Valcyte (valganciclovir) / Roche, Tanabe Pharma - LARVOL DELTA

A phase 1b/2a, open-label, multicenter, randomized, dose escalation study evaluating the safety, tolerability and efficacy of RZ-001 in combination with valganciclovir (VGCV) and atezolizumab/bevacizumab in subjects with hepatocellular carcinoma (AACR 2026) - "Abstract is embargoed at this time."

Clinical • Combination therapy • P1/2 data • Hepatocellular Cancer • Oncology • Solid Tumor

LETERCOR: Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir. (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Maimónides Biomedical Research Institute of Córdoba | Active, not recruiting ➔ Recruiting

Enrollment open • Cytomegalovirus Infection • Infectious Disease • Neutropenia • Respiratory Diseases • Transplantation

THE PERFECT STORM: AN UNEXPECTED CAUSE OF POST-TRANSPLANT ACUTE KIDNEY INJURY FROM CMV-INDUCED MACROPHAGE ACTIVATION SYNDROME (ISN-WCN 2026) - "Her post-transplant course was complicated by antibody mediated rejection 2-months post-transplant, successfully treated with pulse steroids, plasmapheresis, IVIG and rituximab. She was maintained on mycophenolic acid 720 mg twice a day, tacrolimus 2 mg twice a day and prednisone 5 mg daily. Unexpectedly, 5-months post-transplant, she developed an acute febrile illness and cough with hemoptysis, diagnosed with Bordetella pertussis, treated with Azithromycin...Treatment with IV ganciclovir was initiated, with improvement of pancytopenia. Maintenance valganciclovir was continued and renal function returned to prior baseline.Results See aboveConclusion Macrophage activation syndrome (MAS) is a life-threatening hyperinflammatory condition...In our case, allograft dysfunction and pancytopenia heralded the detection of CMV viremia. Targeted anti-viral therapy led to resolution of CMV infection and complete recovery of renal allograft function."

Post-transplantation • Acute Kidney Injury • Antibody-mediated Rejection • Cough • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Glomerulonephritis • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pertussis • Rare Diseases • Renal Disease • Respiratory Diseases • Systemic Inflammatory Response Syndrome • Transplantation • CD8 • IFNG • IL6 • TNFA

POST-TRANSPLANT KAPOSI'S SARCOMA IN A KIDNEY TRANSPLANT RECIPIENT WITH PRIOR STEROID-RESPONSIVE NEPHROTIC SYNDROME AND TUBERCULOSIS LYMPHADENITIS (ISN-WCN 2026) - "Post-transplant therapy included tacrolimus (target level between 8 to 12mg3 , low to moderate risk), mycophenolate mofetil (500 mg twice daily), prednisolone tapered to 5 mg/day, antihypertensives, ethambutol, co-trimoxazole, and valganciclovir prophylaxis.A few months later, he presented with low back pain, severe anemia, and subcutaneous erythematous nodules. The risk of overimmunosuppression is enhanced by the lack of laboratory that measure tacrolimus levels, in Mozambique. This case underlines the diagnostic and therapeutic challenges in managing kidney transplant recipients in low incomes countries."

Clinical • Post-transplantation • Back Pain • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Epstein-Barr Virus Infections • Glomerulonephritis • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Kaposi Sarcoma • Lumbar Back Pain • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Renal Disease • Respiratory Diseases • Sarcoma • Solid Organ Transplantation • Solid Tumor • Transplantation • Tuberculosis

INCIDENCE OF CYTOMEGALOVIRUS INFECTION OR DISEASE USING VALGANCICLOVIR PROPHYLAXIS OR PREEMPTIVE THERAPY IN LIVING-DONOR KIDNEY TRANSPLANT RECIPIENTS AT INTERMEDIATE RISK FOR CMV ON BASILIXIMAB-BASED REGIMEN (ISN-WCN 2026) - "These results support adapting preventive strategies to available resources and diagnostic capacity. In settings with reliable virological monitoring, PT may be a cost-effective alternative, reducing unnecessary antiviral exposure without compromising efficacy."

