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Study results in adult hematopoietic stem cell transplantation (HSCT) patients

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Prophylaxis through Week 14 (~100 days) post-HSCT in adults

Clinically significant CMV infection through Week 24 (~168 days) in adult HSCT patients

PREVYMIS® (letermovir) demonstrated significant efficacy vs placebo in the primary endpoint: Clinically significant CMV infectiona through Week 24 (NC=F approach)b

ParameterPREVYMIS
(n=325)		Placebo
(n=170)
Proportion of subjects who failed prophylaxis
38%
61%
Treatment difference for PREVYMIS vs placebo (95% CI)-23.5 (-32.5, -14.6)
P <0.0001
Reasons for failuresc
Clinically significant CMV infection by Week 24d18%42%
Initiation of PET based on documented CMV viremia16%40%
CMV end-organ disease2%2%
Discontinued study before Week 24e17%16%
Missing outcome in Week 24 visit window3%3%

(a) Clinically significant CMV infection was defined as either the occurrence of CMV end-organ disease or initiation of anti-CMV PET, based on documented CMV viremia and the clinical condition of the patient. Viremia was determined using the Roche COBAS® AmpliPrep/COBAS TaqMan® assay; lower limit of quantification was 137 IU/mL, which is approximately 150 copies/mL.
(b) The Noncompleter=Failure (NC=F) approach was used in which patients who discontinued from the study prior to Week 24 post-HSCT or had a missing outcome at Week 24 post-HSCT were counted as failures.
(c) The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
(d) Through Week 14, 8% of subjects in the PREVYMIS group and 39% of subjects in the placebo group experienced clinically significant CMV infection.
(e) Reasons for discontinuation included adverse event (AE), death, lost to follow-up, physician decision, and withdrawal by subject.

Rate of clinically significant CMV infection in adults

Significantly lower rate of onset of clinically significant CMV infection for PREVYMIS vs placebo1

This Kaplan-Meier plot shows the Rate of Onset of Clinically Significant CMV Infection Through Week 24 Post-Transplant in adult HSCT Recipients. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the Follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, and 24 weeks. On the Y-axis is the cumulative rate of clinically significant CMV infection, in percentages, from 0 percent to 60%. The number of patients at risk at baseline and at Weeks 14 and 24 are listed below the plot (PREVYMIS: 325 baseline, 270 at Week 14, 212 at Week 24; Placebo: 170 baseline, 85 at Week 14, 70 at Week 24). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The placebo group’s cumulative rate of clinically significant CMV infection was 41.3% at Week 14 and 44.3% at Week 24. The PREVYMIS group's cumulative rate of clinically significant CMV infection was 6.8% at Week 14 and 18.9% at Week 24. The difference was statistically significant (P < 0.0001).
This Kaplan-Meier plot shows the Rate of Onset of Clinically Significant CMV Infection Through Week 24 Post-Transplant in adult HSCT Recipients. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the Follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, and 24 weeks. On the Y-axis is the cumulative rate of clinically significant CMV infection, in percentages, from 0 percent to 60%. The number of patients at risk at baseline and at Weeks 14 and 24 are listed below the plot (PREVYMIS: 325 baseline, 270 at Week 14, 212 at Week 24; Placebo: 170 baseline, 85 at Week 14, 70 at Week 24). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The placebo group’s cumulative rate of clinically significant CMV infection was 41.3% at Week 14 and 44.3% at Week 24. The PREVYMIS group's cumulative rate of clinically significant CMV infection was 6.8% at Week 14 and 18.9% at Week 24. The difference was statistically significant (P < 0.0001).
This Kaplan-Meier plot shows the Rate of Onset of Clinically Significant CMV Infection Through Week 24 Post-Transplant in adult HSCT Recipients. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the Follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, and 24 weeks. On the Y-axis is the cumulative rate of clinically significant CMV infection, in percentages, from 0 percent to 60%. The number of patients at risk at baseline and at Weeks 14 and 24 are listed below the plot (PREVYMIS: 325 baseline, 270 at Week 14, 212 at Week 24; Placebo: 170 baseline, 85 at Week 14, 70 at Week 24). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The placebo group’s cumulative rate of clinically significant CMV infection was 41.3% at Week 14 and 44.3% at Week 24. The PREVYMIS group's cumulative rate of clinically significant CMV infection was 6.8% at Week 14 and 18.9% at Week 24. The difference was statistically significant (P < 0.0001).

