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.