Clinical • Cytomegalovirus Infection • Infectious Disease • Transplantation

Nanocarriers for potential treatment of sensorineural hearing loss and retinitis in congenital cytomegalovirus. (PubMed, Nanomedicine (Lond)) - "Newer agents are under investigation to develop alternative treatments for cCMV. The current evidence supports the development of new strategies in nanomedicines to be used either alone or in combination with ganciclovir and oral valganciclovir."

Journal • Review • Cytomegalovirus Infection • Genetic Disorders • Infectious Disease • Ocular Inflammation • Ophthalmology • Otorhinolaryngology • Pediatrics • Retinal Disorders

Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: The Methodist Hospital Research Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Breast Cancer • Cytomegalovirus Infection • Infectious Disease • Oncology • Solid Tumor

Real-world outcomes of valganciclovir prophylaxis and cytomegalovirus reactivation after lung transplantation (ESCMID Global 2026) - No abstract available

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

Chronic Gastric Ulceration Due to Cytomegalovirus in Immunocompetent Adults - A Case Report and Systematic Review. (PubMed, Rev Med Virol) - "This case report and systematic review describe the complete clinical course of chronic gastric ulceration complicating acute gastrointestinal CMV disease in a 72-year-old immunocompetent woman, with demonstrable response to ganciclovir but not valganciclovir. Finally, CMV may represent an under-recognised and treatable contributor to the increasing cohort of patients, particularly older patients, with Helicobacter pylori and non-steroidal anti-inflammatory drug negative gastric ulcers, though CMV-associated gastric ulcers remain rare overall. Accordingly, diagnosis requires a high index of suspicion, with pursuit of CMV PCR and/or immunohistochemistry of gastric ulcer biopsies strongly encouraged."

Journal • Review • Cytomegalovirus Infection • Gastroenterology • Infectious Disease • Peptic Ulcer

Preliminary Results of a Phase II Open-Label Study of Maternal Donor-Derived Cytomegalovirus Cytotoxic T-Lymphocytes and Valganciclovir in Neonates with Moderate/Severe Maternal Acquired CMV Infection (PAS 2026) - No abstract available

Clinical • P2 data • Cytomegalovirus Infection • Infectious Disease

Real-World Adherence and Toxicity of Valganciclovir for Congenital Cytomegalovirus (PAS 2026) - No abstract available

Adherence • Clinical • HEOR • Real-world • Real-world evidence • Cytomegalovirus Infection

LETERMOVIR USE IN PEDIATRIC HSCT PATIENTS UNDER 12 YEARS OLD: UPDATED DATA FROM A RETROSPECTIVE MULTICENTER STUDY OF THE PDWP AND IEWP OF THE EBMT (EBMT 2026) - "Conditioning regimens included treosulfan-based (44.5%), TBI-based (32.2%), busulfan-based (15.1%), and other (8.2%). In-vivo T-cell depletion (TCD) was used in 34.2% of patients (ATG 27.4%, Campath 6.8%), and ex-vivo TCD in 11.6%.Table 1: Patient and transplant characteristics With a median follow-up of 1 year (95% CI: 0.9–1.1), the 1-year cumulative incidence of CMV reactivation was 23.8% (95% CI: 16–30) overall, 21.4% (95% CI: 13.6–29.2) during primary prophylaxis, and 32.6% (95% CI: 13.1–45) during secondary prophylaxis (Figure 1)...Among patients with CMV reactivation, one death was attributed to relapsed disease.Letermovir was well tolerated with only two patients experiencing mild gastrointestinal toxicity, and no additional significant adverse events reported.CMV reactivations were managed using standard antiviral strategies, including valganciclovir (n=10), ganciclovir (n=8), foscarnet (n=7), and cidofovir (n=1) or continued letermovir alone (n=8)... In this..."