From The New England Journal of Medicine, Marty, Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation, Volume No. 377, Page No. 8, Figure No. 2. Copyright © 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

Factors associated with clinically significant CMV infection between Week 14 and Week 24 post-HSCT among adult PREVYMIS patients included:

  • High-risk stratum for CMV reactivation at baseline
  • Having GVHD
  • Steroid use at any time after randomization

Mortality analysis in HSCT

Lower all-cause mortality for PREVYMIS vs placebo in adult HSCT patients2-4 a,b

This Kaplan-Meier plot shows the analysis on the cumulative rate of all-cause mortality in adult CMV-seropositive Recipients [R+] of an Allogeneic Hematopoietic Stem Cell Transplant on the P001 population. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, 24 and 48 weeks. On the Y-axis is cumulative all-cause mortality, in percentages, from 0% to 40%. The number of patients at risk at baseline and at Weeks 24 and 48 are listed below the plot (PREVYMIS: 325 at baseline, 282 at Week 24, 165 at Week 48; Placebo: 170 at baseline, 139 at Week 24, 81 at Week 28). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The on-treatment phase runs from 0 to 14 weeks; the follow-up phase starts at Week 14. At Week 24, cumulative mortality is 12% for PREVYMIS and 17% for placebo; and at Week 48 it is 24% for PREVYMIS and 28% for placebo.
This Kaplan-Meier plot shows the analysis on the cumulative rate of all-cause mortality in adult CMV-seropositive Recipients [R+] of an Allogeneic Hematopoietic Stem Cell Transplant on the P001 population. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, 24 and 48 weeks. On the Y-axis is cumulative all-cause mortality, in percentages, from 0% to 40%. The number of patients at risk at baseline and at Weeks 24 and 48 are listed below the plot (PREVYMIS: 325 at baseline, 282 at Week 24, 165 at Week 48; Placebo: 170 at baseline, 139 at Week 24, 81 at Week 28). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The on-treatment phase runs from 0 to 14 weeks; the follow-up phase starts at Week 14. At Week 24, cumulative mortality is 12% for PREVYMIS and 17% for placebo; and at Week 48 it is 24% for PREVYMIS and 28% for placebo.
This Kaplan-Meier plot shows the analysis on the cumulative rate of all-cause mortality in adult CMV-seropositive Recipients [R+] of an Allogeneic Hematopoietic Stem Cell Transplant on the P001 population. The plot is divided into two sections, the On-treatment phase which was week 0-14 on the left, and the follow-up phase on the right. Time is on the X-axis as weeks post-transplant with markers at 0, 14, 24 and 48 weeks. On the Y-axis is cumulative all-cause mortality, in percentages, from 0% to 40%. The number of patients at risk at baseline and at Weeks 24 and 48 are listed below the plot (PREVYMIS: 325 at baseline, 282 at Week 24, 165 at Week 48; Placebo: 170 at baseline, 139 at Week 24, 81 at Week 28). The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. The on-treatment phase runs from 0 to 14 weeks; the follow-up phase starts at Week 14. At Week 24, cumulative mortality is 12% for PREVYMIS and 17% for placebo; and at Week 48 it is 24% for PREVYMIS and 28% for placebo.

Per Ljungman, Michael Schmitt, Francisco M Marty, Johan Maertens, Roy F Chemaly, Nicholas A Kartsonis, Joan R Butterton, Hong Wan, Valerie L Teal, Kendra Sarratt, Yoshihiko Murata, Randi Y Leavitt, Cyrus Badshah, A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation, Clinical Infectious Diseases, Volume 70, Issue 8, 15 April 2020, Pages 1525–1533, https://doi.org/10.1093/cid/ciz490

(a) Data through week 24 post-HSCT P=0.04.
(b) Data through week 48 post-HSCT P=0.21, not significant.

