Lagevrio for COVID-19: The Complete Guide for 2022

LAST UPDATED 12/14/2021

Lagevrio is a powerful drug for COVID-19.

  • Lagevrio (also known as molnupiravir) has shown to decrease the rate of hospitalization or death for COVID-19 patients by approximately 50%.
 
  • Lagevrio is not yet available in the United States, but when it is available, it will likely require a prescription.
 
  • Patients will likely be able to present a positive COVID-19 test to receive a prescription directly at their local pharmacies.

What is Lagevrio?

Lagevrio is an investigational antiviral medication that is taken by mouth.

Lagevrio has shown to decrease COVID-19 hospitalization or death by approximately 50%.

Does Lagevrio work against COVID-19?

In short: yes.

The drug demonstrated the prevention of progression to more severe symptoms, and helped patients recover from the virus faster. 

 

Here are all the details: 

The MOVe-OUT trial (NCT04575597) was a Phase 3, randomized, placebo-controlled, double-blind, multi-site study testing the effectiveness of Lagevrio in non-hospitalized adult patients with laboratory confirmed mild to moderate COVID-19, at least one risk factor associated with progression of disease, and symptom onset within 5 days of to randomization. 

The MOVe-OUT trial included patients from over 173 different sites from 23 different countries across the planet. The trial enrolled over 1850 participants between all 173 sites. Recruitment in Latin America, Europe, and Africa accounted for 55%, 23% and 15% of the study population, respectively.

The primary outcome measured in the trial was the evaluation of the efficacy of Lagevrio compared to placebo in preventing the hospitalization or death from COVID-19 from trial randomization to day 29. In the interim analysis of the study, Lagevrio has shown to reduce the risk of hospitalization or death by approximately 50%. The Lagevrio group had 7.3%(28/385) of patients either hospitalized or die through day 29 compared to 14.1%(53/377) of patients in the placebo group. A statistically significant difference between the two groups( p=0.0012).

Does Lagevrio work against different variants of COVID-19?

Nearly 80% of the cases in the Lagevrio trial included Delta, Gamma, and Mu variants. The vaccine showed efficacy against these variants.

News is continuing to break about the Omicron variant of COVID-19. When we know more about Lagevrio’s efficacy against this variant, we’ll update this page. 

 

How does Lagevrio work?

Lagevrio is an orally administered ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. Lagevrio interferes with replication of SARS-CoV-2 by causing mutations in the transcription of new virus RNA.

The main target of Lagevrio is the RNA-dependent polymerase of SARS-CoV-2. Lagevrio is a prodrug to N-hydroxylamine(NHC). NHC may also tautomerize into NHC-TP. NHC-TP acts predominantly as a C-analogue and is incorporated opposite to the template to G causing transition mutations. NHC and NHC-TP incorporation lead to an increase in G to A and C to U transition mutations in replicating coronaviruses. The increased mutation frequency leads to the antiviral effects of Lagevrio.

How much does Lagevrio cost?

Lagevrio could possibly be free for patients, as part of the US government’s emergency response.

Earlier in 2021, Merck, the manufacturer of Lagevrio, and the US government entered a procurement agreement to supply the government with 1.7 million courses of the medication upon Emergency Use Authorization or approval of the FDA of the medication.

For non-government funded courses of the medication, the medication will most likely be covered by most health insurance plans.

How to buy Lagevrio

Lagevrio is not currently available for purchase in the United States.

However, when Lagevrio does become available for purchase, it will most likely require a prescription. Lagevrio will most likely not be an over the counter medication. 

Merck filed for Emergency Use Authorization from the FDA on October 11, 2021 which would allow doctors to start prescribing the medication.

When can I get Lagevrio?

Lagevrio will likely be approved under an emergency use authorization in the coming months. Merck recently submitted an Emergency Use Authorization application to the FDA, and the FDA advisory committee is meeting November 30th, 2021 to discuss the application.

