The aim of this study was to evaluate both positive outcomes, including reduction of respiratory support aid and duration of hospital stay, and negative ones, including mortality and a composite of invasive mechanical ventilation or death, in patients with coronavirus disease 2019 (COVID-19) pneumonia treated with or without oral darunavir/cobicistat (DRV/c, 800/150mg/day) used in different treatment durations. The secondary objective was to evaluate the percentage of patients treated with DRV/c who were exposed to potentially severe drug-drug interactions (DDIs) and died during hospitalization. This observational retrospective study was conducted in consecutive patients with COVID-19 pneumonia admitted to a tertiary care hospital in Modena, Italy. Kaplan-Meier survival curves and Cox proportional hazards regression were used to compare patients receiving standard of care with or without DRV/c. Adjustment for key confounders was applied. Two hundred seventy-three patients (115 on DRV/c) were included, 75.8% males, mean age was 64.6 (±13.2) years. Clinical improvement was similar between the groups, depicted by respiratory aid switch (p>.05). The same was observed for duration of hospital stay [13.2 (±8.9) for DRV/c vs. 13.4 (±7.2) days for no-DRV/c, p=.9]. Patients on DRV/c had higher rates of mortality (25.2% vs. 10.1%, p<.0001. The rate of composite outcome of mechanical ventilation and death was higher in the DRV/c group (37.4% vs. 25.3%, p=.03). Multiple serious DDI associated with DRV/c were observed in the 19 patients who died. DRV/c should not be recommended as a treatment option for COVID-19 pneumonia outside clinical trials.

Darunavir/Cobicistat Is Associated with Negative Outcomes in HIV-Negative Patients with Severe COVID-19 Pneumonia / Milic, Jovana; Novella, Alessio; Meschiari, Marianna; Menozzi, Marianna; Santoro, Antonella; Bedini, Andrea; Cuomo, Gianluca; Franceschini, Erica; Digaetano, Margherita; Carli, Federica; Ciusa, Giacomo; Volpi, Sara; Bacca, Erica; Franceschi, Giacomo; Yaacoub, Dina; Rogati, Carlotta; Tutone, Marco; Burastero, Giulia; Faltoni, Matteo; Iadisernia, Vittorio; Dolci, Giovanni; Cossarizza, Andrea; Mussini, Cristina; Pasina, Luca; Guaraldi, Giovanni. - In: AIDS RESEARCH AND HUMAN RETROVIRUSES. - ISSN 0889-2229. - 37:4(2021), pp. 283-291. [10.1089/AID.2020.0305]

Darunavir/Cobicistat Is Associated with Negative Outcomes in HIV-Negative Patients with Severe COVID-19 Pneumonia

Milic, Jovana;Meschiari, Marianna;Menozzi, Marianna;Santoro, Antonella;Bedini, Andrea;Cuomo, Gianluca;Franceschini, Erica;Digaetano, Margherita;Carli, Federica;Ciusa, Giacomo;Volpi, Sara;Bacca, Erica;Franceschi, Giacomo;Yaacoub, Dina;Rogati, Carlotta;Tutone, Marco;Burastero, Giulia;Faltoni, Matteo;Iadisernia, Vittorio;Dolci, Giovanni;Cossarizza, Andrea;Mussini, Cristina;Guaraldi, Giovanni
2021

Abstract

The aim of this study was to evaluate both positive outcomes, including reduction of respiratory support aid and duration of hospital stay, and negative ones, including mortality and a composite of invasive mechanical ventilation or death, in patients with coronavirus disease 2019 (COVID-19) pneumonia treated with or without oral darunavir/cobicistat (DRV/c, 800/150mg/day) used in different treatment durations. The secondary objective was to evaluate the percentage of patients treated with DRV/c who were exposed to potentially severe drug-drug interactions (DDIs) and died during hospitalization. This observational retrospective study was conducted in consecutive patients with COVID-19 pneumonia admitted to a tertiary care hospital in Modena, Italy. Kaplan-Meier survival curves and Cox proportional hazards regression were used to compare patients receiving standard of care with or without DRV/c. Adjustment for key confounders was applied. Two hundred seventy-three patients (115 on DRV/c) were included, 75.8% males, mean age was 64.6 (±13.2) years. Clinical improvement was similar between the groups, depicted by respiratory aid switch (p>.05). The same was observed for duration of hospital stay [13.2 (±8.9) for DRV/c vs. 13.4 (±7.2) days for no-DRV/c, p=.9]. Patients on DRV/c had higher rates of mortality (25.2% vs. 10.1%, p<.0001. The rate of composite outcome of mechanical ventilation and death was higher in the DRV/c group (37.4% vs. 25.3%, p=.03). Multiple serious DDI associated with DRV/c were observed in the 19 patients who died. DRV/c should not be recommended as a treatment option for COVID-19 pneumonia outside clinical trials.
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Darunavir/Cobicistat Is Associated with Negative Outcomes in HIV-Negative Patients with Severe COVID-19 Pneumonia / Milic, Jovana; Novella, Alessio; Meschiari, Marianna; Menozzi, Marianna; Santoro, Antonella; Bedini, Andrea; Cuomo, Gianluca; Franceschini, Erica; Digaetano, Margherita; Carli, Federica; Ciusa, Giacomo; Volpi, Sara; Bacca, Erica; Franceschi, Giacomo; Yaacoub, Dina; Rogati, Carlotta; Tutone, Marco; Burastero, Giulia; Faltoni, Matteo; Iadisernia, Vittorio; Dolci, Giovanni; Cossarizza, Andrea; Mussini, Cristina; Pasina, Luca; Guaraldi, Giovanni. - In: AIDS RESEARCH AND HUMAN RETROVIRUSES. - ISSN 0889-2229. - 37:4(2021), pp. 283-291. [10.1089/AID.2020.0305]
Milic, Jovana; Novella, Alessio; Meschiari, Marianna; Menozzi, Marianna; Santoro, Antonella; Bedini, Andrea; Cuomo, Gianluca; Franceschini, Erica; Digaetano, Margherita; Carli, Federica; Ciusa, Giacomo; Volpi, Sara; Bacca, Erica; Franceschi, Giacomo; Yaacoub, Dina; Rogati, Carlotta; Tutone, Marco; Burastero, Giulia; Faltoni, Matteo; Iadisernia, Vittorio; Dolci, Giovanni; Cossarizza, Andrea; Mussini, Cristina; Pasina, Luca; Guaraldi, Giovanni
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11380/1239787
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