High- and low-risk strata

Efficacy results were consistent across high- and low-risk strata for CMV reactivation in adult patients.

Two separate graphs about the cumulative rate of infection post-HSCT are shown side-by-side comparing the different high and low risk strata for CMV reactivation on adult patients. The chart on the left shows the high risk group which was R+ with additional risk factors at baseline and the chart on the right shows the low risk group which was R+ with no additional risk factors at baseline. Time is on the X-axis for each graph as weeks post-transplant with markers at 0, 2, 6, 10, 14, 18, and 24 weeks. On the Y-axis for each graph is cumulative rate of infection, in percentages, from 0% to 100%. The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. In the left chart showing high risk R+ with additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 102 at baseline, 100 at Week 2, 90 at Week 6, 85 at Week 10, 82 at Week 14, 78 at Week 18 and 61 at Week 24; Placebo: 45 at baseline, 44 at Week 2, 25 at Week 6, 18 at Week 10, 15 at Week 14, 13 at Week 18 and 13 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 50% mark between 6 and 10 weeks before leveling off between 50% and 60% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about the 20% and 30% mark. In the right chart showing low risk R+ with no additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 223 at baseline, 220 at Week 2, 209 at Week 6, 194 at Week 10, 188 at Week 14, 176 at Week 18 and 151 at Week 24; Placebo: 125 at baseline, 125 at Week 2, 110 at Week 6, 78 at Week 10, 70 at Week 14, 64 at Week 18 and 57 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 30% mark between 6 and 10 weeks before reaching between about 30% and 40% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about 10% and 20%.
Two separate graphs about the cumulative rate of infection post-HSCT are shown side-by-side comparing the different high and low risk strata for CMV reactivation on adult patients. The chart on the left shows the high risk group which was R+ with additional risk factors at baseline and the chart on the right shows the low risk group which was R+ with no additional risk factors at baseline. Time is on the X-axis for each graph as weeks post-transplant with markers at 0, 2, 6, 10, 14, 18, and 24 weeks. On the Y-axis for each graph is cumulative rate of infection, in percentages, from 0% to 100%. The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. In the left chart showing high risk R+ with additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 102 at baseline, 100 at Week 2, 90 at Week 6, 85 at Week 10, 82 at Week 14, 78 at Week 18 and 61 at Week 24; Placebo: 45 at baseline, 44 at Week 2, 25 at Week 6, 18 at Week 10, 15 at Week 14, 13 at Week 18 and 13 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 50% mark between 6 and 10 weeks before leveling off between 50% and 60% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about the 20% and 30% mark. In the right chart showing low risk R+ with no additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 223 at baseline, 220 at Week 2, 209 at Week 6, 194 at Week 10, 188 at Week 14, 176 at Week 18 and 151 at Week 24; Placebo: 125 at baseline, 125 at Week 2, 110 at Week 6, 78 at Week 10, 70 at Week 14, 64 at Week 18 and 57 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 30% mark between 6 and 10 weeks before reaching between about 30% and 40% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about 10% and 20%.
Two separate graphs about the cumulative rate of infection post-HSCT are shown side-by-side comparing the different high and low risk strata for CMV reactivation on adult patients. The chart on the left shows the high risk group which was R+ with additional risk factors at baseline and the chart on the right shows the low risk group which was R+ with no additional risk factors at baseline. Time is on the X-axis for each graph as weeks post-transplant with markers at 0, 2, 6, 10, 14, 18, and 24 weeks. On the Y-axis for each graph is cumulative rate of infection, in percentages, from 0% to 100%. The line for the PREVYMIS group is solid purple, and the line for the Placebo group is a gray dashed line. In the left chart showing high risk R+ with additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 102 at baseline, 100 at Week 2, 90 at Week 6, 85 at Week 10, 82 at Week 14, 78 at Week 18 and 61 at Week 24; Placebo: 45 at baseline, 44 at Week 2, 25 at Week 6, 18 at Week 10, 15 at Week 14, 13 at Week 18 and 13 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 50% mark between 6 and 10 weeks before leveling off between 50% and 60% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about the 20% and 30% mark. In the right chart showing low risk R+ with no additional risk factors at baseline, the number of patients at risk at baseline and at Weeks 2, 6, 10, 14, 18 and 24 are listed below the plot (PREVYMIS: 223 at baseline, 220 at Week 2, 209 at Week 6, 194 at Week 10, 188 at Week 14, 176 at Week 18 and 151 at Week 24; Placebo: 125 at baseline, 125 at Week 2, 110 at Week 6, 78 at Week 10, 70 at Week 14, 64 at Week 18 and 57 at Week 24). Between Weeks 2 and 6, the purple and gray lines begin to separate and the gray line reaches around the 30% mark between 6 and 10 weeks before reaching between about 30% and 40% through Week 24. The purple line reaches around 10% before 18 Weeks; between 18 and 24 weeks the purple line reaches between about 10% and 20%.

