Assessing the economic implications of managing adverse drug reactions from Dolutegravir based therapy that require long-term management in Infectious Diseases Institute Mulago : a cost of illness study

Abstract

Introduction: Dolutegravir (DTG)-based antiretroviral therapy (ART) is the World Health Organization’s recommended first-line regimen for people living with HIV (PLWHIV). Despite its clinical advantages, DTG has been associated with adverse drug reactions (ADRs), particularly diabetes mellitus (DM) and hypertension (HTN), which may require long-term management. These ADRs not only affect patient health but also place an economic burden on health systems. However, limited data exists on the cost implications of managing such ADRs in Uganda. Objective: This study aimed to determine the direct healthcare costs associated with managing long-term ADRs linked to DTG-based therapy and assess their budgetary impact on the Infectious Diseases Institute (IDI), Mulago. Methods: A cross-sectional design was employed using quantitative data extracted from the Integrated Clinic Enterprise Application (ICEA) and patient files at IDI. A sample of 144 patients on DTG-based therapy who developed long-term ADRs was selected using simple random sampling. A micro-costing approach estimated the direct medical costs, and a Markov model projected the five-year budget impact. Sensitivity analysis assessed cost variations under different prevalence scenarios. Results: Among the 144 patients reviewed, 60.4% had diabetes mellitus and 39.6% had hypertension. The most frequently used medications were Metformin for DM and Amlodipine for HTN. The annual direct cost of managing these ADRs was USD 4,086.91, with an average of USD 31.73 per diabetic patient and USD 23.26 per hypertensive patient. The five-year projected budget impact was USD 90,669.48, rising to USD 734,345 in worst-case scenario analysis. Conclusion: These study findings suggest a possible metabolic syndrome pattern linked to DTG-based ART. Also, the results of the study show that the costs of management of these ADRs impose a significant financial burden on ART clinics. These therefore call for the need for more stringent clinical monitoring of patients on DTG-based ART, as well as proper allocation of a proportion of clinics’ budgets to account for these costs.