Incidence and determinants of adverse events in individuals with HIV commencing Dolutegravir-based antiretroviral therapy in mainland Tanzania

Tanzania adopted a Dolutegravir (DTG)-based regimen as first-line treatment in 2019 following the World Health Organization recommendation. Data on the DTG safety profile from sub-Saharan Africa including Tanzania are limited. We investigated the incidence of DTG-related adverse events (AEs) and ass...

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Bibliographic Details
Published in:	Scientific reports Vol. 14; no. 1; p. 615
Main Authors:	Fimbo, Adam, Mwalwisi, Yonah H., Mwamwitwa, Kissa, Matiko, Damas, Mfinanga, Elirehema, Lyimo, Johnson, Sabasaba, Amon, Missago, Seth, Bukundi, Elias, Gotora, Goodluck, Respick, Dorice, Nkayamba, Alex, Masunga, Emmanuel, Mnkugwe, Rajabu Hussein, Kunambi, Peter P., Munishi, Castory, Musanhu, Christine Chiedza, Minzi, Omary M. S., Mlugu, Eulambius M.
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 05-01-2024 Nature Publishing Group Nature Portfolio
Subjects:	692/699/255/1901 692/699/255/2514 Adverse events Aged Anti-Retroviral Agents Antiretroviral agents Antiretroviral therapy HIV HIV Infections - drug therapy HIV Infections - epidemiology Human immunodeficiency virus Humanities and Social Sciences Humans Incidence multidisciplinary Prospective Studies Science Science (multidisciplinary) Statistical analysis Tanzania - epidemiology Tanzania
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Summary:	Tanzania adopted a Dolutegravir (DTG)-based regimen as first-line treatment in 2019 following the World Health Organization recommendation. Data on the DTG safety profile from sub-Saharan Africa including Tanzania are limited. We investigated the incidence of DTG-related adverse events (AEs) and associated factors among people living with HIV (PLHIV) initiated on a DTG regimen. A prospective cohort study was conducted from 25 Care and Treatment Clinics in mainland Tanzania. PLHIV aged 12 years and above who were initiated on a DTG-based regimen were actively followed up for three months. The Cox regression model was used to determine the predictors of occurrence of AEs over time. A p -value of 0.05 was considered statistically significant. From January 2020 to June 2022, a cohort of 935 participants who were both newly diagnosed and ART-experienced who transitioned to a DTG-based regimen was enrolled. Out of 935 participants, 59 (6.3%) reported a total of 62 AEs. The most frequently experienced AE was skin itching and rashes (15/62; 24.2%). DTG-associated neuropsychiatric AEs were less common and included headache (6 [9.6%]) and sleep disturbances (3 [4.8%]). The overall incidence of occurrence of the first AEs was 96.7 per 1000 person-months [95% C.I: 74.4–125.7] with the highest incidence observed among the elderly (≥ 60 years). Individuals on WHO HIV Clinical Stage 2 had a 2.7 significantly higher risk of developing AEs (adjusted hazard ratio = 2.73, 95% CI = 1.46–5.12, p = 0.017). We report a low incidence of grade I (mild) and grade II (moderate) DTG-associated AEs suggesting that the regimen is generally safe in the population. Continued monitoring of DTG safety in the population is recommended.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2045-2322 2045-2322
DOI:	10.1038/s41598-023-51144-7