Mapping antiretroviral toxicity: eight years ofpharmacovigilance signals from a tertiary HIV clinic in Gauteng, South Africa

Background: Adverse drug reactions (ADRs) remain a major challenge in the long-term management of HIV/AIDS, particularly in high-burden settings such as South Africa, where antiretroviral therapy (ART) is widely used. Although ART has significantly reduced HIV-related morbidity and mortality, its use is often complicated by toxicities that affect adherence, require regimen changes, and increase healthcare costs. This study aimed to determine the frequency, patterns, and determinants of reported ADRs among adult HIV-positive patients receiving ART at a tertiary hospital in Gauteng Province. Methods: A retrospective medical records review was conducted using routinely collected clinical data from 2015 to 2022. Data were extracted from the TherapyEdge (TE) electronic system, including demographic, clinical, and treatment variables. A total of 1 310 patients with at least one documented ADR were included. Descriptive statistics summarised ADR patterns, while Pearson’s Chi-square test assessed associations between variables and ADR occurrence. Results: A total of 1 606 ADRs were identified across nine ART regimens. Renal complications were most frequent (47.8%), followed by gastrointestinal disturbances (22.3%) and hepatic events (9.8%). The tenofovir, emtricitabine, and efavirenz (TEE) regimen accounted for the highest proportion of ADRs (44.1%), with renal dysfunction and anaemia predominating. A significant association was found between ART regimen type and ADR occurrence (p < 0.001), whereas gender, age, and treatment duration were not statistically significant. Conclusion: These findings highlight the substantial burden of ADRs, particularly with tenofovir-based regimens. Strengthened pharmacovigilance, routine monitoring, and patient-centred regimen selection are essential to improve treatment safety and adherence in resource-limited settings.