Antiviral reduces risk for hospitalization, death by about 50% in patients with COVID-19
Molnupiravir, an investigational oral antiviral drug, significantly reduced the risk for hospitalization or death from COVID-19 among high-risk patients, according to a company press release.
The drug was developed by Merck in collaboration with Ridgeback Biotherapeutics.
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a health care facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, said in the release.
The results were based on an interim analysis of a phase 3 study of 775 at-risk, nonhospitalized adults with mild to moderate COVID-19 on or before Aug. 5. The study — called MOVe-OUT — is a randomized, placebo-controlled, double-blind, multisite trial being conducted globally. Eligible patients experienced symptom onset within 5 days of randomization. They also presented with at least one risk factor associated with poor disease outcomes, the most common of which included obesity, diabetes, heart disease and age 60 years or older. Follow-up continued through day 29 after randomization.
After 29 days, 7.3% of patients who received molnupiravir were hospitalized or died compared with 14.1% in the placebo group (P = .0012), according to Merck. Specifically, the treatment group had no deaths, whereas eight patients died in the placebo group. The incidence of adverse events was similar between the molnupiravir and placebo groups — 35% vs. 40%. The incidence of drug-related adverse events was also similar: 12% vs. 11%. Moreover, fewer patients discontinued therapy due to an adverse event in the treatment group (1.3%) compared with the placebo group (3.4%). Viral sequencing of 40% of patients revealed that “molnupiravir demonstrated consistent efficacy” against SARS-CoV-2 variants, according to the release.
Because of the positive results, an independent data monitoring committee, in consultation with the FDA, recommended that Merck and Ridgeback Biotherapeutics stop the study early. Merck said it will submit an application for an emergency use authorization in the United States as soon as possible.
Merck said it expects to have 10 million courses of treatment produced by the end of 2021.