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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
* Drug interaction
A 27-year-old man developed COVID-19 following immunosuppressive therapy with prednisone and tacrolimus. Additionally, he developed acute kidney injury (AKI) secondary to tacrolimus toxicity following concomitant administration of tacrolimus, darunavir/ritonavir and hydroxychloroquine. The administration of darunavir/ritonavir and hydroxychloroquine was off label [routes and durations of treatments to reactions onsets not stated; not all dosages and outcome stated].
The man was hospitalised with fever on 26 March 2020. His medical history consisted of ulcerative colitis, primary sclerosing cholangitis (PSC) and liver transplantation in April 2018 and relapse of PSC in July 2019. He had been receiving immunosuppressive therapy with tacrolimus and prednisone. He was recently hospitalised for an episode of cholangitis, for which he had received treatment with unspecified antibiotics. Five days prior to presentation, he experienced another episode of fever, and he started receiving unspecified antibiotics. He was tested positive for SARS-CoV-2 infection (COVID-19), and he was hospitalised. He was initiated on off label treatment with darunavir/ritonavir and hydroxychloroquine. In view of well-known drug interaction, the dosage of tacrolimus was reduced from 4mg to 1mg. However, on the next day, tacrolimus levels were found to be slightly increased.
The man's immunosuppressive therapy was discontinued. However, on 30 March 2020, the level of tacrolimus was found high at 22 ng/mL. Additionally, an increase in creatinine levels in the biochemical test indicated AKI. The levels of tacrolimus remained persistently high even on the last day of darunavir/ritonavir administration which was 3 April 2020, despite the suspension of tacrolimus for about one week. He was discharged on 6 April 2020. At the time of discharge, the tacrolimus level was normal. The immunosuppression was resumed. He tested negative in the COVID-19, which was carried out at the week following the discharge.