Livtencity (maribavir) / Takeda, GSK - LARVOL DELTA

Maribavir effectively treated three patients with human herpesvirus-6B infection after allogeneic hematopoietic stem cell transplantation (PubMed, Zhonghua Xue Ye Xue Za Zhi) - "This retrospective analysis describes three cases of HHV-6B reactivation following allo-HSCT, all of which achieved viral clearance with maribavir treatment following failure or intolerance to first-line antiviral therapy with foscarnet sodium. No adverse drug reactions to maribavir were observed. These findings provide preliminary evidence that maribavir may serve as an effective and safe salvage therapy for HHV-6B reactivation in patients receiving allo-HSCT."

Journal • Retrospective data • Bone Marrow Transplantation • CNS Disorders • Epstein-Barr Virus Infections • Infectious Disease • Transplantation

The New Kid On The Block: Use of Maribavir in Pediatric Immunocompromised Hosts (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Post-HSCT Viral Management: Strategies Beyond the Guidelines (ICBMT 2025) - "Despite the integration of Letermovir into standard prophylaxis regimens, breakthrough infections persist, especially beyond D+100, with Korean real - world data showing clinically significant CMV infection (csCMVi) rates rising from 9.5% at 14 weeks to 29.4% by 24 weeks...We present a real -world case of ganciclovir -resistant CMV harbouring the UL97 H520Q mutation, which necessitated sequential therapy with foscarnet and later maribavir...Prophylaxis with oral acyclovir for up to one year reduces early incidence but carries rebound risks and is limited by long -term toxicity and antiviral resistance. The advent of the recombinant zoster vaccine (RZV; Shingrix) offers a promising preventive strategy, particularly in the 6 –24 month window post -transplant...Optimal outcomes require a personalised, adaptive strategy that incorporates novel therapeutics, surveillance tools, and host factors. Through real -world evidence and clinical insight, this lec ture aims to equip..."

Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Herpes Zoster • Immunology • Infectious Disease • Varicella Zoster

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

Real-World Use of Maribavir vs. Valganciclovir in Solid Organ Transplant (SOT) Patients with or without Refractory Cytomegalovirus Disease (WTC 2025) - "MBV demonstrated comparable efficacy to VGC in CMV clearance. It was associated with fewer hematologic complications but led to increased CNI levels, requiring dose adjustments. These findings support MBV as an alternative for CMV treatment in SOT recipients, particularly those at risk for VGC-induced leukopenia."

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

A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection (clinicaltrials.gov) - P=N/A | N=17 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New trial • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Transplantation

TAK-620-5010: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection (clinicaltrials.gov) - P=N/A | N=265 | Completed | Sponsor: Takeda | Recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Transplantation

TAK-620-2004: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT) (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Takeda | Active, not recruiting ➔ Recruiting

Enrollment open • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Maribavir Salvage Therapy for ganciclovir-resistant cytomegalovirus in two women with HIV-related lymphoma (EACS 2025) - No abstract available

Clinical • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease

Emergence of Maribavir Resistance in an AIDS Patient with Refractory Cytomegalovirus Viremia and Retinitis (EACS 2025) - No abstract available

Clinical • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease

In Silico Analysis of Mechanisms of Maribavir-Induced Inhibition and Drug Resistance Mutations in pUL97 Kinase Structural Prediction with AlphaFold2. (PubMed, Viruses) - "Although it does not phosphorylate deoxynucleosides, this enzyme is involved in the first phosphorylation step of ganciclovir (GCV), a viral DNA polymerase inhibitor...Substitutions that induce cross-resistance to MBV and GCV may directly or indirectly affect the environment of D456 and N461 residues in the catalytic loop, with reduced viral replicative capacity. These results have implications for the clinical use of MBV as well as for the design of novel pUL97 kinase inhibitors."

Journal • Cytomegalovirus Infection • Infectious Disease

A New Next-Generation Sequencing Approach in Human Cytomegalovirus for the Identification of Antiviral Resistance Mutations and Genotypic Classification. (PubMed, J Med Virol) - "It expands the classical investigation of mutations in UL54 and UL97 genes, associated with resistance to (val)ganciclovir, foscarnet and cidofovir, to include UL27, UL56 and UL89 genes, which target newer antivirals like maribavir and letermovir. Finally, this approach enabled the identification of HCMV genotypes. This approach improves the monitoring of antiviral resistance and viral diversity, enhancing early clinical decision-making in immunocompromised patients."

Biomarker • Journal • Next-generation sequencing • Cytomegalovirus Infection • Infectious Disease

Real-World Use of Letermovir and Maribavir in Solid Organ Transplant: A Dual-Centre Study (WTC 2025) - "While valganciclovir isfirst-line, resistance and side effects necessitate alternatives...Pre-LET resistance testing in 18 (47%) SP patients detectedganciclovir and/or cidofovir resistance in 11 (29%)... LET used as SP was limited bysignificant breakthrough and MBV treatment by resistance development in ~25% ofcases. Further studies are needed to identify patient-specific factors and CMVDNAemia thresholds to guide optimal use of these antivirals."

