Livtencity (maribavir) / Takeda, GSK - LARVOL DELTA

Single-center retrospective analysis of maribavir in the treatment of refractory and drug-intolerant cytomegalovirus viremia and cytomegalovirus disease after allogeneic hematopoietic stem cell transplantation (ASH 2025) - P3 | "Maribavir, a novel anti-CMV agent, exhibits multimodal anti-CMV activity without cross-resistance to ganciclovir or foscarnet...Fifty patients received letermovir for CMV prophylaxis...The 1-year overall survival rate was 86.5% (95% CI: 74.7%–98.4%). Conclusion Maribavir demonstrated high efficacy and a favorable safety profile in treating refractory or drug-intolerant CMV viremia and CMV disease post- allo HSCT, characterized by rapid viral clearance (shortmedian time to response) and minimal adverse effects."

Retrospective data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock • T Cell Non-Hodgkin Lymphoma • Transplantation

Maribavir for cytomegalovirus infections after hematopoietic stem cell transplantation: A real world comparative cohort study (ASH 2025) - "No treatment-relatedadverse events were observed during therapy.Nineteen patients received first-line maribavir for post-HSCT CMV infection, while 20 control patientsreceived other first-line regimens (12 predominantly foscarnet; 8 received combination therapy includingganciclovir or letermovir). In real-world, maribavir demonstrated rapid, effective, and safe clearance of CMV viremia inHSCT recipients. The comparative cohort study demonstrates comparable CMV clearance rates betweenfirst-line maribavir and conventional antiviral regimens in HSCT recipients. Notably, maribavir wasassociated with a clinically relevant 5-day reduction in median time to viral clearance (7 vs 12 days)."

Clinical • Real-world • Real-world evidence • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Transplantation

Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis. (PubMed, Transpl Int) - P3 | "In the phase 3 SOLSTICE study (NCT02931539), more transplant recipients achieved CMV clearance after 8 weeks with maribavir than investigator-assigned therapy (IAT)...Median (range) time from treatment start to death was 30.5 (3-123) days. This analysis is consistent with other studies showing an increased risk of mortality with post-SOT CMV infection."

Clinical • Journal • Retrospective data • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

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

Enrollment open • Cytomegalovirus Infection • Hematological Malignancies • Multiple Myeloma • Oncology

Cytomegalovirus and Crohn's disease as competing causes of small bowel inflammation after double-lung transplantation. (PubMed, Eur Clin Respir J) - "CMV infection was identified in intestinal biopsies and initially managed with two courses of valganciclovir. Due to persistent symptoms, genotypic analysis was performed, revealing UL97 mutations conferring ganciclovir resistance. Sequential therapy with foscarnet, maribavir, and letermovir achieved virological clearance, but diarrhea persisted...The patient was commenced on standard biological therapy for Crohn's disease, resulting in marked clinical improvement and recovery. This case illustrates the diagnostic challenge of distinguishing CMV enteritis from de novo Crohn's disease and determining the primary driver of the clinical presentation."

Journal • Crohn's disease • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Mucositis • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Reversion of Val(Ganciclovir)-Resistance-Associated Mutations in Two SOT Patients with Mismatched Serostatus for CMV (D+/R-). (PubMed, Viruses) - "Following CMV DNA suppression, secondary prophylaxis with letermovir and val(ganciclovir) was initiated...Therapy was then switched to foscarnet, which was suspended due to renal failure, and then to maribavir...Detecting gene mutations that confer drug resistance is crucial for managing antiviral therapy when virological response is lacking. In our cases, the reversion of (va)ganciclovir-resistance mutations occurred after drug withdrawal, a previously unreported finding."

Journal • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Renal Disease • Solid Organ Transplantation • Transplantation

Role of Cytomegalovirus (CMV) Immunoglobulin in Managing Multidrug-Resistant CMV Infection in a Kidney Transplant Recipient (KIDNEY WEEK 2025) - "He received induction with thymoglobulin and maintenance immunosuppression with tacrolimus, MMF, and prednisone. Prophylaxis included valganciclovir (VGCV) and TMP-SMX...Despite VGCV therapy and MMF reduction, viral load rebounded to 94,600 IU/mL with resistance to VGCV and cidofovir. Maribavir (MBV) was initiated, resulting in temporary improvement, but viremia rebounded to 404,000 IU/mL...Foscarnet (FOS) was started but failed to reduce viremia...At seven months, he was discharged on letermovir (LTV), but viremia rose to 40,200 IU/mL by ten months...While not curative, CMV-Ig appeared to modulate disease activity, especially when standard options were exhausted or unavailable. This case underscores the importance of adherence, timely resistance testing, and the potential role of immunotherapeutics like CMV-Ig in refractory CMV management."

