Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals

Abstract

Introduction: Heavily treatment-experienced (HTE) people living with HIV-1 (PLWH) have limited viable antiretroviral regimens available because of multidrug resistance and safety concerns. The first-in-class HIV-1 attachment inhibitor fostemsavir demonstrated efficacy and safety in HTE participants in the ongoing phase III BRIGHTE trial.

Objectives: We describe patient-reported outcomes (PROs) through week 48.

Methods: Eligible participants for whom their current regimen was failing were assigned to the randomized cohort (RC; one to two fully active agents remaining) or the nonrandomized cohort (NRC; no fully active agents remaining). PRO assessments included the EQ-5D-3L, EQ-VAS, and Functional Assessment of HIV Infection (FAHI) instruments.

Results: Both cohorts achieved increases in EQ-5D-3L US- and UK-referenced utility score from baseline at week 24. Mean visual analog scale (VAS) scores in the RC and NRC increased from baseline by 8.7 (95% CI 6.2-11.2) and 5.6 points (95% CI 1.5-9.7) at week 24 and increased from baseline by 9.8 (95% CI 7.0-12.6) and 4.9 points (95% CI 0.6-9.2) at week 48, respectively. Mean increases in FAHI total score from baseline to weeks 24 and 48 in the RC were 6.9 (95% CI 4.2-9.7) and 5.8 (95% CI 2.7-9.0), respectively, whereas mean increases in physical and emotional well-being subscale scores were 2.7 (95% CI 1.9-3.6) and 2.4 (95% CI 1.3-3.4) and 3.2 (95% CI 2.2-4.2) and 2.6 (95% CI 1.6-3.7), respectively, with little to no change in other subscales.

Conclusions: Improvements in major domains of the EQ-VAS and FAHI through week 48, combined with efficacy and safety results, support the use of fostemsavir for HTE PLWH.

Trial registration number and date: NCT02362503; February 13, 2015.

Conflict of interest statement

S-JA and MW are employees of and own stock in GlaxoSmithKline. MM was an employee of ViiV Healthcare when the work was conducted, is now with Health Analytics and Outcomes, London, UK, and owns/owned stock in GlaxoSmithKline. DC is president of FACIT.org, which licenses FAHI, and has been a consultant to ViiV Healthcare. RG has received research support from ViiV Healthcare, Amgen, and Gilead Sciences; consulting fees from Thera Technologies as member of an advisory board; and speaker fees from ViiV Healthcare. DH has received speaker fees and consulting fees from ViiV Healthcare as a member of an advisory board. WT is an employee of Southern California Permanente Medical Group and has received institutional grants from ViiV Healthcare, Bristol-Myers Squibb, Gilead, Dynavax, and Merck. AC, AP, CL, PA, and ML are employees of ViiV Healthcare and own stock in GlaxoSmithKline.

© 2021. The Author(s).

Figures

Fig. 1

BRIGHTE study disposition at week 24 and week 48