Prevalence, associated factors and management of suspected adverse drug reactions among patients taking dolutegravir in Uganda

Abstract

In 2018, Uganda introduced a newer first-line Antiretroviral Therapy (ART) medicines approved by the World Health Organization (WHO)-Dolutegravir (DTG). The ambitious roll-out of these HIV treatment strategies was not followed by equally aggressive pharmacovigilance systems in Uganda. Adverse Drug Reactions (ADRs) related to ART have been associated with morbidity and mortality in patients. The objective of the study was to determine the prevalence, associated factors and describe the management of suspected adverse drug reactions among patients taking DTG-based regimens in Uganda. A cross-sectional study was conducted six health facilities in northern and western Uganda following ethical approval from Makerere University School of Health Sciences Research and Ethics Committee. Between May and September 2022, 621 People Living with HIV (PLHIV) aged 18 years and older who had been on DTG regimens for at least a year were recruited into the study. Questionnaires and abstraction checklists were used for data collection. Factors associated with ADRs were assessed using logistic regression. The prevalence of suspected ADR was 18% (109/621; 95% CI: 15% - 21%). The independent variables associated with suspected ADRs were history of allergies (OR=6.72, p<0.001, 95% CI [3.97 – 11.38), ability to take medicines in a good way (OR=4.99, p<0.001, 95% CI [3.19 – 7.82) and problems with DTG treatment (OR:44.98, p<0.001, 95% CI [25.42 – 79.58]). 61% (73/120) were reassured after reporting ADR and 48% (54/113) reported that their ADR resolved. At least half 55% (143/261) did not have their baseline blood glucose screened at the time of initiation on DTG. The prevalence of suspected ADR in patients receiving dolutegravir-based ART was 18%, which is much lower than previously reported. The management of patients who experience suspected ADRs is inadequate. The policy makers need to foster interventions for PLHIV taking DTG regimens aimed at increasing ADR detection and management.