Why is Lagevrio sometimes called molnupiravir?

Lagevrio is the brand name under which molnupiravir is sold. 

There are several medication name stems used to reflect a medication is an antiviral medication. One of the most prominent antiviral stem naming classes being the -vir stem class which molnupiravir possesses.

The molnu part of the medication name is where the drug developer’s creativity is demonstrated. The drug developers wanted to name the medication something that represented the antiviral “power”of their new creation.

They decided to name this medication after none other than the devastating weapon of the thunder wielding Asgardian god, Thor. Molnu is derived from the name of Thor’s hammer Mjölnir.

Who should take Lagevrio?

Lagevrio was studied in patients who were symptomatic and newly infected with COVID-19.

The FDA is currently evaluating the safety and efficacy for the treatment of mild-to-moderate COVID-19 in adults who tested positive for the virus and are at risk of progressing to cases of severe COVID-19 that include hospitalization or death.

At risk conditions most commonly associated with worsening of COVID-19 disease include obesity, older age (over 60 years old) diabetes mellitus, and heart disease.

Who makes Lagevrio?

Molnupiravir is sold under the brand name Lagevrio and is manufactured by Merck and Ridgeback.

Merck, known as MSD (Merck Sharp & Dohme) outside the United States and Canada is an American multinational pharmaceutical company headquartered in Kenilworth, New Jersey. Merk was founded in 1891 and primarily focuses on manufacturing vaccines, biologic therapies, and animal health products. 

Ridgeback Biotherapeutics is a biotechnology company founded in 2016 and headquartered in Miami, Florida. Ridgeback focuses on infectious disease treatments including Lagevrio for the treatment of COVID-19 and Ebanga for the treatment of Ebola. 

What is the dose of Lagevrio?

Lagevrio is taken by mouth at a dose of 800 mg twice daily for 5 days. Lagevrio was tested at several doses and well tolerated at all studies doses.

Does Lagevrio have any side effects?

The incidence of side effects was comparable between the Lagevrio and place groups (12% and 11% respectively). The most common side effect associated with Lagevrio was nausea. There were fewer patients in the trial that discontinued therapy because of an adverse event in the placebo group as compared to the Lagevrio group (1.3% and 3.4% respectively).


  1. References:

    https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
    https://www.merck.com/news/merck-and-ridgeback-announce-submission-of-emergency-use-authorization-application-to-the-u-s-fda-for-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-c/
    https://www.idstewardship.com/molnupiravir-new-covid-antiviral-named-thors-hammer/
    https://publichealth.jhu.edu/2021/molnupiravir-the-game-changing-antiviral-pill-for-covid-19
    https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmerck-announces-supply-agreement-with-u-s-government-for-molnupiravir-an-investigational-oral-antiviral-candidate-for-treatment-of-mild-to-moderate-covid-19%2F&esheet=52502008&newsitemid=20211001005189&lan=en-US&anchor=entered&index=1&md5=f1eb49a20aceb153a2c5e31cfdfa3f71
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219109/
    https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meeting-discuss-merck-and-ridgebacks-eua-application-covid-19-oral
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219109/
    https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meeting-discuss-merck-and-ridgebacks-eua-application-covid-19-oral
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219109/
    https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04575597%3Fterm%3Dmolnupiravir%26draw%3D2%26rank%3D2&esheet=52502008&newsitemid=20211001005189&lan=en-US&anchor=NCT04575597&index=3&md5=d00529fc8647b82c99f3f53d57191335
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8110631/
    https://publichealth.jhu.edu/2021/molnupiravir-the-game-changing-antiviral-pill-for-covid-19
    https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meeting-discuss-merck-and-ridgebacks-eua-application-covid-19-oral
    https://www.merck.com/
    https://ridgebackbio.com/
    https://ridgebackbio.com/pipeline/ebanga/
    https://pubmed.ncbi.nlm.nih.gov/34450619/

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