PMID- 38182720 OWN - NLM STAT- MEDLINE DCOM- 20240108 LR - 20240210 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 14 IP - 1 DP - 2024 Jan 5 TI - Incidence and determinants of adverse events in individuals with HIV commencing Dolutegravir-based antiretroviral therapy in mainland Tanzania. PG - 615 LID - 10.1038/s41598-023-51144-7 [doi] LID - 615 AB - 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. CI - (c) 2024. The Author(s). FAU - Fimbo, Adam AU - Fimbo A AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Mwalwisi, Yonah H AU - Mwalwisi YH AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Mwamwitwa, Kissa AU - Mwamwitwa K AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Matiko, Damas AU - Matiko D AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Mfinanga, Elirehema AU - Mfinanga E AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Lyimo, Johnson AU - Lyimo J AD - World Health Organization, Dar Es Salaam, Tanzania. FAU - Sabasaba, Amon AU - Sabasaba A AD - Department of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Missago, Seth AU - Missago S AD - National Institute for Medical Research, Headquarters, Dar Es Salaam, Tanzania. FAU - Bukundi, Elias AU - Bukundi E AD - Department of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Gotora, Goodluck AU - Gotora G AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Respick, Dorice AU - Respick D AD - Department of Epidemiology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Nkayamba, Alex AU - Nkayamba A AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Masunga, Emmanuel AU - Masunga E AD - Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania. FAU - Mnkugwe, Rajabu Hussein AU - Mnkugwe RH AD - Department of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Kunambi, Peter P AU - Kunambi PP AD - Department of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Munishi, Castory AU - Munishi C AD - Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Musanhu, Christine Chiedza AU - Musanhu CC AD - World Health Organization, Dar Es Salaam, Tanzania. FAU - Minzi, Omary M S AU - Minzi OMS AD - Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. FAU - Mlugu, Eulambius M AU - Mlugu EM AD - Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. mlugusonlove@gmail.com. LA - eng GR - 001/WHO_/World Health Organization/International PT - Journal Article DEP - 20240105 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - DKO1W9H7M1 (dolutegravir) RN - 0 (Anti-Retroviral Agents) SB - IM MH - Aged MH - Humans MH - Incidence MH - Prospective Studies MH - Tanzania/epidemiology MH - *Anti-Retroviral Agents MH - *HIV Infections/drug therapy/epidemiology PMC - PMC10770041 COIS- The authors declare no competing interests. EDAT- 2024/01/06 10:41 MHDA- 2024/01/08 06:42 PMCR- 2024/01/05 CRDT- 2024/01/05 23:29 PHST- 2023/05/25 00:00 [received] PHST- 2023/12/31 00:00 [accepted] PHST- 2024/01/08 06:42 [medline] PHST- 2024/01/06 10:41 [pubmed] PHST- 2024/01/05 23:29 [entrez] PHST- 2024/01/05 00:00 [pmc-release] AID - 10.1038/s41598-023-51144-7 [pii] AID - 51144 [pii] AID - 10.1038/s41598-023-51144-7 [doi] PST - epublish SO - Sci Rep. 2024 Jan 5;14(1):615. doi: 10.1038/s41598-023-51144-7.