[Source: Journal of Medical Virology, full page: (LINK). Abstract, edited.]
Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS‐CoV‐2 infection: a retrospective cohort study
Andrea Giacomelli MD, Gabriele Pagani MD, Anna Lisa Ridolfo MD, Letizia Oreni BIT, Federico Conti MD, Laura Pezzati MD, Lucia Bradanini MD, Giacomo Casalini MD, Cinzia Bassoli MD, Valentina Morena MD, Simone Passerini MD, Giuliano Rizzardini MD, Chiara Cogliati MD, Elisa Ceriani MD, Riccardo Colombo MD, Stefano Rusconi MD, Cristina Gervasoni MD, Dario Cattaneo PharmD PhD, Spinello Antinori MD, Massimo Galli MD
First published: 10 August 2020 | DOI: https://doi.org/10.1002/jmv.26407
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/jmv.26407
As it has been shown that lopinavir (LPV) and hydroxychloroquine (HCQ) have in vitro activity against coronaviruses, they were used to treat COVID‐19 during the first wave of the epidemic in Lombardy, Italy.
To compare the rate of clinical improvement between those who started LPV/ritonavir (LPV/r)+HCQ within five days of symptom onset (early treatment, ET) and those who started later (delayed treatment, DT). This was a retrospective intent‐to‐treat analysis of the hospitalized patients who started LPV/r+HCQ between 21 February and 20 March 2020. The association between the timing of treatment and the probability of 30‐day mortality was assessed using uni‐ and multivariable logistic models.
The study involved 172 patients: 43 (25%) in the ET and 129 (75%) in the DT group. The rate of clinical improvement increased over time to 73.3% on day 30, without any significant difference between the two groups (Gray’s test P =0.213). After adjusting for potentially relevant clinical variables, there was no significant association between the timing of the start of treatment and the probability of 30‐day mortality (adjusted odds ratio [aOR] ET vs DT=1.45, 95% confidence interval 0.50‐4.19). Eight percent of the patients discontinued the treatment because of severe gastrointestinal disorders attributable to LPV/r.
The timing of the start of LPV/r+HCQ treatment does not seem to affect the clinical course of hospitalised patients with COVID‐19. Together with the severe adverse events attributable to LPV/r, this raises concerns about the benefit of using this combination to treat COVID‐19.
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Keywords: SARS-CoV-2; COVID-19; Antivirals; Lopinavir; Ritonavir; Chloroquine.