Advanced search
1 file | 378.91 KB Add to list

Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV : results of a 96‐week, phase 3b, open‐label, switch trial in virologically suppressed people ≥65 years of age

Author
Organization
Abstract
Objectives Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is an effective treatment for HIV-1 infection; however, clinical trial data in older people living with HIV (PLWH) are lacking. The primary 24-week and secondary 48-week analyses of study GS-US-380-4449 (NCT03405935), which assessed the efficacy and safety of switching to B/F/TAF in older PLWH, have been published. Here we report the results of the final 96-week analyses from the study. Methods In this 96-week, phase 3b, open-label, single-arm trial, virologically suppressed PLWH aged >= 65 years switched from elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen to B/F/TAF. Viral suppression, resistance, immune response, safety, tolerability and adherence were evaluated through week 96. Results Of 90 participants screened, 86 were enrolled and switched to B/F/TAF. No participants had HIV-1 RNA >= 50 copies/ml (by FDA Snapshot algorithm) at weeks 72 or 96; virologic suppression rates were 94.2% (81/86; 95% CI 87.0-98.1) and 74.4% (64/86; 95% CI 63.9-83.2), respectively. No treatment-emergent resistance was observed, and CD4 counts remained stable. There were no study drug-related serious adverse events. Three participants experienced drug-related treatment-emergent adverse events that led to premature drug discontinuation. There were no clinically relevant changes from baseline to week 96 in fasting lipid parameters, and the median change in body weight at week 96 was 0.0 kg (IQR -2.3, 2.0). Median self-reported adherence was 100% (IQR 100-100%). Conclusions Switching to B/F/TAF is an effective long-term option for virologically suppressed adults >= 65 years of age, with favourable safety and tolerability profiles in this population.
Keywords
Pharmacology (medical), Infectious Diseases, Health Policy, age, bictegravir, clinical trial, emtricitabine, tenofovir alafenamide, TENOFOVIR DISOPROXIL FUMARATE, ANTIRETROVIRAL THERAPY, DOLUTEGRAVIR, BICTEGRAVIR, MULTICENTER, REGIMEN, EMTRICITABINE, POLYPHARMACY, ADHERENCE, B/F/TAF

Downloads

  • HIV Medicine - 2022 - Maggiolo - Bictegravir emtricitabine tenofovir alafenamide in older individuals with HIV Results of.pdf
    • full text (Published version)
    • |
    • open access
    • |
    • PDF
    • |
    • 378.91 KB

Citation

Please use this url to cite or link to this publication:

