Descriptive analysis of adverse drug reactions to antiretroviral therapy: Causality, severity, and preventability assessment at a tertiary care teaching hospital

Introduction: Antiretroviral therapy (ART) is highly toxic, may cause various adverse drug reactions (ADRs). Hence, regular monitoring and reporting of ADRs to ART are essential to ensure the maximum benefit from these medications. The aim/objective of this study is to evaluate the pattern, causality, severity, and preventability of ADRs due to antiretroviral drugs. Materials and Methods: A descriptive observational study was carried out on people living with human immunodeficiency virus (HIV), at ART center of SMS Medical College and attached group of hospitals, Jaipur, after due approval from the Institutional Ethics Committee. ADRs due to various ART regimens were studied over a period of 12 months. Clinical information of ADRs and other relevant details was collected on predesigned pro forma and causality, severity, and preventability of reported ADRs were duly assessed. Results: Five hundred and twenty-four HIV patients taking ART presented with a total of 996 ADRs. Maximum ADRs were implicated by tenofovir + lamivudine + efavirenz and were related to the central nervous system (35.3%) and gastrointestinal system (19.6%). Other ART caused ADRs of anemia, rashes, renal impairment, hepatobiliary impairment, and rare ADR of Steven-Johnson Syndrome (S-J Syndrome) and gynecomastia. Among encountered ADRs, 73.8% were preventable, whereas 26.2% were not preventable. Causality assessment was found to be possible, probable, and certain in 72.7%, 24.9%, and 2.4% of ADRs, respectively. Conclusion: ART is associated with a broad range of ADRs, ranging from mild to life-threatening adverse reactions. The activities of pharmacovigilance, ADR monitoring, and reporting are mandatory to improve the drug safety. The following core competencies are addressed in this article: Medical knowledge, Patient care, Practice-based learning and improvement, and Systems-based practice.