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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
A 75-year-old man developed lengthening of the QT interval, bradycardia and atrioventricular block during off-label treatment with azithromycin and hydroxychloroquine for SARS-CoV-2 infection (COVID-19).
The man had a history of 23 years since HIV diagnosis. He had a resolved hepatitis B virus infection and suffered from high BP and was receiving treatment with perindopril. On 21 March 2020, he was admitted after 7 day history of high fever, diarrhoea and cough. He was found to be SARS-CoV-2 virus positive. His antiretroviral therapy was changed from emtricitabine/rilpivirine/tenofovir alafenamide [rilpivirine/emtricitabine/tenofovir alafenamide] to cobicistat/darunavir/emtricitabine/tenofovir alafenamide [darunavir/cobicistat/emtricitabine/tenofovir alafenamide]. He started receiving off-label hydroxychloroquine for treatment of COVID-19 with antibiotic therapy with azithromycin [routes and dosages not stated]. He also received off-label unspecified low molecular weight heparins for prophylaxis. In the following days, his clinical condition worsened with persistent fever and dyspnoea, which required progressive increase in oxygen supplementation. On 28 March, he started receiving off-label IV sarilumab at 200mg for COVID-19. A second dose of sarilumab was administered at 200mg on 31 March. He was found to have lengthening of the QT interval and marked bradycardia with atrioventricular block [time to reactions onsets not stated].
Thus, on 1 April, both azithromycin and hydroxychloroquine were discontinued. The man had two distinct episodes of haemoptysis. On 4 April, his clinical condition showed progressive improvement with resolution of fever and improvement of respiratory parameters. Oxygen supplementation was discontinued. On repeat testing, he was found to be SARS-Cov-2 negative and was discharged on 9 April with good clinical conditions.
Reference
- Di Giambenedetto S, et al. SARS-CoV-2 infection in a highly experienced person living with HIV. AIDS 34: 1257-1258, No. 8, 1 Jul 2020. Available from: URL: 10.1097/QAD.0000000000002572 [DOI] [PMC free article] [PubMed]