Kaposi Sarcoma in a Lung Transplant Recipient (ISHLT 2025) - "He received 1000 mg solumedrol and basiliximab induction and tacrolimus (goal 8-10 ug/L), mycophenolate mofetil (MMF) 1000 mg BID, and prednisone 10 mg daily maintenance immunosuppression.Three months after transplant, he underwent bronchoscopy with transbronchial biopsy, which showed A1 rejection...Lung function improved but he developed persistent ganciclovir-resistance CMV viremia (peak 1,190 UI/mL) requiring maribavir...He was treated with liposomal doxorubicin 20 mg/m^2, tacrolimus goal was reduced to 4-6 ug/L, he received IVIG repletion, and he started everolimus...Coinfection with CMV activates HHV-8 lytic replication in endothelial cells and fibroblasts. KS treatment, including liposomal doxorubicin and mTOR inhibitor initiation resulted in significant tumor response."

Clinical • Epstein-Barr Virus Infections • Infectious Disease • Kaposi Sarcoma • Oncology • Respiratory Diseases • Sarcoma • Solid Tumor • Transplantation

Reversion of Val(ganciclovir)-Resistance Associated Mutation in Two SOT Patients with Mismatch Serostatus for CMV (D+/R-) (ISHLT 2025) - "We present two cases report, both SOT mismatch for CMV serostatus (D+/R-), showing the reversion of UL97 mutations associated with val(ganciclovir) (VGCV) resistance.Case Report Patient 1: a 30-yr-old man with Danon disease received heart transplant in October 2021; due to the occurrence of multiple episodes of CMV infection in 2022 he was pre-emptively treated with VGCV and subsequently with foscarnet...He was finally treated with maribavir (MBV) in August 2022, when blood CMV DNA was 123,750 copies/ml and was suffering for CMV-associated colitis...After achieving CMV DNA suppression with MBV, the secondary prophylaxis was started with letermovir associated with VGCV...In the two reported cases, the reversion of VGCV-resistance associated mutations was observed after withdrawal of the drug. To our knowledge this observation has never been previously reported, and can be taken into account for the management of antiviral treatment of CMV infections in D+/R- SOT."

Clinical • Cytomegalovirus Infection • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Renal Disease

How Should Cytomegalovirus Infection Be Managed in Allogeneic Hematopoietic Stem Cell Transplant Recipients? A Clinical Grand Round. (PubMed, Infect Chemother) - "During the foscarnet shortage, cidofovir was used, leading to a decline in CMV levels when foscarnet was reintroduced and used for 2 months. Following allo-HCT, CMV prophylaxis with letermovir is crucial to prevent reactivation in seropositive recipients...Maribavir is an option in cases of ganciclovir/valganciclovir resistance or intolerance. CMV gene mutations should be examined in patients with suspected resistance after 2 weeks of appropriate treatment. This case was discussed at the Clinical Grand Round of the Annual Conference of the Korean Society of Infectious Diseases on November 2, 2023."

Grand rounds • Journal • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Gene Therapies • Infectious Disease • Transplantation

IMPACT OF CYTOMEGALOVIRUS VIREMIA CLEARANCE ON POST-HEMATOPOIETIC-CELL TRANSPLANT MORTALITY: SOLSTICE POST-HOC ANALYSIS (EBMT 2025) - P3 | "Background: A post hoc analysis of the Phase 3 SOLSTICE study (NCT02931539) was conducted to assess the impact of cytomegalovirus (CMV) viremia clearance on mortality among hematopoietic-cell transplant (HCT) and solid-organ transplant (SOT) recipients with refractory CMV infection (with/without genotypically documented resistance) who received maribavir or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir). In this study, patients who had CMV clearance at week 8 had a significantly reduced probability of 20-week all-cause mortality than non-responders. This result was consistent across the overall trial population and among patients who had undergone HCT. These data demonstrate the importance of achieving and maintaining CMV clearance in transplant recipients with refractory or resistant CMV infection."

Retrospective data • Cytomegalovirus Infection • Solid Organ Transplantation • Transplantation

A CASE REPORT ON ACUTE MYELOID LEUKEMIA COMPLICATED BY CYTOMEGALOVIRUS PNEUMONIA: DIAGNOSTIC CHALLENGES AND THERAPEUTIC APPROACHES THROUGH METAGENOMIC NEXT-GENERATION SEQUENCING (EBMT 2025) - "This case highlights the importance of rapid control of CMV infection in immunocompromised patients and the advantages of maribavir in the treatment of CMV pneumonia before HSCT. The atypical radiological presentation of CMV pneumonia in this case underscores the need for a comprehensive diagnostic approach, including advanced diagnostic tools such as mNGS, in immunocompromised patients with suspected infections. The successful management of this case offers new insights into the diagnosis and management of CMV pneumonia, emphasizing the integration of advanced diagnostic technologies and novel antiviral agents into clinical practice."

