New data for Lagevrio from phase III MOVe-OUT study in COVID 19.
Merck Inc., and Ridgeback Biotherapeutics announced the Annals of Internal Medicine has published additional data from the Phase III MOVe-OUT trial evaluating Lagevrio (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease.
Analyses of pre-specified exploratory endpoints indicate that a lower proportion of Lagevrio-treated participants in the modified intent-to-treat (MITT) population had an acute care visit or a COVID-19-related acute care visit versus placebo-treated participants in the MITT population: 7.2% of participants who received Lagevrio reported an acute care visit through Day 29, versus 10.6% of placebo participants, with a relative risk reduction [RRR] of 32.1% [CI, 4.4% to 51.7%]; 6.6% of participants who received Lagevrio reported a COVID-19-related acute care visit, versus 10.0% of placebo participants, with a RRR of 33.8% [CI, 5.6% to 53.6%].
The MITT population included all participants who were randomly assigned, received at least one dose of study drug, and were not hospitalized before the first dose of study drug. Based on a post hoc analysis, fewer Lagevrio-treated participants in the MITT population required respiratory interventions (including conventional oxygen therapy, a high-flow heated and humidified device, noninvasive mechanical ventilation, or invasive mechanical ventilation) versus placebo-treated participants, with a RRR of 34.3% [95% CI, 4.3% to 54.9%] for all respiratory interventions. Based on additional post hoc analyses, participants in the safety population who received Lagevrio showed earlier and larger reductions in mean C-reactive protein (CRP) values, and earlier and larger improvements in mean change from baseline oxygen saturation (SpO2) values, compared with participants who received placebo. The safety population consisted of all participants who had undergone randomization and had received at least one dose of Lageviro.
Post hoc analyses also suggest that among the subgroup of participants who were hospitalized after randomization in MOVe-OUT, the median time to hospital discharge was nine days [CI, 7 to 12 days] for participants who received Lagevrio, versus 12 days [CI, 9 to 14 days] in the placebo group. Consistent with the full MITT population data, post hoc analyses also suggest that fewer Lagevrio -treated participants who were hospitalized after randomization required respiratory interventions versus placebo-treated participants, with a RRR of 21.3% [95% CI, 0.2% to 38.0%] for all respiratory interventions.
In addition to the MOVe-OUT trial, Lagevrio 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 Lagevrio in preventing the spread of COVID-19 within households.
See-"Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 - A Randomized, Placebo-Controlled Trial."- Matthew G. Johnson, MD, Amy Puenpatom, PhD, Pablo Andrés Moncada, MD,et al. Annals of Internal Medicine. 7 June 2022 https://doi.org/10.7326/M22-0729.
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