Retrospective data • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hepatology • Immunology • Infectious Disease • Pediatrics

Dynamic Mixed Populations of Resistant CMV in a Lung Transplant Recipient (ISHLT 2026) - "Despite these changes he required IV ganciclovir for rising viral loads, and after initial testing showed resistance only to cidofovir, the patient was transitioned back to valganciclovir...The patient once again developed viremia, and testing now showed resistance to maribavir, ganciclovir, and cidofovir for which foscarnet was restarted...Viral loads improved, and the patient was eventually transitioned to a letermovir/valganciclovir combination therapy, followed by maribavir/letermovir therapy after testing showed his maribavir resistance had resolved. Subsequent surveillance has shown CMV viral levels managed on dual therapy.Summary Prior literature has shown that antiviral therapy can select for resistant strains if mixed populations are present, leading to changes in genotypic susceptibility testing results over time. We present a case of highly resistance mixed genotype CMV populations with changing resistance profiles, that was successfully treated with salvage..."

Clinical • Fibrosis • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Transplantation

Epididymoorchitis as the Presenting Sign of Disseminated Adenovirus Infection in a Kidney Transplant Recipient (NKF-SCM 2026) - "We present a case of disseminated adenovirus infection diagnosed in a transplant recipient on an admission for epididymoorchitis METHODS/CASE SUMMARY A 61-year-old male with past medical history of deceased donor kidney transplant three months prior to admission on immunosuppression of prednisone, tacrolimus, and mycophenolic acid with valganciclovir and bactrim prophylaxis presented with three weeks of worsening scrotal pain and swelling without fever or dysuria. Subsequent immunosuppression reduction is crucial for effective management and clearance of the virus. Very severe disease may require cidofovir or intravenous immunoglobulin"

Clinical • Gastrointestinal Disorder • Infectious Disease • Transplant Rejection • Transplantation • Urology

REAL-WORLD UTILIZATION AND EFFICACY OF LETERMOVIR PROPHYLAXIS IN ADULT ALLOGENEIC HAEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS: SUBGROUP ANALYSIS DEFENDER STUDY (EBMT 2026) - "GVHD prophylaxis included post-transplant cyclophosphamide (63.64%), tacrolimus (45.45%), cyclosporine (41.82%), and mycophenolate mofetil (38.18%)...Pre-emptive therapy was given to 25.45%: ganciclovir (14.55%), valganciclovir (7.27%), cidofovir (3.64%)... Bioequivalent Generic Letermovir (Anvimo) prophylaxis in adult allo-HSCT recipients demonstrated favourable real-world effectiveness with low rates of CMV reactivation and clinically significant reactivation. The 100-day survival rate and low adverse event profile support the safety and tolerability of letermovir in routine clinical practice."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Immunology • Transplantation

Breakthrough CMV Lung Transplant -Multicentre (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: University of Alberta | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

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

EFFICACY AND SAFETY OF LETERMOVIR FOR CYTOMEGALOVIRUS PROPHYLAXIS IN THORACIC ORGAN TRANSPLANTATION: A SYSTEMATIC REVIEW AND META-ANALYSIS (ACC 2026) - "The double-arm meta-analysis revealed no statistically significant difference in breakthrough CMV infection rates between LTV and Valganciclovir (VGC) (RR: 0.40; 95% CI: 0.09-1.68; P = 0.21). LTV prophylaxis demonstrates promising efficacy and safety in reducing breakthrough CMV infections, low-level viremia, and adverse events in TOT recipients. Its favorable safety profile, particularly in mitigating leukopenia, highlights its potential as an effective alternative to VGC. However, this evidence is limited by the small number of studies, heterogeneous populations, and relatively short follow-up periods, underscoring the need for larger randomized trials."

