547. Results of Patient-Reported Outcome Data from the Phase III BRIGHTE Study of Fostemsavir
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Thursday, October 4, 2018
Room: S Poster Hall
Posters
  • IDWeek 2018_Ackerman_BRIGHTE PRO.pdf (153.8 kB)
  • Background: The phase 3 BRIGHTE study evaluated fostemsavir in heavily treatment experienced HIV-1 patients failing their current antiretroviral (ARV) regimen and unable to construct a viable regimen from remaining available agents. Week 24 efficacy and safety have been previously reported - fostemsavir resulted in virological and immunological improvements and was generally well-tolerated. The objective of this abstract is to report analyses of patient-reported outcomes (PROs) from BRIGHTE.

    Methods: BRIGHTE included two cohorts: the randomized cohort (RC) had 1 - 2 classes of ARV therapy available; the non-randomized cohort (NRC) had no ARV classes available. RC patients received fostemsavir or placebo + existing failing regimen for 8 days, and thereafter fostemsavir + optimised background therapy (OBT); NRC received fostemsavir + OBT throughout. PROs included the Functional Assessment of HIV Infection (FAHI), the EuroQol-5D-3L (EQ-5D) and associated visual analogue scale (VAS).

    Results: Both cohorts had advanced disease, low CD4 counts (median of 99.5 in RC and 41 in NRC) and high proportions of patients with AIDS (84% in RC and 90% in NRC). This was reflected in fairly low baseline FAHI scores. Improvements from baseline to week 24 were observed in FAHI total score, physical well-being and emotional well-being subscales, with limited/no change in function/ global well-being, social well-being and cognitive function. Improvements in the RC were close to published values for minimum clinically important differences, with smaller improvements in the NRC. EQ-5D utilities were similar at Week 24 to baseline in both cohorts, with improvements in the EQ-5D VAS (11% in the RC, 8% in the NRC).

    FAHI

    EQ-5D

    Cohort

    Total score

    Physical Well-being

    Emotional Well-being

    Function and Global Well-being

    Social functioning

    Cognitive functioning

    Utility score (US norms)

    VAS

    RC

    Baseline

    122.5

    30.7

    26.2

    35.3

    22.1

    8.4

    0.831

    74.6

    Change from Baseline (CFB) Week 24

    +6.7

    +2.8

    +3.1

    +1.0

    -0.1

    0.0

    +0.02

    +8.1

    NRC

    Baseline

    114.3

    29.1

    24.9

    31.8

    20.6

    7.9

    0.818

    70.8

    CFB Week 24

    +2.1

    +1.2

    +1.6

    +0.7

    -1.6

    +0.2

    +0.03

    +5.6

    Conclusion: The BRIGHTE study demonstrated improvements in PROs in heavily treatment experienced HIV patients, complementing previously published efficacy and safety results.

    Clare Proudfoot, PhD1, Peter Ackerman, MD2, Cyril Llamoso, MD2, David Cella, PhD3, Andrew Clark, MD1 and Miranda Murray, PhD1, (1)ViiV Healthcare UK Ltd, Brentford, United Kingdom, (2)ViiV Healthcare, Branford, CT, (3)Medical Social Sciences, Northwestern, Chicago, IL

    Disclosures:

    C. Proudfoot, viiv healthcare: Employee , Salary .

    P. Ackerman, ViiV Healthcare: Employee , Salary .

    C. Llamoso, ViiV Healthcare: Employee , Salary .

    D. Cella, None

    A. Clark, ViiV healthcare: Employee , Salary .

    M. Murray, Viiv healthcare: Employee , Salary .

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.