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2 Diseases |  |
32 Trials |
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32 Trials |  |
1662 News |  |
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- | Vistide (cidofovir) / Gilead
Journal: Investigational antiviral therapy models for the prevention and treatment of congenital cytomegalovirus infection during pregnancy. (Pubmed Central) - Jun 22, 2021
In this study, aciclovir and the HCMV-specific antivirals letermovir, maribavir, and cidofovir were compared with ganciclovir for antiviral effects in model systems of pregnancy, including first-trimester TEV-1 trophoblast cell cultures and third-trimester ex vivo placental explant histocultures...They partly fulfil requirements for use as safe and effective therapeutics during pregnancy to control congenital HCMV. Clinical trials of these newer agents would assist assessment of their utility in pregnancy.
- | Prevymis (letermovir) / Merck (MSD)
Journal: Positive HCMV DNAemia in stem cell recipients undergoing letermovir prophylaxis is expression of abortive infection. (Pubmed Central) - Jun 22, 2021
Then, the presence of circulating infectious HCMV particles was determined by virus isolation and degradation of free-floating viral DNA. This report provide the first evidence that during LMV prophylaxis the clinical relevance of HCMV DNAemia should be critically considered.
- | Prevymis (letermovir) / Merck (MSD), Cytovene (ganciclovir) / Roche
Journal: A Novel Triple-Fluorescent HCMV Strain Reveals Gene Expression Dynamics and Anti-Herpesviral Drug Mechanisms. (Pubmed Central) - Jun 22, 2021
We demonstrate distinct inhibitory profiles of foscarnet, fomivirsen, phosphonoacetic acid, ganciclovir, and letermovir reflecting their mode-of-action. In conclusion, our data argues that this experimental approach allows the identification and characterization of new drug candidates in a single step.
- || Prevymis (letermovir) / Merck (MSD), Noxafil (posaconazole) / Merck (MSD)
Clinical, Journal: Concomitant Administration of posaconazole and isavuconazole with Letermovir: Clinical and Pharmacological Considerations. (Pubmed Central) - Jun 22, 2021
PCZ/IVC-C were not found to be significantly different between cases and controls: 1.31 mg/l (median) (0.90; IQR) vs 1.36 mg/l (1.16) (P-value: 0.31) and 3.20 mg/l (2.40) vs 2.35 mg/l (1.50) (P-value: 0.17), respectively. In conclusion, we observed PCZ/IVC-C levels within the expected range and no significant effect of LET co-administration.
- | Prevymis (letermovir) / Merck (MSD)
Journal: Rifampicin and Letermovir as potential repurposed drug candidate for COVID-19 treatment: insights from an in-silico study. (Pubmed Central) - Jun 22, 2021
In conclusion, we observed PCZ/IVC-C levels within the expected range and no significant effect of LET co-administration. This study provides an insight into the drug repurposing approach in which several FDA approved drugs were examined to inhibit COVID-19 infection by targeting the main protease of SARS-COV-2 and the cytokine storm.
- || Prevymis (letermovir) / Merck (MSD)
Clinical, Journal: Use of Letermovir for Salvage Therapy for Resistant Cytomegalovirus in a Pediatric Hematopoietic Stem Cell Transplant Recipient. (Pubmed Central) - Jun 16, 2021
A 14-year-old girl underwent a double unrelated umbilical cord blood transplantation to treat her sickle cell disease (hemoglobin SS) and developed ganciclovir-resistant CMV DNAemia with end-organ involvement that was treated successfully with a combination of foscarnet and letermovir. After she was transitioned to letermovir monotherapy for secondary prophylaxis, she developed recurrent DNAemia with laboratory-confirmed ganciclovir, foscarnet, and letermovir resistance.
