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Worsening of liver injury following off-label use: 7 case reports A study of men, who were admitted Foggia Hospital, Italy, with bilateral COVID-19 pneumonia, described seven men, aged 44–73 years, who developed worsening of liver injury during off-label treatment with lopinavir/ritonavir for bilateral COVID-19 pneumonia [routes not stated]. Seven men were admitted to the Foggia Hospital in Italy with acute hypoxaemic respiratory failure, dyspnoea and fever due to bilateral COVID-19 pneumonia. They had no history of liver or pulmonary disease. IL-6 was significantly increased in six men. All men had increased CRP and D-dimer levels. At admission, the men had AST, ALT and gamma-glutamyl transpeptidase (GGT) levels of 26–65 U/L, 30–118 U/L and 21–181 U/L, respectively. These lab tests were consistent with mild liver injury due to COVID-19. Thereafter, the men started receiving off-label treatment with hydroxychloroquine 400mg daily, azithromycin 500mg daily for 3 days and lopinavir/ritonavir 400/100 daily. However, all the men showed a worsening in clinical conditions within a week after admission and required mechanical ventilation support. Therefore, all men were planned to receive off-label tocilizumab; however, prior to the tocilizumab administration all men had increased transaminases [up to five times the upper limit of normal]. At that time AST, ALT and GGT levels were 78–189 U/L, 49–199 U/L and 35–420 U/L, respectively. These lab findings were consistent with worsening of liver injury, which was attributed to lopinavir/ritonavir and inflammatory response to COVID-19. Thereafter, all men received tocilizumab 8 mg/kg/day for two consecutive days (Total tocilizumab dose: 560–800mg). One week later, the AST, ALT and GGT levels were 26–55 U/L, 39–118 U/L and 23–167 U/L, respectively. Three weeks after tocilizumab treatment, AST, ALT and GGT levels were 17–39 U/L, 28–54 U/L and 16–54 U/L, respectively. After tocilizumab treatment, all men fully recovered with normalisation of liver function tests and respiratory function. All men were discharged with outpatient follow up. Serviddio G, et al. Tocilizumab and liver injury in patients with COVID-19. Therapeutic Advances in Gastroenterology 13: Jan-Dec 2020. Available from: URL: http:// 803518351 doi.org/10.1177/1756284820959183

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Reactions 5 Dec 2020 No. 1833