Theratechnologies Unveils Study Design and Baseline Characteristics of PROMISE-US Trial of Ibalizumab in Heavily Treatment-Experienced People with HIV and Multidrug Resistance

Core Insights - Theratechnologies Inc. is conducting the PROMISE-US study to evaluate long-term clinical outcomes for heavily treatment-experienced individuals with HIV, focusing on the efficacy and safety of ibalizumab [1][3][4] Group 1: Study Design and Objectives - PROMISE-US is a phase 4, multicenter, observational study designed to assess the long-term efficacy and safety of ibalizumab-based regimens compared to other regimens in heavily treatment-experienced individuals [3][4] - The primary objective is to evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretroviral therapies [4] - The study captures patient-reported outcomes such as satisfaction and adherence to treatment, making it the first real-world registry study for this patient population [3] Group 2: Participant Characteristics and Findings - As of November 2023, 114 participants were enrolled, with 70 in the control cohort and 42 receiving ibalizumab [5] - Participants receiving ibalizumab had higher viral loads (p = 0.0629) and declining CD4 T cells (p = 0.001) compared to those not on ibalizumab [5] - Ibalizumab was well tolerated, with no infusion reactions reported, and 80% of participants in the ibalizumab cohort remained on therapy for over 12 months [6] Group 3: Implications and Future Directions - The study aims to provide insights into the factors contributing to maintaining virologic response in heavily treatment-experienced individuals, addressing a significant unmet need in HIV treatment [7] - Theratechnologies is committed to analyzing data from PROMISE-US to understand the long-term safety and efficacy of ibalizumab, particularly in combination with long-term injectable therapies [7]