Livtencity (maribavir) / Takeda, GSK - LARVOL DELTA

Clinical Challenges in Managing Ganciclovir-Resistant CMV Ileitis (ACG 2026) - "Case Description/ A 63-year-old male with type 1 diabetes mellitus and end-stage renal disease status post deceased donor renal transplantation (CMV D+/Râ) two months prior, on mycophenolate 720 mg twice daily and Belatacept 5mg/kg every 28 days presented to the emergency department with seven episodes of non-bloody diarrhea...Diarrhea improved after treatment with Maribavir and immunosuppression was resumed...UL54 encodes the catalytic subunit of viral DNA polymerase conferring resistance to ganciclovir as well as foscarnet and cidofovir...This case highlights the clinical course of a patient with CMV in a notably uncommon location, the terminal ileum. Figure: A. Endoscopic images of terminal ileum showing ulcers due to CMV Ileitis."

Clinical • Cytomegalovirus Infection • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus

Not All Granulomas Are Infection: A Case of De Novo Sarcoidosis in a Liver Transplant Recipient (ACG 2026) - "He was started on prednisone 20 mg daily for sarcoidosis and maribavir for the rising CMV viremia. Moderate-to-severe portal and moderate lobular mixed inflammation is also present. Native interlobular bile ducts are present and focally reactive, but granulomas are not clearly associated with bile ducts (both images taken at 200x from H&E stained slides)."

Clinical • Acute Kidney Injury • Cytomegalovirus Infection • Endocrine Disorders • Epstein-Barr Virus Infections • Fibrosis • Hepatology • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Sarcoidosis • Solid Organ Transplantation • Transplant Rejection • Transplantation

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections (clinicaltrials.gov) - P3 | N=20 | Completed | Sponsor: Takeda | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jul 2026 | Trial primary completion date: Dec 2026 ➔ Jul 2026

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

Thrombotic Microangiopathy post Simultaneous Pancreas-Kidney (SPK) transplant: a challenging scenario (TTS 2026) - "Management strategies vary and may include withdrawal of CNI therapy, plasma exchange or complement inhibition with drugs like eculizumab...She received induction immunosuppression with anti-thymocyte globulin, followed by standard maintenance therapy: prednisolone, tacrolimus, and mycophenolate mofetil (MMF)...Tacrolimus was subsequently replaced with Belatacept. However, CMV reactivated, necessitating a switch to an mTOR inhibitor (everolimus). Due to concerns for maribavir resistance, valganciclovir was restarted... Delayed post-transplant TMA may be multi-factorial, with contributions from CNI toxicity, viral infections, and genetic mutations. This case highlights the importance of dynamic immunosuppression adjustment and infection management. Ongoing management requires careful balancing of rejection risk and infectious complications, with complement inhibition considered for recurrent or refractory TMA."

Antibody-mediated Rejection • Beta-Thalassemia • Diabetes • Diabetic Nephropathy • Genetic Disorders • Gynecology • Hematological Disorders • Infectious Disease • Metabolic Disorders • Neutropenia • Transplantation • Type 1 Diabetes Mellitus

Cytomegalovirus and antiviral related outcomes in kidney transplant recipients over a 24-month period from an Australian transplanting centre. (TTS 2026) - "The remaining 54 patients (89%) received universal prophylaxis with valganciclovir (VGC)...CMV treatment was initiated in 30% of at-risk patients and 18% were transitioned to everolimus... CMV infection remains a significant complication of transplantation with a third of our cohort requiring treatment for CMV infection and/or experiencing neutropenia on VGC. The greatest incidence of high-grade viremia, hospitalisation due to CMV disease and RRI emergence was observed in patients with discordant D+/R- serology. Maribavir was effective in treating CMV RRI with resolution of infection in affected patients."

Clinical • Cytomegalovirus Infection • Infectious Disease • Neutropenia • Septic Shock • Transplantation

Maribavir efficacy and safety by baseline neutropenia status in solid organ transplant recipients with refractory cytomegalovirus: post hoc analysis of phase 2 and 3 trials (TTS 2026) - P2, P3 | "Maribavir is an anti-CMV agent with lower incidence of myelosuppression than valganciclovir/ganciclovir in solid organ transplant (SOT) recipients treated for refractory CMV infection. This post hoc analysis of maribavir-treated SOT recipients with refractory CMV infection found comparable response rates and time to CMV clearance between patients with and without baseline neutropenia. Similar AE profiles were observed between groups. Although these findings are based on small sample sizes, particularly for moderate-to-severe neutropenia (Study 202 only), they support use of maribavir as a therapeutic option for SOT recipients with CMV infection with and without neutropenia."

