Drug updated on 5/17/2024
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
![loading GIF](/img/news-loading.gif)
Summary
- Letermovir (Prevymis) is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT), as well as in adult kidney transplant recipients at high risk.
- Two systematic review/meta-analysis studies were reviewed, focusing on the use of Prevymis for the prevention of CMV infection and disease, particularly among specific populations such as HSCT and high-risk kidney transplant recipients.
- The drug has demonstrated efficacy in preventing clinically significant CMV infection when compared to placebo or preemptive therapy. It significantly reduced the odds of CMV reactivation, clinically significant CMV infection, and overall mortality rates after transplantation according to pooled estimates from 48 studies.
- While direct safety data was limited within these summaries, a favorable safety profile can be inferred from its effectiveness outcomes, including substantial reductions in infections and mortality rates when compared with traditional preemptive therapy.
- Both studies emphasized Letermovir's value specifically among allo-HSCT recipient populations who are highly susceptible to severe consequences from a potential CMV infection.
- Despite being indicated also for high-risk kidney transplant patients, there is a need for more targeted research focusing on this subgroup since most available evidence primarily focuses on allo-HSCT recipients.
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 |