08:06 AM EDT, 10/17/2024 (MT Newswires) -- Theratechnologies ( THTX ) on Thursday announced the study design and baseline characteristics of participants in a prospective observational study of multidrug-resistant patient outcomes with and without the company's ibalizumab in a real-world setting in the U.S. (PROMISE-US).

The study seeks to fill a gap in long-term clinical outcomes for heavily treatment-experienced people with HIV (PWH).

PROMISE-US is a phase 4, multicenter, retrospective and prospective study and is the first real-world registry study that captures patient-reported outcomes such as satisfaction and adherence to treatment in this specific patient population.

In a poster presentation at IDWeek 2024 in Los Angeles, PROMISE-US investigators reported that ibalizumab was more frequently selected for use in certain advanced, HTE participants. Ibalizumab also demonstrated good durability, with the majority of subjects staying on therapy for more than 24 months.

"The phenomenon of multidrug resistance is most prevalent in persons with HIV with extensive prior exposure to antiretroviral therapies, making it challenging to establish and maintain virologic control, due to the limited availability of medications for constructing a fully suppressive regimen," said presenting author Charlotte-Paige Rolle, director of research operations, Orlando Immunology Center. "Given the need for more options to treat this subset of PWH and to understand how they respond to treatment, we designed PROMISE-US to compare the long-term efficacy and safety of ibalizumab-based regimens to other regimens used in heavily treatment-experienced individuals in the real-world setting."