Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi - LARVOL DELTA

Comparing interest in thigh administration of long-acting cabotegravir/rilpivirine among hypothetical users, early adopters and trial participants with experience. (PubMed, Clin Infect Dis) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Necrotic skin reaction following the administration of intramuscular injections of long-acting cabotegravir/rilpivirine and alternatively-sourced testosterone. (PubMed, Int J STD AIDS) - "After being reviewed in ambulatory care, the emergency department and an outpatient plastic surgery clinic settings over the course of 3 weeks, the swelling and skin changes gradually resolved. He was then switched back to oral ART on subsequent review."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain

Cabotegravir Plus Rilpivirine Injection for Virally Suppressed Persons with HIV-1 infection: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Clin Ther) - "However, more adverse effects were reported with the oral treatment [RR 1.32 (95% CI; 1.12-1.54), I2 = 56%]. Pooled reports showed a significant an increased risk of treatment withdrawal in the oral group, [RR 3.61 (95% CI; 0.87-14.98), I2 = 53 IMPLICATION: Findings from this meta-analysis emphasised the efficacy and safety of Cabotegravir/rilpivirine long-acting formulation in providing long-term maintenance of viral load suppression in HIV-1 infection with a tolerable safety profile."

Journal • Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

Long-acting injectable cabotegravir and rilpivirine in observational cohort studies: A systematic review on virological failure, resistance and re-suppression outcomes in virally suppressed individuals living with HIV. (PubMed, HIV Med) - "In OCS, VF was a very uncommon occurrence and comparable with clinical trials. However, when it did occur, it was frequently accompanied by resistance. Post-VF regimens used to achieve suppression varied, including LA-I CAB+RPV maintenance and were highly successful."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

IMAdART: Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units". (clinicaltrials.gov) - P=N/A | N=90 | Active, not recruiting | Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Sep 2024 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=45 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease

To Switch or not to Switch to Long-acting Injectable Cabotegravir/Rilpivirine in PWH With Past Hepatitis B Virus (HBV) Coinfection: Which HBV Markers to Manage Risk of HBV Reactivation? (PubMed, Open Forum Infect Dis) - "We report the occurrence of low-level hepatitis B virus (HBV) viremia in people with HIV with controlled CD4 counts and isolated core antibody reactivity switched to long-acting injectable cabotegravir/rilpivirine. This series raises questions about the reintroduction of anti-HBV medications, presents the variation of several HBV markers alongside HBV-DNA and reveals an effective spontaneous immune response."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Influence of patient characteristics and oral lead-in on long-acting cabotegravir and rilpivirine pharmacokinetics and outcomes in people with HIV: a real-world study. (PubMed, Antimicrob Agents Chemother) - "Rates of virological failure (1 SWI vs. 2 OLI; P = 0.999) and low-level viremia (18.5% vs. 17.6%, P = 0.999) were comparable. Sex, BMI, and smoking influenced CAB and RPV levels, whereas OLI use had no significant impact on PK or virological outcomes, supporting flexible CAB +RPV LA initiation strategies."

Journal • PK/PD data • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

CAPRI: A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA (clinicaltrials.gov) - P3 | N=12 | Completed | Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ May 2025

Trial completion • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • Renal Disease

Quantitative and Qualitative Perspectives of Participants Who Received Long-Acting Injectable Cabotegravir-Rilpivirine at Home or in Clinic. (PubMed, AIDS Patient Care STDS) - "We identified six broad themes related to the participant experience that involved (1) strengths of injectable therapy, (2) negatives of injectable therapy, (3) treatment setting preference, (4) reasons for preferring injectable therapy at home, (5) reasons for preferring injectable therapy in the clinic, and (6) general impressions related to injectable therapy. This work provides insight into patient perceptions and preferences regarding injectable HIV therapy, perspectives that will be important to consider for efforts designed to enhance accessibility of injectable HIV therapy and optimize the patient experience."

Journal • Fatigue • Human Immunodeficiency Virus • Infectious Disease

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Aug 2025 ➔ Jun 2026

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Efficacy and Safety of Switching to Long-Acting Cabotegravir + Rilpivirine Versus Continuing Bictegravir/Emtricitabine/Tenofovir Alafenamide in Japanese Participants: 12-Month Results From the Phase 3b Randomized SOLAR Trial. (PubMed, J Infect Chemother) - P3 | "Though limited, these data suggest switching to CAB+RPV LA from BIC/FTC/TAF was well tolerated in Japanese participants, with comparable efficacy and improved treatment satisfaction. ClinicalTrials.gov; NCT04542070 (https://www.clinicaltrials.gov/study/NCT04542070)."

Journal • P3 data • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Eligibility for Intramuscular Cabotegravir/Rilpivirine in HIV-Positive Patients: An Observational Study. (PubMed, J Pharm Technol) - "Objective: The purpose of this study was to determine the proportion of patients with HIV-1 on antiretroviral therapy (ART) who meet the criteria for the use of intramuscular CAB/RPV. However, lack of adherence and the costs associated with intramuscular therapy represent barriers to its implementation. Strategies to improve adherence and cost-effectiveness studies are needed."

Journal • Observational data • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Long-Acting Cabotegravir/Rilpivirine (CAB/RPV LA) in Older Adults with HIV: High Adherence and Low Complications in a Real-World Setting (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Adherence • Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Real-world virologic outcomes of high BMI on CAB+RPV LA-I: A systematic review (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Real-world • Real-world evidence • Review

Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND) (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Clinical data • Real-world • Real-world evidence

Real-World Efficacy and Tolerability of Long-Acting Cabotegravir/Rilpivirine in Woman with HIV and Polypharmacy plus Comorbidities (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Adherence • Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical

The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in newly diagnosed people living with HIV (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Perspectives of healthcare providers on long-acting injectable cabotegravir and rilpivirine delivery in clinic and community settings in the UK: longitudinal survey findings from the ILANA study (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: Suppression Phase outcomes from the Phase 3b VOLITION study (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

P3 data • Human Immunodeficiency Virus • Infectious Disease

Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND) (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Clinical outcomes among women in the OPERA Cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Clinical data

Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease