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Liver Injury in People With HIV on Antituberculosis and/or Antiretroviral Therapy-Assessing Causality Using the
H M Gunter1, G Tatz1, G Maartens1
1Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
Pharmacoepidemiology and Drug Safety
|October 10, 2024
Summary
The Roussel Uclaf Causality Assessment Method (RUCAM) showed low sensitivity in identifying drug-induced liver injury (DILI) from tuberculosis and HIV therapies. Expert panel review is crucial for accurate causality assessment in patients with multiple medications.
Area of Science:
- Pharmacovigilance
- Hepatology
- Infectious Diseases
Background:
- Drug-induced liver injury (DILI) is a significant concern in patients receiving antituberculosis therapy (ATT) and/or antiretroviral therapy (ART).
- Assessing causality for DILI in patients on multiple medications, particularly people with HIV (PWH), is complex.
- Accurate causality assessment is vital for managing DILI and optimizing treatment regimens.
Purpose of the Study:
- To compare the performance of the Roussel Uclaf Causality Assessment Method (RUCAM) against a multidisciplinary expert panel review.
- To evaluate the accuracy of RUCAM in identifying DILI caused by ATT and/or ART in hospitalized patients.
Main Methods:
- A prospective registry of hospitalized adults with suspected DILI due to ATT and/or ART in Cape Town, South Africa, was utilized.
- Expert panel review, guided by World Health Organization Uppsala Monitoring Centre criteria, served as the reference standard for causality assessment.
- The RUCAM was applied to each potentially implicated drug, and its sensitivity and specificity were calculated against the expert panel's findings.
Main Results:
- The study included 48 participants, all of whom were people with HIV (PWH).
- Twenty-seven participants were on concomitant ART and ATT, with a median of six potentially hepatotoxic drugs per case.
- The RUCAM demonstrated a sensitivity of 7% and a specificity of 100% in identifying probable or certain drug causes of liver injury compared to expert panel review.
Conclusions:
- Patients with DILI receiving ATT and/or ART, especially PWH, often take multiple potentially hepatotoxic drugs, complicating causality assessment.
- The RUCAM exhibited low sensitivity in detecting probable or certain drug-induced liver injury when compared to expert panel review.
- Multidisciplinary expert panel review remains a critical tool for accurate DILI causality assessment in complex cases involving ATT and ART.
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