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Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS‐CoV‐2 infection: A retrospective cohort study
Author(s) -
Giacomelli Andrea,
Pagani Gabriele,
Ridolfo Anna L.,
Oreni Letizia,
Conti Federico,
Pezzati Laura,
Bradanini Lucia,
Casalini Giacomo,
Bassoli Cinzia,
Morena Valentina,
Passerini Simone,
Rizzardini Giuliano,
Cogliati Chiara,
Ceriani Elisa,
Colombo Riccardo,
Rusconi Stefano,
Gervasoni Cristina,
Cattaneo Dario,
Antinori Spinello,
Galli Massimo
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26407
Subject(s) - lopinavir , medicine , lopinavir/ritonavir , ritonavir , hydroxychloroquine , retrospective cohort study , odds ratio , confidence interval , adverse effect , logistic regression , covid-19 , immunology , viral load , human immunodeficiency virus (hiv) , disease , antiretroviral therapy , infectious disease (medical specialty)
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 5 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 univariable 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 = .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 becausebecause 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 hospitalized 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.