From New England Journal of Medicine, Marty, Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation, Volume No. 377;25, Page No. 8 Copyright © (2017) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.4

Overview of CMV-seropositive recipients [R+] status and additional risk factors at baseline

This is a pie chart that shows the percentage of CMV-seropositive recipients that had either no additional risk factors at baseline or had additional risk factors at baseline. Baseline data were collected at randomization in the trial that evaluated PREVYMIS Prophylaxis Through Week 14 Post-HSCT (Trial P001). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 70% of the pie chart and shows that 70% of the CMV R+ patients did not have additional risk factors at baseline. The striped section is 30% of the pie chart and shows that 30% of CMV R+ patients had additional risk factors.
This is a pie chart that shows the percentage of CMV-seropositive recipients that had either no additional risk factors at baseline or had additional risk factors at baseline. Baseline data were collected at randomization in the trial that evaluated PREVYMIS Prophylaxis Through Week 14 Post-HSCT (Trial P001). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 70% of the pie chart and shows that 70% of the CMV R+ patients did not have additional risk factors at baseline. The striped section is 30% of the pie chart and shows that 30% of CMV R+ patients had additional risk factors.
This is a pie chart that shows the percentage of CMV-seropositive recipients that had either no additional risk factors at baseline or had additional risk factors at baseline. Baseline data were collected at randomization in the trial that evaluated PREVYMIS Prophylaxis Through Week 14 Post-HSCT (Trial P001). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 70% of the pie chart and shows that 70% of the CMV R+ patients did not have additional risk factors at baseline. The striped section is 30% of the pie chart and shows that 30% of CMV R+ patients had additional risk factors.

Baseline data collected at randomization in the phase 3 trial.

The majority of patients in the phase 3 trial in adults were R+ with no additional risk factors at baseline. Thirty percent of patients were R+ with ≥1 of the following additional risk factors and were placed in the high-risk stratum:

  • Related donor with human leukocyte antigen (HLA) mismatch
  • Haploidentical donor
  • Unrelated donor with HLA mismatch
  • Use of umbilical cord blood
  • Use of ex vivo T-cell–depleted grafts
  • GVHD requiring systemic corticosteroids
See study design

Prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in adults

PREVYMIS® (letermovir) demonstrated significant efficacy vs placebo

Primary endpoint: Clinically significant CMV infectiona through Week 28 post-HSCT (OF approachb)

Eligible subjects who completed PREVYMIS prophylaxis through ~100 days post-HSCT were randomized to receive PREVYMIS or placebo from Week 14 through Week 28 post-HSCT

Efficacy results in HSCT recipients at risk for late CMV infection and disease

ParameterPREVYMIS
(~200 days PREVYMIS) (n=144)		Placebo
(~100 days PREVYMIS) (n=74)
Failuresc2.8%18.9%
Clinically significant CMV infection from Week 14 through Week 28d1.4%17.6%
Initiation of PET based on documented CMV viremia0.7%14.9%
CMV end-organ disease0.7%2.7%
Discontinued from study with CMV viremia before Week 281.4%1.4%
Stratum-adjusted treatment difference (PREVYMIS (~200 days PREVYMIS)-Placebo (~100 days PREVYMIS))-16.1 (-25.8, -6.5)
(P=0.0005)
Difference (95% CI)

