Drug updated on 9/4/2024
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.
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Summary
- Lagevrio (molnupiravir) is indicated 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.
- This summary is based on the review of 10 systematic reviews/meta-analyses. [1-10]
- Molnupiravir significantly improved clinical outcomes and PCR negativity in COVID-19 patients at Day 5 (RR 2.41, 95% CI 1.18-4.92 and RR 2.78, 95% CI 1.38-5.62, respectively) and Day 10 (RR 1.45, 95% CI 1.04-2.01 and RR 1.18, 95% CI 1.07-1.31, respectively).
- Molnupiravir reduced mortality (RR 0.28; 95% CI 0.10-0.79) and hospitalization (RR 0.67; 95% CI 0.45-0.99) among nonhospitalized patients but did not significantly impact all-cause mortality in the overall population (RR 0.43; 95% CI 0.10-1.77).
- Time to viral clearance was reduced by 1.81 days (95% CI -3.31 to -0.31), and time to symptom resolution or clinical improvement was reduced by 2.39 days (95% CI -3.71 to -1.07) in patients treated with molnupiravir.
- Paxlovid showed superior efficacy compared to molnupiravir in reducing mortality (OR 0.54; 95% CI 0.44-0.67), hospitalization (OR 0.61; 95% CI 0.54-0.69), and PCR conversion time (mean difference -1.55 days; 95% CI -1.74 to -1.37).
- There was no significant difference in the occurrence of adverse events (AEs) and serious adverse events (SAEs) between molnupiravir and control groups across multiple studies.
- Common adverse effects included nausea, diarrhea, and headache, with no significant differences in adverse events leading to treatment discontinuation between molnupiravir and placebo groups.
- In a comparison study with nirmatrelvir/ritonavir (Paxlovid), a higher incidence of any adverse events was observed in the Paxlovid group, but no significant difference was noted regarding adverse events leading to treatment discontinuation.
- There is no population types or subgroups information available in the reviewed documents.
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 |