Retrospective data • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Disorders • Leukopenia • Transplantation

Evaluation of Pneumocystis jirovecii (PJP) and Cytomegalovirus (CMV) Prophylaxis Duration in Kidney Transplant Recipients (UKKW 2026) - "Valganciclovir is also administered to patients receiving alemtuzumab (Campath) induction immunosuppression, unless both donor and recipient are CMV- negative...57 patients were identified as having been started on co-trimoxazole/atovaquone, and 17 patients on valganciclovir, using a data collection tool developed by the Leicester Kidney Pharmacy Team... Of the 57 patients on PJP prophylaxis, 13 (23%) continued treatment beyond the 6 month period. Similarly, 6 out of 17 patients (35%) prescribed valganciclovir extended beyond the recommended duration. No documented clinical reasons justified these prolonged courses."

Clinical • Cytomegalovirus Infection • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases • Transplant Rejection • Transplantation

Maribavir use in managing cytomegalovirus infection among UK kidney transplant recipients (UKKW 2026) - "Refractory CMV encompasses CMV infection which is resistant (either suspected or confirmed) to first line treatments, with UL97 gene mutations being resistant to valganciclovir and ganciclovir. Maribavir is an effective and well tolerated oral option to treat refractory CMV in an outpatient setting, avoiding the associated costs of hospital facilities and reducing the need for nephrotoxic or myelotoxic alternatives. The average treatment duration reflects reports from the SOLSTICE trial, however real- world data highlights high reactivation rates post treatment, and strengthens the importance of close PCR monitoring following treatment cessation. Reported adverse effects were similar to the trials, but demonstrates the need for pre- emptive tacrolimus dose alterations to avoid toxicity and its associated nephrotoxicity."

Clinical • Cytomegalovirus Infection • Infectious Disease • Transplantation

FROM VISION TO REALITY: EVALUATING SAFETY OF THE FIRST IN HOUSE IMPLEMENTED CD19 CAR-T IN UNITED ARAB EMIRATES FOR SLE PATIENTS (EBMT 2026) - "Biologic B-cell–targeted therapies such as rituximab and BAFF (BlyS) inhibitor therapy such as belimumab have advanced disease control by reducing autoantibody production and modulating immune activation...After rigorous quality control—including sterility, immunophenotyping, and vector copy number—patients received lymphodepletion with fludarabine (25 mg/m² for three days) and cyclophosphamide (1,000 mg/m² for one day)...Treatment demonstrated a favorable safety profile: two patients developed grade <3 cytokine release syndrome resolving after a single tocilizumab dose, and no grade ≥4 CRS or ICANS occurred...Two patients experienced CMV reactivation, managed successfully with oral valganciclovir. UAE's locally produced CD19 CAR-T therapy for SLE shows feasibility, safety, and powerful efficacy, inspiring a bold new era of accessible cellular treatments transforming autoimmune care worldwide for patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Autoimmune Hemolytic Anemia • Cardiovascular • Glomerulonephritis • Hematological Disorders • Hemophilia • Hemophilia A • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rare Diseases • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

RISK FACTORS FOR REFRACTORY CYTOMEGALOVIRUS INFECTION IN HEMATOPOIETIC STEM CELL AND SOLID ORGAN TRANSPLANT RECIPIENTS (EBMT 2026) - "Hot map of risk factors for refractory or resistance CMV infection.Notes: The numbers in the hot map indicate the number of articles corresponding to the factors.Abbreviations: aGVHD, acute graft-versus-host disease; ATG, anti-thymocyte globulin; CMV: cytomegalovirus; BM: bone marrow; BU: busulfan; CB: cord blood; Cy: cyclophosphamide; EB, Epstein-Bar; MMF: mycophenolate mofetil; MP: methylprednisolone; MSD: matched sibling donor; MUD: matched unrelated donor; MZR: mizoribine; PB: peripheral blood; TBI: total body irradiation; VGCV: valganciclovir; WBC: white blood cell. The HSCT-specific risk factors for refractory CMV infection included host immune status, transplantation regimens and viral load, genotypes and blood parameters, while, CMV serological status of donor and recipient, anti-CMV drug exposure, and persistent disease were SOT-specific risk factors for refractory and resistance CMV. Early identification of patients at risk of refractory CMV infection can help..."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Solid Organ Transplantation • Transplantation • CD8

