Prevalence and factors associated with adverse drug reactions among patients on highly active antiretroviral therapy at a tertiary hospital in south western Uganda: A cross-sectional study

Abstract

Background: HIV/AIDS remains a global health challenge, with significant prevalence in sub-Saharan Africa. Highly active antiretroviral therapy (HAART) is the mainstay treatment for HIV, and the number of people living with HIV (PLWHIV) on HAART has considerably increased worldwide. The use of HAART has led to improved patient outcomes; however, it is associated with adverse drug reactions (ADRs) and drug-drug interactions (DDIs), which pose serious concerns in the management of patients with HIV. The aim of the study was to determine the prevalence and factors associated with ADRs among patients on HAART. Methodology: This was a hospital-based cross-sectional study carried out among 312 HIV patients on HAART attending HIV clinics at Mbarara Regional Hospital. Data was collected using an interviewer-administered, semi-structured questionnaire and a review of patient charts. ADRs were assessed for causality and categorized using Naranjo ADR assessment scale into probable, possible and definite, for severity using the modified Hartwig and Siegel criteria into mild, moderate and Severe, and for preventability using Schumock and Thornton criteria into definite, probable and non-preventable. Lexicomp® Drug Interaction Checker software was used to identify and rate clinically significant drug-drug interactions The prevalence of ADRs and potential DDI was analyzed using descriptive statistics while logistic regression analysis was used to establish the association of variables. Results: 312 patients were interviewed and their records reviewed. The prevalence of ADRs during this study was 76.0%. On assessment, 78.3% of the ADRs were mild and 76.6% of ADRs were definitely preventable. CD4 count below 200 cells/mm3 (AOR = 1.00, 95% CI: 1.00– 1.02; p value = 0.04), primary education level (AOR = 3.27, 95% CI: 1.34–7.95; p value = 0.009), and secondary education level (AOR = 3.64, 95% CI: 1.39–9.52; p value = 0.009) were identified as independent risk factors. Patients who experienced a significant DDI were 5.66 times more likely to experience an ADR (p value = 0.02, 95% CI: 1.32–24.18). Conclusion: There is a high prevalence of adverse drug reactions among patients with HIV on HAART. Low CD4 count and lower education levels are risk factors for ADRs in this population; therefore, tailored interventions to these subgroups should be implemented for early ADR identification and management. Significant drug-drug interactions are highly associated with the occurrence of ADRs among HIV patients on HAART, which calls for intensified pharmacovigilance and pharmaceutical care in this population.