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

IMAdART: Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units". (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Trial completion date: Jul 2025 ➔ Feb 2026 | Active, not recruiting ➔ Completed

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

CHOICE: Combined Injectable Treatment for HIV and OUD (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Rhode Island Hospital | N=40 ➔ 0 | Active, not recruiting ➔ Withdrawn

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

Cabotegravir plus Rilpivirine for Persons with HIV and Adherence Challenges. (PubMed, N Engl J Med) - P3 | "Monthly injections of long-acting cabotegravir-rilpivirine were superior to standard oral ART in reducing the risk of regimen failure among persons with HIV who had adherence challenges. (Funded by the National Institute of Allergy and Infectious Diseases; LATITUDE ClinicalTrials.gov number, NCT03635788.)."

Journal • Allergy • Human Immunodeficiency Virus • Immunology • Infectious Disease

Optimizing the patient journey: Insights from early implementation of long-acting cabotegravir and rilpivirine in four urban Ryan White-funded clinics in the United States. (PubMed, J Int AIDS Soc) - "Optimizing the LAI-CAB/RPV patient journey requires developing a specialized support framework that is distinct from oral ART protocols. This new treatment modality requires a tailored approach that addresses unique challenges, including facilitating candid discussions about adherence contingencies, managing the physical and psychological aspects of injection experiences, ensuring meaningful and consistent provider relationships amid changing care patterns and providing enhanced support during treatment transitions."

Journal • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Pain • Psychiatry

Long-acting cabotegravir and rilpivirine in people with HIV and obesity: Real-world outcomes from the RELATIVITY cohort. (PubMed, HIV Med) - "In this real-world cohort, LAI CAB + RPV was safe and effective in PWH with obesity, with comparable VF rates, tolerability, and adherence to participants without obesity. These findings support the use of LAI CAB + RPV across diverse PWH populations, including those with a BMI ≥ 30 kg/m2, and highlight its feasibility in PWH with multiple comorbidities."

Journal • Real-world evidence • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Pulmonary Disease • Respiratory Diseases

Comprehensive longitudinal profiling of blood-tissue reservoirs reveals the mechanism of failure to long-acting cabotegravir/rilpivirine (ESCMID Global 2026) - No abstract available

Virological failure of long-acting cabotegravir/rilpivirine: a multifactorial case involving low drug exposure, high viral reservoir and rapid weight loss (ESCMID Global 2026) - No abstract available

Clinical

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Yale University | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Impact of sex, age and body composition on rilpivirine and cabotegravir trough concentrations in people with HIV receiving long-acting injectable antiretroviral therapy. (PubMed, J Antimicrob Chemother) - "Sex, age and muscle mass significantly influence cabotegravir-but not rilpivirine-trough concentrations in PWH receiving LAI therapy. Therapeutic drug monitoring combined with body composition assessment may help to optimize dosing interval adjustment."

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

Exploring the impact of Cabotegravir-Rilpivirine long-acting on weight gain, body composition and quality of life in adults living with HIV. (PubMed, HIV Med) - "CAB + RPV LA was not associated with significant weight gain, clinically relevant changes in body composition or adverse metabolic effects over 48 weeks. Virologic suppression was maintained, renal laboratory parameters improved in prior INSTI users and treatment was well tolerated with increasing satisfaction. These findings support CAB + RPV LA as a safe, effective and metabolically neutral alternative to daily oral ART."

HEOR • Journal • Dyslipidemia • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease

The implementation of long-acting cabotegravir/rilpivirine among personnel of the Spanish Armed Forces living with HIV (ESCMID Global 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Bimonthly Administered Long-Acting Cabotegravir and Rilpivirine Are Highly Effective and Well-Tolerated in People With Human Immunodeficiency Virus Above 65 Years. (PubMed, Open Forum Infect Dis) - "Older people with HIV (PWH) may benefit from long-acting cabotegravir/rilpivirine (LA-CAB/RPV), a population underrepresented in trials and observational cohorts. After 17.4 months, virological suppression (HIV-RNA <50 copies/mL) was maintained in all, while 15 participants discontinued them (11.1%, 10% in the first 12 months): 1 participant with isolated HbCAb at baseline showed a late HBV reactivation (19.4 months after starting). These findings support LA-CAB/RPV's efficacy and tolerability in older PWH."

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

Cabotegravir+rilpivirine long-acting every 2 months in a real-world setting: 24-month outcomes in people with HIV-1. (PubMed, AIDS) - "In this real-world study, CAB+RPV LA maintained high rates of virologic suppression, was well tolerated, and led to increased treatment satisfaction through 24 months following switch. These data reinforce the findings of the Phase 3/3b CAB+RPV LA program and support the continued use of CAB+RPV LA in routine clinical care."

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

Y181C-associated virologic failure during long-acting injectable cabotegravir/Rilpivirine in a patient engaged in intensive intravenous Chemsex. (PubMed, HIV Med) - "This case highlights that unexpected resistance can emerge during adequately administered LA-CAB/RPV therapy. Careful clinical evaluation is warranted when virologic failure occurs, particularly in the presence of extreme behavioural or physiological stressors."