EFFICACY AND SAFETY OF MARIBAVIR IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS BY BASELINE NEUTROPENIA STATUS: A POST HOC ANALYSIS OF PHASE 2 AND 3 CLINICAL TRIALS (EBMT 2026) - P2, P3 | "Clinical Trial Registry: NCT01611974, https://clinicaltrials.gov/study/NCT01611974NCT02931539, https://www.clinicaltrials.gov/study/NCT02931539 Background: Recipients of hematopoietic cell transplantation (HCT) are susceptible to myelotoxicity associated with anti-cytomegalovirus (CMV) agents such as ganciclovir or valganciclovir. This post hoc analysis of phase 2 and 3 clinical data in HCT recipients with refractory CMV infection showed no statistically significant differences in time to CMV DNAemia clearance and broadly similar overall AE profiles in maribavir-treated patients with and without baseline neutropenia. Although these findings are based on small sample sizes, especially in the neutropenia groups, they support the use of maribavir as a therapeutic option in HCT recipients with refractory CMV infection, regardless of neutropenia, and warrant further research."

Clinical • P2 data • Retrospective data • Bone Marrow Transplantation • Cytomegalovirus Infection • Hematological Disorders • Infectious Disease • Neutropenia • Transplantation

PHYSICIAN SURVEY OF REAL-WORLD MARIBAVIR USE AND TREATMENT DECISION MAKING IN REFRACTORY CYTOMEGALOVIRUS INFECTION AFTER TRANSPLANTATION (EBMT 2026) - P3 | "The anti-CMV agent maribavir has shown higher clearance rates and lower incidence of myelosuppression compared with ganciclovir/valganciclovir in transplant recipients with RR CMV infection in a randomized clinical trial (NCT02931539). Survey findings indicate variability and perceived gaps between guidelines and clinical practice in the management of RR CMV infection following transplantation. Following the introduction of new treatment options, physicians reported a tendency to switch earlier to maribavir if the current agent was ineffective or to avoid toxicity. These results highlight the need for treatment options that achieve CMV clearance with fewer treatment-related toxicities, and for practical guidance on optimizing maribavir use in real-world practice."

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

REAL-WORLD USE, EFFECTIVENESS AND SAFETY OF MARIBAVIR IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH REFRACTORY/RESISTANT CMV OR INTOLERANCE TO ANTI-CMV AGENTS: INTERIM ARISE RESULTS (EBMT 2026) - "Interim results of this European retrospective study support the real-world effectiveness and safety of maribavir in adult HCT recipients with refractory/resistant CMV or intolerance to anti-CMV agents. CMV clearance rates at maribavir discontinuation appeared to be higher than previously observed in the HCT population within the phase 3 SOLSTICE trial. The lower incidence of myelosuppression and nephrotoxicity after versus before maribavir initiation is in line with the lower hematologic and renal toxicity of maribavir compared with ganciclovir/valganciclovir and foscarnet in the overall SOLSTICE transplant population."

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

LATE CYTOMEGALOVIRUS REACTIVATION AFTER ALLOGENEIC HSCT PERSISTS IN THE ERA OF LETERMOVIR PROPHYLAXIS – A SINGLE-CENTRE REAL WORLD STUDY (EBMT 2026) - "413/480 (86%) received reduced intensity conditioning regimens, and 397/480 were T-cell deplete (Campath 226/480; 47.1%, ATG 93/480; 19.4%, PTCy 79/480; 16.5%)...20/27 (74.1%) of the post-letermovir reactivators required treatment with an additional anti-viral agent (p=0.52); 3 required admission for treatment with foscarnet (2 having been pre-treated with valganciclovir)... CMV reactivation remains a frequent issue post-allo-HSCT. Letermovir defers the median onset of csCMV to post-D100, but does not reduce the need for further anti-viral treatment."

Clinical • Real-world • Real-world evidence • Bone Marrow Transplantation • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Ocular Inflammation • Ophthalmology • Pneumonia • Retinal Disorders