Prevalence and Patterns of Adverse Drug Events Among Adult Patients with Human Immune Virus Infection on Dolutegravir-Based Antiretroviral Drug Regimens in Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-Up Study.

BACKGROUND: Antiretroviral therapy (ART) refers to any HIV treatment that uses a combination of two or more drugs to suppress viral load and preserve immunofunction. Despite the success of ART, adverse events persist, in particular in patients with baseline viral loads >100,000 copies/mL. Apart from premarketing surveillance, the safety and risk profile of dolutegravir has not been thoroughly researched in Ethiopia. Therefore, this study aimed to assess the prevalence and patterns of adverse drug events among HIV-infected adult patients on dolutegravir-based ART regimens at Amhara comprehensive specialized hospitals, northwest Ethiopia.

METHODS: A retrospective follow-up study was conducted from January 1, 2019 to December 31, 2021 at Amhara comprehensive specialized hospitals, with a sample size of 423. Simple random sampling was employed and data collected using kobo tool box software by four trained BSc nurses from March to April, 2022. SPSS 25 was used for analysis. Descriptive summary statistics are used and data presented using tables and text.

RESULTS: A total of 372 patient charts were included in the final analysis, and the prevalence of adverse events associated with dolutegravir was found to be 37.6% (95% CI 32.1%-42.1%). Nearly two-thirds (60.7%) of the participants had neuropsychiatric symptoms, followed by gastrointestinal symptoms (23.6%) and hepatic problems (7.14%). All recorded adverse events were mild.

CONCLUSION: Dolutegravir adverse events were relatively low compared to previous studies. Common adverse events reported were neuropsychiatric symptoms and gastrointestinal symptoms, followed by hepatic and renal events. All adverse events were mild and none was severe or life-threatening events. Therefore, we recommend the use of dolutegravir in clinical settings.