Molnupiravir

(Lagevrio®)

Lagevrio®

Drug updated on 5/17/2024

Dosage FormCapsule (oral: 200 mg)
Drug ClassSARS-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
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  • Molnupiravir (Lagevrio) is indicated for the treatment of adults with a current diagnosis of mild-to-moderate COVID-19 who are at risk for progression to severe disease. It effectively reduces viral RNA load and accelerates the clearance of SARS-CoV-2 in non-hospitalized patients, showing a significant reduction in nasopharyngeal viral load.
  • A total of 10 systematic reviews/meta-analyses provided insights into the safety, effectiveness, and comparative analysis of molnupiravir, including considerations for different populations and subgroups.
  • Regarding hospitalization and mortality rates among non-hospitalized, mild-to-moderate COVID-19 patients at risk for progressing to severe disease, molnupiravir has been associated with reductions. However, its impact on mortality is inconsistent across studies.
  • The benefits of molnupiravir are more pronounced in non-hospitalized patients, while a potential increase in mortality is noted in hospitalized patients as suggested by one study.
  • Across dosages ranging from 200 to 800 mg, molnupiravir exhibits no significant increase in adverse events compared to placebo; common side effects include nausea, diarrhea, and headache. Serious adverse events do not significantly differ between those treated with molnupiravir and those receiving placebo, indicating a favorable safety profile.
  • Molnupiravir shows lesser effectiveness than nirmatrelvir/ritonavir (Paxlovid) when it comes to reducing all-cause mortality, hospitalization rates, and time to viral clearance. However, Paxlovid was associated with a higher incidence of adverse events. The role of molnupiravir in vaccinated populations appears limited, requiring further investigation.

Product Monograph / Prescribing Information

Document TitleYearSource
Lagevrio (molnupiravir) Prescribing Information.2023Merck Sharp & Dohme LLC., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Virology and safety profile of Molnupiravir at three different doses for treatment of SARS-CoV-2: a systematic review and meta-analysis. 2024APMIS: Acta Pathologica, Microbiologica, et Immunologica Scandinavica
Efficacy and safety of molnupiravir treatment for COVID-19: a systematic review and meta-analysis of randomized controlled trials.2023International Journal of Antimicrobial Agents
Clinical efficacy and safety of molnupiravir for nonhospitalized and hospitalized patients with COVID-19: a systematic review and meta-analysis of randomized control trials.2023Journal of Medical Virology
Molnupiravir for treatment of adults with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials.2023Clinical Microbiology and Infection
Efficacy and safety of molnupiravir for the treatment of SARS-CoV-2 infection: a systematic review and meta-analysis.2023Journal of Antimicrobial Chemotherapy
Comparative efficacy and safety of nirmatrelvir/ritonavir and molnupiravir for COVID-19: a systematic review and meta-analysis.2023Journal of Medical Virology
Efficacy and safety of molnupiravir in COVID-19 patients: a systematic review.2022Irish Journal of Medical Science
Rapid review and meta-analysis of adverse events associated with molnupiravir in patients with COVID-19.2022British Journal of Clinical Pharmacology
The pill of recovery; molnupiravir for treatment of COVID-19 patients; a systematic review.2022Saudi Pharmaceutical Journal
Molnupiravir in COVID-19: a systematic review of literature.2021Diabetes & Metabolic Syndrome: Clinical Research & Reviews

Clinical Practice Guidelines