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- | Prevymis (letermovir) / Merck (MSD)
Journal: An Attenuated Strain of Human Cytomegalovirus for the Establishment of a Subviral Particle Vaccine. (Pubmed Central) - Aug 27, 2022
The resulting strain, termed TR-VAC, produced high amounts of DB under IE1/IE2 repressive conditions and concomitant supplementation of the viral terminase inhibitor letermovir to the producer cell culture...Exposure of donor-derived monocytic cells to DB led to the activation of a rapid innate immune response. This comprehensive data set thus shows that TR-VAC is an optimal attenuated seed virus strain for the production of a DB vaccine to be tested in clinical studies.
- | Prevymis (letermovir) / Merck (MSD)
Journal: Letermovir vs. high-dose valacyclovir for cytomegalovirus prophylaxis following haploidentical or mismatched unrelated donor allogeneic hematopoietic cell transplantation receiving post-transplant cyclophosphamide. (Pubmed Central) - Aug 24, 2022
Median CMV event-free-survival was improved with LET (not reached vs. 80 days, HR 0.114, 95% CI 0.07-0.61, p = .004). These data support the efficacy of LET in alternative donor transplants.
- || Prevymis (letermovir) / Merck (MSD), foscarnet / Generic mfg., Livtencity (maribavir) / Takeda, GSK
Looks like neck and neck on bringing VL down further versus just starting with maribavir. I am in the foscarnet camp personally, but wouldn’t delay discharge for it. Interesting that letermovir got so little love but it seems to perform adequately when VL suppressed. (Twitter) - Aug 24, 2022
- | Prevymis (letermovir) / Merck (MSD)
Journal: Therapeutic Drug Monitoring of Orally Administered Letermovir Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplant Recipients. (Pubmed Central) - Aug 22, 2022
Letermovir exposure was not affected by gastrointestinal symptoms, but with posaconazole and cyclosporine administration. Associations between letermovir and concomitantly administered agents and adverse events warrant additional clinical studies.
- |||| Prevymis (letermovir) / Merck (MSD)
Clinical: It seems that letermovir is also a promising option for use in CMV prophylaxis in pediatric allo-HSCT patients. https://t.co/H20JECJiQ1 (Twitter) - Aug 21, 2022
- ||| Prevymis (letermovir) / Merck (MSD), foscarnet / Generic mfg., Cytovene (ganciclovir) / Roche
FDA event: Another #PriorAuth fail for letermovir (FDA approved for prophylaxis in BMT). #PriorAuth denied because has not failed ganciclovir or foscarnet 🤔 (Twitter) - Aug 19, 2022
- ||| Prevymis (letermovir) / Merck (MSD), acyclovir / Generic mfg., Flumadine (rimantadine) / AbbVie
Clinical, Reimbursement: Another one to add to hall of #PriorAuth fails: #BMT patient’s letermovir (used for CMV prevention) denied by insurance company … suggested two alternatives Me: 😮 alternatives to letermovir!!?? Insurance: Use acyclovir or rimantadine 🤦♂️😂😭 (Twitter) - Aug 19, 2022
- | Prevymis (letermovir) / Merck (MSD)
Retrospective data, Journal: Letermovir discontinuation at D+100 after Allogeneic Stem Cell Transplant is associated with increased CMV-related mortality. (Pubmed Central) - Aug 5, 2022
Patients with subclinical CMV viremia before transplant, high risk transplants, PTCy, MMUD had decreased CMV reactivation with letermovir. Although there was no difference in CMV reactivation in the CMV D+/R- cohort, the subset treated with PTCy for acute graft-versus-host disease prophylaxis had decreased CMV reactivation with letermovir.
- | voriconazole / Generic mfg.
Journal, Real-world evidence: Voriconazole in hematopoietic stem cell transplantation and cellular therapies: Real-world usage and therapeutic level attainment at a major transplant center. (Pubmed Central) - Aug 5, 2022
VCZ continues to remain an important option in the treatment and prevention of invasive fungal infections in an era when alternative oral mold-active triazoles are available. In spite of long-standing experience with VCZ prescribing, therapeutic level attainment remains a challenge.
- || Prevymis (letermovir) / Merck (MSD)
PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of Letermovir Following Single- and Multiple-Dose Administration in Healthy Japanese Subjects. (Pubmed Central) - Aug 3, 2022
Based on the population pharmacokinetic analysis, weight differences primarily accounted for the higher exposures observed in Asians. Letermovir was generally well tolerated following oral and IV administration to healthy Japanese subjects.
