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3. Pharmacokinetics, Safety, and Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Adolescent Hematopoietic Cell Transplantation Recipients

Author

Groll, Andreas H., primary, Schulte, Johannes H., additional, Antmen, Ali Bülent, additional, Fraser, Christopher J., additional, Teal, Valerie L., additional, Haber, Barbara, additional, Caro, Luzelena, additional, McCrea, Jacqueline B., additional, Fancourt, Craig, additional, Patel, Mayankbhai, additional, Menzel, Karsten, additional, and Badshah, Cyrus, additional

Published
2024
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4. Efficacy and safety of extended duration letermovir prophylaxis in recipients of haematopoietic stem-cell transplantation at risk of cytomegalovirus infection: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Russo, Domenico, primary, Schmitt, Michael, additional, Pilorge, Sylvain, additional, Stelljes, Matthias, additional, Kawakita, Toshiro, additional, Teal, Valerie L, additional, Haber, Barbara, additional, Bopp, Charlene, additional, Dadwal, Sanjeet S, additional, and Badshah, Cyrus, additional

Published
2023
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5. 2563. Cytomegalovirus (CMV) Prophylaxis with Letermovir (LET) in Pediatric (Birth to < 18 years of age) Allogeneic Hematopoietic Cell Transplant (HCT) Recipients: Pharmacokinetics (PK), Safety and Efficacy Results of a Phase 2b study

Author

Schulte, Johannes H, primary, Gefen, Aharon, additional, Groll, Andreas H, additional, Fraser, Christopher J, additional, Teal, Valerie L, additional, Haber, Barbara A, additional, Gilbert, Christopher L, additional, McCrea, Jacqueline B, additional, Patel, Mayankbhai, additional, Menzel, Karsten, additional, and Badshah, Cyrus, additional

Published
2023
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6. Factors Associated With Depressive Symptoms and Use of Antidepressant Medications Among Participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC Studies

Author

Fischer, Michael J, Xie, Dawei, Jordan, Neil, Kop, Willem J, Krousel-Wood, Marie, Tamura, Manjula Kurella, Kusek, John W, Ford, Virginia, Rosen, Leigh K, Strauss, Louise, Teal, Valerie L, Yaffe, Kristine, Powe, Neil R, Lash, James P, and Investigators, CRIC Study Group

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Prevention, Kidney Disease, Mental Health, Depression, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Renal and urogenital, Mental health, Aged, Albuminuria, Antidepressive Agents, Comorbidity, Cross-Sectional Studies, Female, Glomerular Filtration Rate, Hispanic or Latino, Humans, Kidney Function Tests, Male, Middle Aged, Prevalence, Regression Analysis, Renal Insufficiency, Chronic, Risk Factors, chronic kidney disease, disparities, antidepressants, CRIC Study Group Investigators, Public Health and Health Services, Urology & Nephrology, Clinical sciences
Abstract

BackgroundDepressive symptoms are correlated with poor health outcomes in adults with chronic kidney disease (CKD). The prevalence, severity, and treatment of depressive symptoms and potential risk factors, including level of kidney function, in diverse populations with CKD have not been well studied.Study designCross-sectional analysis.Settings & participantsParticipants at enrollment into the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies. CRIC enrolled Hispanics and non-Hispanics at 7 centers in 2003-2007, and H-CRIC enrolled Hispanics at the University of Illinois in 2005-2008.MeasurementDepressive symptoms measured by Beck Depression Inventory (BDI).PredictorsDemographic and clinical factors.OutcomesElevated depressive symptoms (BDI score ≥11) and antidepressant medication use.ResultsOf 3,853 participants, 27.4% had evidence of elevated depressive symptoms and 18.2% were using antidepressant medications; 31.0% of persons with elevated depressive symptoms were using antidepressants. The prevalence of elevated depressive symptoms varied by level of kidney function: 23.6% for participants with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m(2) and 33.8% of those with eGFR

Published
2012

7. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients

Author

Limaye, Ajit P., primary, Budde, Klemens, additional, Humar, Atul, additional, Vincenti, Flavio, additional, Kuypers, Dirk R. J., additional, Carroll, Robert P., additional, Stauffer, Nicole, additional, Murata, Yoshihiko, additional, Strizki, Julie M., additional, Teal, Valerie L., additional, Gilbert, Christopher L., additional, and Haber, Barbara A., additional

Published
2023
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8. A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended from 100 to 200 Days Post-Transplant in Cytomegalovirus (CMV)-Seropositive Recipients (R+) of an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Author

Dadwal, Sanjeet Singh, primary, Russo, Domenico, additional, Stelljes, Matthias, additional, Schmitt, Michael, additional, Pilorge, Sylvain, additional, Teal, Valerie L., additional, Haber, Barbara A., additional, Bopp, Charlene, additional, and Badshah, Cyrus, additional