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

Real World Maribavir Use in Solid Organ Transplant Patients in a Single Academic Center (WTC 2025) - "Maribavir was a viable option for the management of resistant or refractoryCMV infection in our real-world single center cohort, as success mirrored that seen in other studies. However, there was a clinically significant portion of patients who failed maribavir or had recurrent CMV. Continued multi-center analysis of maribavir timing, secondary prophylaxis, and patient characteristics that may predict success are warranted to help improve the use of this valuable agent."

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

A Single-Center Review of Resistant CMV Infection in Solid Organ Transplant Recipients (WTC 2025) - "The development of resistance to standard therapies, valganciclovir (vGCV), the mainstay of CMV prophylaxis following SOT, and ganciclovir (GCV), the first line therapy for CMV infection, leads to limited treatment options with significant toxicities, higher mortality rates, and longer hospital stays...Once undergoing treatment for suspected resistance, treatment was escalated to either maribavir or foscarnet... Most patients developed CMV resistance while on prophylaxis with under-dosing of vGCV likely a key contributing factor. The challenge of dosing vGCV amid fluctuating renal function post-transplant highlights a key area for improvement, such as, closer renal function monitoring or the use of medications like letermovir that do not require renal adjustment. While ID involvement was infrequent early in CMV diagnosis and its impact on CMV treatment outcomes is unknown, we advocate for early ID consultation to enhance monitoring and clinical decision-making for CMV..."

Clinical • Review • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

A Retrospective, Observational Analysis of Real-World Maribavir Treatment Patterns for Post-Transplant Refractory Cytomegalovirus Infection (CMVi) in the US (WTC 2025) - "Pts had confirmed post-transplant CMVi (Jan 1, 2015-Mar 31, 2024) and received maribavir for refractory CMVi (defined as val/ganciclovir, cidofovir, foscarnet or letermovir use as 1st line of therapy [LoT] for the 1st CMVi episode). This descriptive research may help clinicians understand the real-world populations receiving maribavir for refractory CMVi, and provides preliminary evidence of higher success rates for maribavir when used earlier in the treatment sequence for refractory CMVi."

Post-transplantation • Real-world • Real-world evidence • Retrospective data • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Transplant Rejection • Transplantation

Risk Factors and Real-World Implications of CMV Resistance Mutations After Treatment with Maribavir or Foscarnet for Resistant and Refractory CMV (WTC 2025) - "In our study population, prolonged exposure to either drug was associated with development of antiviral resistance. Consideration should be given to limiting duration of MBV treatment as possible and avoiding use as secondary prophylaxis due to possible association with increased risk of MBV resistance."

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

6-Month Outcomes of a Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients (WTC 2025) - "6-month findings from this RCT comparing VGC to MAR for CMV prophylaxis in high-risk KTX demonstrate similar rates of CMV infections and clinical outcomes, with a strong signal of improved tolerability in those receiving MAR (less neutropenia, less antiviral dose adjustments, fewer ED visits) vs VGC. ."

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

Effect of Secondary Prophylaxis on the Risk of Recurrent Cytomegalovirus Infection Among Solid Organ Transplant Recipients (WTC 2025) - "Secondary prophylaxis was mostly valganciclovir (N=114, 91.2%), though 9 (7.2%) received letermovir and 2 (1.6%) received maribavir. Solid organ transplant recipients who received secondary prophylaxis had a lower risk of rcsCMVi. Secondary prophylaxis should be considered among patients at high risk for recurrent CMV."

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

Management of Cytomegalovirus Infection in Allogeneic Hematopoietic Stem Cell and in Solid Organ Transplantation: Updated Recommendations by the GITMO, SITO, SIMIT, and AMCLI Italian Societies. (PubMed, Clin Transplant) - "Key recommendations include: in both allo-HSCT and SOT, donor and recipient should be evaluated for anti-CMV serological status before transplant for risk stratification; monitoring of CMV infection after transplant should be performed by assaying CMV DNAemia with real time PCR; CMV-specific cell mediated immunity should be monitored after transplantation in allo-HSCT and SOT; in CMV seropositive adult allo-HSCT recipients with negative CMV DNAemia, letermovir prophylaxis is recommended; there is no mandatory indication to universal prophylaxis in SOT recipients; preemptive antiviral therapy is recommended in patients with clinically significant CMV infection (CS-CMV-i); in patients with resistant or refractory CMV infection or disease after first-line antiviral therapy, oral maribavir is recommended as second line antiviral therapy. In conclusion, these recommendations aim to guide clinical practice and improve outcomes in this high-risk population."

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

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

Dynamics of dual CMV and EBV co-reactivation and emergence of resistance in an HSCT recipient. (PubMed, J Antimicrob Chemother) - "The use of NGS and Sanger sequencing revealed evolution of CMV drug resistance under antiviral treatment. Our findings highlight the potential of maribavir to treat EBV infection and the difficulties in managing CMV/EBV co-reactivation in immunocompromised hosts."

Journal • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Infectious Disease • Transplantation

Population Pharmacokinetics and Exposure-Response Relationships of Maribavir in Transplant Recipients With First Episode or Refractory Cytomegalovirus. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "In conclusion, maribavir's efficacy, safety, and favorable tolerability profile in transplant recipients with first CMV infection after transplant or refractory CMV infection is supported by PK exposure metrics. Higher maribavir steady-state concentrations were not associated with greater efficacy or a higher frequency of adverse events other than nausea and vomiting."

Journal • PK/PD data • Cytomegalovirus Infection • 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