Livtencity (maribavir) / Takeda, GSK - LARVOL DELTA

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

REFRACTORY CYTOMEGALOVIRUS INFECTION AND PROLONGED IMMUNE DEFICIENCY FOLLOWING BCMA-DIRECTED CAR-T CELL THERAPY: IMPLICATIONS FOR INFECTIOUS DISEASE SURVEILLANCE AND MANAGEMENT (EHA 2025) - "While cytomegalovirus (CMV) reactivation is well-documented in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients, there is limited evidence of clinically significant CMV infection following CAR-T therapy in MM patients.Here, we highlight the challenges in CMV management post-CAR-T, emphasizing the need for systematic surveillance, early intervention, and long-term immune monitoring and report on the first documented case of refractory CMV disease with pulmonary, gastrointestinal, and retinal involvement following CAR-T (ciltacabtagene autoleucel) in a patient with refractory multiple myeloma with extramedullary mass.Despite having achieved complete remission of MM, the patient still requires from months 11 post CAR-T continuous maribavir treatment after failure of valganciclovir and foscarnet. This case highlights that BCMA-directed CAR-T therapy induces prolonged immune suppression, predisposing patients to severe and persistent CMV infection with..."

CAR T-Cell Therapy • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Respiratory Diseases • Solid Organ Transplantation • B3GAT1 • CD4 • CD8 • IFNG • NCAM1

REAL-WORLD INSIGHT ON TREATMENT WITH MARIBAVIR FOR CLINICALLY-SIGNIFICANT CMV INFECTION IN ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS: A RETROSPECTIVE INTERNATIONAL IDWP EBMT STUDY (EHA 2025) - "The majority of MBV courses were given <1 month after a previous antiviral (given alone or in combination) including valganciclovir (34; 49%) ganciclovir (18; 6%) foscarnet ( 5; 36%) or cidofovir (7; 10%). In agreement with the data from the clinical trials our real-world data support the high efficacy of MBV in treating CMV infection post-HCT."

Real-world • Real-world evidence • Retrospective data • Bone Marrow Transplantation • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Transplantation

Adverse event profile differences between maribavir and valganciclovir: findings from the FDA adverse event reporting system. (PubMed, Front Pharmacol) - "This comprehensive analysis of FAERS data enhances our understanding of the safety. These findings hold implications for ongoing clinical surveillance efforts and provide a foundational basis for subsequent investigations into the safety profiles of these agents."

Adverse events • Journal • Cytomegalovirus Infection • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Leukopenia • Neutropenia • Thrombocytopenia • Transplantation

MALMBA: Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P2 trial • Cytomegalovirus Infection • Hematological Malignancies • Multiple Myeloma • Oncology

Maribavir Treatment in Resistant/Refractory Cytomegalovirus Infection Among Kidney Transplant Recipients: A Real-World Experience (ERA 2025) - "Maribavir (MBV) selectively inhibits the viral kinase UL97, offering a different mechanism of action compared to conventional treatments such as ganciclovir and valganciclovir (GCV/ VGC). Maribavir shows high efficacy in treating refractory cytomegalovirus (CMV) infections, with significant benefits from its oral administration and low side effect profile. These factors support outpatient management and reduce the need for hospitalization. Our data showed superior efficacy rates compared to published literature, maintaining comparable recurrence rates."

Clinical • Real-world • Real-world evidence • Cardiovascular • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Neutropenia • Solid Organ Transplantation • Transplant Rejection • Transplantation

Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using Lab-linked claims Data in the United States. (PubMed, Expert Rev Anti Infect Ther) - P3 | "MBV's favorable benefit-risk profile makes it a potentially valuable addition to the CMV treatment armamentarium. www.clinicaltrials.gov identifier is NCT02931539."

