Data demonstrates that treatment with Lagevrio was associated with more rapid elimination of infectious SARS-CoV-2 than placebo.- Merck Inc., + Ridgeback Biotherapeutics.
Merck Inc., and Ridgeback Biotherapeutics announced that data evaluating Lagevrio (molnupiravir), an investigational oral antiviral COVID-19 medicine, will be presented at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) (Abstract #4514).
The presentation includes final analyses evaluating virologic outcomes throughout and following a five-day course of Lagrevrio as part of the Phase III MOVe-OUT trial, which studied Lagevrio versus placebo for the treatment of COVID-19 in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease. Among study participants for whom samples were available, viral infectivity was assessed via a plaque-forming assay in Vero cells. Prespecified exploratory virologic outcomes included changes from baseline in SARS-CoV-2 RNA levels, and the percentage of study participants with viral clearance (i.e., undetectable SARS-CoV-2 RNA) and undetectable infectious SARS-CoV-2 through Day 29 in the modified intent-to-treat (mITT) population (?1 dose of study intervention and not hospitalized prior to first dose).
In participants with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, molnupiravir was associated with more rapid elimination of infectious virus than placebo. At Day 3 of treatment, among patients with infectious virus at baseline, infectious SARS-CoV-2 was detected in 0.0% (n=0/92) of patients who received Lagevrio, compared with 21.8% (n=20/96) of patients who received placebo. At Day 5, infectious virus was detected in 0.0% (n=0/91) of patients in the Lagevrio arm compared with 2.2% (n=2/89) in the placebo arm. At Day 10, no infectious virus was detected in either arm for patients with infectious virus at baseline. Molnupiravir was also associated with greater mean reductions from baseline in SARS-CoV-2 RNA than placebo from Days 3 through 10, though molnupiravir and placebo were associated with comparable rates of viral RNA clearance through Day 29.
In addition to the MOVe-OUT trial, molnupiravir is being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.
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