Clinical • P2 data • Retrospective data • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Neutropenia • Solid Organ Transplantation • Transplantation

Real-world CMV hyperimmunoglobulin prophylaxis in heart and lung transplantation: one-year interim results from a prospective multicenter study (TTS 2026) - "Antiviral exposure during follow-up included valganciclovir (79%), ganciclovir (30%), letermovir (6%), and maribavir (5%). In this prospective real-world HTx and LuTx cohort, adjunctive CMVIG prophylaxis was associated with low rates of treatment-requiring CMV, CMV syndrome, and tissue-invasive disease at one year, with low rates of CMVIG-related adverse events. Final results from the complete 553-patient cohort will further clarify the role of CMVIG across CMV management settings in HTx and LuTx."

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

Maribavir for the Management of a Complex Cytomegalovirus (CMV) Infection After Liver Transplantation: Refractoriness and Intolerance to Standard Therapies in the Intensive Care Unit. (PubMed, Cureus) - "In the first case, maribavir achieved rapid viral suppression in a 30-year-old patient with refractory CMV infection. In the second case, it served as effective salvage therapy, enabling bone marrow recovery following valganciclovir-induced toxicity while maintaining viral control.  Although both patients ultimately succumbed to non-CMV-related ICU complications, maribavir demonstrated clinical utility in achieving virological control, providing a crucial alternative for complex cases where conventional options are limited."

Journal • Critical care • Cytomegalovirus Infection • Infectious Disease • Transplantation

Virologic clearance with maribavir by baseline cytomegalovirus DNAemia in solid organ transplant recipients: A post hoc analysis of phase 2 and 3 trials (TTS 2026) - P2, P3 | "Among maribavir-treated SOT recipients with refractory CMV infection in this post hoc analysis, CMV DNAemia clearance was achieved more often and faster in those with low/intermediate versus high baseline CMV DNAemia. Overall incidence of AEs was similar between groups. Additional research is warranted to determine if switching to maribavir earlier in the course of CMV infection could improve clinical outcomes in patients with refractory post-SOT CMV infection."

Clinical • P2 data • Retrospective data • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Real world efficacy of maribavir when used as pre-emptive therapy for cytomegalovirus reactivation in alloHCT patients who are intolerant, refractory or resistant (TTS 2026) - "Existing antivirals (val)ganciclovir and foscarnet have significant toxicities (myelosuppression and renal dysfunction) and often necessitate inpatient admissions. This real-world study demonstrates that MBV is an effective, well-tolerated antiviral when used as PET. It is beneficial in cases of bone marrow dysfunction and reduces inpatient hospitalisation days in patients who require foscarnet."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Cytomegalovirus Infection • Infectious Disease • Nephrology • Renal Disease

Real-world effectiveness and safety of maribavir in solid organ transplant recipients with refractory/resistant cytomegalovirus or intolerance to anti-cytomegalovirus drugs: Interim results from the ARISE study (TTS 2026) - "The data support real-world effectiveness and safety of maribavir in adult SOT recipients with RR and I CMV. The observed CMV clearance rates, and lower incidence of myelosuppression and hospitalizations after than prior to maribavir initiation, align with results from SOLSTICE. All-cause mortality was mostly attributed to non-CMV related causes, and rates were consistent with lower range estimates in the literature."

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

Cytomegalovirus DNAemia clearance with maribavir in solid organ transplant recipients with symptomatic versus asymptomatic infection: a post hoc analysis of phase 2 and 3 trials (TTS 2026) - P2, P3 | "In this post hoc analysis of maribavir clinical trials, there was a trend towards faster CMV DNAemia clearance in those with asymptomatic CMV than in those with symptomatic CMV. Overall incidence of AEs was similar between groups. The data support the need for additional research to assess whether early identification of symptomatic CMV and initiation/switch to maribavir could improve clinical outcomes in SOT recipients with refractory CMV infection."

Clinical • P2 data • Retrospective data • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Takeda Corporate Breakfast Symposium on Illuminated constellations: How diverse institutional experiences guide practical CMV management (TTS 2026) - "Insights from emerging real-world data and clinical trial evidence will also be explored to evaluate the role of newer anti-CMV agents, including maribavir, in contemporary practice. Through case studies, the audience will explore the potential impact of maribavir on intervention strategies in complex patients."

Clinical • Cytomegalovirus Infection

Low level drug resistance linked to cytomegalovirus UL97 and UL27 mutations detected in maribavir clinical trials. (PubMed, Antiviral Res) - "Among 8 UL97 kinase variants tested, none were found to confer maribavir resistance, while amino acid substitution G598A conferred borderline ganciclovir resistance (1.9-fold increased 50% effective concentration [EC50]) and K599N did not (1.1-fold). Both resistant UL27 mutants were observed in connection with maribavir treatment failure, but L317V differs in being detected as an emergent mutation after 29 days of therapy rather than at baseline. The clinical significance of baseline and emergent UL27 mutations for maribavir therapy requires further surveillance."

