Introduction. The chronic nature of human immunodeficiency virus infection necessitates long-term antiretroviral therapy, which may be accompanied by the development of adverse reactions, including hepatotoxicity. Hepatic injury adversely affects treatment outcomes, increases the risk of therapy discontinuation, and reduces patients’ quality of life. Aim. To assess the frequency of liver-related adverse reactions associated with the administration of antiretroviral drugs, based on an analysis of spontaneous reports of adverse reactions. Materials and Methods. The study was conducted using data from a regional adverse reactions reporting database covering the period from 2018 to 2020. Reports were included if they met the following criteria: Presence of antiretroviral drugs in the “Suspected Drug” category and liver-related clinical manifestations in the category “Description of adverse reactions” category. Duplicates and invalid entries were excluded. Statistical analysis was performed using Microsoft Excel 2021, with frequency and percentage values calculated. Results and Discussion. In total, 83 hepatotoxicity cases were identified. Adverse reactions were most frequently associated to atazanavir (59.1%) and efavirenz (33.7%). The majority of patients were aged 31–45 years (50.6%). The main clinical manifestations included elevated alanine aminotransferase levels (33.7%), hyperbilirubinemia (28.9%), and jaundice (22.9%). Full recovery was observed in 68.7% of cases. These findings partially contradict the existing literature, which generally considers protease inhibitors to be less hepatotoxic. The role of various contributing factors in the development of adverse reactions is discussed. Conclusions. Hepatotoxicity associated with antiretroviral drugs remains a significant concern requiring enhanced pharmacovigilance and personalized treatment strategies that take into account age, comorbidities, and genetic factors. The use of modern antiretroviral agents with improved safety profiles is recommended. The findings highlight the need for further research.
Beitullaev et al. (Fri,) studied this question.