Journal • Real-world evidence • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Leukopenia • Neutropenia • Solid Organ Transplantation • Transplantation

CMV infections after HSCT: prophylaxis and treatment. (PubMed, Blood Res) - "Letermovir, a terminase complex inhibitor, has become the standard of care for primary prophylaxis in CMV-seropositive recipients because of its efficacy and favorable safety profile. PET involves regular monitoring of CMV DNAemia via polymerase chain reaction (PCR) and initiation of antiviral therapy, most commonly ganciclovir or valganciclovir, upon detection of early viral reactivation...Maribavir, a UL97 kinase inhibitor, has demonstrated superior efficacy and improved tolerability compared to conventional therapies in the phase 3 SOLSTICE trial, making it a promising therapy for refractory or resistant CMV. Optimal CMV management requires a risk-adapted, individualized approach that integrates prophylaxis, early detection, and timely intervention to reduce CMV-related complications."

Journal • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Transplantation

Use of Maribavir for Multidrug-Resistant Cytomegalovirus in an Immunocompromised Host With HIV and Common Variable Immunodeficiency. (PubMed, Ann Intern Med Clin Cases) - "Although his initial CMV pharyngitis resolved, the CMV isolated from blood became resistant to ganciclovir and cidofovir and eventually required treatment with foscarnet. After 6 weeks, the patient's viremia resolved and remained undetectable for 6 months after treatment initiation with maribavir. This case demonstrates the feasibility of using maribavir for resistant CMV in a nontransplant, immunocompromised patient."

Journal • Bone Marrow Transplantation • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease • Primary Immunodeficiency • Transplantation

Interplay of Belatacept Immunosuppression and Maribavir Antiviral Activity in Recurrent CMV Viremia: Clinical Implications and Literature Review. (PubMed, Viruses) - "The viremia showed an incomplete response to first-line antiviral therapy with valganciclovir, and the use of the novel antiviral agent maribavir also failed to achieve long-lasting viremic clearance. This case and literature review underscores the need for clinicians to remain vigilant for atypical CMV infections in renal transplant recipients treated with belatacept. If the complete clearance of viremia cannot be achieved despite the use of different antiviral agents, consideration should be given to modifying immunosuppressive therapy."

Journal • Review • Acute Kidney Injury • Cytomegalovirus Infection • Infectious Disease • Nephrology • Transplantation

MARIBAVIR: A SALVAGE OPTION FOR RESISTANT CMV IN PEDIATRIC HEART TRANSPLANT (ESPID 2025) - "Despite valganciclovir prophylaxis (250mg/day), CMV replication persisted. In October 2024, treatment was switched to intravenous ganciclovir (5mg/kg/12h), but viral load increased (6logUI/mL)...Treatment was switched to foscarnet in November 2024 (90mg/kg/12h), with aggressive hydration to mitigate renal toxicity. One week into treatment, acute severe renal toxicity developed (glomerular filtration rate estimated at 24mL/min), likely exacerbated by tacrolimus overdose, insufficient hydration (at the beginning), and concurrent vancomycin for fever and gastrointestinal symptoms...Learning Points/Discussion Maribavir can be considered a salvage therapy for pediatric CMV infection in solid organ transplant recipients, with careful blood level monitoring to ensure efficacy and avoid under-dosing. In this case, the optimal initial dose would have been 100 mg/8h."

Clinical • Cytomegalovirus Infection • Infectious Disease

Maribavir: Double edged sword. (PubMed, J Heart Lung Transplant) - No abstract available

Journal

Two Cases of Maribavir Treatment of Refractory/Resistant Cytomegalovirus Infection in Solid-Organ Transplant Recipients: Time for a New Paradigm? (PubMed, Exp Clin Transplant) - "Our experience suggested that the goal to achieve complete viremia clearance may not always be necessary if clinical resolution and stable viremic responses (ie, viral load <1000 IU/mL) are achieved. In such cases, discontinuation of therapy with close monitoring may be a viable option."

Journal • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • 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

The Importance of Drug Exposure in the Development of Cytomegalovirus Resistance. (PubMed, Int J Antimicrob Agents) - "This disease is routinely managed by antiviral agents including (val)ganciclovir, foscarnet, cidofovir, letermovir, and maribavir. With solid knowledge of these relationships, more predictive in vitro and in vivo markers of clinical efficacy can be identified. Additionally, pharmacokinetic-pharmacodynamic models and combination therapies should be further explored in to improve the management of CMV."

