Drug updated on 3/28/2024
| 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-])
Summary
- Letermovir (Prevymis) is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant, as well as for prophylaxis of CMV disease in adult kidney transplant recipients at high risk.
- Two systematic reviews/meta-analyses were reviewed which provided insights into the effectiveness and safety profile of letermovir compared to other antiviral agents used for similar indications.
- The first review found that letermovir demonstrated efficacy against placebo in phase III randomized controlled trials. It was also observed that all studies with a comparator group resulted in lower rates of clinically significant CMV infection (csCMVi) for patients using letermovir.
- However, it was noted that there are varying degrees of effectiveness when comparing letermovir prophylaxis with preemptive therapy alone. This variation could be due to differences across studies regarding the threshold cutoffs used for determining CMV viral load and test units.
- The second review conducted a meta-analysis on several different antiviral agents including acyclovir, ganciclovir, maribavir, brincidofovir, valacyclovir besides letermovire. In terms of relative efficacy against CMV infection or disease prevention; ganciclovire showed best results while Letermovire ranked first among these drugs respectively.
- Regarding safety considerations from this analysis; both acyclovire and Letermovire had significantly reduced risk profiles compared to Gancicloviere making them safer options according to this study's findings.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prevymis (letermovir) Prescribing Information. | 2022 | Merck & Co. Inc., 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 |
| Letermovir for preventing cytomegalovirus disease after a stem cell transplant. | 2019 | NICE |
| Clinical review report: letermovir (Prevymis). | 2018 | CADTH |
| Comparative efficacy and safety of different antiviral agents for cytomegalovirus prophylaxis in allogeneic hematopoietic cell transplantation: a systematic review and meta-analysis. | 2018 | Biology of Blood and Marrow Transplantation |