- |||||||||| Livtencity (maribavir) / Takeda, GSK
COST-EFFECTIVENESS OF MARIBAVIR FOR POST-TRANSPLANT CYTOMEGALOVIRUS INFECTION THAT IS REFRACTORY TO ALTERNATIVE TREATMENTS FROM THREE HEALTHCARE SYSTEM PERSPECTIVES: ITALY, UK AND US (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1244;
P3
Maribavir has demonstrated superior CMV clearance among patients with post-transplant refractory CMV infection, a complication that increases morbidity and mortality risk. These economic analyses indicate that maribavir is also cost-effective, and in some cases cost-saving, across three different payor systems, Italy, UK, and US, compared with alternative treatments.
- |||||||||| Livtencity (maribavir) / Takeda, GSK
COST-EFFECTIVENESS OF MARIBAVIR FOR POST-TRANSPLANT CYTOMEGALOVIRUS INFECTION THAT IS REFRACTORY TO ALTERNATIVE TREATMENTS FROM THREE HEALTHCARE SYSTEM PERSPECTIVES: ITALY, UK AND US (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1243;
P3
Maribavir has demonstrated superior CMV clearance among patients with post-transplant refractory CMV infection, a complication that increases morbidity and mortality risk. These economic analyses indicate that maribavir is also cost-effective, and in some cases cost-saving, across three different payor systems, Italy, UK, and US, compared with alternative treatments.
- |||||||||| Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Cytovene (ganciclovir) / Roche
Journal: CMV-induced Hearing Loss. (Pubmed Central) - Feb 13, 2024
Several vaccine candidates are currently in testing and one candidate vaccine in phase 3 trials. Until a CMV vaccine becomes available, behavioral and educational interventions may be the most effective strategy to prevent maternal CMV infection.
- |||||||||| Cytovene (ganciclovir) / Roche
OPTIMIZING GANCICLOVIR DOSING FOR CYTOMEGALOVIRUS INFECTION IN IMMUNOCOMPROMISED CHILDREN (Hall C1M1) - Feb 9, 2024 - Abstract #ESPID2024ESPID_284;
Conclusions/Learning Points The study demonstrates low serum ganciclovir drug exposure using standard paediatric dosing with less than half achieving the lowest ganciclovir AUC24 target. In addition, children demonstrated a longer duration of viraemia in those with an AUC <40 mg.h/L.
- |||||||||| Cytovene (ganciclovir) / Roche
Review, Journal: Cytomegalovirus and Pregnancy: A Narrative Review. (Pubmed Central) - Jan 26, 2024
In recent years, however, valacyclovir at a dose of 8 g/day has been shown to be effective in preventing vertical transmission, and ganciclovir has been shown to be effective in preventing long-term sequelae in the treatment of symptomatic neonates. The aim of this article is to review congenital CMV infection, from its epidemiology to its treatment, using the most recent studies in the literature, and to help in the decision to modify protocols for universal testing of pregnant women according to the possibilities of each locality.
- |||||||||| Prevymis (letermovir) / Merck (MSD)
Journal: Letermovir Rescue Therapy in Kidney Transplant Recipients with Refractory/Resistant CMV Disease. (Pubmed Central) - Jan 11, 2024
(4) LTV, which is currently evaluated for CMV prophylaxis in kidney transplantation, also shows promising results for the treatment of patients with VGCV/GCV resistance despite the risk of developing LTV resistance. Additional studies are needed to further define its role in the treatment of patients with CMV resistance.
- |||||||||| Prevymis (letermovir) / Merck (MSD), Cytovene (ganciclovir) / Roche, Nulojix (belatacept) / BMS
Early Onset Pancytopenia Post Heart Transplant: Calcineurin Inhibitor-Induced Thrombotic Microangiopathy versus Cytomegalovirus Infection (Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1657;
CMV was treated aggressively with intravenous ganciclovir and oral letermovir...CNI was discontinued, she was transitioned to a regimen consisting of prednisone and belatacept as the antimetabolites mycophenolate and azathioprine caused dangerous leukopenia...While CMV viremia is considered a contraindication to belatacept, aggressive intervention by the infectious disease service allowed its continuation. Further research is needed regarding the safety and efficacy in the use of belatacept in heart transplant patients at high risk for CMV.