Journal • Review • Cytomegalovirus Infection • Transplantation

CMV Viremia and Colitis in Simultaneous Pancreas-Kidney Transplantation. (PubMed, Am J Case Rep) - "CONCLUSIONS In transplant patients, cytomegalovirus (CMV) infection, particularly when complicated by antiviral resistance, presents significant therapeutic challenges. A strategic approach, including the switch from ganciclovir to maribavir, foscarnet, and finally to letermovir, was critical in successfully managing the infection and preventing severe complications."

Journal • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Transplantation

Successful Use of Maribavir for Secondary CMV Prophylaxis in a Pediatric HSCT Patient (ASPHO 2025) - "Despite Letermovir prophylaxis, she developed CMV viremia post-HSCT, leading to primary engraftment failure. She received Foscarnet and Ganciclovir before transitioning to maribavir as secondary prophylaxis during her second HSCT... This case represents the first reported use of maribavir as secondary CMV prophylaxis in a pediatric HSCT patient, demonstrating its safety and efficacy in managing CMV viremia without compromising engraftment or exacerbating comorbidities. Further research is warranted to explore maribavir's role in earlier-stage CMV management and pediatric populations."

Clinical • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Otorhinolaryngology • Pediatrics • Respiratory Diseases • Sinusitis • Transplant Rejection

Human Cytomegalovirus Virion-Associated mRNA as a Marker of Productive Infection in Immunocompromised Patients. (PubMed, J Med Virol) - "Moreover, UL21.5 mRNA was positive in patients who developed HCMV infection resistant to letermovir or maribavir, whereas it was undetectable in the plasma of patients with transient self-resolving DNAemia blips during letermovir prophylaxis (not associated with drug-resistance). HCMV UL21.5 mRNA in plasma is virion-associated and represents a marker for productive HCMV infection. The determination of UL21.5 mRNA could improve current strategies for the management of HCMV infection in immunocompromised patients."

Biomarker • Journal • Cytomegalovirus Infection • Infectious Disease • Transplantation

Tackling CMV in Transplant Recipients: Past, Present, and Future. (PubMed, Infect Dis Ther) - "Letermovir, a selective CMV terminase inhibitor, has emerged as a critical prophylactic agent in high-risk transplant populations, significantly lowering infection rates and improving survival with fewer adverse effects than older antivirals. Maribavir, a UL97 kinase inhibitor, is another recently approved promising option for treating CMV, especially in patients with ganciclovir-resistant or refractory CMV infections...Looking into the future, ongoing innovations in immune monitoring and antiviral development will likely lead to a more personalized approach to CMV prevention and treatment, optimizing care based on patient-specific risk profiles and immune competence. As this field continues to evolve, integrating novel therapies, improved diagnostics, and immunity-driven protocols holds promise for further reducing CMV-related complications and improving overall outcomes for transplant recipients."

Journal • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Optimizing CMV therapy: Population pharmacokinetics and Monte Carlo simulations for letermovir and maribavir dosage. (PubMed, PLoS One) - "Our findings suggest a strong rationale to reconsider and potentially modify the approved dosing guidelines for letermovir and maribavir in CMV treatment. Adjusting dosing regimens, including the use of loading doses and increased doses after missed doses, could enhance treatment outcomes by ensuring higher probabilities of achieving therapeutic targets and better managing missed doses."

Journal • PK/PD data • Cytomegalovirus Infection • Infectious Disease

TAK-620-5010: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Takeda | Trial completion date: Apr 2025 ➔ Jul 2025 | Trial primary completion date: Apr 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Infectious Disease • Transplantation

Case Report: Maribavir for refractory cytomegalovirus viremia after renal transplantation in a child with Schimke's immune-osseous dysplasia. (PubMed, Front Immunol) - "Blood CMV levels rose to 1.64 × 105 copies/ml after one month of ganciclovir treatment. Significant bone marrow suppression was observed after combined treatment with foscarnet...This case demonstrates the successful short-term use of maribavir in the treatment of refractory CMV infection in an immune-deficient child after renal transplantation. Further studies are required to explore the efficacy and safety of maribavir in pediatric patients."

Journal • Chronic Kidney Disease • Cytomegalovirus Infection • Infectious Disease • Nephrology • Pain • Pediatrics • Renal Disease • Solid Organ Transplantation • 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