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Molnupiravir

New COVID-19 Treatment Could Reduce Hospitalization and Death

    As of October 2021, more than 700,000 people have died from COVID-19 infection. Although vaccination provides great protection from COVID-19 infection, there is still the possibility of breakthrough infections. During the pandemic, there has been much discussion over treatment options for individuals who are infected with the coronavirus. Already, treatment options such as convalescent plasma have been developed. However, all authorized treatments in the US are given through an IV or injection. A pill taken from home would not only allow more people to be treated quickly but also ease pressure on hospitals. On October 1, 2021, the pharmaceutical company Merck announced that their experimental pill for COVID-19 infection reduced hospitalization and death by the coronavirus by one half.

About the Study

   Molnupiravir, or the oral antiviral medicine developed by Merck, is a drug developed to specifically eliminate infectious RNA virus and prevent transmission by blocking virus replication. In a recent press release, Merck shared their interim analysis data from a phase 3 clinical trial called MOVe-OUT. As of August 5, 2021, the MOVe-OUT trial tracked 775 adult patients with mild to moderate COVID-19 who were considered high risk for severe disease due to health problems such as obesity, diabetes and heart disease. Participants of the study hailed from around the world and were from countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. The 775 participants were randomized into two groups: 385 were given the Molunpiravir drug and 377 were given a placebo treatment.

Study Results

     At the interim analysis of the study, data showed that Molnupiravir reduced the risk of hospitalization or death by approximately 50%. Of the 385 patients who received Molnupiravir, 7.3% were either hospitalized or died 29 days following randomization. Meanwhile, 14.1% of patients who received placebo were either hospitalized or died 29 days following randomization. Through Day 29, no deaths were reported in patients who received Molnupiravir, as compared to 8 deaths in patients who received placebo. 

In addition to efficacy, the data also suggests that Molunprivair is safe to use. The incidence of adverse events was comparable in the Molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Only 1.3% of subjects discontinued study therapy due to an adverse event in the Molnupiravir group compared to 3.4% of subjects in the placebo group.

It’s important to note that the trial is still ongoing and that there is a plan to enroll a total of 1550 patients in the study. A more complete data analysis is needed before any conclusions can be made.  

Implications

     The interim analysis of the clinical data of Molnupiravir looks encouraging. So far, Molnupiravir seems to be not only effective in reducing hospitalization and death, but also safe to use with little to no adverse events. If approved, it would be the first oral drug for COVID-19 treatment. Molnupiravir would not only be easily accessible to individuals with COVID-19 symptoms, but would also help to reduce coronavirus transmission and help patients recover from infection.

Sources

1. Fischer, William, et al. “Molnupiravir, an Oral Antiviral Treatment for Covid-19.” MedRxiv, Cold Spring Harbor Laboratory Press, 17 June 2021, https://www.medrxiv.org/content/10.1101/2021.06.17.21258639v1.

2. “Merck and Ridgeback's Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study.” Merck.com, 6 Oct. 2021, 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/.

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