- |||||||||| Prevymis (letermovir) / Merck (MSD)
Efficacy of Letermovir for CMV Prophylaxis in Heart Transplant Recipients with Moderate to High Risk CMV Serostatus (Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1622;
1000 IU/mL) before LT initiation, but none of these patients developed high-grade CMV viremia on LT (peak VL 210 IU/mL across all patients). Two patients developed high-grade CMV viremia on LT, and none developed CMV disease on LT during the study period.Conclusion The present study demonstrates that LT is effective for CMV prophylaxis in heart transplant recipients regardless of CMV risk status or a history of high-grade CMV viremia.
- |||||||||| Cytovene (ganciclovir) / Roche, Livtencity (maribavir) / Takeda, GSK
Development of Maribavir-Resistant Cytomegalovirus Infection Following Treatment of Ganciclovir-Resistant Cytomegalovirus Infection (Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1485;
The viral load decreased to <300 IU after 2 weeks of treatment, and he transitioned to letermovir 480 mg daily for CMV prophylaxis.Summary Maribavir is an exciting advancement in the management of non-life threatening, ganciclovir-resistant CMV, but is still susceptible to drug resistance that may lead to treatment failure. Further study is needed to identify risk factors associated with maribavir resistance and therapeutic options to combat refractory and resistant CMV infection.
- |||||||||| Prevymis (letermovir) / Merck (MSD), Cytovene (ganciclovir) / Roche
Use of Letermovir as Secondary Prophylaxis in Cardiac Transplant Patient, Mismatch for CMV (d+/r-), Resistant to Ganciclovir and Foscarnet (Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1464;
After achieving VL suppression, in September 2022, the secondary prophylaxis was started with LET 450 mg/day and valganciclovir 900 mg bd, the last one was later discontinued...The patient is currently on prophylaxis with LET and has been asymptomatic during the treatment, with no side effects.Summary Although the use of LET to treat CMV infection is limited in SOT, larger series of cases have documented its successful use when initiated in patients with low/suppressed CMV viremia. In our case the use of LET was effective in obtaining VL suppression for about 1 year in a patient with a CMV strain resistant to both gancyclovir and foscarnet, ensuring the absence of CMV disease.
- |||||||||| Cytovene (ganciclovir) / Roche
Review, Journal: Epstein-Barr Virus Encephalitis: A Review of Case Reports from the Last 25 Years. (Pubmed Central) - Dec 23, 2023
Ganciclovir (30%), corticoids (52%), and immunoglobulins (15%) were mainly used in association with other drugs...This diagnostic test is useful; however, it is imperfect. New complementary diagnostic tools, approved treatments, and standardized practices could improve patient management.
- |||||||||| Cytovene (ganciclovir) / Roche
It's not always IBD (Sancy - Hilton Antwerp Old Town) - Dec 19, 2023 - Abstract #BWG2024BWG_76;
The patient was put on ganciclovir and broad-spectrum antibiotics based on cephalosporines (ceftriaxone) and quinolones (levofloxacin), and immunoglobulin (tegelin). She passed away within 24 hours following a state of septic shock.
- |||||||||| Prevymis (letermovir) / Merck (MSD)
Journal: Real-life experience in two cases of secondary prophylaxis with letermovir for CMV infection in solid organ transplantation. (Pubmed Central) - Dec 17, 2023
Our study emphasizes that monitoring of CMV disease in the patient and early genotypic detection of resistance mutations are essential when using new antiviral drugs for off-label indication in patients experiencing CMV relapses or not responding to standard antiviral therapy. These cases and the bibliography reviewed can be helpful for other researchers and clinicians working in the field to optimize the use of new treatments for transplant recipients since drug-resistant CMV infection is an important emerging problem even with new developments in antiviral treatment.