(a) Clinically significant CMV infection (csCMVi) was defined as the occurrence of either CMV end-organ disease or initiation of anti-CMV PET based on documented CMV viremia and the clinical condition of the subject.
(b) The Observed Failure (OF) approach was used, where subjects who discontinued prematurely from the study without viremia or were missing data at the timepoint were not counted as failures. The number of subjects who discontinued from the study before Week 28 without viremia was 14 (9.7%) in the PREVYMIS arm and 0 in the placebo arm. The number of subjects with a missing outcome in the Week 28 visit window was 3 (2.1%) in the PREVYMIS arm and 4 (5.4%) in the placebo arm, none had prior viremia.
(c) The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
(d) Clinically significant CMV infection was defined as CMV end-organ disease (proven or probable) or initiation of PET based on documented CMV viremia and the clinical condition of the subject.

Among subjects in the PREVYMIS group, the cumulative rate of clinically significant CMV infection increased from 1.6% at the end of prophylaxis (Week 28) to 15.6% at Week 38. In the placebo group, the cumulative rate of clinically significant CMV infection increased from 17.6% at Week 28 to 19.0% at Week 38. There were no additional cases of clinically significant CMV infection in either group between Weeks 38 and 48.

Risk factors for late CMV infection and disease

This is a pie chart that shows the percentage of risk factors for late CMV infection and disease in CMV-seropositive recipients that had either 2 or more risk factors at baseline or had one additional risk factor at baseline in the trial that evaluated PREVYMIS prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT (Trial P040). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 64% of the pie chart and shows that 64% of the CMV R+ patients had 2 or more additional risk factors. The striped section is 36% of the pie chart and shows that 36% of CMV R+ patients had 1 additional risk factor.
This is a pie chart that shows the percentage of risk factors for late CMV infection and disease in CMV-seropositive recipients that had either 2 or more risk factors at baseline or had one additional risk factor at baseline in the trial that evaluated PREVYMIS prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT (Trial P040). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 64% of the pie chart and shows that 64% of the CMV R+ patients had 2 or more additional risk factors. The striped section is 36% of the pie chart and shows that 36% of CMV R+ patients had 1 additional risk factor.
This is a pie chart that shows the percentage of risk factors for late CMV infection and disease in CMV-seropositive recipients that had either 2 or more risk factors at baseline or had one additional risk factor at baseline in the trial that evaluated PREVYMIS prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT (Trial P040). The pie chart is divided into two color coded sections. One section is solid purple and the other section is striped. The solid purple section is 64% of the pie chart and shows that 64% of the CMV R+ patients had 2 or more additional risk factors. The striped section is 36% of the pie chart and shows that 36% of CMV R+ patients had 1 additional risk factor.

At study entry, all subjects had risk factors for late CMV infection and disease, with 64% having two or more risk factors. The risk factors included:

  • HLA-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR
  • Haploidentical donor
  • Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
  • Use of umbilical cord blood as stem cell source
  • Use of ex vivo T-cell-depleted grafts
  • Receipt of anti-thymocyte globulin
  • Receipt of alemtuzumab
  • Use of systemic prednisone (or equivalent) at a dose of ≥1 mg/kg of body weight per day
See study design

References

  1. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. N Engl J Med. 2017;377(25):2433–2444. doi:10.1056/NEJMoa1706640
  2. Ljungman P, Schmitt M, Marty FM, et al. A mortality analysis of letermovir prophylaxis for cytomegalovirus (CMV) in CMV seropositive recipients of allogeneic hematopoietic cell transplantation. Clin Infect Dis. 2020;70(8):1525-1533. Accessed July 24, 2025. https://pmc.ncbi.nlm.nih.gov/articles/instance/7146004/bin/ciz490_suppl_supplementary_figure_1.pdf
  3. Ljungman P, Schmitt M, Marty FM, et al. A mortality analysis of letermovir prophylaxis for cytomegalovirus (CMV) in CMV seropositive recipients of allogeneic hematopoietic cell transplantation. Clin Infect Dis. 2020;70(8):1525-1533. Accessed July 24, 2025. https://pmc.ncbi.nlm.nih.gov/articles/instance/7146004/bin/ciz490_suppl_supplementary_figure_2.pdf
  4. Ljungman P, Schmitt M, Marty FM, et al. A mortality analysis of letermovir prophylaxis for cytomegalovirus (CMV) in CMV seropositive recipients of allogeneic hematopoietic cell transplantation. Clin Infect Dis. 2020;70(8):1525-1533. doi:10.1093/cid/ciz490