- | Prevymis (letermovir) / Merck (MSD)
Retrospective data, Journal: Risk factors for late cytomegalovirus infection after completing letermovir prophylaxis. (Pubmed Central) - Jul 29, 2022
In this study, transplant outcomes did not differ between patients with and without late-csCMV infection. This suggests a need to clarify the efficacy of extended administration of LMV for preventing late-csCMV infection in a larger number of allo-HCT recipients, especially those with "high-risk" donors.
- | Prevymis (letermovir) / Merck (MSD)
Journal: Risk factor analysis for cytomegalovirus reactivation under prophylaxis with letermovir after allogeneic hematopoietic stem cell transplantation. (Pubmed Central) - Jul 27, 2022
This suggests a need to clarify the efficacy of extended administration of LMV for preventing late-csCMV infection in a larger number of allo-HCT recipients, especially those with "high-risk" donors. Our study showed that letermovir prophylaxis significantly reduced the incidence of CS-CMVi and NRM in a real-world setting and that the CMV serostatus of the donor remained as a risk factor for CS-CMVi even under letermovir prophylaxis.
- | Prevymis (letermovir) / Merck (MSD)
Journal: Letermovir for Cytomegalovirus Prevention in Adolescent Patients Following Hematopoietic Cell Transplantation. (Pubmed Central) - Jul 27, 2022
No patients developed clinically significant CMV while taking letermovir. Letermovir was well tolerated and efficacious in preventing CMV infections.
- Prevymis (letermovir) / Merck (MSD)
What Have We Learned From Half a Decade of Letermovir? (201) - Jul 23, 2022 - Abstract #IDWeek2022IDWEEK_291;
- Prevymis (letermovir) / Merck (MSD), Livtencity (maribavir) / Takeda, GSK
119 - The New Landscape of CMV in Transplant (201) - Jul 23, 2022 - Abstract #IDWeek2022IDWEEK_289;
Letermovir was well tolerated and efficacious in preventing CMV infections. CME Credits : Maximum of 1.25 hours of AMA PRA Category 1 Credit™ MOC Credits : Maximum of 1.25 hours of MOC Credit CNE Credits : Maximum of 1.25 hours of ANCC Credit ACPE Credits : ACPE 1.25 contact hours of pharmacy CE ACPE Number : JA0007082-0000-22-002-L01-P Learning Objectives: At the conclusion of this session, participants will be able to: describe clinical uses for Maribavir in the treatment of CMV infections in transplantation; discuss the benefits and limitations of Letermovir prophylaxis for CMV prevention
- || Review, Journal: Cytomegalovirus infection in transplant recipients: Newly approved additions to our armamentarium. (Pubmed Central) - Jul 20, 2022
Despite major advancements, breakthrough CMV infections and development of refractory and resistant CMV infections remain major complications post-transplantation. We highlight emerging therapeutics that tolerably and effectively prevent and treat CMV infections, especially refractory and resistant cases.
- ||| Prevymis (letermovir) / Merck (MSD)
The unresolved question is if CMV is the chicken or the egg. If one treated CMV viremia, would it improve outcomes? @Merck was not interested in providing #letermovir for a RCT, at least not in Africa, last time that we asked -- even if all the funding came from elsewhere. (Twitter) - Jul 18, 2022
- | Prevymis (letermovir) / Merck (MSD)
Journal: First clinical description of letermovir resistance mutation in cytomegalovirus UL51 gene and potential impact on the terminase complex structure. (Pubmed Central) - Jul 15, 2022
As an isolated mutation in pUL51 in a clinical isolate can lead to LMV resistance, genotyping for resistance should involve sequencing of the pUL51, pUL56 and pUL89 genes. With terminase modelling, we make the hypothesis that LMV could bind to domains were UL56-L257I and UL51-A95V mutations were localized.