Clinical • Cardiovascular • Chronic Kidney Disease • Cytomegalovirus Infection • Diabetes • Fibrosis • Gout • Hematological Disorders • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Leukopenia • Liver Cirrhosis • Metabolic Disorders • Rheumatology • Transplantation

Applying the Evidence-Generation Continuum Concept to Support Patient Access to Innovative Therapies in France: A Use Case in Rare Diseases (ISPOR-EU 2025) - "The EGC applied to maribavir supported its value demonstration, while allowing for patient access in a context of high unmet medical need. These data were complementary to those from the pivotal trial and confirmed existing data from French maribavir users."

Clinical • Cytomegalovirus Infection • Infectious Disease • Rare Diseases • Solid Organ Transplantation

"Severe Cytomegalovirus Infection in a Patient with Prolonged Immunodeficiency Following BCMA-Directed CAR-T Cell Therapy" (DGHO 2025) - "In this report, we present a patient with refractory MM who developed severe HCMV end-organ manifestation following treatment with ciltacabtagene autoleucel (cilta-cel), and provide first insights into the underlying immunological background. Clinical data were retrieved from electronic records...Initial valganciclovir therapy caused transfusion-dependent pancytopenia and was replaced by foscarnet...18 months post-CAR-T, despite ongoing treatment with maribavir, the patient developed HCMV retinitis, prompting re-initiation of ganciclovir after excluding HCMV polymerase and phosphotransferase mutations. Our case indicates that BCMA CAR-T patients require intense infectious disease monitoring strategies similar to those after allogeneic hematopoietic stem cell transplantation including routine HCMV screening, preemptive therapy. This case confirms the importance of antiviral prophylaxis."

CAR T-Cell Therapy • Clinical • IO biomarker • Bone Marrow Transplantation • Cachexia • Cytomegalovirus Infection • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Ocular Inflammation • Ophthalmology • Retinal Disorders • B3GAT1 • CD4 • CD8 • IFNG • NCAM1

A Rare Case of CMV Hepatitis Occurring in a Young Patient With Autoimmune Polyglandular Syndrome and Pediatric-Onset Autoimmune Hepatitis (ACG 2025) - "Although cases of CMV hepatitis have been reported, there is only 1 case report of CMV hepatitis occurring in a patient with autoimmune hepatitis (AIH) (on azathioprine [AZA] and steroids), along with Sweet Syndrome...AZA and steroids were held and she was treated with valganciclovir...She remains on maribavir for now, along with low dose prednisone. This is a rare case of acute CMV hepatitis in an immunocompromised host with longstanding AIH, on maintenance AZA and steroids...An early diagnosis is key to instituting effective treatment and achieving a good outcome. The therapeutic challenge will be navigating re-institution of her immunosuppression regimen for AIH, while at the same time monitoring closely for persistence or reactivation of her CMV hepatitis after her anti-viral therapy is completed."

Clinical • Autoimmune Hepatitis • Cytomegalovirus Infection • Dermatology • Fatigue • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Ocular Infections • Pediatrics • Solid Organ Transplantation

Determinants of Virological Outcomes in Kidney Transplant Recipients Treated with Maribavir for Refractory CMV Infection. (PubMed, Am J Transplant) - "We conducted a retrospective cohort study that involved 88 kidney transplant recipients (KTRs) from 22 transplantation centers, all of whom had refractory CMV infections treated with maribavir (63 with ganciclovir resistance mutations and 25 without). In summary, refractory CMV infections characterized by high levels of CMV DNAemia or symptomatic presentations are more challenging to treat with maribavir. These findings may support the development of new strategies for patients at risk of poor outcomes."