Published
2023
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9. LB2307. Safety and Efficacy of Letermovir (LET) versus Valganciclovir (VGCV) for Prevention of Cytomegalovirus (CMV) Disease in Kidney Transplant Recipients (KTRs): A Phase 3 Randomized Study

Author

Limaye, Ajit P, primary, Budde, Klemens, additional, Humar, Atul, additional, Garcia-Diaz, Julia, additional, Carroll, Robert P, additional, Murata, Yoshihiko, additional, Teal, Valerie L, additional, Gilbert, Christopher L, additional, and Haber, Barbara A, additional

Published
2022
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10. 623. Preliminary Dosing for Adolescent Hematopoietic Stem-Cell Transplant (HSCT) Recipients Based on Pharmacokinetic (PK), Safety, and Efficacy Data of Letermovir (LET) for Cytomegalovirus (CMV) Prophylaxis

Author

Groll, Andreas H, primary, Schulte, Johannes H, additional, Antmen, Ali Bulent, additional, Fraser, Christopher J, additional, Teal, Valerie L, additional, Haber, Barbara A, additional, Caro, Luzelena, additional, McCrea, Jacqueline B, additional, Fancourt, Craig, additional, Menzel, Karsten, additional, and Badshah, Cyrus, additional

Published
2022
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11. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation

Author

Marty, Francisco M., Ljungman, Per, Chemaly, Roy F., Maertens, Johan, Dadwal, Sanjeet S., Duarte, Rafael F., Haider, Shariq, Ullmann, Andrew J., Katayama, Yuta, Brown, Janice, Mullane, Kathleen M., Boeckh, Michael, Blumberg, Emily A., Einsele, Hermann, Snydman, David R., Kanda, Yoshinobu, DiNubile, Mark J., Teal, Valerie L., Wan, Hong, Murata, Yoshihiko, Kartsonis, Nicholas A., Leavitt, Randi Y., and Badshah, Cyrus

Published
2017
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14. 76 - A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended from 100 to 200 Days Post-Transplant in Cytomegalovirus (CMV)-Seropositive Recipients (R+) of an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Author

Dadwal, Sanjeet Singh, Russo, Domenico, Stelljes, Matthias, Schmitt, Michael, Pilorge, Sylvain, Teal, Valerie L., Haber, Barbara A., Bopp, Charlene, and Badshah, Cyrus

Published
2023
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15. A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation

Author

Ljungman, Per, primary, Schmitt, Michael, primary, Marty, Francisco M, primary, Maertens, Johan, primary, Chemaly, Roy F, primary, Kartsonis, Nicholas A, primary, Butterton, Joan R, primary, Wan, Hong, primary, Teal, Valerie L, primary, Sarratt, Kendra, primary, Murata, Yoshihiko, primary, Leavitt, Randi Y, primary, and Badshah, Cyrus, primary

Published
2019
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16. A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation.

Author

Ljungman, Per, Schmitt, Michael, Marty, Francisco M, Maertens, Johan, Chemaly, Roy F, Kartsonis, Nicholas A, Butterton, Joan R, Wan, Hong, Teal, Valerie L, Sarratt, Kendra, Murata, Yoshihiko, Leavitt, Randi Y, and Badshah, Cyrus

Subjects
ANTIVIRAL agents, CYTOMEGALOVIRUS diseases, HEMATOPOIETIC stem cell transplantation, RISK assessment, STATISTICAL sampling, STATISTICS, TRANSPLANTATION of organs, tissues, etc., DATA analysis, RANDOMIZED controlled trials, TREATMENT effectiveness, DISEASE incidence, PROPORTIONAL hazards models, DESCRIPTIVE statistics, KAPLAN-Meier estimator, PHARMACODYNAMICS
Abstract

Background In a phase 3 trial, letermovir reduced clinically significant cytomegalovirus infections (CS-CMVi) and all-cause mortality at week 24 versus placebo in CMV-seropositive allogeneic hematopoietic cell transplantation (HCT) recipients. This post hoc analysis of phase 3 data further investigated the effects of letermovir on all-cause mortality. Methods Kaplan-Meier survival curves were generated by treatment group for all-cause mortality. Observations were censored at trial discontinuation for reasons other than death or at trial completion. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox modeling, adjusting for risk factors associated with mortality. Results Of 495 patients with no detectable CMV DNA at randomization, 437 had vital-status data available through week 48 post-HCT at trial completion (101 deaths, 20.4%). Following letermovir prophylaxis, the HR for all-cause mortality was 0.58 (95% CI, 0.35–0.98; P =.04) at week 24 and 0.74 (95% CI, 0.49–1.11; P =.14) at week 48 post-HCT versus placebo. Incidence of all-cause mortality through week 48 post-HCT in the letermovir group was similar in patients with or without CS-CMVi (15.8 vs 19.4%; P =.71). However, in the placebo group, all-cause mortality at week 48 post-HCT was higher in patients with versus those without CS-CMVi (31.0% vs 18.2%; P =.02). The HR for all-cause mortality in patients with CS-CMVi was 0.45 (95% CI, 0.21–1.00; P =.05) at week 48 for letermovir versus placebo. Conclusions Letermovir may reduce mortality by preventing or delaying CS-CMVi in HCT recipients. Clinical Trials Registration clinicaltrials.gov, NCT02137772. [ABSTRACT FROM AUTHOR]

