Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 240 mg, 480 mg), Injection (intravenous; 240 mg/12 mL, 480 mg/24 mL) |
| Drug Class | CMV DNA terminase complex inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- Indicated for prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
Latest News
Summary
- Prevymis (letermovir) is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT), and for prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Clinically Significant CMV Infection (csCMVi): Letermovir (LET) reduced the risk of csCMVi in adult allogeneic hematopoietic stem cell transplant (allo-HCT) patients compared to placebo and preemptive therapy (PET), as indicated by both randomized trials and observational studies.
- CMV Reactivation and Disease: LET primary prophylaxis significantly decreased the odds of CMV reactivation with pooled odds ratios (pOR) of 0.13 by day +100 and 0.24 by day +200. Additionally, LET reduced the odds of CMV disease, with pORs of 0.31 by day +100 and 0.35 by day +200, all statistically significant (P<.05).
- Mortality: LET primary prophylaxis was associated with a reduction in all-cause mortality (pOR, 0.73; P<.01) and non-relapse mortality (pOR, 0.65; P=.01) beyond day 200 post-allo-HCT.
- There is no safety information available in the reviewed studies.
- There is no population or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prevymis (letermovir) Prescribing Information. | 2022 | Merck Sharp & Dohme LLC, Rahway, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effectiveness of letermovir for cytomegalovirus prophylaxis in allogeneic hematopoietic stem cell transplant recipients: A global systematic review. | 2023 | Journal of the American Pharmacists Association |
| Real-world outcomes associated with letermovir use for cytomegalovirus primary prophylaxis in allogeneic hematopoietic cell transplant recipients: a systematic review and meta-analysis of observational studies. | 2022 | Open Forum Infectious Diseases |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Cytomegalovirus in solid organ transplant recipients— Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. | 2019 | Clinical Transplantation |
| Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL 7). | 2019 | The Lancet Infectious Diseases |
| Letermovir for preventing cytomegalovirus disease after a stem cell transplant. | 2019 | National Institute for Health and Care Excellence |