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Clinical Trial
. 2023 Jan;24(1):27-36.
doi: 10.1111/hiv.13319. Epub 2022 May 8.

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

Franco Maggiolo  1 , Giuliano Rizzardini  2   3 , Jean-Michel Molina  4 , Federico Pulido  5 , Stephane De Wit  6 , Linos Vandekerckhove  7 , Juan Berenguer  8 , Michelle L D'Antoni  9 , Christiana Blair  9 , Susan K Chuck  9 , David Piontkowsky  9 , Hal Martin  9 , Richard Haubrich  9 , Ian R McNicholl  9 , Joel Gallant  9
Affiliations
Clinical Trial

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

Franco Maggiolo et al. HIV Med. 2023 Jan.

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: age; bictegravir; clinical trial; emtricitabine; tenofovir alafenamide.

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Conflict of interest statement

FM reports advisory board fees from Gilead, ViiV, MSD and Janssen, and institutional grant support from Janssen, MSD and ViiV, outside the submitted work. GR reports personal fees from ViiV, Gilead and MSD, outside the submitted work. J‐MM reports grants from Gilead and personal fees from Gilead, Sanofi, Merck, ViiV and Aelix, outside the submitted work. FP reports payment to his institution from Gilead during the conduct of the study, personal fees and non‐financial support from Gilead, grants and personal fees from Janssen, personal fees from MSD, and personal fees and non‐financial support from ViiV, outside the submitted work. SDW reports grants from Gilead during the conduct of the study, and grants from Gilead, Janssen, MSD and ViiV, outside the submitted work. LV has nothing to disclose. JB reports personal fees from Janssen, and grants and personal fees from Gilead, MSD and ViiV, outside the submitted work. MLD'A, CB, SKC, DP, HM, RH, IRM and JG are employed by Gilead and hold stocks in Gilead.

Figures

FIGURE 1
FIGURE 1
Participant disposition
FIGURE 2
FIGURE 2
Virologic suppression at weeks 72 and 96 (FDA Snapshot analysis; full analysis set, N = 86). Values shown as percentage of participants (95% CI). FDA, Food and Drug Administration
FIGURE 3
FIGURE 3
Changes in (a) estimated glomerular filtration rate calculated by the Cockcroft–Gault equation* and (b) fasting lipids and glucose at week 96 (safety analysis set). *Creatinine samples analysed on or after 1 July 2018 were from a new calibrator; the corrected values are summarized. HDL, high‐density lipoprotein; IQR, interquartile range; LDL, low‐density lipoprotein
See this image and copyright information in PMC

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