- ||| Prevymis (letermovir) / Merck (MSD)
The d+100 limit has always seemed somewhat arbitrary to me - a way to identify those at highest risk for post-letermovir CMV (~20%) would help. Those with active GVHD or still requiring IST, perhaps - but would be nice to be able to reliably quantify immune reconstitution . (Twitter) - Jun 11, 2021
- || Prevymis (letermovir) / Merck (MSD)
#Letermovir? (Twitter) - Jun 10, 2021
- | Prevymis (letermovir) / Merck (MSD)
Yeah -- tried to get letermovir supp when it went down to undetectable for a bit but it was 2k out of pocket pay for her per mo 🙄 she couldn't afford it (Twitter) - Jun 9, 2021
- ||| Prevymis (letermovir) / Merck (MSD)
Clinical: Patients on letermovir need to stay on acyclovir. Letermovir does not prevent hsv/vzv (Twitter) - Jun 9, 2021
- ||| Prevymis (letermovir) / Merck (MSD)
Reimbursement: Ahh forgot about the insurance part… clearly I am not yet an attending 🤣 And very helpful - ideally continue letermovir until off tac or based on serial PB CMVs being negative as a bridge to acyclovir? (Twitter) - Jun 9, 2021
- |||| Prevymis (letermovir) / Merck (MSD)
Retrospective data, Review: Shockingly, it was retrospective chart review #ASCO21 oral that intrigued me most - letermovir PPx improving OS in pts with active GVHD. And ?? continuing past D+100. Tons of confounders, but have you ever kept on past D+100 in high-risk? Asking Aaron^2 @hemedoc & @BldCancerDoc (Twitter) - Jun 9, 2021
- ||| Prevymis (letermovir) / Merck (MSD)
This is amazing. Some others that I don’t see already: Fosfomycin/UTIs Vanco MICs of 2 Linezolid/serotonin tox Linezolid/renal dose adjustment Aminoglycosides/AUC dosing IV therapy for osteo BLI exposures ISA capsules can’t be opened Letermovir can’t be crushed (Twitter) - Jun 8, 2021
- ||||| Prevymis (letermovir) / Merck (MSD)
Retrospective data: #ASCO21 #bmtsm Wolfe: Letermovir CMV ppx in pts w acute GVHD. Retrospective comparison of Letermovir vs no ppx, prim endpt CMV infxn in first 200 days in those with gr 2+ aGVHD, n=119 (Let), 143 (none), HR 0.08 with Let in those with aGVHD gr 2+, Letermovir a/w OS advantage. (Twitter) - Jun 4, 2021
- || Prevymis (letermovir) / Merck (MSD)
Appreciate that they described the antimicrobial prophylaxis. Interesting that Letermovir isn’t utilized and that despite antimicrobial prophy 50% bacteremias occurred. (Twitter) - Jun 3, 2021
- | Prevymis (letermovir) / Merck (MSD)
Journal: Drug interaction between letermovir and voriconazole after allogeneic hematopoietic cell transplantation. (Pubmed Central) - Jun 1, 2021
Our results suggest that voriconazole trough concentration decreases when voriconazole is combined with letermovir in allogeneic HCT recipients. Therefore, close therapeutic drug monitoring of voriconazole trough concentration is warranted in allogeneic HCT recipients after starting or discontinuing letermovir.
- || Prevymis (letermovir) / Merck (MSD)
And of course Letermovir for CMV (Twitter) - May 27, 2021
- | Prevymis (letermovir) / Merck (MSD)
New P4 trial: Letermovir Use in Heart Transplant Recipients (clinicaltrials.gov) - May 26, 2021
P4, N=35, Not yet recruiting, Sponsor: Tufts Medical Center
- || Prevymis (letermovir) / Merck (MSD)
Clinical, Journal: Letermovir Administration to Prevent Cytomegalovirus Reactivation Is the Potential Risk of Chronic Graft-Versus-Host Disease in Patients Who Received Haploidentical Stem-Cell Transplantation With Post-Transplant Cyclophosphamide. (Pubmed Central) - May 20, 2021
Our observations suggest that an early increase in the levels of HLA-DR activated T-cells may be implicated in the development of cGVHD in patients treated with PTCy who received LTV. Further studies are warranted to validate our results and elucidate the detailed mechanisms of our new insights.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Impact of co-administration of letermovir on isavuconazole plasma concentration in allogeneic hematopoietic cell transplant (HCT) recipients () - May 20, 2021 - Abstract #ECCMID2021ECCMID_3350;
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Interim report of post-marketing surveillance of letermovir in Japanese allogenic haematopoietic stem cell transplantation recipients () - May 20, 2021 - Abstract #ECCMID2021ECCMID_3208;
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] First experience with letermovir for prevention of cytomegalovirus (CMV) reactivation in CMV-seropositive paediatric patients post-allogeneic haematopoietic cell transplantation () - May 20, 2021 - Abstract #ECCMID2021ECCMID_3205;