- |||||||||| Cytovene (ganciclovir) / Roche
Retrospective data, Journal: Reliability of QuantiFERON (Pubmed Central) - Dec 17, 2023
These cases and the bibliography reviewed can be helpful for other researchers and clinicians working in the field to optimize the use of new treatments for transplant recipients since drug-resistant CMV infection is an important emerging problem even with new developments in antiviral treatment. In the population of heart transplant recipients, most of whom received ATG-based induction, the QuantiFERON
- |||||||||| Review, Journal: EBV Reactivation and Lymphomagenesis: More Questions than Answers. (Pubmed Central) - Dec 17, 2023
Further research is needed to establish EBV monitoring protocols in high-risk populations, such as those with autoimmune disease, cancer, HIV, or receiving immunosuppressive therapy. Additionally, standardized treatments for both the prevention of EBV reactivation in high-risk populations and treatment of EBV reactivation and lymphoproliferation need to be established.
- |||||||||| Prevymis (letermovir) / Merck (MSD), Cytovene (ganciclovir) / Roche, Livtencity (maribavir) / Takeda, GSK
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Efficacy, Safety, and Cost-effectiveness Analysis of Antiviral Agents for Cytomegalovirus Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation Recipients. (Pubmed Central) - Dec 5, 2023
Future clinical guidelines should consider the implementation of dedicated diagnostic and treatment strategies. Currently, letermovir is an effective and well-tolerated treatment for preventing CMV infection, and it might be a cost-effective choice in allo-HSCT recipients in China.
- |||||||||| Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Cytovene (ganciclovir) / Roche
Trial completion date, Trial primary completion date: STACCATO: Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (clinicaltrials.gov) - Nov 29, 2023
P2/3, N=99, Recruiting,
Currently, letermovir is an effective and well-tolerated treatment for preventing CMV infection, and it might be a cost-effective choice in allo-HSCT recipients in China. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Cytovene (ganciclovir) / Roche
Enrollment closed, Trial primary completion date: Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis (clinicaltrials.gov) - Nov 28, 2023
P4, N=25, Active, not recruiting,
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Mar 2025 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Jan 2024
- |||||||||| Cytovene (ganciclovir) / Roche
Preclinical, Review, Journal: From Animal Models to Clinical Trials: The Potential of Antimicrobials in Multiple Sclerosis Treatment. (Pubmed Central) - Nov 25, 2023
Antivirals included acyclovir, valacyclovir, and ganciclovir...While the effect of antimicrobials in animal models was promising, only minocycline and hydroxychloroquine improved outcome measures in pwMS...The number and size of clinical trials testing antimicrobials have been limited. Large, multicenter, well-designed studies are needed to further evaluate the effect of antimicrobials in MS.
- |||||||||| Cytovene (ganciclovir) / Roche
Journal: 'Synthesis, antiviral activity, molecular docking, and molecular dynamics studies of ethoxy phthalimide pyrazole derivatives against Cytomegalovirus and Varicella-Zoster virus: potential consequences and strategies for developing new antiviral treatments'. (Pubmed Central) - Nov 15, 2023
HighlightsTwo components synthesis of substituted ethoxy phthalimide pyrazole derivatives (6a-e).Tested compounds (6a-e) have antiviral and cytotoxicity activity against CMV and Varicella-Zoster virus (VZV) in HEL cells.Compounds bind to TK, Varicella-Zoster protease (VZP) of VZV, and modeled TPpp71 of Cytomegalovirus (CMV).In comparison to reference drugs, compounds have strong binding free energy and interactions with VZV and CMV protein complexes.The RMSD, RMSF, Rg, residual correlative motion (RCM), No. of hydrogen bonds, protein secondary structure content, per-residue protein secondary structure and MM/PBSA energy calculated for the selected compound with thymidine kinase (TK), VZP of VZV, and modeled tegument protein pp71 (TPpp71) of CMV through MD simulation studies for 50?ns.In comparison to the two reference drugs, ligands/compounds were found to meet the Lipinski rule of five and to have strong biological activity.Communicated by Ramaswamy H. Sarma.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Targeting EBV Encoded Viral Kinases with GCV, AZT, Rituximab and Dexamethasone (GARD) Results in Durable Responses in Patients with CNS Lymphoproliferative Disease (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5919;
After induction, dexamethasone was tapered, and GCV/AZT was switched to maintenance oral dosing of 450mg valganciclovir twice daily and 300mg of AZT twice daily...This expression of viral kinases in CNS-LPD supports the mechanistic rationale of this antiviral approach and could be further investigated as a predictive biomarker. Overall, this research highlights unique epigenetic features of EBV in CNS-LPD that support the use of antiviral, specifically the GARD regimen, in EBV+ CNS-LPD.
