Drug updated on 4/17/2024
| Dosage Form | Capsule (oral: 200 mg) |
| Drug Class | SARS-CoV-2 nucleoside analogue |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adults with a current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19) who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Summary
- Molnupiravir (Lagevrio) functions by increasing the viral genome's error rate during RNA replication, significantly affecting SARS-CoV-2's ability to replicate effectively. It has been found effective in reducing SARS-CoV-2 RNA viral load and decreasing the incidence of death among non-hospitalized patients with COVID-19.
- These studies primarily focused on non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease.
- When compared to nirmatrelvir/ritonavir (Paxlovid), molnupiravir showed inferior outcomes in terms of all-cause mortality, hospitalization rates, and time to PCR negativity, especially during the prevalence of the Omicron variant. However, it was associated with fewer adverse events than nirmatrelvir/ritonavir.
- Molnupiravir is generally well-tolerated across different dosages including 200mg, 400mg, and 800mg without a significant increase in adverse events when compared to placebo. Common side effects reported include nausea, diarrhea, and headaches indicating its safety for short-term use.
- In terms of subgroup considerations, molnupiravir appears most beneficial for non-hospitalized patients with mild-to-moderate COVID-19 as it likely reduces the risk of hospital admission while accelerating time towards viral clearance and symptom resolution. For hospitalized patients, however, the drug may not improve clinical outcomes significantly or could potentially increase mortality, suggesting that it is less appropriate for severe cases or later stages of the disease.
- The role played by Molnupiravir is pivotal within the demographic consisting mainly of those who are not hospitalized as there seems to be a reduction in both mortality rates as well as hospital admissions. However, its benefits appear restricted when compared to other therapies like Nirmatrelvir/Ritonavir which showed greater efficacy in similar patient populations. Despite this, Molnupiravir's safety profile remains a significant advantage as it does not significantly increase the risk of serious adverse events.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lagevrio (molnupiravir) Prescribing Information. | 2023 | Merck Sharp & Dohme LLC., Rahway, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Pan-American Guidelines for the treatment of SARS-CoV-2/COVID-19: a joint evidence-based guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API). | 2023 | Annals of Clinical Microbiology and Antimicrobials |
| Japanese rapid/living recommendations on drug management for COVID-19: updated guidelines (July 2022) | 2022 | Acute Medicine and Surgery |
| A living WHO guideline on drugs for covid-19. | 2020 | WHO |