Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19

Jun Chen, Lu Xia, Li Liu, Qingnian Xu, Yun Ling, Dan Huang, Wei Huang, Shuli Song, Shuibao Xu, Yingzhong Shen, Hongzhou Lu, Jun Chen, Lu Xia, Li Liu, Qingnian Xu, Yun Ling, Dan Huang, Wei Huang, Shuli Song, Shuibao Xu, Yingzhong Shen, Hongzhou Lu

Abstract

Background: We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients.

Methods: In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)-confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274).

Results: From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2-5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups (P = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable (P = 1.0). The frequencies of adverse events in the 2 groups were comparable.

Conclusions: Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.

Keywords: COVID-19; SARS-CoV-2; antiviral activity; darunavir; protease inhibitors.

© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Trial profile. Abbreviation: DRV/c, darunavir/cobicistat.
Figure 2.
Figure 2.
Proportion of patients in each group with positive reverse transcription polymerase chain reaction results on oropharyngeal swabs during follow-up. Abbreviations: DRV/c, darunavir/cobicistat; HR, hazard ratio; PCR, polymerase chain reaction.

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Source: PubMed

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