Prevalence and Factors Associated With Adverse Drug Events Among Patients On Dolutegravir-Based Regimen At The Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: A Retrospective Cross-Sectional Study.

Abstract

Background: Highly Active Antiretroviral Therapy is efficacious in suppression of Human Immunodeficiency Virus (HIV) however; it is associated with numerous toxicities hence great effort has been put into development of antiretrovirals with better tolerability. The World Health Organization recommended dolutegravir as first-line antiretroviral therapy however, recent studies have raised concerns regarding its safety in real-clinical settings due to adverse drug reactions (ADEs). Hence the purpose of this study was to establish the prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome (ISS) Clinic- Mbarara Regional Referral Hospital (MRRH). Methods: A retrospective cross-sectional study was conducted at ISS Clinic-MRRH among 375 randomly selected patients who had been exposed to DTG-based regimen for at least 12 weeks. The patients were interviewed to obtain data on socio-demographics, dietary habits and thereafter their files reviewed to obtain data on ADEs. Data entry was done using Epi-data 3.0 and exported to SPSS version 25.0 for analysis. The prevalence of ADEs was determined as a percentage, and ADE associated factors were assessed using bivariate analysis, those found significant were further subjected to multivariate logistic regression model and were considered significant at P<0.05. Results: The prevalence of adverse drug events among patients on DTG-based regimen was found to be 33.1% (124/375) with 5.6% (7/124) participants discontinued from treatment due ADEs, 4 of which were due to hyperglycemia and 3 due to liver toxicity. The commonly experienced ADEs included abdominal pain, hyperglycemia and liver toxicity each at 7.3%, headache at 11.3%, and allergy at 36.3%. Male sex (AOR 1.571, 95% CI 1.433- 1.984), WHO stage one at entry to care (AOR 4.586, 95% CI 1.649-12.754), stage two (AOR 4.536, 95% CI 1.611-12.776), stage three (AOR 3.638, 95% CI 1.262-10.488), were significantly associated with ADEs. Patients with undetectable viral load at initiation of DTG-based regimen were 60 less likely to experience ADEs (AOR = .324, 95% CI .1167-.629). Conclusions: Up to a third of patients on DTG-based regimen experienced ADEs. Male sex, WHO HIV disease stage and a detectable viral load at initiation of DTG-based regimen were significantly associated with ADEs. It is crucial to actively monitor patients with these characteristics for ADEs.