Achievement of Undetectable Hiv Rna in the Promise-Us Study in Subjects Viremic at Baseline

Document Type

Conference Proceeding

Publication Date

4-15-2025

Publication Title

Top Antivir Med

Keywords

classical complement pathway C3 C5 convertase, ibalizumab, adult, CD4 lymphocyte count, CD4+ T lymphocyte, clinical outcome, cohort analysis, conference abstract, drug therapy, female, human, Human immunodeficiency virus infection, male, middle aged, multicenter study, multidrug resistance, severity of illness index, United States, viremia, virus load

Abstract

Background: It is estimated that there are over 1.2 million people with HIV (PWH) in the United States. Of these, ∼1% are heavily treatment-experienced (HTE) with multidrug resistant (MDR) HIV infection. MDR HIV is found most often in PWH with extensive prior exposure to antiretrovirals (ARVs). For these underrepresented HTE patients with MDR HIV-1, it can be challenging to establish and maintain virologic control, due to fewer active ARVs available for constructing a fully suppressive regimen. The PROMISE-US registry is dedicated to evaluating the efficacy of regimens used in this specific, complex patient population struggling with high unmet needs in the real-world. Methods: PROMISE-US (ClinicalTrials.gov Identifier: NCT05388474) is a phase 4 multicenter, retrospective and prospective, observational, non-interventional registry study. The primary objective is to evaluate the long-term efficacy and durability of ibalizumab in combination with other ARVs by comparing the clinical outcomes of patients receiving ibalizumab treatment (Cohort 2; C2) vs. matched patients not receiving ibalizumab (Cohort 1; C1). This abstract reports a sub-analysis from the first interim analysis, focusing on subjects who were viremic (>50 RNA copies/mL) at baseline and for whom matching has not yet been performed. Results: By 8-Nov-2023, a total of 112 subjects were enrolled; 70 in C1, 42 in C2. Of these, 27 subjects in C1 and 25 in C2 were viremic at baseline (39% and 57%, respectively; p=0.0279); 84% of subjects in C1 had CD4+ T-cell counts above 200 cells/mm3 at baseline, compared to 50% of subjects in C2 (p=0.0002). Table 1 describes the sub-population of viremic subjects in this study. Subjects in C2 had statistically significantly higher mean viral loads (1060 vs. 12101 copies/ mL; p=0.0424) and lower mean CD4 T-cells counts (417 vs. 259 cells/mm3, p=0.0386) compared to C1. However, similar rates of undetectability (<50 RNA copies/mL) are achieved in those on ibalizumab compared to subjects on non-ibalizumab containing regimens at 6 (50% for C1 vs. 47.3% for C2) and 12 months (42.9 for C1 vs. 42.1% for C2). Conclusions: Despite displaying characteristics indicative of more severe HIV disease, subjects on ibalizumab-containing regimens have similar measures of undetectability at 6 and 12 months in the PROMISE-US registry compared to controls without ibalizumab in their regimens. Limitations of this analysis include small sample size, and unmatched disease severity between the two treatment groups.

Volume

33

Issue

1

First Page

197

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