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

Conserved mode of nuclear lamina distortion by primate cytomegaloviruses: importance of the pSer22 motif, viral kinase and cis/trans isomerase Pin1 activity. (PubMed, J Gen Virol) - "Our new results demonstrate the following: (i) currently available Pin1-inhibitory small molecules, similar to the antiviral drug maribavir (MBV), exert an antiviral activity against human and non-human primate cytomegaloviruses (CMVs); (ii) site-specific phosphorylation at serine 22, a Pin1 recognition motif within lamin A/C, is consistently mediated by the pUL97 kinase homologs of these viruses; (iii) the phosphorylation of serine 22 is sensitive to the virus-specific kinase inhibitor MBV; (iv) a doxycycline-inducible expression of autofluorescent lamin A/C-red fluorescent protein (RFP) fusion constructs in HFFs supports the productive HCMV replication; (v) these lamin A/C-RFP reporter cells indicated a virus-induced formation of lamina-depleted areas (LDAs), dependent on serine 22 but independent of the infecting CMV species; and (vi) treatment of CMV-infected cells with kinase or Pin1 inhibitors exerted distinct effects on the magnitude of LDA formation. Combined,..."

Journal • Cytomegalovirus Infection • Infectious Disease • LMNA

Investigational treatments for cytomegalovirus infection in phase I and II study. (PubMed, Expert Opin Investig Drugs) - "Despite recent advances in CMV chemoprevention and treatment in transplant recipients, there remains a need for a broader, more diversified approach to mitigating the impact of CMV infection in both transplant and non-immunocompromised persons. Intravenous brincidofovir would provide an important alternative option to current antivirals in the right clinical setting. Several promising vaccine candidates are in various stages of clinical development. A safe and effective vaccine may also expand preventative strategies beyond transplant recipients and into healthy persons, specifically for the prevention of maternal-to-fetal transmission. The therapeutic possibilities of VST and TCR therapy represent important potential adjuncts to antivirals."

Journal • P1 data • Review • Cytomegalovirus Infection • Infectious Disease • Transplantation

MARIBAVIR AS ANTI-CMV TREATMENT IN REFRACTORY OR RESISTANT DISEASES IN A NON-TRANSPLANT SETTING (SIE 2025) - "First CMV reactivation was observed during induction with RDHAX; it was resolved with Valganciclovir...Foscarnet was started as second-line, obtaining virus clearance...After two weeks, we obtained a complete response, permitting us to start a bridge therapy to HSCT with Glofitamab. After Maribavir stop, it was also started a prophylactic therapy with Letermovir...Ganciclovir therapy was started and despite a clinical improvement, after 3 weeks CMV was still detectable...That permitted us to start the anti-HCL therapy with 2-CDA, after which the patient expe- rienced pancytopenia with two bacterial complications, but no CMV positivity was anymore detected even after Maribavir stop...In both cases we obtained a long lasting virus clearance after two weeks of treatment. Further evaluations are needed, but from these first datas we can speculate about the possibility to extend the use of Maribavir also in immunocompromised not-transplanted patients."

Bone Marrow Transplantation • Cytomegalovirus Infection • Diffuse Large B Cell Lymphoma • Genetic Disorders • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Ocular Inflammation • Retinal Disorders • Transplantation • Uveitis

Refractory CMV Enteritis in Small Bowel Transplantation: A Case Highlighting the Challenges of Balancing Immunosuppression and Novel Antiviral Therapies. (PubMed, Viruses) - "He developed refractory CMV disease, marked by non-response to first line therapy with ganciclovir-despite the absence of genotypic resistance-necessitating sequential use of foscarnet, dual antivirals, CMV immunoglobulin, and novel agents (maribavir and letermovir). Profound immunosuppression required to manage acute graft rejection episodes complicates antiviral management and disease clearance. Despite best efforts in CMV management in this population, outcomes may still be compromised by unrelated or compounding factors."

Journal • Cytomegalovirus Infection • Gastrointestinal Disorder • Transplant Rejection • Transplantation

Understanding antiviral intolerance in the management of cytomegalovirus; a scoping review. (PubMed, Curr Opin Infect Dis) - "The most commonly identified intolerances were acute kidney injury, hematological and gastrointestinal effects in older anti-CMV agents. Fewer studies described intolerance of the newer agents. Detailed descriptions of intolerances are absent within the literature and there is an opportunity to standardize terminology used to help guide clinical practice."

Journal • Acute Kidney Injury • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Leukopenia • Nephrology • Neutropenia • Renal Disease • Thrombocytopenia • Transplantation

New evidence in the management of CMV infection: impact on prophylaxis and treatment. (PubMed, Rev Esp Quimioter) - "The role of novel agents such as letermovir and maribavir is highlighted. These findings support personalized strategies that balance efficacy, toxicity, and resistance in managing CMV infection."