- |||||||||| Cytovene (ganciclovir) / Roche
Time of Origin and Environmental Drivers of Leukemia Immune Escape after Transplantation (SDCC - Room 11) - Nov 3, 2023 - Abstract #ASH2023ASH_1419;
Our data indicate that in the majority of patients HLA loss variants originate after transplant, and that the genotoxicity of ganciclovir is a potent facilitator of the phenomenon. Defining the time of origin of therapy resistance has fundamental clinical consequences, implying that immune escape clones can only be targeted by post-transplant interventions, and warranting the development of new tools to anticipate the rapid detection of relapse.
- |||||||||| Cytovene (ganciclovir) / Roche
Journal: Fungal Keratitis Associated with Curvularia lunata: First Case Report from T (Pubmed Central) - Oct 31, 2023
Intrastromal and subconjunctival voriconazole injection was applied to the patient who was unresponsive to empirically initiated oral moxifloxacin and different topical treatments (vancomycin, ceftazidime, flucanozole, ganciclovir, cyclopentolate hydrochloride, hyaluronic acid and trehalose)...This will also help prevent complications that may occur. This article aims to present a case of fungal keratitis associated with C.lunata.
- |||||||||| Review, Journal: New Treatment Options for Refractory/Resistant CMV Infection. (Pubmed Central) - Oct 30, 2023
Recent introduction of new CMV agents including maribavir and letermovir as well as the use of adoptive T cell therapy may improve the outcome of these difficult-to-treat infections in SOT recipients. In this expert review, we focus on new treatment options for resistant/refractory CMV infection and disease in SOT recipients, with an emphasis on maribavir, letermovir, and adoptive T cell therapy.
- |||||||||| Cytovene (ganciclovir) / Roche
Review, Journal: Antiviral Treatment of Maternal and Congenital Cytomegalovirus (CMV) Infections. (Pubmed Central) - Oct 28, 2023
HCMV screening during pregnancy is not routinely offered due to lack of awareness, hurdles to accurate diagnosis, and lack of well-established effective treatment options during pregnancy. This review will focus on antiviral treatment options currently available for use during pregnancy and in the newborn period for the treatment of maternal and congenital HCMV infections.
- |||||||||| nanatinostat (VRx-3996) / Viracta Therap, Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe
P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study. (Pubmed Central) - Oct 22, 2023
P1b/2, P2
The most common adverse events (AEs) were nausea (38% any grade) and cytopenias (Grade 3/4 neutropenia [29%], thrombocytopenia [20%], and anemia [20%]). This novel oral regimen provided encouraging efficacy across several EBV+ lymphoma subtypes and warrants further evaluation; a confirmatory Phase 2 study (NCT05011058) is underway.
- |||||||||| nanatinostat (VRx-3996) / Viracta Therap, Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe
Global Phase 2 Basket Trial of Nanatinostat in Combination with Valganciclovir in Patients with EBV-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1, trial in progress) (Hall B) - Sep 30, 2023 - Abstract #DGHO2023DGHO_572;
P1b/2, P2
Nstat induces the expression of the lytic BGLF4 protein kinase, activating Ganciclovir, resulting in termination of DNA replication and apoptosis...T/NK-NHL patients (n=15) had an ORR/CR of 60%/27%; in EBV+ DLBCL, NOS (n=6), ORR/CR was 67%/33% (CRs in patients refractory to first-line R-CHOP)...Enrollment since May 2021. Key Words : Epstein-Barr Virus (EBV), EBV positive T cell lymphoma, extranodal NK-T Cell Lymphoma (ENKTCL), peripheral T cell lymphoma (PTCL)
- |||||||||| Cytovene (ganciclovir) / Roche
Review, Journal: Targeting Posterior Eye Infections with Colloidal Carriers: The Case of Ganciclovir. (Pubmed Central) - Sep 20, 2023
This paper discusses several colloidal carriers combined with GCV to treat opportunistic CMV infection in the posterior ocular system. It reviews the limitations of conventional ocular therapy and explores various novel formulation approaches to improve the ocular bioavailability of GCV in the posterior chamber of the eye.
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