Efficacy of Nirmatrelvir/ritonavir in reducing the risk of severe outcome in patients with SARS-CoV-2 infection: a real-life full-matched case-control study (SAVALO Study)

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2024年12月18日

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Ivan Gentile,
Agnese Giaccone,
Maria Michela Scirocco,
Francesco Di Brizzi,
Federica Cuccurullo,
Maria Silvitelli,
Luigi Ametrano,
Francesco Antimo Alfè,
Daria Pietroluongo,
Irene Irace,
Mariarosaria Chiariello,
Noemi De Felice,
Simone Severino,
Giulio Viceconte,
Nicola Schiano Moriello,
Alberto Enrico Maraolo,
Antonio Riccardo Buonomo,
Riccardo Scotto,
Anna Borrelli,
Ferdinando Calabria,
Giuseppe Castaldo,
Letizia Cattaneo,
Maria Rosaria Chiariello,
Mariarosaria Cotugno,
Alessia d’Agostino,
Dario Diana,
Giovanni Di Filippo,
Isabella Di Filippo,
Antonio Di Fusco,
Federico Di Panni,
Gaia Di Troia,
Nunzia Esposito,
Mariarosaria Faiella,
Lidia Festa,
Maria Foggia,
Maria Elisabetta Forte,
Ludovica Fusco,
Antonella Gallicchio,
Gianpaolo Gargiulo,
Antonia Gesmundo,
Carmela Iervolino,
Antonio Iuliano,
Federica Licciardi,
Giuseppe Longo,
Matteo Lorito,
Simona Mercinelli,
Fulvio Minervini,
Giuseppina Muto,
Mariano Nobile,
Biagio Pinchera,
Giuseppe Portella,
Laura Reynaud,
Alessia Sardanelli,
Marina Sarno,
Fabrizio Scordino,
Stefano Mario Susini,
Anastasia Tanzillo,
Grazia Tosone,
Emilia Trucillo,
Ilaria Vecchietti,
Emanuela Zappulo,
Giulia Zumbo

摘要

Background

Ritonavir-boosted nirmatrelvir (N/r) is an antiviral which targets the main viral protease, administered to prevent the progression of SARS-CoV-2 infection in patients at high risk for severe COVID-19. We present a real-life case-control study evaluating the efficacy of N/r therapy in SARS-CoV-2 omicron variants positive outpatients in Campania region, Italy, with the aim of assessing the occurrence of three outcomes (hospital admission, admission in ICU and death) in cases and controls.

Methods

We enrolled SARS-CoV-2 positive subjects that came to our attention in Early antiviral treatment ambulatory of Infectious Diseases ward of University Federico II of Naples, Italy from January 1st, 2022, to December 31st, 2022, during the first five days from symptoms occurrence. Patients were enrolled as cases or controls if they were treated with N/r or not treated at all, respectively.

Results

1607 patients were included (cases: 423, controls: 1184). Cases showed a lower mortality compared with controls while no differences were observed for other outcomes. Vaccinated patients showed a lower mortality compared with non-vaccinated ones (0.5% vs. 7.8%, p < 0.001). After full-matching propensity score, N/r reduced hospitalization rate only in unvaccinated patients. In contrast N/r significantly reduced mortality regardless of vaccination status.

Conclusions

Treatment with N/r has proven effective in reducing mortality among outpatients with SARS-CoV-2 infection during several omicron variant surges. The beneficial effect of N/r treatment in reducing progression is more pronounced in unvaccinated patients.