Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials
Issued Date
2023-03-01
Resource Type
ISSN
14642662
eISSN
14681293
Scopus ID
2-s2.0-85136240517
Pubmed ID
36912172
Journal Title
HIV Medicine
Volume
24
Issue
3
Start Page
290
End Page
300
Rights Holder(s)
SCOPUS
Bibliographic Citation
HIV Medicine Vol.24 No.3 (2023) , 290-300
Suggested Citation
Avihingsanon A., Chetchotisakd P., Kiertiburanakul S., Ratanasuwan W., Siripassorn K., Supparatpinyo K., Martin H., Wang H., Wong T.H., Wang H.Y. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Medicine Vol.24 No.3 (2023) , 290-300. 300. doi:10.1111/hiv.13386 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/82395
Title
Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials
Author's Affiliation
Siriraj Hospital
Faculty of Medicine, Chiang Mai University
Faculty of Medicine, Khon Kaen University
The HIV Netherlands Australia Thailand Research Collaboration
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Gilead Sciences Incorporated
Faculty of Medicine, Chulalongkorn University
Gilead Sciences
Gilead Sciences
Bamrasnaradura Infectious Diseases Institute
Faculty of Medicine, Chiang Mai University
Faculty of Medicine, Khon Kaen University
The HIV Netherlands Australia Thailand Research Collaboration
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Gilead Sciences Incorporated
Faculty of Medicine, Chulalongkorn University
Gilead Sciences
Gilead Sciences
Bamrasnaradura Infectious Diseases Institute
Other Contributor(s)
Abstract
Objectives: Data on switching to bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed Asian people living with HIV are limited. We performed a pooled analysis of virologically suppressed Asian participants from three international phase III trials to evaluate the efficacy and safety of switching to B/F/TAF. Methods: Virologically suppressed people living with HIV were randomized to switch to B/F/TAF or to stay on baseline regimens. The primary endpoint was the proportion of participants with plasma HIV-1 RNA ≥50 copies/ml at week 48. We analysed the incidence of adverse events (AEs), laboratory abnormalities, and changes in relevant tolerability parameters through 48 weeks. Results: Overall, 136 Asian participants were included. The proportions of participants with plasma HIV-1 RNA ≥50 copies/ml at week 48 were low in both arms (0% for B/F/TAF vs 1.4% for those who stayed on baseline regimens). Those who switched to B/F/TAF had virological suppression rates similar to those who stayed on baseline regimens (100% vs 95.9%, p = 0.2485), with no treatment-emergent resistance. Drug-related AEs occurred in three participants in each arm; none were serious. No participants discontinued the study drug because of AEs, and no deaths were observed. No significant differences were observed between the arms in the median changes in estimated glomerular filtration rate, body weight, and most lipid parameters. Switching from tenofovir disoproxil fumarate-containing regimens to B/F/TAF resulted in a significant decrease in tubular proteinuria compared with those who stayed on baseline regimens (p < 0.01). Conclusions: Virologically suppressed Asian people living with HIV who switched to B/F/TAF maintained 100% virological suppression at week 48, with no treatment-emergent drug resistance and safety profiles comparable to those seen in people who stayed on baseline regimens. Clinical Trial Number: ClinicalTrials.gov (NCT02603120, NCT02652624, and NCT02603107).