- ||||| Prevymis (letermovir) / Merck (MSD)
Clinical: Extended Duration Letermovir Prophylaxis for Cytomegalovirus Infection after Cord Blood Transplantation in Adults https://t.co/dnn8dFNrrg @MSKCancerCenter @MSK_DeptOfMed @ipolitikos @DrMiguelPerales @GunjanLShah @GenPapaMD @sean_m_devlin Extend letermovir in all high risk patient (Twitter) - Jul 13, 2022
- | Prevymis (letermovir) / Merck (MSD)
Journal: Extended Duration Letermovir Prophylaxis for Cytomegalovirus Infection after Cord Blood Transplantation in Adults. (Pubmed Central) - Jul 9, 2022
Overall, 20 patients stopped letermovir at a median of 354 days (range 119-455) post-transplant, with only 5 requiring one (n = 4) or two (n = 1) valganciclovir courses (median total duration 58 days, range 12-67) for post-prophylaxis viremia, with no subsequent csCMVi...Of 62 historic controls who received acyclovir only, 51 developed csCMVi (median onset 34 days, range 5-74) for a day 100 incidence of 82% (95%CI:73-92)...Letermovir is highly effective, well tolerated prophylaxis that mitigates CMV infection, CMV-related mortality and antiviral therapy toxicities in CBT recipients. Our data supports prophylaxis duration of at least 6 months after CBT.
- || Prevymis (letermovir) / Merck (MSD)
PK/PD data, Retrospective data, Journal: Evaluation of the pharmacokinetic interaction between letermovir and tacrolimus in allogeneic hematopoietic cell transplant recipients. (Pubmed Central) - Jul 8, 2022
The pharmacokinetic interaction between tacrolimus and letermovir is substantial based on results from this study and continued to affect tacrolimus concentrations over the 14-day period after letermovir initiation. Close monitoring of tacrolimus trough concentration upon initiation of letermovir should be considered.
- | Prevymis (letermovir) / Merck (MSD)
Retrospective data, Journal, Real-world evidence: Real-world efficacy of letermovir prophylaxis for cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation: A single-center retrospective analysis. (Pubmed Central) - Jul 8, 2022
Close monitoring of tacrolimus trough concentration upon initiation of letermovir should be considered. LET prophylaxis was highly effective in preventing csCMVi and could potentially improve transplant outcomes, particularly when initiated early after transplantations.
- | Prevymis (letermovir) / Merck (MSD)
Retrospective data, Journal: Letermovir Prophylaxis for Cytomegalovirus Infection in Children After Hematopoietic Cell Transplantation. (Pubmed Central) - Jul 8, 2022
Our data support letermovir prophylaxis efficacy and safety in pediatric patients after allo-HCT. Compared with the historical group, prophylactic use of letermovir decreased the number of CMV reactivations in children.
- | Prevymis (letermovir) / Merck (MSD), Noxafil (posaconazole) / Merck (MSD)
Journal: Results of an Innovative Program for Surveillance, Prophylaxis, and Treatment of Infectious Complications Following Allogeneic Stem Cell Transplantation in Hematological Malignancies (BATMO Protocol). (Pubmed Central) - Jul 6, 2022
The efficacy of anti-CMV prophylaxis with letermovir was confirmed by a significant reduction in CMV reactivations. Even though patients in Cohort B were at higher risk of developing fungal infections (more haploidentical transplants with more myeloablative regimens), the extensive use of posaconazole for prophylaxis balanced this risk, and no increase in the incidence of fungal-associated complications was observed.
- | Prevymis (letermovir) / Merck (MSD)
New P3 trial: CYMEVAL3-step2: Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Versus Valaciclovir (clinicaltrials.gov) - Jul 5, 2022
P3, N=46, Not yet recruiting, Sponsor: Assistance Publique - H
- | Prevymis (letermovir) / Merck (MSD)
New P2 trial: CYPHER-TXPilot: Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients (clinicaltrials.gov) - Jun 26, 2022
P2, N=90, Not yet recruiting, Sponsor: University Medical Centre Ljubljana
- | Prevymis (letermovir) / Merck (MSD)
Journal: The changing impact of cytomegalovirus among hematopoietic cell transplant recipients during the past decade: A single institutional cohort study. (Pubmed Central) - Jun 23, 2022
Preemptive therapy does not negate the impact of CMV-CSI on peri-engraftment toxicity and healthcare utilization. This cohort represents a large single center study on the impact of CMV in the preletermovir era and serves as a real-world comparator for assessing the impact of future prophylaxis.
