Molnupiravir

(Lagevrio®)

Lagevrio®

Drug updated on 11/1/2024

Dosage FormCapsule (oral: 200 mg)
Drug ClassSARS-CoV-2 nucleoside analogues
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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  • This summary is based on the review of 25 systematic review(s)/meta-analysis(es). [1-25]
  • Reduction in Hospitalization or Death: Molnupiravir reduced COVID-19-related hospitalization or death compared to placebo (OR (odds ratio), 0.67; 95% CI (confidence interval): 0.46-0.99), with an overall summary indicating reduced hospitalization risk (RR (relative risk) = 0.63; 95% CI: 0.47-0.85). In other analyses, it showed reduced mortality (RR, 0.43; 95% CI, 0.20-0.94) and a reduced risk of hospital admission (RR, 0.67; 95% CI, 0.45-0.99).
  • Symptom Resolution and Viral Clearance: Molnupiravir may decrease the time to viral clearance (mean difference, -1.81 days; 95% CI, -3.31 to -0.31) and to symptom resolution or clinical improvement (mean difference, -2.39 days; 95% CI, -3.71 to -1.07). Increased virological clearance at day 5 (RR 2.68; 95% CI: 1.94-4.22) and a higher proportion of clinical improvement (Day 5 RR 2.41; 95% CI 1.18-4.92) were also observed.
  • Comparative Effectiveness: Nirmatrelvir/ritonavir had the lowest hospitalization or death risk (OR, 0.12; 95% CI: 0.06-0.24), followed by remdesivir (OR, 0.13; 95% CI: 0.03-0.57), with molnupiravir comparatively less effective (OR, 0.67; 95% CI: 0.46-0.99).
  • Effectiveness in Different Populations: No benefits were observed for molnupiravir in immunized populations, with higher trial mean age and a female-majority population associated with an elevated hospitalization risk.
  • Anti-viral agents, including molnupiravir, were not associated with an increased risk of adverse events compared with placebo, and molnupiravir likely does not increase serious adverse events (RR, 0.84; 95% CI, 0.61-1.15).
  • Molnupiravir showed a higher incidence of adverse events compared to sotrovimab (OR = 1.67, 95% CI: 1.21, 2.30).
  • Molnupiravir’s safety profile was comparable to nirmatrelvir/ritonavir and remdesivir, and it may offer a higher safety profile for oral COVID-19 treatment.
  • Studies included older adults aged 60 and above, outpatients with COVID-19 across various ages, sexes, and comorbidities, both vaccinated and unvaccinated individuals, and adults with mild to moderate COVID-19 (mean age 35–56.6 years); molnupiravir demonstrated effectiveness in reducing severe outcomes particularly among older outpatients but showed no benefit in vaccinated populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Lagevrio (molnupiravir) Prescribing Information.2024Merck & Co., Inc., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Molnupiravir for the treatment of COVID-19 outpatients: An updated meta-analysis2024Journal Of Microbiology, Immunology, And Infection = Wei Mian Yu Gan Ran Za Zhi
Comparison of effectiveness and safety of molnupiravir versus sotrovimab for COVID-19: A systematic review and meta-analysis2024Immunity, Inflammation And Disease
A Systematic Review of Nirmatrelvir/Ritonavir and Molnupiravir for the Treatment of Coronavirus Disease 20192024Open Forum Infectious Diseases
Effectiveness of nirmatrelvir/ritonavir and molnupiravir in non-hospitalized adults with COVID-19: systematic review and meta-analysis of observational studies2024The Journal Of Antimicrobial Chemotherapy
Safety of RNA-Dependent RNA Polymerase Inhibitors, Molnupiravir and VV116, for Oral Treatment of COVID-19: A Meta-Analysis2024Iranian Journal Of Medical Sciences
Molnupiravir Use Among Patients with COVID-19 in Real-World Settings: A Systematic Literature Review2024Infectious Diseases And Therapy
Virology and safety profile of Molnupiravir at three different doses for treatment of SARS-CoV-2: a systematic review and meta-analysis2024Apmis : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica
Drug interventions for prevention of COVID-19 progression to severe disease in outpatients: a systematic review with meta-analyses and trial sequential analyses (The LIVING Project)2023Bmj Open
Molnupiravir for treatment of adults with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials2023Clinical Microbiology And Infection : The Official Publication Of The European
Efficacy and Safety of Molnupiravir Treatment for COVID-19: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2023International Journal Of Antimicrobial Agents
Efficacy and safety of molnupiravir for the treatment of SARS-CoV-2 infection: a systematic review and meta-analysis2023The Journal Of Antimicrobial Chemotherapy
Evaluation of oral small molecule drugs for the treatment of COVID-19 patients: a systematic review and network meta-analysis2023Annals Of Medicine
Molnupiravir for the treatment of non-severe COVID-19: a systematic review and meta-analysis of 14 randomized trials with 34 570 patients2023The Journal Of Antimicrobial Chemotherapy
Efficacy and safety of Molnupiravir in COVID-19 patients: a systematic review2023Irish Journal Of Medical Science
Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13 694 patients with meta-analysis2023The Journal Of Antimicrobial Chemotherapy
The Clinical Efficacy and Safety of Anti-Viral Agents for Non-Hospitalized Patients with COVID-19: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2022Viruses
Efficacy of COVID-19 treatments among geriatric patients: a systematic review2022Therapeutic Advances In Infectious Disease
The pill of recovery; Molnupiravir for treatment of COVID-19 patients; a systematic review2022Saudi Pharmaceutical Journal : Spj : The Official Publication Of The Saudi
A Systematic Review of the Global Intervention for SARS-CoV-2 Combating: From Drugs Repurposing to Molnupiravir Approval2022Drug Design, Development And Therapy
Antiviral Treatment in COVID-19 Outpatients: A Systematic Review of Randomized Controlled Trials2022Acta Medica Indonesiana
Drug interactions between common dermatological medications and the oral anti-COVID-19 agents nirmatrelvir-ritonavir and molnupiravir2022Annals Of The Academy Of Medicine, Singapore
Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis2022Cmaj : Canadian Medical Association Journal = Journal De L'Association Medicale
Efficacy and safety of three new oral antiviral treatment (molnupiravir, fluvoxamine and Paxlovid) for COVID-19:a meta-analysis2022Annals Of Medicine
Rapid review and meta-analysis of adverse events associated with molnupiravir in patients with COVID-192022British Journal Of Clinical Pharmacology
Molnupiravir in COVID-19: A systematic review of literature2021Diabetes & Metabolic Syndrome

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