Biomarker • Case report • Clinical • Next-generation sequencing • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pneumonia • Respiratory Diseases • Sarcoma • Solid Tumor

LEVERAGING FRENCH COMPASSIONATE PROGRAM DATA IN REFRACTORY CMV TO FURTHER DESCRIBE MARIBAVIR EFFECTIVENESS AND RESISTANCE PROFILE (EBMT 2025) - "The present analysis is the first to report maribavir resistance profile and effectiveness over time outside the pivotal trial. The maribavir resistance rate was lower than the findings from the pivotal study, while effectiveness was consistent with the trial findings with the additional patients who achieved CMV clearance beyond 8 weeks of treatment."

Cytomegalovirus Infection • Infectious Disease

LEVERAGING FRENCH COMPASSIONATE PROGRAM DATA IN REFRACTORY CMV TO FURTHER DESCRIBE MARIBAVIR EFFECTIVENESS AND RESISTANCE PROFILE (EBMT 2025) - "The present analysis is the first to report maribavir resistance profile and effectiveness over time outside the pivotal trial. The maribavir resistance rate was lower than the findings from the pivotal study, while effectiveness was consistent with the trial findings with the additional patients who achieved CMV clearance beyond 8 weeks of treatment."

Cytomegalovirus Infection • Infectious Disease

IMPLIED PHYSICIAN PREFERENCES FOR MARIBAVIR VS VALGANCICLOVIR FOR TREATMENT OF POST-HCT CMV: RESULTS FROM A MULTI-CRITERIA DECISION ANALYSIS (EBMT 2025) - P3 | "Based on the preference and clinical trial data for the specified attributes, a greater proportion of physicians would favor maribavir vs. valganciclovir as pre-emptive treatment for patients with post-HCT CMV. This preference was greater for patients with neutropenia at the time of CMV reactivation."

Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Neutropenia • Thrombocytopenia

IMPLIED PHYSICIAN PREFERENCES FOR MARIBAVIR VS VALGANCICLOVIR FOR TREATMENT OF POST-HCT CMV: RESULTS FROM A MULTI-CRITERIA DECISION ANALYSIS (EBMT 2025) - P3 | "Based on the preference and clinical trial data for the specified attributes, a greater proportion of physicians would favor maribavir vs. valganciclovir as pre-emptive treatment for patients with post-HCT CMV. This preference was greater for patients with neutropenia at the time of CMV reactivation."

Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Neutropenia • Thrombocytopenia

A Case of Relentless CMV Viremia Two Years Post Kidney Transplant (NKF-SCM 2025) - "Mycophenolate mofetil was held, valganciclovir treatment dose was started...Unfortunately, she had a persistent CMV PCR on letermovir and she was switched maribavir, which initially controlled CMV viremia to undetectable. By 1 year, she developed CMV IgG yet had positive CMV requiring valganciclovir with filgrastim which provided remission for 7 months...Patient has remained on low level tacrolimus (goal 4-7ng/ml) and prednisone 5mg since first detection of CMV viremia and every time her antiviral was held for a few weeks, she had a significant and symptomatic rebound of CMV viremia and as to this date (2 years post-transplant) requires antiviral therapy...This case highlights the unusually persistent, rebounding, and relapsing course of infection. Management of this patient required a variety of prolonged antiviral therapy while balancing efficacy with toxicity.Conclusion This case underscores the importance of monitoring and treatment strategies in cases that may not..."

Clinical • Hematological Disorders • Infectious Disease • Leukopenia • Transplantation

Evaluating maribavir use in solid organ transplant recipients: a real-world perspective (ESCMID Global 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Solid Organ Transplantation • Transplantation

Leveraging French compassionate programme data in refractory CMV to further describe maribavir effectiveness and resistance profile (ESCMID Global 2025) - No abstract available

Real-life experience with maribavir for the treatment of cytomegalovirus infection in hematological patients. (ESCMID Global 2025) - No abstract available

Clinical • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease

Real-world administration of maribavir beyond the eight weeks established in the clinical trial (ESCMID Global 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Transplantation

Dual Resistance to Maribavir and Ganciclovir in Transplant Recipients. (PubMed, Viruses) - "Although a high prevalence of CMV resistance mutations was identified, this must be taken in the context of healthcare providers submitting samples from patients with suspected CMV resistance. Most MBV-resistant samples were also resistant to GCV, suggesting that use of MBV as an alternative to GCV may benefit from genotypic resistance testing to achieve the effective control of CMV disease."

