Antiretroviral adverse drug events reported among adult HIV patients in a Nigerian tertiary hospital: A retrospective study

Background: The use of Highly Active Antiretroviral Therapy (HAART) has changed HIV/AIDS from a near-certainly fatal illness to one that can be managed chronically. A significant constraint of HAART is the high prevalence of adverse drug events (ADE) among HIV patients taking them.

Objectives: The study determined the frequency and severity of reported antiretroviral adverse events among HIV-infected adults (≥16 years) at the Institute of Human Virology (IHV) Clinic of Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria, within five years. Antiretroviral therapies implicated in the reported adverse drug events were also determined.

Method: Information on reported ADEs was extracted from the NAFDAC Pharmacovigilance forms in the Pharmacovigilance section of the IHV Clinic Pharmacy. The severity of ADEs was classified using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index for categorizing errors.

Results: A hundred and nineteen (119) patients reported 161 ADEs within the 5-year study period (2017-2021). Most ADE reports came from females (74.53%) and patients 36-55 years old. Dizziness (31.1%), Rashes (14.3%), and Fatigue (13.0%) were prominent among all the ADE reports documented. TDF/3TC/EFV (57.8%) and AZT/3TC/NVP (11.8 %) combinations were the frequently implicated antiretroviral regimen. All the ADEs reported were mild (Category ‘E’). ADE reports appreciated in the second year and progressively declined afterwards.

Conclusion: There is a need to improve the system for antiretroviral ADE reporting through sensitization and developing a specific tool that enhances ADE reports from patients and healthcare providers.