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Cmv Specific Cellmediated Immune Reconstitution During Letermovir Prophylaxis in High Risk Hematopoietic Cell Transplant Recipients () - May 18, 2021 - Abstract #ATC2021ATC_2179;
4.5% of CMV R+ participants had no CMV CMI response pre-HCT, consistently lacked CMV CMI response post-HCT and did not reactivate CMV, indicating that patients may be falsely characterized by CMV antibody assay. CMV CMI assays rather than CMV serologies pre-HCT may be a useful tool to guide risk stratification for CMV monitoring and letermovir usage.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Managing the Significant Drug-Drug Interaction Between Tacrolimus and Letermovir in Solid Organ Transplant Recipients () - May 18, 2021 - Abstract #ATC2021ATC_2153;
An approximate tacrolimus dose reduction of 30% may be warranted when initiating letermovir to achieve a comparable dose-corrected trough concentration. Regardless of empiric adjustment, we recommend repeating a tacrolimus trough concentration within 5-7 days after starting letermovir.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Letermovir Prophylaxis in Solid Organ Transplant – CMV Breakthrough and Tacrolimus Drug Interaction () - May 18, 2021 - Abstract #ATC2021ATC_1808;
Patients converted from valganciclovir to letermovir did not show an increased rate of CMV breakthrough compared to a historical, matched cohort of patients remaining on valganciclovir. A significant drug interaction was noted with tacrolimus, leading to a recommendation to reduce the dose by 40-50% upon initiation of letermovir.
- | Prevymis (letermovir) / Merck (MSD)
Journal, Heterogeneity: Heterogeneous impact of cytomegalovirus reactivation on nonrelapse mortality in hematopoietic stem cell transplantation. (Pubmed Central) - May 15, 2021
The utility of CMV prophylaxis with letermovir has been reported; however, the specific applications remain unclear...In the test cohort, CMV reactivation was significantly associated with increased 3-year NRM among patients with 2 to 4 factors (22.1% vs 13.1%; P < .001) but was comparable among patients with 0 or 1 factor (23.2% vs 20.4%; P = .62). We propose that CMV prophylaxis should be determined based on reactivation risk, as well as these other factors.
- Prevymis (letermovir) / Merck (MSD), Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] LETERMOVIR FOR CMV PROPHYLAXIS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION - CLINICAL 'REAL WORLD' EXPERIENCE () - May 13, 2021 - Abstract #EHA2021EHA_753;
Patients with low, but detectable CMV levels (<137 IU/mL) and patients with the highest risk of CMV reactivation (such as patients with GvHD receiving corticosteroids, or patients who received ATG) might need a specifically tailored anti-CMV approach. Further studies addressing these questions are warranted.
- || Prevymis (letermovir) / Merck (MSD)
Clinical, Journal: Letermovir Primary Prophylaxis in High-Risk Hematopoietic Cell Transplant Recipients: A Matched Cohort Study. (Pubmed Central) - May 1, 2021
Primary anti-CMV letermovir prophylaxis decreased the incidence of csCMV infection and the administration of CMV-associated treatments and costs, particularly those associated with valganciclovir. An effect of letermovir on platelet reconstitution and renal function of csCMV post-HCT was observed and needs further investigation.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Letermovir prophylaxis and cytomegalovirus reactivation in adult allogeneic hematopoietic cell transplant recipients with graft versus host disease. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1208;
Letermovir prophylaxis significantly decreased CS-CMVi and improved NRM and OS in this real-world analysis . In addition, patients with acute GVHD had significantly less CMV viremia, suggesting potential benefit in continuing letermovir prophylaxis in this patient population.
- | Prevymis (letermovir) / Merck (MSD), maribavir (TAK-620) / Takeda, GSK
Review, Journal: New Advances in the Management of Cytomegalovirus in Allogeneic Haemopoietic Stem Cell Transplantation. (Pubmed Central) - Apr 28, 2021
A number of significant advances in the understanding and management of CMV infection have occurred in the last few years including improved diagnostics, monitoring of CMV immunity, availability of novel anti-CMV drugs, and emerging use of immunotherapies including CMV-specific T cell infusions. In addition to reviewing these advances we also explore some of the more practical prescribing issues of the older and newer CMV drugs including cost, toxicity and drug interactions to help clinicians navigate this new era of CMV management.