- |||| Prevymis (letermovir) / Merck (MSD), VIC-1911 / VITRAC Therap
PTCy / siro / MMF as #GVHD prophylaxis. With letermovir, 11% grade III-IV aGVHD, 6% mod/severe cGVHD. Relapse at 21% greatest unmet need. We are testing this platform as well as PTCy / siro /VIC-1911 to ⬆️ GVL in separate phase II studies @UMNHOT @jmaakaron @Mjuckett @UMNCancer https://t.co/b2O6B7lJ0z (Twitter) - Jun 9, 2022
- ||| Prevymis (letermovir) / Merck (MSD)
Enrollment open: 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) - Jun 3, 2022
P2, N=180, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This cohort represents a large single center study on the impact of CMV in the preletermovir era and serves as a real-world comparator for assessing the impact of future prophylaxis. Suspended --> Recruiting
- | Prevymis (letermovir) / Merck (MSD)
Journal: Letermovir reduces chronic GVHD risk in calcineurin inhibitor-free GVHD prophylaxis after hematopoietic cell transplantation. (Pubmed Central) - May 22, 2022
Suspended --> Recruiting No abstract available
- Prevymis (letermovir) / Merck (MSD), Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Cytovene (ganciclovir) / Roche
Cytomegalovirus Prevention in Kidney and Pancreas Transplant Recipients: A Successful Pharmacist-Led Multidisciplinary Approach (Hynes Halls C & D: Board No. A003) - May 20, 2022 - Abstract #ATC2022ATC_3337;
This approach was well received by the txp team and additional task forces have been established based on this model. Our report demonstrated that a proactive and systematic method of tackling a high-value post-txp problem is effective and pharmacists play an important role in bringing these to fruition.
- Prevymis (letermovir) / Merck (MSD)
Assessment of Letermovir as Universal Prophylaxis for Cytomegalovirus Infection in Lung Transplant Recipients (Hynes Halls C & D: Board No. C269) - May 20, 2022 - Abstract #ATC2022ATC_3293;
An antimetabolite was successfully reinitiated in a proportion of patients previously requiring antimetabolite cessation prior to letermovir initiation. Preliminary results indicate a comparable incidence of rejection at 6 months post-transplant.
- Prevymis (letermovir) / Merck (MSD)
Letermovir for Prophylaxis of Cytomegalovirus After Solid Organ Transplantation: A Single-Center, Observational Study (Hynes Halls C & D: Board No. D116) - May 20, 2022 - Abstract #ATC2022ATC_3156;
Letermovir may be an alternative for primary CMV prophylaxis in SOT. Breakthrough CMV DNAemia is frequent in patients receiving letermovir for secondary prophylaxis.
- Prevymis (letermovir) / Merck (MSD)
Cmv-Specific Cell-Mediated Immune Reconstitution in High-Risk Hematopoietic Cell Transplant Recipients Receiving Letermovir Prophylaxis (Hynes Room 311) - May 20, 2022 - Abstract #ATC2022ATC_1342;
However, CMV reactivation during letermovir prophylaxis was not always accompanied by viremia and not all documented episodes of CMV reactivation were accompanied by early CMV-IR. aGVHD was an important contributor to symptomatic or asymptomatic cCMV.
- | Prevymis (letermovir) / Merck (MSD)
Preclinical, Journal: In vitro activity of letermovir against human cytomegalovirus isolates with different drug susceptibility phenotypes. (Pubmed Central) - May 18, 2022
The susceptibility of LTV against the different recombinant HCMV mutants with amino acid substitutions in the UL97 kinase or in the UL54 DNA polymerase was similar to that of the wild type virus. LTV was also effective against recombinant HCMV harboring UL97 mutations conferring resistance to maribavir.
- ||||| Prevymis (letermovir) / Merck (MSD)
Trial suspension: 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) - May 17, 2022
P2, N=180, Suspended, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
LTV was also effective against recombinant HCMV harboring UL97 mutations conferring resistance to maribavir. Not yet recruiting --> Suspended
- | Prevymis (letermovir) / Merck (MSD)
Journal: Letermovir for cytomegalovirus primary prophylaxis in a multiple abdominal/ small bowel transplant recipient. (Pubmed Central) - May 15, 2022
Not yet recruiting --> Suspended No abstract available
- Prevymis (letermovir) / Merck (MSD)
A RISK-BASED STRATEGY FOR THE USE OF LETERMOVIR IN CMV-POSITIVE RECIPIENTS OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION () - May 13, 2022 - Abstract #EHA2022EHA_2471;
For high-risk and low-risk patients, overall survival, progression-free survival, incidence of relapse, and relapse-free mortality were not significantly different between the 2 periods. Conclusion A risk-based strategy for the use of letermovir, rather than systematically, is feasible in CMV-positive recipients of allo-HCT without increasing the risk of clinically significant CMV infection and CMV disease.
