Table 2.
Reporting odds ratio for the lopinavir-ritonavir compared to other drugs in patients with COVID-19a
| Comparison | No. of liver injury/No. of other ADEs | Reporting odds ratio (95% CI) | Chi-squared test statistic (p-value) | |
|---|---|---|---|---|
| Lopinavir-ritonavir | Comparator | |||
| Drug-induced liver injuryc | ||||
| Lopinavir-ritonavir vs all other drugsb | 313/532 | 532/15,825 | 2.99 (2.59–3.46) | 240.00 (< 0.0001) |
| Lopinavir-ritonavir vs hydroxychloroquine/chloroquine | 249/371 | 2,614/3,404 | 3.16 (2.68, 3.73) | 203.04 (< 0.0001) |
| Lopinavir-ritonavir vs remdesivir | 311/527 | 1,362/12,433 | 5.39 (4.63, 6.26) | 578.87 (< 0.0001) |
| Severe drug-induced liver injury d | ||||
| Lopinavir-ritonavir vs all other drugs | 90/532 | 672/15,825 | 3.98 (3.15, 5.05) | 152.32 (< 0.0001) |
| Lopinavir-ritonavir vs hydroxychloroquine/chloroquine | 75/371 | 467/12,306 | 5.33 (4.09, 6.94) | 189.81 (< 0.0001) |
| Lopinavir-ritonavir vs remdesivir | 90/367 | 552/12,433 | 3.85 (3.03, 4.89) | 139.92 (< 0.0001) |
ADEs adverse drug events, SMQ standardized medical dictionary for regulatory activities query
aMedDRA preferred terms related to COVID-19 including "asymptomatic COVID-19", "COVID-19", "COVID-19 pneumonia", "suspected COVID-19", "SARS-COV-2 carrier", "exposure to SARS-COV-2", "occupational exposure to communicable disease", "occupational exposure to SARS-COV-2", "coronavirus test", "coronavirus test negative", "SARS-COV-2 test", "SARS-COV-2 test false negative", "SARS-COV-2 test negative", "SARS-COV-2 test positive", "COVID-19 prophylaxis", "COVID-19 treatment", "COVID-19 immunisation", "patient isolation", "quarantine", "multisystem inflammatory syndrome in children", "SARS-COV-2 sepsis", "SARS-COV-2 viraemia", "SARS-COV-2 test false positive", "SARS-COV-2 antibody test"
bAll other drugs including the all drugs except lopinavir-ritonavir used in the COVID-19 cases
cIdentified by a narrow SMQ of “Drug related hepatic disorders,” which includes narrow scope of cholestasis and jaundice of hepatic origin, liver related investigations, signs and symptoms, liver-related coagulation and bleeding disturbances, noninfectious hepatitis, hepatic failure, fibrosis, cirrhosis, other drug-related liver damage, liver neoplasms (benign, including cysts and polyps), and liver neoplasms (malignant and unspecified)
dIdentified by a narrow SMQ of “Drug related hepatic disorders—severe events only,” which includes narrow scope of noninfectious hepatitis, hepatic failure, fibrosis, cirrhosis, other drug-related liver damage, liver neoplasms (benign, including cysts and polyps), and liver neoplasms (malignant and unspecified)