Rekambys (rilpivirine LA) / J&J - LARVOL DELTA

HOLA: Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine (clinicaltrials.gov) - P4 | N=103 | Completed | Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Long-Term Real-World Use of Cabotegravir/Rilpivirine: Adherence and Virological Efficacy over a 44-Month Observation Period. (PubMed, Infect Dis Ther) - "This real-world study, with a 44-month observation period and follow-up of up to 10 years on LA-CAB/RPV, confirms its long-term efficacy and safety, supporting its durability as a maintenance option for PLWH, even with occasional delays and slightly lower adherence than seen in clinical trials, and additionally underscores the importance of individualized care and structured monitoring in real-world settings."

Journal • Real-world evidence • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Psychiatry

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CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=45 ➔ 0 | Not yet recruiting ➔ Withdrawn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

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

HOLA: Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine (clinicaltrials.gov) - P4 | N=110 | Active, not recruiting | Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

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

Clinical Outcomes and Perspectives of People With Human Immunodeficiency Virus Type 1 Twelve Months After Initiation of Long-acting Cabotegravir and Rilpivirine in an Observational Real-world US Study (BEYOND). (PubMed, Open Forum Infect Dis) - "Long-acting cabotegravir plus rilpivirine (CAB + RPV LA) administered monthly or every 2 months is recommended by treatment guidelines for maintenance of virologic suppression in people with human immunodeficiency virus type 1 (HIV-1). Proportions of participants reporting "always" or "often" experiencing challenges related to HIV-1 treatment (fear of disclosure, adherence anxiety, reminder of HIV-1 status, and feeling stigmatized) decreased from baseline to month 12. Month 12 results from the real-world BEYOND study support the effectiveness of CAB + RPV LA for maintenance of virologic suppression and as a preferred treatment option for people with HIV-1."

Clinical data • Journal • Real-world evidence • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

A review of pharmacokinetic data describing long-acting injectable cabotegravir during pregnancy. (PubMed, Expert Opin Pharmacother) - "For treatment, CAB-LA is currently approved in combination with long-acting rilpivirine (RPV-LA). Other long-acting prevention and treatment strategies are in development. Future studies assessing long-acting strategies are necessary during drug development to ensure equitable and timely access to novel therapies for all individuals."

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

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE (clinicaltrials.gov) - P3 | N=456 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=310 ➔ 456

Enrollment change • Human Immunodeficiency Virus • Infectious Disease

Efficacy of long-acting cabotegravir plus rilpivirine in viraemic people living with HIV: A systematic review and meta-analysis. (PubMed, HIV Med) - "This is the first meta-analysis that assessed the efficacy of LA-CAB/RPV in viraemic people living with HIV; oral treatment efficacy was jeopardized by low compliance due to adherence or psychological issues. Our results can justify the use of LA-CAB/RPV also in viraemic patients without alternative oral options."

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

Acceptability and feasibility interventions measures (AIM & FIM) of the implementation of long-acting cabotegravir plus rilpivirine (CAB LA + RPV LA) administration out of HIV units: the IMADART study (ESCMID Global 2025) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

FLAIR: Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (clinicaltrials.gov) - P3 | N=631 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2026 ➔ Dec 2025

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Characteristics of People With HIV Prescribed Long-Acting Cabotegravir/Rilpivirine in a US Cohort (CROI 2025) - "Background Long-acting cabotegravir/rilpivirine (LA-CAB/RPV) has the potential to reduce medication burden for people with HIV (PWH) and improve outcomes in PWH who struggle to achieve or maintain viral suppression, reflected in recent guideline changes regarding use in PWH with adherence challenges. Conclusions While each academic HIV clinic has been prescribing LA-CAB/RPV to underserved populations, including people with VNS and people who inject drugs, the rollout across clinics is uneven. Future scale-up efforts need to address access issues at the state/health system level to ensure that the diverse PWH populations that each clinic serves can benefit from LA-CAB/RPV."