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

Changing scenario in prevention and management of CMV infections in pediatric hematopoietic stem cell transplant patients. (PubMed, Bone Marrow Transplant) - "Clinical data and recent FDA/EMA approval of letermovir in children are also providing a breakthrough in pediatric CMV disease prevention. Pre-emptive treatment remains the preferred approach in case of clinically significant CMV infection in both adults and children; meanwhile, new available options such as maribavir and broader application of viral-specific T-cells represent valid strategies for the management of refractory/resistant CMV infection, offering a less-toxic therapeutic alternative to conventional, still effective, antivirals."

Journal • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • Transplantation

Emergence of maribavir resistance in an AIDS patient with refractory cytomegalovirus viremia and retinitis (EACS 2025) - "Antiretroviral therapy with BIC/FTC/TAF was initiated...Relapsed CMV viremia (2.2 x 10⁵ copies/mL) was detected, despite valganciclovir prophylaxis and a ganciclovir resistance mutation (UL97 L595S) was confirmed. Foscarnet was attempted but discontinued due to nephrotoxicity...Letermovir was used as salvage anti-CMV therapy, the patient died from febrile neutropenia and septic shock due to Pseudomonas aeruginosa bacteremia...To the best of our knowledge, no other cases of genotypic maribavir resistance in treated patients with AIDS have been reported to date. Novel antiviral strategies may be critical in managing resistant CMV in non-transplant, immunocompromised patients."

Clinical • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease • Septic Shock • CD4

Maribavir salvage therapy for ganciclovir-resistant cytomegalovirus in two women with HIV-related lymphoma (EACS 2025) - "Valganciclovir resistance-associated mutation (L595S) appeared at month 5 of secondary prophylaxis Following intolerance to foscarnet, maribavir was initiated. This is the first report of off-label maribavir use in PWH with ganciclovir-resistant CMV infection. Maribavir provided rapid virological control and clinical stabilization of CMV infection in two severely immunocompromised PWH. Emergence of maribavir resistance in one case highlights the need for close monitoring of CMV viraemia."

Clinical • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease • CD4

SUCCESSFUL TREATMENT OF REFRACTORY CYTOMEGALOVIRUS INFECTION WITH NOVEL ANTIVIRAL AGENT IN AN ADOLESCENT WITH KIDNEY TRANSPLANTATION (ESPN 2025) - "At the time of the diagnosis, his treatment included prednisolone, cyclosporine, and MMF...Initially, he was treated with intravenous ganciclovir followed by oral valganciclovir and courses of intravenous human CMV immunoglobulin... The new antiviral agent, maribavir, seems to be effective and well tolerated in cases of ganciclovir resistant CMV infection giving a new option for the management of resistant CMV infection in pediatric kidney transplant recipients."

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

Revisiting cytomegalovirus in pediatric allogeneic hematopoietic stem cell transplant recipients: current strategies for prevention and management in the letermovir era. (PubMed, Front Pediatr) - "Other novel additions to the diagnosis, risk stratification, and treatment of CMV include the measurement of CMV-specific cellular-mediated immunity and the approval of maribavir as a treatment option for resistant/refractory CMV infection and disease. Other prevention and treatment modalities currently under development include virus-specific T cells, monoclonal antibodies, and vaccines. Despite these promising advancements, additional pediatric-specific studies are needed to better understand the viral and immunological implications of these novel preventive and therapeutic methods in this patient population."

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

Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients (clinicaltrials.gov) - P4 | N=70 | Completed | Sponsor: Medical University of South Carolina | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Aug 2025 | Trial primary completion date: Nov 2025 ➔ Jun 2025

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

Management of refractory cytomegalovirus esophagitis in a patient with lymphoma and severe immunosuppression: foscarnet versus maribavir. (PubMed, Enferm Infecc Microbiol Clin (Engl Ed)) - No abstract available

Journal • Cytomegalovirus Infection • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Oncology

A Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for Cytomegalovirus (CMV) Prophylaxis in High-Risk Kidney Transplant Recipients: Study Protocol. (PubMed, Cureus) - P4 | "In this preliminary report, we describe the study design, methods, aims, and outcome measures that will be utilized in the ongoing Maribavir IIR clinical trial. Trial registration The trial is registered at ClinicalTrials.gov NCT06034925: https://www.clinicaltrials.gov/study/NCT06034925."

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