Implémentation de CAB+RPV LA: résultats de l'étude européenne CARISEL

Welzen, Berend van; Vandekerckhove, L.; Jonsson-Oldenbuettel, Celia; Hocqueloux, Laurent; DeMoor, Rebecca; Scherzer, Jörg; Barnes, Nicola Jane; Czarnogorski, Maggie; Gutner, Cassidy A.; Slama, Laurence

doi:10.1016/j.mmifmc.2023.03.356

Cited by 1 publication

(2 citation statements)

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“…This is consistent with the primary outcome in CARISEL (reported separately), in which the mean scores of acceptability, appropriateness, and feasibility of the implementation of CAB + RPV LA reported by SSPs demonstrated no significant difference between implementation arms. 15 The virologic outcomes in CARISEL are similar to those observed at week 48 in the 3 large phase 3/3b CAB + RPV LA trials. 6 – 8 When examined across predefined subgroups [age group (<50 and ≥50 years old), sex at birth, race, country, and baseline CD4 + count (<350 and ≥350 cells/mm 3 )], rates of virologic suppression were similar.…”

Section: Discussionsupporting

confidence: 53%

“…The presence of 2 or more baseline factors (of the following 3: preexisting RPV RAMs, HIV-1 subtype A6/A1, and/or BMI ≥30 kg/m 2 ) has been previously associated with an increased risk of CVF during CAB + RPV LA treatment in multivariable analyses. 15 , 16 In CARISEL, the PSP with CVF had RPV RAMs present at baseline (E138A) and failure (E138A + M230L) with no INSTI RAMs detected. CAB and RPV plasma concentrations were consistent with previous observations for Q2M dosing.…”

Section: Discussionmentioning

confidence: 98%

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Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings

Jonsson-Oldenbüttel,

Ghosn,

van der Valk

et al. 2024

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. Here, we report Month 12 clinical outcomes in patient study participants (PSPs) in the CARISEL study. Setting: CARISEL is a Phase 3b implementation–effectiveness study. Methods: CARISEL was designed as a two-arm, unblinded study with centers randomized to either enhanced or standard implementation arms. For PSPs, the study is single arm, unblinded, and interventional; all PSPs switched from daily oral therapy to CAB + RPV LA dosed Q2M. The primary objective was to evaluate the perceived acceptability, appropriateness, and feasibility of CAB + RPV LA implementation for staff participants (presented separately). Clinical secondary endpoints assessed through Month 12 included: the proportion of PSPs with plasma HIV-1 RNA ≥50 copies/mL and <50 copies/mL (Snapshot algorithm), incidence of confirmed virologic failure (CVF; two consecutive plasma HIV-1 RNA levels ≥200 copies/mL), adherence to injection visit windows, and safety and tolerability. Results: 430 PSPs were enrolled and treated; mean age was 44 years (30% ≥50 years), 25% were female (sex at birth), 22% were persons of color. At Month 12, 87% (n=373/430) of PSPs maintained HIV-1 RNA <50 copies/mL, with 0.7% (n=3/430) having HIV-1 RNA ≥50 copies/mL. One PSP had CVF. The safety profile was consistent with previous findings. Overall, results were similar between implementation arms. Conclusion: CAB + RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression with a low rate of virologic failure.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 98%