- ||||| Prevymis (letermovir) / Merck (MSD)
Enrollment closed: Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) (clinicaltrials.gov) - Apr 27, 2021
P3, N=600, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
In addition to reviewing these advances we also explore some of the more practical prescribing issues of the older and newer CMV drugs including cost, toxicity and drug interactions to help clinicians navigate this new era of CMV management. Recruiting --> Active, not recruiting
- | Prevymis (letermovir) / Merck (MSD)
Trial completion date, Trial primary completion date: MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) (clinicaltrials.gov) - Apr 23, 2021
P3, N=20, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Trial completion date: Apr 2022 --> Jul 2022 | Trial primary completion date: Apr 2022 --> Jul 2022
- ||| Prevymis (letermovir) / Merck (MSD)
Clinical, P3 data, Journal: Impact of Letermovir Use for Cytomegalovirus Prophylaxis on Re-Hospitalization Following Allogeneic Hematopoietic Stem Cell Transplantation: An Analysis of a Phase III Randomized Clinical Trial. (Pubmed Central) - Apr 20, 2021
P3
Trial completion date: Apr 2022 --> Jul 2022 | Trial primary completion date: Apr 2022 --> Jul 2022 In this post-hoc analysis, letermovir was associated with lower rates of CMV-associated and all-cause re-hospitalizations with a shorter length of stay (especially within the first 14 weeks post-transplant).
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] Budget-IMPACT Analysis of Letermovir for Preventing Cytomegalovirus in Adult Cytomegalovirus Seropositive Allogeneic Hematopoietic Cell Transplant Recipients in the United States () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_660;
In this post-hoc analysis, letermovir was associated with lower rates of CMV-associated and all-cause re-hospitalizations with a shorter length of stay (especially within the first 14 weeks post-transplant). Letermovir was associated with limited budget impact to the hospitals, primarily driven by drug acquisition costs but partially offset by lower cost of CMV antivirals used for PET and their associated AEs, and reduction in CMV-related rehospitalizations.
- |||| Prevymis (letermovir) / Merck (MSD)
Clinical: Important and convincing confirmation of the value of letermovir in #CMV prophylaxis. And sadly, another reminder of the importance of the clinical contributions of @FranciscoMarty_ who we tragically lost yesterday. #TxID #InfectiousDisease #RIPFrancisco (Twitter) - Apr 9, 2021
- |||| Prevymis (letermovir) / Merck (MSD)
Clinical: Primary letermovir prophylaxis effectively prevents refractory or resistant CMV infections, decreases NRM, as well as clinically significant CMV infections and disease after allogeneic HCT https://t.co/7BTgzyvbDq @MDAndersonNews @RichardChamplin @EJShpallMD @lab_rezvani #bmtsm (Twitter) - Apr 9, 2021
- |||| Prevymis (letermovir) / Merck (MSD)
New P2 trial: ELICIT: A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes. (clinicaltrials.gov) - Apr 9, 2021
P2, N=180, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- | Prevymis (letermovir) / Merck (MSD)
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - STEP 1 (CYMEVAL3-STEP1) (clinicaltrials.gov) - Apr 4, 2021
P=N/A, N=10, Recruiting, Sponsor: Assistance Publique - H
Letermovir was associated with limited budget impact to the hospitals, primarily driven by drug acquisition costs but partially offset by lower cost of CMV antivirals used for PET and their associated AEs, and reduction in CMV-related rehospitalizations. Not yet recruiting --> Recruiting | Trial completion date: Nov 2027 --> Feb 2028 | Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: Nov 2026 --> Feb 2027
- || Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe
Clinical, Journal: Cytomegalovirus prophylaxis using low-dose valganciclovir in patients with acute leukemia undergoing allogeneic hematopoietic stem-cell transplantation. (Pubmed Central) - Mar 23, 2021
Four of 20 (20%) patients discontinued valganciclovir prophylaxis because of adverse events. Low-dose valganciclovir prophylaxis could be an alternative to letermovir to prevent CMV infection in allo-HSCT, especially in resource-limited countries.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] THE IMPACT OF LETERMOVIR PRESCRIBING ON THE RATE OF CYTOMEGALOVIRUS REACTIVATION FOLLOWING ALLOGENEIC STEM CELL TRANSPLANTATION (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3512;
Letermovir prophylaxis reduced CMV reactivation, treatment requirement and hospitalisation up to day+168 post-transplant but increased overall expenditure. Further studies are needed to assess optimal duration of letermovir therapy and impact on quality of life.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] THE IMPACT OF LETERMOVIR PRESCRIBING ON THE RATE OF CYTOMEGALOVIRUS REACTIVATION FOLLOWING ALLOGENEIC STEM CELL TRANSPLANTATION (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3511;
Letermovir prophylaxis reduced CMV reactivation, treatment requirement and hospitalisation up to day+168 post-transplant but increased overall expenditure. Further studies are needed to assess optimal duration of letermovir therapy and impact on quality of life.
