Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals

Delgado, Ana Sofia; Stewart, Stefan; Urroz, Mikel; Rodríguez, Anaís García; Borobia, Alberto M.; Akatbach-Bousaid, Ibtissam; González‐Muñoz, Miguel; Ramírez, Elena

doi:10.3390/jcm10194432

Cited by 24 publications

(53 citation statements)

References 43 publications

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“…However, 62.5% of the DILI cases that caused hospitalization were moderate or severe cases and with longer latencies. These data are consistent with previous DILI publications of the group ( Pedraza et al, 2020 ; Delgado et al, 2021 ).…”

Section: Discussionsupporting

confidence: 93%

“…RUCAM can standardise and support the clinical assessment of DILI; however, the RUCAM algorithm has some limitations ( Andrade et al, 2019 ), including that it cannot discriminate between concomitant hepatotoxic drugs with the same temporal sequence ( García-Cortés et al, 2011 ; Weber et al, 2021 ). The recently published study by our group ( Delgado et al, 2021 ) describing the characteristic of DILI cases in COVID-19 patients showed that 98% of patients had been treated with five or more drugs. The updated RUCAM scale discriminated one in five drugs (from 1,308 used drugs to 263 related drugs), 51.2% of the cases had at least one probable cause and 48.8% possible, but the median number of related drugs was 3 (range 1–7).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Utility of Lymphocyte Transformation Test for Assisting Updated Roussel Uclaf Causality Assessment Method in Drug-Induced Liver Injury: A Case-Control Study

et al. 2022

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Background: The Roussel Uclaf Causality Assessment Method (RUCAM) is a validated tool for assessing causality in cases of suspected drug-induced liver injury (DILI). However, RUCAM cannot discriminate between concomitant hepatotoxic drugs with the same temporal sequence.Objective: To analyse the utility of the lymphocyte transformation test (LTT) for assisting updated RUCAM in 45 patients and 40 controls with a clinical diagnosis of DILI.Methods: Suspected DILI cases were detected through the Prospective Pharmacovigilance Program from Laboratory Signals in Hospital (PPLSH) or by consultations. The controls completed the drug therapy with no adverse reactions during the study period. A receiver operating characteristics (ROC) curve analysis was performed to calculate the optimal cut-off value for the stimulation index (SI), corresponding to the largest sum for the specificity and sensitivity values of LTT for true DILI cases.Results: Out of 45 patients diagnosed with DILI, 42 cases were detected by the PPLSH, two cases by consultation and one case by both methods. Most DILI cases (64.4%) arose during hospitalization. According to the biochemical parameters, 24 cases (53.3%) had the hepatocellular phenotype, 14 (31.1%) had the cholestatic phenotype, and 7 cases (15.6%) had the mixed phenotype. Considering the severity criteria, 7 (15.5%) cases were classified as moderate DILI, and 4 (8.9%) were severe DILI; there were no fatal cases. A total of 149 drugs (median/case, 3; IQR, 2–5) were suspected to be involved in the DILI cases (RUCAM score ≥3). In 8 cases, only one drug was suspected, and polypharmacy (≥5 drugs) was identified in 29% of the cases. Of all DILI cases, 46 (30.9%) of the 149 suspected drugs produced positive LTT results, and the LTT was positive in 34 (75.5%) of the 45 patients. No exposed controls produced positive LTT results. The optimal cut-off of 1.95 for the SI was obtained with a sensitivity of 77% and specificity of 100% (area under the curve, 0.91; 95% asymptotic confidence interval 0.84–0.97; p < 0.001). The sensitivity of the hepatocellular phenotype was 92%.Conclusion: Our results demonstrate that LTT is an add on strengthening causality in cases of suspected idiosyncratic DILI, especially for patients with several suspected drugs and a hepatocellular phenotype.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Utility of Lymphocyte Transformation Test for Assisting Updated Roussel Uclaf Causality Assessment Method in Drug-Induced Liver Injury: A Case-Control Study

et al. 2022

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“…hospital DILI was observed with remdesivir, followed by azithromycin, hydroxychloroquine and LPV/R. The incidence of DILI with Toclizumab was lower and similar to Ceftriaxone (72).…”

Section: Accepted Manuscriptmentioning

confidence: 86%

Liver, NAFLD and COVID-19

Hoffmann¹,

Gerber²,

Cavelti-Weder³

et al. 2022

Horm Metab Res

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Coronavirus disease 2019 (COVID-19) is characterized by a wide clinical spectrum that includes abnormalities in liver function indicative of liver damage. Conversely, people with liver diseases are at higher risk of severe COVID-19. In the current review, we summarize first the epidemiologic evidence describing the bidirectional relationship between COVID-19 and liver function/liver diseases. Additionally, we present the most frequent histologic findings as well as the most important direct and indirect mechanisms supporting a COVID-19 mediated liver injury. Furthermore, we focus on the most frequent liver disease in the general population, non-alcoholic or metabolic-associated fatty liver disease (NAFLD/MAFLD), and describe how COVID-19 may affect NAFLD/MAFLD development and progression and conversely how NAFLD/MAFLD may further aggravate a COVID-19 infection. Finally, we present the long-term consequences of the pandemic on the development and management of NAFLD.

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“…In patients with COVID-19, drug-induced liver injury (DILI) has often been observed ( Figure 1 ). In total, 10.9% patients with COVID-19 were found to have DILI [ 11 ]. The frequency of DILI in patients who recovered from COVID-19-induced hepatitis was 36.2% [ 11 ].…”

mentioning

confidence: 99%

“…In total, 10.9% patients with COVID-19 were found to have DILI [ 11 ]. The frequency of DILI in patients who recovered from COVID-19-induced hepatitis was 36.2% [ 11 ]. The most commonly associated drugs were hydroxychloroquine, azithromycin, tocilizumab and ceftriaxone [ 11 ].…”

mentioning

confidence: 99%