- ||| Prevymis (letermovir) / Merck (MSD)
Clinical: Don't use a ton of it so can't comment specifically on letermovir. Usually tolerate low-level CMV viremia in low-risk patients up to ~500 U/mL. Curious what @zamora_danniel has to say given his excellent work on cell-mediate imunity while on letermovir in SOT. (Twitter) - May 10, 2022
- || Prevymis (letermovir) / Merck (MSD)
Wow, thank you for sharing this, so much variability in CMV VLs over time despite letermovir (Twitter) - May 9, 2022
- |||| Prevymis (letermovir) / Merck (MSD)
Clinical: We use letermovir as 1/2ary prophy in selected scenarios. Agree @KottonNelson that low-level DNAemia doesn't seem to be clinically relevant. This pub from @amjtransplant suggests that a proportion may be the result of abortive infection. https://t.co/SLEN1mvE2q (Twitter) - May 9, 2022
- ||| Prevymis (letermovir) / Merck (MSD)
Clinical: Nice work @camwolfe et al. We see these low-level positive results that don’t seem to be clinically significant. Nonetheless, low barrier to resistance with letermovir so I always try to use it just for prophylaxis (esp with GCV Resistant/refractory disease). Await kidney trial. (Twitter) - May 9, 2022
- |||| Prevymis (letermovir) / Merck (MSD)
Clinical: Question for #IDTwitter, How much CMV viremia are people seeing after starting letermovir for prophy? How much viremia is too much? When do people get worried about breakthrough infections? @camwolfe @KottonNelson @MichaelGIsonMD @JoshuaHillMD @AndrewKaraba @DocWoc71 (Twitter) - May 9, 2022
- ||| Prevymis (letermovir) / Merck (MSD)
HEOR: Excellent presentations about the use of letermovir for cmv prophylaxis!It’s cost effective in the USA(based on USA HCT costs).We need similar studies in Brazil because costs related to HCT are much lower here!I’m anxious for the ped data.Thanks @DrMiguelPerales and @ChemalyRoy👏 (Twitter) - May 7, 2022
- || Prevymis (letermovir) / Merck (MSD)
Clinical, Review, Journal: Prevention of viral infections in solid organ transplant recipients in the era of COVID-19: a narrative review. (Pubmed Central) - May 6, 2022
In the upcoming years, further data are expected to better delineate the role of virus-specific cell mediated immune monitoring for the prevention of CMV and potentially other viral diseases, and the role of the letermovir in the prevention of CMV in SOT recipients. Future studies including clinical endpoints will hopefully facilitate the integration of successful new influenza vaccination strategies into clinical practice.
- | Prevymis (letermovir) / Merck (MSD)
New trial: Letermovir in ART-treated HIV-infected Persons (clinicaltrials.gov) - May 5, 2022
P=N/A, N=60, Not yet recruiting, Sponsor: Jean-Pierre Routy
- | Prevymis (letermovir) / Merck (MSD)
Journal: Assessment of UL56 Mutations before Letermovir Therapy in Refractory Cytomegalovirus Transplant Recipients. (Pubmed Central) - Apr 30, 2022
Our study emphasizes that the clinical follow-up in combination with genotypic and phenotypic studies is essential for the assessment and optimization of patients experiencing HCMV relapses or not responding to antiviral therapy. This information may be important for other researchers and clinicians working in the field to improve the care of transplant patients since drug-resistant CMV infections are an important emerging problem even with the new antiviral development.
- ||| Prevymis (letermovir) / Merck (MSD), Cytovene (ganciclovir) / Roche, leflunomide / Generic mfg.
Clinical: Nice thought. Leflunomide has activity against CMV+BKV. Again, patient progressing on Leflunomide would still be sensitive for Ganciclovir (CMV). The design should be Leflunomide vs. SoC (including Letermovir) in Haplo. LefvsLet not feasible. #Drugrepurposing (Twitter) - Apr 27, 2022
- ||| Prevymis (letermovir) / Merck (MSD)
Head-to-Head: @DrMiguelPerales Thanks Dr Perales, in the context of India , we are not looking for superiority per se, but may be non-inferiority, accessibility, sustainability and availability The added cost and inaccessibility of a drug like Letermovir is a massive barrier for us (Twitter) - Apr 26, 2022
- || Prevymis (letermovir) / Merck (MSD)
Clinical, Journal: Letermovir treatment for CMV infection in kidney and pancreas transplantation: a valuable option for complicated cases. (Pubmed Central) - Apr 26, 2022
After the end of treatment, recurrent low-grade CMV-DNAemia was common requiring reinitiating antiviral therapy to achieve viral clearance. To conclude, letermovir was a well-tolerated valuable option for the treatment of refractory or resistant CMV infection in kidney and pancreas transplantation.