Journal • Human Immunodeficiency Virus • Infectious Disease

Implementation of a Hospital in the Home Model for Delivery of Long-acting Injectable Antiretroviral Therapy: Development, Integration and Early Experience. (PubMed, Sex Health) - "HITH delivery of CAB/RPV is feasible, safe and well accepted, providing a scalable, decentralised model for HIV treatment in Australia."

Journal • Human Immunodeficiency Virus • Infectious Disease

LACRIS: Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study (clinicaltrials.gov) - P=N/A | N=250 | Not yet recruiting | Sponsor: Pomeranian Medical University Szczecin

New trial • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Dual Long-Acting Cabotegravir/Rilpivirine Plus Lenacapavir in Integrase Strand Transfer Inhibitor Resistance: A Case Report and Review of the Literature. (PubMed, Open Forum Infect Dis) - "His viral load declined to 143 copies/mL within 6 weeks after initiation of injectable ART and has remained undetectable thereafter. This case suggests that dual LAI ART may be effective in certain cases of underlying INSTI resistance and highlights the need for further study of this novel regimen in treatment-experienced individuals."

Journal • Human Immunodeficiency Virus • Infectious Disease

Impact of Switching from Oral to Long-Acting Injectable Cabotegravir and Rilpivirine on the Lipid Profile of HIV-Positive Patients. (PubMed, Microorganisms) - "Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) have been incorporated into the treatment of people living with HIV (PLWH), but evidence on their metabolic impact in real-world settings remains limited. These findings suggest that switching to long-acting injectable cabotegravir and rilpivirine maintains virological and immunological control without adversely affecting the total cholesterol, LDL cholesterol, or triglycerides, and is associated with an improvement in HDL cholesterol. LA-CAB/RPV therefore appears to be a metabolically safe therapeutic option for PLWH, with a potentially favorable effect on cardiovascular risk factors."

Journal • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. (PubMed, Lancet HIV) - P1/2 | "Acceptability and tolerability of intramuscular cabotegravir-rilpivirine remained high through to 48 weeks of treatment, suggesting that this long-acting intramuscular treatment approach is well received by diverse populations of adolescents with HIV across multiple settings."

Journal • P1/2 data • Human Immunodeficiency Virus • Infectious Disease • Pain

Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. (PubMed, Lancet HIV) - P1/2 | "Week 48 data from the first virologically suppressed adolescents with HIV-1 who switched from daily oral to intramuscular cabotegravir and intramuscular rilpivirine every 8 weeks showed favourable safety, pharmacokinetics, and virological suppression informing both real-world use, where approved, and ongoing regulatory submissions, where approval is pending."

Journal • P1/2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pain • Pediatrics

Acute hepatitis B following a switch to long-acting cabotegravir plus rilpivirine in an individual with a history of hepatitis B vaccination. (PubMed, Sex Transm Infect) - "Unlike regimens containing tenofovir with lamivudine (3TC) or emtricitabine (FTC), it lacks therapeutic activity against the hepatitis B virus, and hepatitis B vaccination is recommended for non-immune individuals. We present a case of acute hepatitis B after switching to CAB+RPV LA in a previously vaccinated individual."

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

Hepatitis B Outcomes After Switching to Long-Acting Cabotegravir/Rilpivirine in People With HIV: Reactivation, Incident Infection, and Liver Safety Across Diverse Serological Profiles. (PubMed, Clin Infect Dis) - "LA-CAB/RPV appears safe in individuals with prior HBV exposure, including those with isolated anti-HBc. Comprehensive HBV screening, vaccination, and liver monitoring are essential."

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

Trial design and enrolment characteristics of LATA (long-acting treatment in adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12... (PubMed, Contemp Clin Trials) - P3 | "LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing."

Head-to-Head • HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Evaluating long-acting injectable HIV treatment: an update on cabotegravir and rilpivirine. (PubMed, Expert Rev Anti Infect Ther) - "Long-acting cabotegravir (CAB) and rilpivirine (RPV) provide the first complete regimen administered by intramuscular injections every 4 or 8 weeks, enabling virologic maintenance without daily pills...Phase II (LATTE, LATTE-2) and phase III (FLAIR, ATLAS, ATLAS-2 M, SOLAR) trials demonstrated that CAB+RPV long-acting is non-inferior to oral therapy, showing durable viral suppression...Its successful implementation requires careful patient selection, robust systems to support timely injections, and strategies to mitigate pharmacokinetic challenges. Future directions include expanding eligibility to broader populations, optimizing ultra-long-acting formulations, and integrating injectables into differentiated care models to ensure equity of access."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Point-of-care ultrasound guidance for long-acting cabotegravir-rilpivirine administration improves injection-site tolerability and preserves pharmacokinetics. (PubMed, AIDS) - "These findings support ultrasound guidance as a practical approach to improve injection accuracy and patient comfort, particularly in individuals at higher risk of poor intramuscular deposition or prior tolerability issues."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease