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Evaluation of the Adverse Effects of TenofovirLamivudine-Dolutegravir Combination Regimen in People Living with HIV in Sierra-Leone

Sikiru O. Usman(1), Timothy F. Kamara(2), AbdulWasiu A. Busari(3), Ibrahim A. Oreagba(4), Esther O. Agbaje(5),


(1) Department of Pharmacology, Therapeutics and Toxicology, Faculty of Basic Medical Science, College of Medicine of the University of Lagos, Lagos State, Nigeria. Pharmacovigilance Department, African Centre of Excellence for Drugs Research, Herbal Medicine Development and Regulatory Service
(2) Pharmacovigilance Department, African Centre of Excellence for Drugs Research, Herbal Medicine Development and Regulatory Service
(3) Basic Medical Science, College of Medicine of the University of Lagos, Lagos State, Nigeria.
(4) Basic Medical Science, College of Medicine of the University of Lagos, Lagos State, Nigeria. Pharmacovigilance Department, African Centre of Excellence for Drugs Research, Herbal Medicine Development and Regulatory Service
(5) Basic Medical Science, College of Medicine of the University of Lagos, Lagos State, Nigeria. Pharmacovigilance Department, African Centre of Excellence for Drugs Research, Herbal Medicine Development and Regulatory Service
Corresponding Author

Abstract


Background: Dolutegravir-based antiretroviral regimen is one of the highly effective antiretroviral therapies that were introduced recently for the treatment of HIV in SierraLeone. However, its adverse effects have not been fully elucidated in patients living with HIV in Sierra-Leone. 

Objectives: This study aimed to evaluate the adverse effects of tenofovir/lamivudine/dolutegravir (TDF/3TC/DTG) in patients living with HIV in Sierra-Leone.

Methods: This is a retrospective study involving the review of charts reporting adverse drug effects (ADEs) to TDF/3TC/DTG from five Hospitals in Freetown, between 1st July 2021 and 30th June 2024, for participants above 18 years. Patient’s case files were used as main sources of data collection. These ADEs were analyzed using SPSS version 27 for the type of reactions, body systems involvement, and severity of the reaction, interventions used in the management of the ADEs and the risk factors for ADEs to TDF/3TC/DTG. 

Results: The ADEs of TDF/3TC/DTG were reported in 132 of the participants giving a prevalence of 35.5 %. They were mild or moderate and were mostly anorexia (29; 7.9%), insomnia (25; 6.8%), vomiting (24; 6.5%), and pruritus (2, 0.5%). 

Conclusion: Dolutegravir-based antiretroviral regimen of tenofovir-lamivudinedolutegravir combination was well tolerated among adult patients living with HIV in Sierra-Leone. The adverse events reported were few and mild and occurred in less than half of the participants. However, futher studies are required to investigate the safety of the regimen in children and pregnant women.

Keywords


Adverse drug events, Tenofovir-lamivudine-dolutegravir, HIV, Sierra-Leone

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