Journal • Cytomegalovirus Infection • Transplantation

Cost-Effectiveness of Maribavir for Post-Transplant Refractory (With or Without Resistance) Cytomegalovirus Infection in China (ISPOR 2025) - "Maribavir is a cost-effective treatment for post-transplant patients with R/R CMV in China, particularly after its inclusion in the National Reimbursement Drug List. These findings support its use in clinical practice and provide evidence for resource allocation decisions to optimize health outcomes for this patient population."

Cost effectiveness • HEOR • Post-transplantation • Cytomegalovirus Infection • Infectious Disease • Transplantation

Challenging Cases: Novel Antiviral Therapies for Treatment of Refractory or Resistant Cytomegalovirus in Pediatric Oncology and Stem Cell Transplant (HOPA 2025) - "This session will present challenging cases of r/r CMV in pediatric oncology and SCT patients, highlighting the use of novel antiviral agents such as letermovir and maribavir. Discuss the indications, pediatric pharmacy pearls for administration, and patient monitoring parameters of novel antivirals available for the treatment of resistant/refractory cytomegalovirus in pediatric oncology and stem cell transplant patients2. Outline a therapeutic approach for treatment of resistant/refractory CMV infection incorporating patient-specific factors, primary literature, and drug properties"

Clinical • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Oncology • Pediatrics • Transplantation

305: CMV You Never: Practical Issues Regarding Cytomegalovirus Prophylaxis/Management in the HCT Population (HOPA 2025) - "Session Description: The landscape of cytomegalovirus (CMV) prophylaxis and treatment for patients undergoing allogeneic hematopoietic stem cell transplant (HCT) has evolved over the past decade, with emergence of newer therapies such as letermovir and maribavir. Gone are the days of toxic agents like ganciclovir, foscarnet, and cidofovir—or are they?...Attendees will walk away from this session with tangible pearls that will enhance their ability to safely and effectively manage CMV prophylaxis and treatment in their own patients. Knowledge or Application Based: Application Learning Objectives: Coming soon!"

Clinical • Bone Marrow Transplantation • Cytomegalovirus Infection

Efficacy of antimicrobials in preventing resistance in solid organ transplant recipients: A systematic review of clinical trials. (PubMed, World J Transplant) - "All clinical trials reported significant proportions of antimicrobial-resistant microorganisms following interventions. More high-quality randomized clinical trials are needed to corroborate these results."

Clinical • Journal • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation

Collapsing FSGS in a Kidney Transplant Recipient on Sirolimus who Recently Treated for Resistant CMV Viremia (NKF-SCM 2025) - "She developed severe resistant CMV viremia despite Valganciclovir prophylaxis, needing Foscarnet followed by Maribavir for >6 months. In this setting, the immunosuppression was changed from tacrolimus to sirolimus, and she was started on Cytogam every 2 weeks...The pathophysiology of this phenomenon is not completely understood. Nephrologists need to be vigilant and monitor renal function and proteinuria closely when using mTORi."

Clinical • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hepatology • Nephrology • Renal Disease • Transplantation

Navigating Cytomegalovirus Retinitis in a Patient With Myelodysplastic Syndromes Transitioning to Acute Myeloid Leukemia Post Transplant: A Case Study. (PubMed, Cureus) - "Her UL97 resistance posed significant challenges to CMV management, necessitating a transition from ganciclovir to foscarnet and maribavir. The CMV polymerase chain reaction (PCR) levels initially >10,000 copies/mL decreased to <300 copies/mL with combination therapies, though fluctuations persisted until letermovir prophylaxis was initiated. Six months after the transplant, AML relapse was treated with cladribine, cytarabine, granulocyte-colony-stimulating factor/filgrastim, and mitoxantrone (CLAG-M) and venetoclax, leading to measurable clearance of TP53 mutations to undetectable levels by NGS and reduction of CD34+ blasts from 25% to 0%...This case illustrates the aggressive nature of MDS-AML progression, the critical role of vigilant CMV surveillance, and the nuanced approach needed for treatment, balancing efficacy against potential side effects. The successful navigation of these complexities offers valuable insights for similar cases."

Journal • Acute Graft versus Host Disease • Acute Kidney Injury • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Nephrology • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Transplantation • CD34 • TP53

Author response to Maribavir: Double Edged Sword. (PubMed, J Heart Lung Transplant) - No abstract available

Journal

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Cytomegalovirus Infection • Infectious Disease • Transplantation