MLA
Maggiolo, Franco, et al. “Bictegravir/Emtricitabine/Tenofovir Alafenamide in Older Individuals with HIV : Results of a 96‐week, Phase 3b, Open‐label, Switch Trial in Virologically Suppressed People ≥65 Years of Age.” HIV MEDICINE, 2022, doi:10.1111/hiv.13319.
APA
Maggiolo, F., Rizzardini, G., Molina, J., Pulido, F., De Wit, S., Vandekerckhove, L., … Gallant, J. (2022). Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV : results of a 96‐week, phase 3b, open‐label, switch trial in virologically suppressed people ≥65 years of age. HIV MEDICINE. https://doi.org/10.1111/hiv.13319
Chicago author-date
Maggiolo, Franco, Giuliano Rizzardini, Jean‐Michel Molina, Federico Pulido, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, et al. 2022. “Bictegravir/Emtricitabine/Tenofovir Alafenamide in Older Individuals with HIV : Results of a 96‐week, Phase 3b, Open‐label, Switch Trial in Virologically Suppressed People ≥65 Years of Age.” HIV MEDICINE. https://doi.org/10.1111/hiv.13319.
Chicago author-date (all authors)
Maggiolo, Franco, Giuliano Rizzardini, Jean‐Michel Molina, Federico Pulido, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, Michelle L. D’Antoni, Christiana Blair, Susan K. Chuck, David Piontkowsky, Hal Martin, Richard Haubrich, Ian R. McNicholl, and Joel Gallant. 2022. “Bictegravir/Emtricitabine/Tenofovir Alafenamide in Older Individuals with HIV : Results of a 96‐week, Phase 3b, Open‐label, Switch Trial in Virologically Suppressed People ≥65 Years of Age.” HIV MEDICINE. doi:10.1111/hiv.13319.
Vancouver
1.
Maggiolo F, Rizzardini G, Molina J, Pulido F, De Wit S, Vandekerckhove L, et al. Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV : results of a 96‐week, phase 3b, open‐label, switch trial in virologically suppressed people ≥65 years of age. HIV MEDICINE. 2022;
IEEE
[1]
F. Maggiolo et al., “Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV : results of a 96‐week, phase 3b, open‐label, switch trial in virologically suppressed people ≥65 years of age,” HIV MEDICINE, 2022.
@article{8758913,
  abstract     = {{Objectives Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is an effective treatment for HIV-1 infection; however, clinical trial data in older people living with HIV (PLWH) are lacking. The primary 24-week and secondary 48-week analyses of study GS-US-380-4449 (NCT03405935), which assessed the efficacy and safety of switching to B/F/TAF in older PLWH, have been published. Here we report the results of the final 96-week analyses from the study. Methods In this 96-week, phase 3b, open-label, single-arm trial, virologically suppressed PLWH aged >= 65 years switched from elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen to B/F/TAF. Viral suppression, resistance, immune response, safety, tolerability and adherence were evaluated through week 96. Results Of 90 participants screened, 86 were enrolled and switched to B/F/TAF. No participants had HIV-1 RNA >= 50 copies/ml (by FDA Snapshot algorithm) at weeks 72 or 96; virologic suppression rates were 94.2% (81/86; 95% CI 87.0-98.1) and 74.4% (64/86; 95% CI 63.9-83.2), respectively. No treatment-emergent resistance was observed, and CD4 counts remained stable. There were no study drug-related serious adverse events. Three participants experienced drug-related treatment-emergent adverse events that led to premature drug discontinuation. There were no clinically relevant changes from baseline to week 96 in fasting lipid parameters, and the median change in body weight at week 96 was 0.0 kg (IQR -2.3, 2.0). Median self-reported adherence was 100% (IQR 100-100%). Conclusions Switching to B/F/TAF is an effective long-term option for virologically suppressed adults >= 65 years of age, with favourable safety and tolerability profiles in this population.}},
  author       = {{Maggiolo, Franco and Rizzardini, Giuliano and Molina, Jean‐Michel and Pulido, Federico and De Wit, Stephane and Vandekerckhove, Linos and Berenguer, Juan and D'Antoni, Michelle L. and Blair, Christiana and Chuck, Susan K. and Piontkowsky, David and Martin, Hal and Haubrich, Richard and McNicholl, Ian R. and Gallant, Joel}},
  issn         = {{1464-2662}},
  journal      = {{HIV MEDICINE}},
  keywords     = {{Pharmacology (medical),Infectious Diseases,Health Policy,age,bictegravir,clinical trial,emtricitabine,tenofovir alafenamide,TENOFOVIR DISOPROXIL FUMARATE,ANTIRETROVIRAL THERAPY,DOLUTEGRAVIR,BICTEGRAVIR,MULTICENTER,REGIMEN,EMTRICITABINE,POLYPHARMACY,ADHERENCE,B/F/TAF}},
  language     = {{eng}},
  pages        = {{10}},
  title        = {{Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV : results of a 96‐week, phase 3b, open‐label, switch trial in virologically suppressed people ≥65 years of age}},
  url          = {{http://dx.doi.org/10.1111/hiv.13319}},
  year         = {{2022}},
}

Altmetric
View in Altmetric
Web of Science
Times cited: