Prevalence of neuropsychiatric adverse events and associated factors among adult patients on Dolutegravir attending Mulago ISS clinic.

Abstract

Introduction: Dolutegravir (DTG) is a second-generation integrase strand transfer inhibitor that is recommended by World Health Organization for use as the preferred first line and second line anti-retroviral regimen in HIV infected patients. In 2018, Uganda started using DTG-based regimens as the preferred first line antiretroviral therapy. However, there have been increased concerns regarding the potential neurotoxicity of DTG. There is limited data in Uganda on the occurrence of neuropsychiatric adverse events and the associated factors among adult patients who are initiated or switched to a DTG based first line or second line anti-retroviral regimen. Objective: This study aimed to determine the prevalence of neuropsychiatric adverse events (NPAEs) among adult patients on DTG and the factors associated with the occurrence of NPAEs. Methods: A Cross-sectional study was conducted using questionnaires administered by a trained research assistant between 15 November 2021 and 15 December 2021. The study included HIV positive patients aged 18 years above who were either initiated or switched to a DTG based antiretroviral therapy (ART) regimen between 1 January 2018 and 31 October 2021. Data was collected from 892 participants attending Mulago ISS clinic after informed consent was obtained. Data was collected on age, sex, marital status, disclosure status, current regimen, duration on ART, concurrent illness, concurrent medications, Year of switch to DTG, duration on DTG, whether the onset of NPAEs was immediate or delayed, history of alcohol or smoking use, level of education, report of NPAEs while on DTG, history of NPAE while on previous regimen. Data was entered into Epidata Version 4.6.0.2 then exported to Stata version 14 for analysis. Results: Of the 892 adults on DTG attending Mulago ISS clinic, 41.7% (95%CI: 38.5 – 44.9%) experienced at least one NPAE. DTG duration in years (aPR= 1.21, p = 0.024), disclosure status (aPR= 1.40, p = 0.042), concurrent medications (aPR= 1.31, p = 0.026), year of switch to DTG and concurrent illness were the covariates associated with increased occurrence of NPAEs. xii Conclusions: The prevalence of NPAEs was found to be higher than that reported by any randomised clinical trial. About 9.1% of the participants experienced severe to life threatening NPAEs that required intervention of a health care professional to ensure better tolerability. The high prevalence found requires that clinicians carryout screening for NPAEs at very visit and reassure the patients in order to maximize the benefits of long term ART.