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. In this study, we report month 12 clinical outcomes in patient study participants (PSPs) in the CAB and RPV Implementation Study in European Locations (CARISEL) study.
Setting: CARISEL is a phase 3b implementation-effectiveness study.
Methods: CARISEL was designed as a 2-arm, unblinded study with centers randomized to either enhanced or standard implementation arms. For PSPs, this 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 and <50 copies/mL (Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive plasma HIV-1 RNA levels ≥200 copies/mL), adherence to injection visit windows, and safety and tolerability.
Results: Four hundred thirty PSPs were enrolled and treated; the mean age was 44 years (30% ≥50 years), 25% were women (sex at birth), and 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, the 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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http://dx.doi.org/10.1097/QAI.0000000000003448 | DOI Listing |
J Acquir Immune Defic Syndr
December 2024
ViiV Healthcare, Durham, NC, United States.
Background: Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB+RPV LA) Phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people living with HIV switching to CAB+RPV LA dosed every 2 months (Q2M) vs. continuing bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF).
View Article and Find Full Text PDFAIDS Res Hum Retroviruses
December 2024
Department of Infectious Disease, The School of Public Health of Nanjing Medical University, The Second Hospital of Nanjing, Nanjing, China.
Daily oral medication is currently the most common antiretroviral therapy (ART) for people living with human immunodeficiency virus (PLWH). As the first complete long-acting (LA) ART regimen, cabotegravir (CAB) and rilpivirine (RPV), offer a novel treatment approach with less frequent administration, via bimonthly infusion. Due to the upcoming availability of this regimen in China, the study aimed to analyze the willingness and reasons of PLWH to switch to CAB+RPV therapy.
View Article and Find Full Text PDFCurr Opin HIV AIDS
January 2025
Division of Infectious Diseases, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Curr Opin HIV AIDS
January 2025
Blizard Institute, Centre for Immunology and Infectious Disease: Queen Mary University of London.
Clin Infect Dis
November 2024
Division of Infectious Diseases, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Background: The first long-acting injectable antiretroviral, cabotegravir/rilpivirine (LA-CAB/RPV), was FDA approved in January 2021 for persons with HIV suppressed on their current regimen. Body mass index (BMI) ≥30 kg/m2 has been identified as a risk factor for virologic failure, however data is limited due to small sample sizes. The aim of this study was to evaluate the impact of BMI on the efficacy of LA-CAB/RPV in a real-world setting.
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