Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals
Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical manifestations. An elevation of liver damage markers has been observed in numerous cases, which could be related to the empirical use of potentially hepatotoxic drugs. The aim of this study was to describe the clinical and analytica...
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| Format: | Article |
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MDPI AG
2021-09-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/19/4432 |
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| author | Ana Delgado Stefan Stewart Mikel Urroz Amelia Rodríguez Alberto M. Borobia Ibtissam Akatbach-Bousaid Miguel González-Muñoz Elena Ramírez |
| author_facet | Ana Delgado Stefan Stewart Mikel Urroz Amelia Rodríguez Alberto M. Borobia Ibtissam Akatbach-Bousaid Miguel González-Muñoz Elena Ramírez |
| author_sort | Ana Delgado |
| collection | DOAJ |
| description | Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical manifestations. An elevation of liver damage markers has been observed in numerous cases, which could be related to the empirical use of potentially hepatotoxic drugs. The aim of this study was to describe the clinical and analytical characteristics and perform a causality analysis from laboratory signals available of drug-induced liver injury (DILI) detected by a proactive pharmacovigilance program in patients hospitalised for COVID-19 at La Paz University Hospital in Madrid (Spain) from 1 March 2020 to 31 December 2020. The updated Roussel Uclaf Causality Assessment Method (RUCAM) was employed to assess DILI causality. A lymphocyte transformation test (LTT) was performed on 10 patients. Ultimately, 160 patients were included. The incidence of DILI (alanine aminotransferase >5, upper limit of normal) was 4.9%; of these, 60% had previous COVID-19 hepatitis, the stay was 8.1 days longer and 98.1% were being treated with more than 5 drugs. The most frequent mechanism was hepatocellular (57.5%), with mild severity (87.5%) and subsequent recovery (88.1%). The most commonly associated drugs were hydroxychloroquine, azithromycin, tocilizumab and ceftriaxone. The highest incidence rate of DILI per 10,000 defined daily doses (DDD) was with remdesivir (992.7/10,000 DDD). Some 80% of the LTTs performed were positive, with a RUCAM score of ≥4. The presence of DILI after COVID-19 was associated with longer hospital stays. An immune mechanism has been demonstrated in a small subset of DILI cases. |
| first_indexed | 2024-03-10T06:58:10Z |
| format | Article |
| id | doaj.art-a7ebad9cfdd242da9324032ac392d55d |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T06:58:10Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-a7ebad9cfdd242da9324032ac392d55d2023-11-22T16:19:29ZengMDPI AGJournal of Clinical Medicine2077-03832021-09-011019443210.3390/jcm10194432Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory SignalsAna Delgado0Stefan Stewart1Mikel Urroz2Amelia Rodríguez3Alberto M. Borobia4Ibtissam Akatbach-Bousaid5Miguel González-Muñoz6Elena Ramírez7Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainImmunology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, SpainImmunology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainCoronavirus disease 2019 (COVID-19) has a wide spectrum of clinical manifestations. An elevation of liver damage markers has been observed in numerous cases, which could be related to the empirical use of potentially hepatotoxic drugs. The aim of this study was to describe the clinical and analytical characteristics and perform a causality analysis from laboratory signals available of drug-induced liver injury (DILI) detected by a proactive pharmacovigilance program in patients hospitalised for COVID-19 at La Paz University Hospital in Madrid (Spain) from 1 March 2020 to 31 December 2020. The updated Roussel Uclaf Causality Assessment Method (RUCAM) was employed to assess DILI causality. A lymphocyte transformation test (LTT) was performed on 10 patients. Ultimately, 160 patients were included. The incidence of DILI (alanine aminotransferase >5, upper limit of normal) was 4.9%; of these, 60% had previous COVID-19 hepatitis, the stay was 8.1 days longer and 98.1% were being treated with more than 5 drugs. The most frequent mechanism was hepatocellular (57.5%), with mild severity (87.5%) and subsequent recovery (88.1%). The most commonly associated drugs were hydroxychloroquine, azithromycin, tocilizumab and ceftriaxone. The highest incidence rate of DILI per 10,000 defined daily doses (DDD) was with remdesivir (992.7/10,000 DDD). Some 80% of the LTTs performed were positive, with a RUCAM score of ≥4. The presence of DILI after COVID-19 was associated with longer hospital stays. An immune mechanism has been demonstrated in a small subset of DILI cases.https://www.mdpi.com/2077-0383/10/19/4432coronavirus disease 2019 (COVID-19)drug induced liver injury (DILI)pharmacovigilanceupdated Roussel Uclaf Causality Assessment Method (RUCAM)lymphocyte transformation test (LTT) |
| spellingShingle | Ana Delgado Stefan Stewart Mikel Urroz Amelia Rodríguez Alberto M. Borobia Ibtissam Akatbach-Bousaid Miguel González-Muñoz Elena Ramírez Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals Journal of Clinical Medicine coronavirus disease 2019 (COVID-19) drug induced liver injury (DILI) pharmacovigilance updated Roussel Uclaf Causality Assessment Method (RUCAM) lymphocyte transformation test (LTT) |
| title | Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals |
| title_full | Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals |
| title_fullStr | Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals |
| title_full_unstemmed | Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals |
| title_short | Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals |
| title_sort | characterisation of drug induced liver injury in patients with covid 19 detected by a proactive pharmacovigilance program from laboratory signals |
| topic | coronavirus disease 2019 (COVID-19) drug induced liver injury (DILI) pharmacovigilance updated Roussel Uclaf Causality Assessment Method (RUCAM) lymphocyte transformation test (LTT) |
| url | https://www.mdpi.com/2077-0383/10/19/4432 |
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