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J Med Virol . Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: a retrospective cohort study

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  • J Med Virol . Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: a retrospective cohort study


    J Med Virol


    . 2020 Aug 10.
    doi: 10.1002/jmv.26407. Online ahead of print.
    Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: a retrospective cohort study


    Andrea Giacomelli 1 2 , Gabriele Pagani 1 2 , Anna Lisa Ridolfo 1 , Letizia Oreni Bit 1 , Federico Conti 1 2 , Laura Pezzati 1 2 , Lucia Bradanini 1 2 , Giacomo Casalini 1 2 , Cinzia Bassoli 1 2 , Valentina Morena 1 2 , Simone Passerini 1 , Giuliano Rizzardini 1 3 , Chiara Cogliati 4 , Elisa Ceriani 4 , Riccardo Colombo 5 , Stefano Rusconi 1 2 , Cristina Gervasoni 1 , Dario Cattaneo 6 , Spinello Antinori 1 2 , Massimo Galli 1 2



    Affiliations

    Abstract

    Background: 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.
    Methods: 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.
    Results: 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.
    Conclusion: 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. This article is protected by copyright. All rights reserved.

    Keywords: COVID-19; antiviral treatment; early; hydroxychloroquine; lopinavir; mortality.

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