Molnupiravir

(Lagevrio®)

Lagevrio®

Drug updated on 9/4/2024

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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  • 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 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