“ Author Information ”“
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a prospective study of 113 patients, 2 patients [ages and sexes not stated] were described, who developed QT-interval prolongation, ventricular arrhythmias, torsade de point, ventricular fibrillation or non-sustained ventricular tachycardia during off label treatment with hydroxychloroquine, darunavir/ritonavir or azithromycin for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pneumonia [routes not stated].
The patients, who had SARS-CoV-2 pneumonia, started receiving off label treatment with hydroxychloroquine in combination with darunavir/ritonavir or azithromycin. First patient, who received hydroxychloroquine 200mg twice a day in combination with darunavir/ritonavir 800/100mg everyday developed ventricular arrhythmias along with torsade de point and ventricular fibrillation. The patient was successfully treated with direct-current shock following 6 days of therapy. The second patient, who received hydroxychloroquine 200mg twice a day in combination with azithromycin 500mg everyday, developed ventricular arrhythmias along with non-sustained ventricular tachycardia after 4 days.
Both patients had prolonged QT interval with a QTc value >500ms and the treatment was discontinued in them [not all outcomes stated].
Moschini L, et al. Effects on QT interval of hydroxychloroquine associated with ritonavir/darunavir or azithromycin in patients with SARS-CoV-2 infection. Heart and Vessels 36: 115-120, No. 1, Jan 2021. Available from: URL: http://doi.org/10.1007/s00380-020-01671-4