Frequently Asked Questions about PREVYMIS™ (letermovir)
For answers to questions you may have, select any of the topics below. To see a complete list of Q&As, scroll down.
PREVYMIS™
(letermovir) 240 mg, 480 mg tablets; Injection 20 mg/mL
For answers to questions you may have, select any of the topics below. To see a complete list of Q&As, scroll down.
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.
Drug interactions may occur based on results from studies. Drug interactions may also occur based on predicted interactions. Potentially significant drug interactions include, but are not limited to, the following (information below applies to co-administration of PREVYMIS and the concomitant drug without cyclosporine, unless otherwise indicated):
PREVYMIS is an antiviral approved for CMV prophylaxis in adult CMV-seropositive recipients of allogeneic HSCT. A novel CMV DNA terminase complex inhibitor, PREVYMIS targets a component of the terminase complex involved in viral DNA cleavage and packaging, restricting drug activity to the virus alone.1
Reference
1. Griffiths PD, Emery VC. Taming the transplantation troll by targeting terminase. N Engl J Med. 2014;370(19):1844–1846.
Yes. The Merck Access Program for PREVYMIS may be able to help answer questions about insurance coverage for patients, benefit investigations, and the prior authorization and appeals process.
Yes. Eligible privately insured patients may pay as little as $15 per prescription on each of up to 4 qualifying prescriptions for up to a one-month's supply per prescription. Maximum savings is $2,500 per prescription.
Your patients can visit PREVYMIS.com to request a coupon, and if eligible, activate and bring to their pharmacy along with their prescription.
Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Tell your eligible, privately insured patients to visit PREVYMIS.com to review the Terms and Conditions.
Also, eligible health care professionals may request coupons for PREVYMIS for use with their appropriate patients.
Yes. HSCT patients are at increased risk for CMV infection, disease, and associated mortality.1–4
Positive CMV serostatus pre-HSCT is a strong predictor of CMV infection and disease.1,2
Any level of CMV viremia is associated with an increased risk of mortality in R+ allogeneic HSCT patients in the first year post-HSCT.4,a
(a) Results from a large, retrospective, noninterventional cohort study of previously collected CMV viral load and clinical outcome measures (N=926).4
View Clinical Data page for more information
1. George B, Pati N, Gilroy N, et al. Pre-transplant cytomegalovirus (CMV) serostatus remains the most important determinant of CMV reactivation after allogeneic hematopoietic stem cell transplantation in the era of surveillance and preemptive therapy. Transpl Infect Dis. 2010;12(4):322–329.
2. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant recipients. Hematol Oncol Clin North Am. 2011;25(1):151–169.
3. Sousa H, Boutolleau D, Ribeiro J, et al. Cytomegalovirus infection in patients who underwent allogeneic hematopoietic stem cell transplantation in Portugal: a five-year retrospective review. Biol Blood Marrow Transplant. 2014;20(12):1958–1967.
4. Green ML, Leisenring W, Xie H, et al. Cytomegalovirus viral load and mortality after haematopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective cohort study. Lancet Haematol. 2016;3(3):e119–e127.
5. Teira P, Battiwalla M, Ramanathan M, et al. Early cytomegalovirus reactivation remains associated with increased transplant-related mortality in the current era: a CIBMTR analysis. Blood. 2016; 127(20)2427-2438. doi:10.1182/blood-2015-11-679639
Yes. PREVYMIS demonstrated significant efficacy vs placebo in the primary endpoint: Clinically significant CMV infectiona at week 24 (NC=F approach)b. See full clinical data and end points at the link below.
View study data on the efficacy of PREVYMIS
(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-transplant or had a missing outcome at week 24 post-transplant were counted as failures.
The cardiac AE rate (regardless of investigator-assessed causality) was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%). The most common cardiac AEs were tachycardia (reported in 4% of PREVYMIS subjects and in 2% of placebo subjects) and atrial fibrillation (reported in 3% of PREVYMIS subjects and in 1% of placebo subjects). Among those subjects who experienced 1 or more cardiac AEs, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.
All grade AEs reported in ≥10% of patients treated with PREVYMIS at a frequency at least 2% greater than placebo
Drug-related renal and hepatic AEs1
Rates of discontinuation due to AEs were comparable between PREVYMIS and placebo (13% vs 12%, respectively)
1. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-CYT-01149.
2. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. N Engl J Med. 2017;377(25)(suppl):1-54. Accessed June 3, 2022. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1706640/suppl_file/nejmoa1706640_appendix.pdf
Yes. Please see additional professional resources and medical education videos on the Professional Resources page, at the link below. There you can learn and understand about early CMV reactivation, identify appropriate patients for prophylaxis with PREVYMIS, and view clinical data for PREVYMIS.
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Drug interactions may occur based on results from studies. Drug interactions may also occur based on predicted interactions. Potentially significant drug interactions include, but are not limited to, the following (information below applies to co-administration of PREVYMIS and the concomitant drug without cyclosporine, unless otherwise indicated):
Before prescribing PREVYMIS, please read the accompanying Prescribing Information. The Patient Information also is available.