Journal • Cytomegalovirus Infection

Maribavir Use in Transplant Recipients (IDWeek 2026) - No abstract available

Clinical • Infectious Disease

The Heavy Hitters of Transplant ID (IDWeek 2026) - "Learning Objectives: At the conclusion of this session, participants will be able to:Analyze the epidemiologic exposure risks, timeline after transplantation (early, intermediate, late), and distinct clinical manifestations of major opportunistic pathogens in solid organ (SOT) and hematopoietic stem cell transplant (HSCT) recipients focusing on high-consequence viral (CMV, EBV, BK virus) and invasive fungal pathogens (Aspergillus, Mucorales)Evaluate modern diagnostic modalities for complex transplant-related infections, including quantitative viral PCR monitoring, resistance genotyping (e.g., UL97/UL54 mutations in refactory CMV), and non-invasive fungal biomarkers to guide timely clinical intervention.Develop patient-specific prevention and treatment plans that integrate novel antimicrobial agents (e.g., maribavir, letermovir, isavuconazole), adjust underlying immunosuppressive therapy to balance rejection risk against infection control, and apply preemptive management..."

Infectious Disease

ANZTCT cytomegalovirus practice survey for allogeneic haemopoietic stem cell transplant and cellular therapy recipients in Australia and New Zealand. (PubMed, Intern Med J) - "Institutional preferences and medicine funding drives variability in ANZ practice. This leaves potential for healthcare inequity since newer antiviral agents are inconsistently used, contrasting with international guidelines."

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

Multi-Criteria Decision Analysis using Physician Preferences from a Global Discrete Choice Experiment to Investigate the Selection of Preemptive Antiviral Treatments for Post-Hematopoietic Cell Transplant Cytomegalovirus Infection. (PubMed, Open Forum Infect Dis) - "Maribavir had a higher overall benefit-risk score than ganciclovir and foscarnet in both ANC cohorts. Within this MCDA framework, maribavir was preferred over valganciclovir, ganciclovir, and foscarnet for preemptive treatment of CMV after HCT."

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

A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina (clinicaltrials.gov) - P=N/A | N=28 | Completed | Sponsor: Takeda | Recruiting ➔ Completed | N=10 ➔ 28

Enrollment change • Trial completion • Cytomegalovirus Infection • Infectious Disease • Transplantation

Maribavir in lung transplant recipients with cytomegalovirus infection: real-life experience. (PubMed, Infection) - "In conclusion, maribavir represents an important therapeutic option for R/R CMV after lung transplantation. However, treatment failure, relapse, and resistance remained common, highlighting the need for careful monitoring and further optimization of treatment strategies."

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

Disseminated Ganciclovir-Resistant Cytomegalovirus in a Nontransplant Pediatric ALL Patient: A Case Report. (PubMed, J Pediatr Hematol Oncol) - "This case underscores the potential severity of CMV in nontransplant pediatric ALL with prolonged lymphopenia, challenges of antiviral resistance, and limited treatment options for central nervous system involvement. The progression from asymptomatic viremia to clinically significant CMV disease remains poorly understood. Enhanced CMV surveillance protocols and resistance-guided treatment strategies may be warranted in selected high-risk populations."

Journal • Acute Lymphocytic Leukemia • Cytomegalovirus Infection • Genetic Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Ocular Inflammation • Oncology • Ophthalmology • Pediatrics • Retinal Disorders • T Acute Lymphoblastic Leukemia • Transplantation

MARIBEL: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium (clinicaltrials.gov) - P=N/A | N=66 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection • Infectious Disease • Transplantation

TAK-620-4013: A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection (clinicaltrials.gov) - P=N/A | N=250 | Recruiting | Sponsor: Takeda | Trial completion date: Aug 2031 ➔ Jun 2028 | Trial primary completion date: Aug 2031 ➔ Jun 2028

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

A novel inhibitor of human cytomegalovirus acts through a specific antiviral mechanism that involves the helicase-primase complex. (PubMed, Antimicrob Agents Chemother) - "The terminase inhibitor (letermovir) and viral UL97 kinase inhibitor (maribavir) have improved the CMV armamentarium; however, both select for resistance, and have limited therapeutic indications...While its maximal time of HCMV inhibition overlaps with ganciclovir (GCV), it remains active against GCV-resistant strains, suggesting a distinct mechanism involving the CMV replisome...Sequence alignment revealed some similarity between GPCMV and HCMV UL70 486-487. In summary, we identified an inhibitor of HCMV replication that acts through a novel mechanism involving the H/P complex, opening new avenues in the development of HCMV-specific drugs."

Journal • Cytomegalovirus Infection • Transplantation

Real-world use of maribavir for refractory CMV infection and intolerance to conventional anti-CMV agents after allogeneic hematopoietic cell transplantation. (PubMed, Transplant Cell Ther) - "MBV achieved high rates of initial CMV viremia clearance with acceptable tolerability in this real-world allo-HCT cohort. Although recurrent CMV viremia after treatment discontinuation was common, most recurrent cases remained clinically manageable with retreatment or alternative anti-CMV therapy. Further studies are needed to define the optimal treatment duration and post-treatment monitoring strategy."

Journal • Real-world evidence • Cytomegalovirus Infection • Gastroenterology • Hematological Disorders • Infectious Disease • Transplantation