Published
2020
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17. 1730. Outcomes of Patients With Detectable Cytomegalovirus (CMV) DNA at Randomization in the Double-blind, Placebo-Controlled Phase 3 Trial of Letermovir (LET) Prophylaxis for CMV-Seropositive Allogeneic Hematopoietic-Cell Transplantation (HCT) Recipients

Author

Marty, Francisco M, primary, Ljungman, Per, additional, Chemaly, Roy F, additional, Wan, Hong, additional, Teal, Valerie L, additional, Butterton, Joan, additional, Yeh, Wendy W, additional, Leavitt, Randi Y, additional, and Badshah, Cyrus, additional

Published
2018
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18. A Mortality Analysis of the Cytomegalovirus (CMV) Infection Letermovir Prophylaxis Trial in CMV-Seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation (HCT)

Author

Maertens, Johan, primary, Schmitt, Michael, additional, Marty, Francisco M, additional, Ljungman, Per, additional, Chemaly, Roy F, additional, Kartsonis, Nicholas A, additional, Butterton, Joan, additional, Wan, Hong, additional, Teal, Valerie L, additional, Sarratt, Kendra, additional, Murata, Yoshihiko, additional, Leavitt, Randi Y, additional, and Badshah, Cyrus, additional

Published
2017
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20. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients A Randomized Clinical Trial

Author

Limaye, Ajit P, Budde, Klemens, Humar, Atul, Vincenti, Flavio, Kuypers, Dirk RJ, Carroll, Robert P, Stauffer, Nicole, Murata, Yoshihiko, Strizki, Julie M, Teal, Valerie L, Gilbert, Christopher L, and Haber, Barbara A

Subjects
kidney transplant, prohpylaxis, valganciclovir, cytomegalovirus, letermovir
Abstract

Importance: Valganciclovir for 200 days is standard care for cytomegalovirus (CMV) prophylaxis in high-risk CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor, but its use is limited by myelosuppression. Objective: To compare the efficacy and safety of letermovir with valganciclovir for prevention of CMV disease in CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor. Design, Setting, and Participants: Randomized, double-masked, double-dummy, noninferiority, phase 3 trial in adult CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor at 94 participating sites between May 2018 and April 2021 (final follow-up in April 2022). Interventions: Participants were randomized in a 1:1 ratio (stratified by receipt of lymphocyte-depleting induction immunosuppression) to receive letermovir, 480 mg, orally daily (with acyclovir) or valganciclovir, 900 mg, orally daily (adjusted for kidney function) for up to 200 days after transplant, with matching placebos. Main Outcomes and Measures: The primary outcome was CMV disease, confirmed by an independent masked adjudication committee, through posttransplant week 52 (prespecified noninferiority margin, 10%). CMV disease through week 28 and time to onset of CMV disease through week 52 were secondary outcomes. Exploratory outcomes included quantifiable CMV DNAemia and resistance. The rate of leukopenia or neutropenia through week 28 was a prespecified safety outcome. Results: Among 601 participants randomized, 589 received at least 1 dose of the study drug (mean age, 49.6 years; 422 [71.6%] men). Letermovir (n = 289) was noninferior to valganciclovir (n = 297) for prevention of CMV disease through week 52 (10.4% vs 11.8% of participants with committee-confirmed CMV disease; stratum-adjusted difference −1.4% [95% CI, −6.5% to 3.8%]). No participants who received letermovir vs 5 participants (1.7%) who received valganciclovir developed CMV disease through week 28. Time to onset of CMV disease was comparable between the groups (hazard ratio, 0.90 [95% CI, 0.56-1.47]). Quantifiable CMV DNAemia was detected in 2.1% of participants in the letermovir group vs 8.8% in the valganciclovir group by week 28. Of participants evaluated for suspected CMV disease or CMV DNAemia, none (0/52) who received letermovir and 12.1% (8/66) who received valganciclovir had resistance-associated substitutions. The rate of leukopenia or neutropenia through week 28 was lower with letermovir vs valganciclovir (26% vs 64%; difference, −37.9% [95% CI, −45.1% to −30.3%]; P

Published
2023

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