Patients reported neuropsychiatric adverse events and associated factors among PLHIV patients receiving DTG-based regimen antiretroviral therapy real-life clinical practice in Ethiopia: multi center crossetional study

Abstract

Background: Dolutegravir-based antiretroviral therapy has established itself as a key component for treating individuals with HIV. In reality, clinical settings in resource-poor areas like Ethiopia often face difficulties when using dolutegravir-based treatment due to neuropsychiatric side effects, which can not only reduce the therapy's effectiveness but also lead to non-adherence, switching, diminished therapeutic outcomes and discontinuation. This research aimed to determine the prevalence and factors related to neuropsychiatric side effects among people living with HIV who recently began receiving Dolutegravir-based Antiretroviral Therapy in real-life clinical settings in Ethiopia.

Method: A multicenter cross-sectional study was conducted from December 1, 2023, to August 30, 2023, peoples with HIV who were initiating a Dolutegravir-based regimen for the first time. Data collection was conducted using a structured questionnaire designed to gather sociodemographic, clinical characteristics, and neuropsychiatric adverse effects from patient interviews and medical records. Bivariate and multivariate analyses were employed to identify variables significantly associated with neuropsychiatric adverse events, with P-value of ≤ 0.05.

Results: A total of 620 participants were included in the analysis, revealing a 28.3% prevalence of neuropsychiatric adverse events. The most commonly reported events were depression, insomnia, and aggressive mood. Being female [AOR = 1.72], age between 47 and 54 years [AOR = 3.8] and 55-75 years [AOR = 1.27], unemployment status [AOR = 1.35], lack of physical activity [AOR = 3.6], and minimal of physical activity [AOR = 2.4], duration since DTG-based regimen initiation, 6-12 months[AOR = 3.35], and 13-24 months [AOR = 2.67], WHO clinical stage II [AOR = 3.65], III and IV [AOR = 4.21], Detectable viral load level at the start therapy [AOR = 1.24 (1.97.6-2.05)] were significantly associated with neuropsychiatric adverse events.

Conclusion: Being female, aged 47-75 years, unemployed, engaged in minimal or no physical activity, having a treatment duration of 6-24 months, advanced disease stage (WHO stage II-IV) and had a detectable viral load at the start of therapy. Monitoring these groups for neuropsychiatric adverse events is essential to facilitate timely interventions and improve patient outcomes.

Keywords: Antiretroviral therapy; Ethiopia; Neuropsychiatric adverse events; PLHIV dolutegravir based regimen.

Fig. 1

Schematic presentation of the sampling procedure for assessing neuropsychiatric adverse events to initiating DTG-based regimen among PLHIV, 2023 (n = 620)

Fig. 2

Prevalence of NPAEs among PLHIV on the DTG-based regimen, 2023 (n = 620)