Prevalence and factors associated with adverse drug events among patients on dolutegravir‑based regimen at the Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: a mixed design study
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
AIDS Research and Therapy
Abstract
In low income countries such as Uganda progress has been made towards achieving the United
Nations AIDS programme 95-95-95 target however efforts are still impeded by pretreatment drug resistance and
adverse drug events (ADEs) hence introduction of dolutegravir-based antiretroviral therapy as first-line treatment
due to a higher genetic barrier to resistance, better tolerability and safety profile. However, recent studies have raised
concerns regarding its safety in real-clinical settings due to ADEs and being a recently introduced drug there is need
to actively monitor for ADEs, hence this study aimed to establish the prevalence and factors associated with ADEs
among patients on dolutegravir-based regimen at the Immune Suppression Syndrome (ISS) Clinic- Mbarara Regional
Referral Hospital (MRRH).
Methods: A mixed design study was conducted at ISS Clinic-MRRH among 375 randomly selected patients who
had been exposed to DTG-based regimen for at-least 12 weeks. These were interviewed to obtain data on sociodemographics,
dietary habits and their files reviewed for ADEs. Data entry was done using Epi-data 3.0 and exported
to SPSS 25.0 for analysis. Prevalence was determined as a percentage, and ADE associated factors assessed using
bivariate analysis, those found significant were further subjected to multivariate analysis and considered significant at
P < 0.05.
Results: The prevalence of ADEs among patients on DTG-based regimen was found to be 33.1% (124/375) with 5.6%
(7/124) participants discontinued from treatment due ADEs, 4 due to hyperglycemia and 3 liver toxicity. The commonly
experienced ADE was allergy at 36.3%. Male sex (AOR 1.571, 95% CI 1.433–1.984), WHO stage one at entry to
care (AOR 4.586, 95% CI 1.649–12.754), stage two (AOR 4.536, 95% CI 1.611–12.776), stage three (AOR 3.638, 95% CI
1.262–10.488), were significantly associated with ADEs. Patients with undetectable viral load at initiation of DTG-based
regimen were 67.6% less likely to experience ADEs (AOR = 0.324, 95% CI 0.1167–0.629). Conclusion: This study reports a prevalence of 33.1% of ADEs among patients on DTG-based regimen. The most
commonly experienced ADE was allergy. Male sex, early HIV disease stage at entry into care and detectable viral load
at initiation of DTG-based regimen
Description
Keywords
Dolutegravir-based, Adverse drug events, HIV, Uganda
Citation
Namulindwa, A., Wasswa, J. H., Muyindike, W., Tamukong, R., & Oloro, J. (2022). Prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: a mixed design study. AIDS Research and Therapy, 19(1), 1-8. https://doi.org/10.1186/s12981-022-00442-7