New data were announced from 2 real-world studies evaluating the COVID-19 oral antiviral molnupiravir.
In the PANORAMIC study, which was conducted at the University of Oxford in the UK, highly-vaccinated patients (mean age, 56.6 years) with confirmed COVID-19 infection and comorbidities that made them clinically vulnerable were randomly assigned to receive molnupiravir plus usual care (n=12,821) or usual care alone (n=12,962). Treatment was initiated within 5 days of symptom onset. The primary endpoint was the reduction of hospitalizations and death within 28 days of randomization. The study was conducted during the period when the circulating SARS-CoV-2 variant was predominately Omicron.
Preliminary analysis showed no difference between the groups; 103 patients in the molnupiravir arm and 96 patients in the usual care arm were hospitalized or died in the first 28 days (incidence of 0.8% in both groups). Molnupiravir treatment was associated with an improvement in time to first self-reported recovery (main secondary endpoint); the median time to first recovery was observed to be 9 days with molnupiravir and 15 days with usual care. Earlier recovery with molnupiravir was reported to be consistent across key subgroups.
“The observed 6-day improvement symptom resolution in the PANORAMIC study is an important finding as we look for ways to further reduce the burden of this virus,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.
In the Clalit study, an observational, retrospective cohort study conducted in Israel, nonhospitalized patients 40 years of age and older believed to be at high risk of progression to severe disease received treatment with molnupiravir. Study participants were infected by the Omicron variant and were not eligible for ritonavir-boosted nirmatrelvir therapy due to drug-drug interactions or impaired renal function.
Results showed that treatment molnupiravir reduced the rate of hospitalizations and death due to COVID-19 in patients 65 years and older, but not younger patients. In patients 65 years of age and older (n=13,569), hospitalizations related to COVID-19 (primary endpoint), occurred in 18 molnupiravir-treated patients (74.6 per 100,000 person-days) vs 513 untreated patients (127.6 per 100,000 person-days) (adjusted hazard ratio [HR], 0.55 [95% CI, 0.34-0.88]). Death due to COVID-19 (secondary endpoint) in this age group occurred in 4 of 845 molnupiravir-treated patients and 137 of 12,724 untreated patients (adjusted HR, 0.26 [95% CI, 0.10-0.73]).
In patients 40 to 64 years of age (n=6,229), COVID-19-related hospitalization occurred in 8 molnupiravir-treated patients (125.8 per 100,000 person-days) vs 97 untreated patients (49.1 per 100,000 person-days) (adjusted HR, 1.80 [95% CI, 0.86-3.77]). Death due to COVID-19 (secondary endpoint) in this age group occurred in 4 of 224 molnupiravir-treated patients and 7 of 6,075 untreated patients (adjusted HR, 12.82 [95% CI, 3.41-48.17]).
“The totality of the data from both PANORAMIC and Clalit give us critical insights into the ways certain patients may benefit from treatment with [molnupiravir],” said Dr Dean Y. Li, president, Merck Research Laboratories. “Most significantly, the Clalit study reinforces what the phase 3 MOVe-OUT study demonstrated – a reduction in hospitalizations and mortality in an older population at high risk for progression to severe disease, where a clinically meaningful benefit was observed.”
Molnupiravir is currently authorized for emergency use for the treatment of mild to moderate COVID-19 in adults 18 years of age and older with positive results of direct SARS-CoV-2 viral testing and who are at risk for progressing to severe COVID-19 and/or hospitalization, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. The trade name for molnupiravir in the US is Lagevrio™.
Merck and Ridgeback Biotherapeutics provide update on new clinical and non-clinical studies of Lagevrio™ (molnupiravir). News release. October 6, 2022. https://www.businesswire.com/news/home/20221006006068/en/Merck-and-Ridgeback-Biotherapeutics-Provide-Update-on-New-Clinical-and-Non-Clinical-Studies-of-LAGEVRIO%E2%84%A2-molnupiravir
This article originally appeared on MPR