Efficacy, safety, and tolerability of dolutegravir-based ART regimen in Durban, South Africa: a cohort study.

Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

HIV Infections*/drug therapy ; HIV Integrase Inhibitors*/adverse effects ; Oxazines* ; Piperazines* ; Pyridones*; Adult ; Humans ; Cohort Studies ; Retrospective Studies ; South Africa ; Cross-Sectional Studies ; Heterocyclic Compounds, 3-Ring/adverse effects ; Anti-Retroviral Agents/therapeutic use

Background: Dolutegravir is an integrase strand transfer inhibitor that has been recommended for use in first-line antiretroviral regimens by the World Health Organisation and is currently being rolled out globally. There has been safety concerns with dolutegravir which has caused concern about its use in the general population. Dolutegravir first-line regimens have been used in South Africa since early 2020. Therefore, the aim of the present study was to assess the efficacy, safety, and tolerability of first-line dolutegravir-based antiretrovirals amongst adults living with HIV in Durban, South Africa.
Methods: This was a mixed-methods study, which comprised a cross-sectional survey and longitudinal retrospective follow-up of medical records. The study was conducted between October 2020 and January 2022. Data were described using descriptive and summary statistics. Bivariate logistic regression was applied to socio-demographic and clinical variables and crude odds ratios with a 95% confidence interval was calculated. Pearson chi-square tests, paired sample T-tests, and cross-tabulations were performed on selected variables.
Results: A total of 461 participants were enrolled in the study. There was a significant change in immunological outcomes (p < 0.001) after dolutegravir initiation. Furthermore, an assessment of laboratory parameters showed that there was a significant decrease in cholesterol (p < 0.001) and increase in creatinine (p < 0.001) levels. Increased weight was shown by 60.7% of the participants but was not associated with age, gender, CD4 counts, and previous antiretroviral usage. The study found that 43.6% of the participants experienced at least one side-effect. A total of 21.6% and 23.2% of the participants experienced neuropsychiatric and central nervous system side-effects, respectively. In the bivariate analyses, only gender was shown to be associated with side-effects, and only 1.7% of the participants discontinued the study due to side-effects.
Conclusion: Our results suggest that dolutegravir is effective, safe, and well tolerated in the study population.
(© 2024. The Author(s).)

Cureus. 2016 Mar 01;8(3):e515. (PMID: 27054050)
AIDS Res Hum Retroviruses. 2017 Dec;33(12):1181-1184. (PMID: 28793781)
EClinicalMedicine. 2019 Mar 18;9:26-34. (PMID: 31143879)
Radiol Technol. 2013 Jan-Feb;84(3):247-67; quiz p.268-70. (PMID: 23322863)
Clin Pharmacokinet. 2017 Jan;56(1):25-40. (PMID: 27317415)
PLoS One. 2013 Oct 16;8(10):e77448. (PMID: 24146996)
HIV Clin Trials. 2014 Sep-Oct;15(5):199-208. (PMID: 25350958)
Clin Infect Dis. 2020 Sep 12;71(6):1379-1389. (PMID: 31606734)
Expert Opin Drug Saf. 2015 Jan;14(1):141-7. (PMID: 25347230)
Drug Metab Dispos. 2013 Feb;41(2):353-61. (PMID: 23132334)
Clin Drug Investig. 2015 Mar;35(3):211-9. (PMID: 25637061)
BMC Infect Dis. 2014 Apr 04;14:181. (PMID: 24708645)
Adv Ther. 2021 Aug;38(8):4480-4504. (PMID: 34275116)
Expert Rev Anti Infect Ther. 2015;13(10):1195-212. (PMID: 26293294)
Clin Pharmacokinet. 2013 Nov;52(11):981-94. (PMID: 23824675)
J Antimicrob Chemother. 2017 Jun 1;72(6):1752-1759. (PMID: 28333231)
PLoS One. 2017 Oct 30;12(10):e0186557. (PMID: 29084275)
Expert Opin Pharmacother. 2015 Jun;16(9):1313-24. (PMID: 26001181)
S Afr Med J. 2016 Dec 21;107(1):28-30. (PMID: 28112085)
AIDS. 2017 Jun 19;31(10):1499-1500. (PMID: 28574967)
PLoS One. 2014 Sep 04;9(9):e105653. (PMID: 25188312)
AIDS. 2018 Jul 31;32(12):1551-1561. (PMID: 29746295)
Lancet HIV. 2018 Jul;5(7):e400-e404. (PMID: 29884404)
Br J Pharmacol. 2006 Dec;149(7):815-27. (PMID: 17043670)
Antimicrob Agents Chemother. 2013 Aug;57(8):3536-46. (PMID: 23669385)
J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):507-13. (PMID: 19730111)
J Antimicrob Chemother. 2019 Feb 1;74(2):473-479. (PMID: 30380053)
Infect Dis Ther. 2014 Dec;3(2):83-102. (PMID: 25134686)
J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):527-531. (PMID: 28825943)
BMC Infect Dis. 2019 Sep 5;19(1):775. (PMID: 31488063)
Lancet HIV. 2019 Feb;6(2):e116-e127. (PMID: 30503325)
Clin Infect Dis. 2020 Feb 3;70(4):549-556. (PMID: 30918967)
Clin Infect Dis. 2015 Jun 15;60(12):1852-9. (PMID: 25761868)
AIDS. 2017 Aug 24;31(13):1853-1858. (PMID: 28692533)
BMC Infect Dis. 2016 Jun 13;16:280. (PMID: 27296625)
HIV Med. 2017 Jan;18(1):56-63. (PMID: 27860104)
N Engl J Med. 2013 Nov 7;369(19):1807-18. (PMID: 24195548)
AIDS. 2016 Nov 28;30(18):2831-2834. (PMID: 27824625)
AIDS Rev. 2014 Oct-Dec;16(4):199-212. (PMID: 25350530)
J Virus Erad. 2019 Jan 1;5(1):41-43. (PMID: 30800425)

Keywords: Dolutegravir; Efficacy; HIV/AIDs; Integrase strand transfer inhibitors; Safety; Tolerability

DKO1W9H7M1 (dolutegravir)
0 (Heterocyclic Compounds, 3-Ring)
0 (Anti-Retroviral Agents)
0 (HIV Integrase Inhibitors)
0 (Oxazines)
0 (Piperazines)
0 (Pyridones)

Date Created: 20240322 Date Completed: 20240325 Latest Revision: 20240325

20250114

PMC10958909

10.1186/s12879-024-09202-6

38515041