A study of the monitoring of the adverse drug reactions caused by antiretroviral drugs

Abstract

Introduction: Human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS) is a disease of the human immune system. The drugs used in the treatment of HIV/AIDS are known to cause adverse effects, therefore this study was carried out for the monitoring and evaluation of adverse drug reactions (ADRs) caused by the use of antiretroviral drugs in patients of HIV/AIDS. Methods: A prospective, observational, cross sectional study was done in Andaman & Nicobar Islands institute of medical sciences, to monitor ADRs caused by Antiretroviral therapy (ART) over a period of 10 months in 120 patients of HIV/AIDS. Out of 120 patients, 84 had ADR’s. The data collected was filled in the spontaneous ADR reporting forms and Causality assessment was done using the WHO-UMC and Naranjo scale, seriousness was considered as per the ADR reporting form. Results: The study shows that out of 84 patients with ADR’s, 52 patients (61.9%) reported at least one ADR. 68 ADR’s (80.9%) were attributed to the tenofovir + lamivudine + efavirenz regimen. Most of the ADRs were from the system organ class of neurological disorders as 55 patients (65.4%) and 16 patients (19%) were having gastrointestinal ADR’s (19.44%) followed by Cutaneous ADR’s in 5 patients (5.9%). Causality assessment by WHO-UMC scale revealed most of the reactions as ‘possible’ (99.2%) while Naranjo scale assessed most of them as ‘probable’ (69.8%). Conclusion: Antiretroviral drugs have a huge potential for causing ADRs specially neurological and gastrointestinal. Active Pharmacovigilance is vital in recognizing such reactions to ensure timely management and optimal therapeutic outcomes.