Clinical Outcomes and Adverse Drug Events Identified in Patients Treated with Hydroxychloroquine and Azithromycin

Abstract

Aim To assess clinical outcomes and adverse drug events in patients hospitalised with COVID -19 treated with off-label hydroxychloroquine and azithromycin. Methods We performed a retrospective analysis of hospitalised COVID-19+ patients who received hydroxychloroquine plus azithromycin over a 2 week period. The primary end point was clinical improvement on day 7 defined as either hospital discharge or an improvement of two points on a six-category ordinal scale. Secondary outcomes evaluated included mortality at day 28, ICU admission, requirement for mechanical ventilation and incidence of adverse drug events. Results Data from a total of 82 patients with laboratory confirmed SARS-CoV-2 infection was evaluated. Clinical improvement was seen in 26.8% of patients at Day 7. 31% of patients were admitted to ICU, 16 (19.5%) underwent mechanical ventilation and Day 28 mortality was 28%. Age over 70, history of cardiovascular disease and 3 or more comorbidities were risk factors for mortality. The incidence of adverse drug events was 42%. No patient experienced a Grade 4 or 5 toxicity. Over a fifth of patients (23) had raised LFTs (65% had raised LFTs at baseline), 11 patients experienced prolonged QT and 1 patient experienced grade 1 hypoglycaemia. Treatment was stopped early in 6(7.3%) patients due to prolonged QT interval or LFT elevations. Conclusion This descriptive study details the clinical outcomes of COVID-19 positive patients treated with these agents and highlights the importance of monitoring all repurposed agents for adverse drug events.

Abnormal Liver Biochemistry Tests and Acute Liver Injury in COVID-19 Patients: Current Evidence and Potential Pathogenesis

“…In a case study of seven patients by Serviddio et al the combination of lopinavir, ritonavir, hydroxychloroquine and azithromycin caused significant increase in transaminases levels up to five times the upper limit of normal in COVID-19 patients with no prior history of liver disease [94]. In a more recent retrospective study of 134 hospitalized patients with COVID-19 administered with hydroxychloroquine and azithromycin, there was a higher risk of QT prolongation and hypoglycemia that was associated with elevated liver function tests [103].…”