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Safety and Efficacy Concerns of Lopinavir/Ritonavir in COVID-19 Affected Patients: A Retrospective Series

Context: Originally developed for the treatment of human immunodeficiency virus (HIV), the antiviral combination lopinavir/ritonavir (LPV/r) is being investigated for use against coronavirus disease (COVID-19). We present a case series raising safety and efficacy concerns in COVID-19 affected patients. Methods: We measured LPV trough concentrations in 12 patients treated at our center and reviewed their clinical charts for side effects known to occur in HIV patients. Results: Compared to established LPV trough concentrations in HIV treated patients, concentrations in COVID-19 affected patients were 3-fold greater (20.64 +/- 10.14 mcg/mL versus 6.25 mcg/mL). In addition, cholestasis and dyslipidemia toxicity thresholds were exceeded in 12/12 and 11/12 patients respectively. No patients achieved the presumed therapeutic concentration. The side effects noted were mainly gastrointestinal symptoms (5/12, 42%), electrolytes imbalances (4/12, 33%), liver enzyme disturbances (5/12, 42%), and triglyceride elevations (2/12, 17%). Conclusion: None of our patients reached presumed therapeutic LPV concentrations despite experiencing side effects and exceeding cholestasis and dyslipidemia toxicity thresholds. This raises concerns for the safety and efficacy of LPV/r. Clinicians should consider closely monitoring for side effects and not necessarily attribute them to COVID-19 itself.