Early administration of nirmatrelvir/ritonavir leads to faster negative SARS-CoV-2 nasal swabs than monoclonal antibodies in COVID 19 patients at high-risk for severe disease.

COVID-19 Immunosuppression Monoclonal antibodies Nirmatrelvir/Ritonavir Time to negativization

Journal

Virology journal
ISSN: 1743-422X
Titre abrégé: Virol J
Pays: England
ID NLM: 101231645

Informations de publication

Date de publication:
20 Mar 2024
Historique:
received: 07 09 2023
accepted: 28 02 2024
medline: 21 3 2024
pubmed: 21 3 2024
entrez: 21 3 2024
Statut: epublish

Résumé

Besides the well-established efficacy in preventing severe COVID-19, the impact of early treatments, namely antivirals and monoclonal antibodies (mAbs), on the time length to negativization of SARS-CoV-2 nasal swabs is still unclear. The aim of this study was to compare the efficacy of different early treatments in reducing the SARS-CoV-2 viral shedding, identifying a single drug that might potentially lead to a more rapid negativization of SARS-CoV-2 nasal swab. This was a single-centre, retrospective, observational study conducted at Ospedale Luigi Sacco in Milan. Data of high-risk COVID-19 patients who received early treatments between 23 December 2021 and March 2023 were extracted. The comparison across treatments was conducted using the Kruskall-Wallis test for continuous variables. Dunn's test with Bonferroni adjustment was performed for post-hoc comparisons of days to negativization. Secondly, a negative binomial regression adjusted for age, sex, number of comorbidities, immunosuppression, and SARS-CoV-2 vaccination status was implemented. Data from 428 patients receiving early treatments were collected. The majority were treated with Nirmatrelvir/Ritonavir and were affected by SARS-CoV-2 Omicron infection with BA.2 sublineage. The median length time to SARS-CoV-2 nasal swab negativization was 9 days [IQR 7-13 days]. We found that Nirmatrelvir/Ritonavir determined a significant decrease of the length time to SARS-CoV-2 nasal swab negativization compared to mAbs (p = 0.003), but not compared to Remdesivir (p = 0.147) and Molnupiravir (p = 0.156). Our findings highlight the importance of promptly treating high-risk COVID-19 patients with Nirmatrelvir/Ritonavir, as it also contributes to achieving a faster time to negative SARS-CoV-2 nasal swabs.

Identifiants

pubmed: 38509536
doi: 10.1186/s12985-024-02333-x
pii: 10.1186/s12985-024-02333-x
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

68

Informations de copyright

© 2024. The Author(s).

Références

Clark A, et al. Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health conditions in 2020: a modelling study. Lancet Glob Health. Aug. 2020;8(8):e1003–17. https://doi.org/10.1016/S2214-109X(20)30264-3 .
Cohen MS, Wohl DA, Fischer WA, Smith DM, Eron JJ. Outpatient Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 Infection to Prevent Coronavirus Disease 2019 Progression., Clin Infect Dis, vol. 73, no. 9, pp. 1717–1721, Nov. 2021, https://doi.org/10.1093/cid/ciab494 .
Wong CKH, Au ICH, Lau KTK, Lau EHY, Cowling BJ, Leung GM. Real-world effectiveness of molnupiravir and nirmatrelvir plus ritonavir against mortality, hospitalisation, and in-hospital outcomes among community-dwelling, ambulatory patients with confirmed SARS-CoV-2 infection during the omicron wave in Hong Kong: an observational study., Lancet, vol. 400, no. 10359, pp. 1213–1222, Oct. 2022, https://doi.org/10.1016/S0140-6736(22)01586-0 .
Corey L, Beyrer C, Cohen MS, Michael NL, Bedford T, Rolland M. SARS-CoV-2 Variants in Patients with Immunosuppression, New England Journal of Medicine, vol. 385, no. 6, pp. 562–566, Aug. 2021, https://doi.org/10.1056/NEJMsb2104756 .
Farmaci utilizzabili per il trattamento della malattia COVID-19 | Agenzia Italiana del Farmaco. https://www.aifa.gov.it/aggiornamento-sui-farmaci-utilizzabili-per-il-trattamento-della-malattia-covid19 (accessed Jul. 13, 2023).
Butler CC, et al. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. Jan. 2023;401(10373):281–93. https://doi.org/10.1016/S0140-6736(22)02597-1 .
Sung A, et al. Isolation of SARS-CoV-2 in viral cell culture in immunocompromised patients with persistently positive RT-PCR results. Front Cell Infect Microbiol. 2022;12:804175. https://doi.org/10.3389/fcimb.2022.804175 .
doi: 10.3389/fcimb.2022.804175 pubmed: 35186791 pmcid: 8847756
Martin-Blondel G et al. Apr., Time to negative PCR conversion amongst high-risk patients with mild-to-moderate Omicron BA.1 and BA.2 COVID-19 treated with sotrovimab or nirmatrelvir., Clin Microbiol Infect, vol. 29, no. 4, pp. 543.e5-543.e9, 2023, https://doi.org/10.1016/j.cmi.2022.12.016 .
Gentile I et al. Oct., Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study., Vaccines (Basel), vol. 10, no. 10, 2022, https://doi.org/10.3390/vaccines10101731 .

Auteurs

Marta Colaneri (M)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.
Centre for Multidisciplinary Research in Health Science (MACH), University of Milan, Milan, Italy.

Giovanni Scaglione (G)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Federico Fassio (F)

Department of Public Health, Experimental and Forensic Medicine, Unit of Biostatistics and Clinical Epidemiology, University of Pavia, Pavia, Italy.

Lucia Galli (L)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Alessia Lai (A)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.

Annalisa Bergna (A)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.

Arianna Gabrieli (A)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.

Maciej Tarkowski (M)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.

Carla Della Ventura (CD)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.

Valeria Colombo (V)

Department of Infectious Diseases, Unit I, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Laura Cordier (L)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Davide Bernasconi (D)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Mario Corbellino (M)

Institute of Infectious Diseases & Tropical Medicine, III Division, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Gianfranco Dedivitiis (G)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Silvia Borghetti (S)

Pharmacy Unit, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Debora Visigalli (D)

Pharmacy Unit, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Salvatore Sollima (S)

Institute of Infectious Diseases & Tropical Medicine, III Division, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Giacomo Casalini (G)

Institute of Infectious Diseases & Tropical Medicine, III Division, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Giuliano Rizzardini (G)

Department of Infectious Diseases, Unit I, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.

Andrea Gori (A)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.
Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.
Centre for Multidisciplinary Research in Health Science (MACH), University of Milan, Milan, Italy.

Spinello Antinori (S)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.
Institute of Infectious Diseases & Tropical Medicine, III Division, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Agostino Riva (A)

Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.
Institute of Infectious Diseases & Tropical Medicine, III Division, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.

Monica Schiavini (M)

Department of Infectious Diseases, Unit II, L. Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy. schiavini.monica@asst-fbf-sacco.it.

Classifications MeSH