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. 2022 Oct 17;10(10):1731.
doi: 10.3390/vaccines10101731.

Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study

Ivan Gentile  1 , Riccardo Scotto  1 , Nicola Schiano Moriello  1 , Biagio Pinchera  1 , Riccardo Villari  1 , Emilia Trucillo  1 , Luigi Ametrano  1 , Ludovica Fusco  1 , Giuseppe Castaldo  2   3 , Antonio Riccardo Buonomo  1 , Federico Ii Covid Team
Affiliations

Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study

Ivan Gentile et al. Vaccines (Basel). .

Abstract

Molnupiravir and nirmatrelvir were the first available oral antivirals (OAs) active against SARS-CoV-2. Trials evaluating the efficacy of OAs involved patients unvaccinated and infected with variants different from those currently circulating. We conducted a retrospective study on patients with confirmed SARS-CoV-2 infection treated with OAs during the omicron surge in Italy in order to provide real-life data on the efficacy and safety of OAs during the omicron surge of the COVID-19 pandemic. Among 257 patients, 56.8% received molnupiravir, while 43.2% received nirmatrelvir/ritonavir. Patients in the molnupiravir group were older, had a lower body mass index, and had a higher rate of chronic heart disease than those treated with nirmatrelvir/ritonavir. Three hospitalizations were recorded in the molnupiravir (2.1%) group and one in the nirmatrelvir/ritonavir (0.9%) group. One patient treated with molnupiravir died. The median time to negativity was 8 days in the nirmatrelvir/ritonavir group vs. 10 days in the molnupiravir group, p < 0.01. We recorded 37 ADRs (mainly dysgeusia, diarrhea, and nausea) in 31 individuals (12.1%). Only two patients (0.8%) treated with molnupiravir terminated treatment due to ADRs. In conclusion, in a population of mostly vaccinated patients treated with OAs, we observed a low rate of hospitalization, death, and adverse drug reactions. These rates were lower than those reported in pivotal trials.

Keywords: COVID-19; SARS-CoV-2; adverse drug reactions; hospitalization; molnupiravir; nirmatrelvir/ritonavir.

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Conflict of interest statement

I.G. reports personal fees from MSD, AbbVie, Gilead, Pfizer, GSK, SOBI, Nordic/Infecto Pharm, Angelini, and Abbott, as well as departmental grants from Gilead and support for attending a meeting from Janssen, outside the submitted work. Other authors have no conflicts of interest to declare.

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