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INDICATIONS

PREVYMIS® (letermovir) is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

 

PREVYMIS is indicated for prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

SELECTED SAFETY INFORMATION

  • PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids.
      • Increased pimozide concentrations may lead to QT prolongation and torsades de pointes.
      • Increased ergot alkaloids concentrations may lead to ergotism.
  • PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.
  • The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.
  • Intravenous formulation of PREVYMIS contains the excipient hydroxypropyl betadex. PREVYMIS injection should be used only in patients unable to take oral therapy and patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. If possible, intravenous administration should not exceed 4 weeks.
  • In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, closely monitor serum creatinine levels.
  • Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity. The active ingredient, letermovir, is not known to be associated with ototoxicity.
  • The rate of adverse events occurring in at least 10% of adult HSCT recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).
  • Hypersensitivity reaction, with associated moderate dyspnea, occurred in one adult HSCT recipient following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.
  • The most common adverse event occurring in at least 10% of adult kidney transplant recipients treated with PREVYMIS and at a frequency greater than valganciclovir was diarrhea (32% vs 29%).
  • The safety profile of PREVYMIS in pediatric subjects was consistent with the safety profile observed in clinical trials of PREVYMIS in adults.
  • If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.
  • If PREVYMIS is co-administered with cyclosporine in pediatric HSCT patients less than 12 years of age, dose adjustment may be required.
  • Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions.
  • Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection.
  • PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.
  • The safety and effectiveness of PREVYMIS have not been established for:
      • HSCT recipients less than 6 months of age or weighing less than 6 kg, or
      • Kidney transplant recipients less than 12 years of age or weighing less than 40 kg.
  • For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.

Before prescribing PREVYMIS® (letermovir), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.

INDICATIONS
SELECTED SAFETY INFORMATION

PREVYMIS® (letermovir) is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

 

PREVYMIS is indicated for prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

SELECTED SAFETY INFORMATION

  • PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids.
      • Increased pimozide concentrations may lead to QT prolongation and torsades de pointes.
      • Increased ergot alkaloids concentrations may lead to ergotism.
  • PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.
  • The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.
  • Intravenous formulation of PREVYMIS contains the excipient hydroxypropyl betadex. PREVYMIS injection should be used only in patients unable to take oral therapy and patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. If possible, intravenous administration should not exceed 4 weeks.
  • In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, closely monitor serum creatinine levels.
  • Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity. The active ingredient, letermovir, is not known to be associated with ototoxicity.
  • The rate of adverse events occurring in at least 10% of adult HSCT recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).
  • Hypersensitivity reaction, with associated moderate dyspnea, occurred in one adult HSCT recipient following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.
  • The most common adverse event occurring in at least 10% of adult kidney transplant recipients treated with PREVYMIS and at a frequency greater than valganciclovir was diarrhea (32% vs 29%).
  • The safety profile of PREVYMIS in pediatric subjects was consistent with the safety profile observed in clinical trials of PREVYMIS in adults.
  • If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.
  • If PREVYMIS is co-administered with cyclosporine in pediatric HSCT patients less than 12 years of age, dose adjustment may be required.
  • Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions.
  • Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection.
  • PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.
  • The safety and effectiveness of PREVYMIS have not been established for:
      • HSCT recipients less than 6 months of age or weighing less than 6 kg, or
      • Kidney transplant recipients less than 12 years of age or weighing less than 40 kg.
  • For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.

Before prescribing PREVYMIS® (letermovir), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.