- Prevymis (letermovir) / Merck (MSD)
[VIRTUAL] THE IMPACT OF LETERMOVIR PRESCRIBING ON THE RATE OF CYTOMEGALOVIRUS REACTIVATION FOLLOWING ALLOGENEIC STEM CELL TRANSPLANTATION (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3510;
Letermovir prophylaxis reduced CMV reactivation, treatment requirement and hospitalisation up to day+168 post-transplant but increased overall expenditure. Further studies are needed to assess optimal duration of letermovir therapy and impact on quality of life.
- Prevymis (letermovir) / Merck (MSD), Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe
[VIRTUAL] Cavitary Lung Nodules Caused by HSV Pneumonitis in a Patient with Systemic Lupus Erythematosus () - Mar 14, 2021 - Abstract #ATS2021ATS_2382;
Case Presentation: A 33 year-old female with a history of SLE on chronic prednisone and mycophenolate presented to the hospital with chest pain during dialysis...She was started on valganciclovir and underwent a CT-guided core needle biopsy of a right lung nodule...She was ultimately discharged on valacyclovir to treat necrotizing HSV pneumonitis and letermovir to treat the CMV viremia...Our patient presented with pleural effusions as well as pulmonary nodules that later developed cavitation, which is infrequently described in the literature. Pulmonary nodules carry a broad differential including malignancy, fungal infections, and autoimmune conditions; including HSV pneumonitis in the differential for pulmonary nodules in an immunocompromised patient may aid in diagnosis and prompt treatment.
- || Prevymis (letermovir) / Merck (MSD)
CMV & letermovir. If the risk is higher, the benefit is larger. #EBMT21 #EBMT #EBMTYA #EBMTYA (Twitter) - Mar 14, 2021
- || Prevymis (letermovir) / Merck (MSD)
Trial completion date, Trial primary completion date: A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection (clinicaltrials.gov) - Mar 11, 2021
P2, N=86, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Pulmonary nodules carry a broad differential including malignancy, fungal infections, and autoimmune conditions; including HSV pneumonitis in the differential for pulmonary nodules in an immunocompromised patient may aid in diagnosis and prompt treatment. Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
- || Prevymis (letermovir) / Merck (MSD)
Review, Journal: Structures and Divergent Mechanisms in Capsid Maturation and Stabilization Following Genome Packaging of Human Cytomegalovirus and Herpesviruses. (Pubmed Central) - Mar 7, 2021
A new terminase inhibitor, letermovir, recently proved effective against human cytomegalovirus...In this review, we summarize recent findings on capsid assembly and DNA packaging. We also described what is known about the structure and function of capsid and terminase proteins to identify novels targets for the development of new therapeutic options.
- ||| Prevymis (letermovir) / Merck (MSD)
But Letermovir prophylaxis may reduce polyfunctional CMV-specific T-cell immunity after hematopoietic cell transplantation. https://t.co/3H1Qr05QgL (Twitter) - Mar 6, 2021
- || Prevymis (letermovir) / Merck (MSD)
Let’s hope they discussed their prophylaxis strategies - letermovir has been a game changer. But it was approved 2017 so don’t think it was used here (Twitter) - Mar 6, 2021
- |||| Prevymis (letermovir) / Merck (MSD)
PTCy ⬆️CMV infection🦠➡️increase cGVHD. A CIBMTR Analysis. #letermovir 💊@gvhd_hub @ASTCT https://t.co/926I5GxFmS (Twitter) - Mar 6, 2021
- |||| Prevymis (letermovir) / Merck (MSD)
Cytomegalovirus-specific T-cell Reconstitution following Letermovir Prophylaxis after Hematopoietic Cell Transplantation | Blood | @zamora_danniel, @joshua_schiffer and @fredhutch colleagues https://t.co/0ps2aqWTs0 (Twitter) - Mar 5, 2021