Human Immunodeficiency Virus • Infectious Disease

Interim Week 48 Results in Young South Africans on Long-Acting Injectable ART: The AFINAty Study (CROI 2025) - "When virally suppressed, YLHIV were offered a switch to cabotegravir and rilpivirine LAI administered every 8-weeks, with an optional oral lead-in...Conclusions High retention and high viral suppression rates at Week 48 have been demonstrated in this community-based cohort of YLHIV in Cape Town, South Africa. Long-acting cabotegravir and rilpirivine LAI are an effective, acceptable and feasible treatment option and should be considered as a priority in national ART programs for adolescents and young adults living with HIV."

Fatigue • Human Immunodeficiency Virus • Infectious Disease

A5359: Decreasing Oral Induction Duration in Support of LAI ART Use With Hardly Reached Populations (CROI 2025) - "ACTG 5359, a phase III, prospective, randomized, open-label trial comparing long acting cabotegravir + rilpivirine (LAI) vs. oral standard of care (SOC) ART in PWH with a history of suboptimal adherence (persistent HIV-1 RNA >200 c/mL or loss to follow-up), successfully enrolled 437 participants in the US when an independent Data and Safety Monitoring Board recommended to stop randomization and offer LAI to all eligible participants at an interim review. Of the 411 eligible for transition at the interim analysis, 61%, 77%, and 89% transitioned successfully to Step 2 with progressively shorter duration of viral suppression in Step 1(Table). Conclusions A5359 successfully enrolled a population not generally included in studies of investigational ART strategies and demonstrated that in-stream shortening of the required duration of virologic suppression significantly increased enrollment for the randomized strategy comparison."

Clinical • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry • CD4

Implementation of LA-CAB/RPV in US Clinic Settings: A Survey of Front-Line Clinicians (CROI 2025) - "Background Long-acting Cabotegravir and Rilpivirine (LA-CAB/RPV), approved in January 2021, is the first complete injectable regimen for virologically suppressed patients with HIV-1 without a history of resistance. Conclusions While most clinicians surveyed have incorporated LA-CAB/RPV into their practices, key challenges remain, particularly among adolescents, cis-gender female patients, those with resolved Hepatitis B, and those with higher BMIs. Addressing barriers related to insurance and approval processes, along with continued education, is crucial to expanding access and optimizing the use of LA-CAB/RPV."

Clinical • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Long-Acting Cabotegravir and Rilpivirine in Older People With HIV in the GEPPO Cohort (CROI 2025) - "Background The association of intramuscularly administered Long-acting cabotegravir and rilpivirine (LA CAB+RPV) has been proven to be effective and safe in the maintenance treatment of people with HIV (PWH)...The pre-switch regimen was mainly based on a three-drug combination in 53.5% of study participants (mostly bictegravir or rilpivirine-based) or two-drug combinations by 45.1% (mostly dolutegravir/rilpivirine and dolutegravir/lamivudine)...Conclusions Our results suggest that the LA CAB+RPV combination is effective and safe in OPWH despite a long history of ART and a high prevalence of multimorbidity and polypharmacy. Older age should not be a barrier to the LA regimen: this study paves the way to evaluate the risk of an ageism attitude when clinicians consider ART choices in older PWH."

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pain • CD4

Safety and Pharmacokinetics of Long-Acting Cabotegravir and Rilpivirine in Children 20 to 40 kg (CROI 2025) - "Background Long-acting cabotegravir (CAB-LA) plus long-acting rilpivirine (RPV-LA) are approved for maintenance of viral suppression in adults and adolescents >35kg with HIV-1 infection. Conclusions Administration of PO CAB+RPV followed by Q4W IM CAB-LA+RPV-LA in children 20-<40 kg achieved exposure concentrations comparable to adolescents and adults receiving this regimen. No new or unanticipated safety concerns were identified."

Clinical • Late-breaking abstract • PK/PD data • Cough • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Pain • Psychiatry • Respiratory Diseases

Low-Level Viremia and Risk Factors for Failure on Long-Acting Cabotegravir/Rilpivirine (LA CAB/RPV) (CROI 2025) - "This study is the first to report that low-level viremia was not associated with virologic failure in clinical practice. Further research is needed to identify those at risk of virologic failure and to develop optimal prevention strategies."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-Acting Cabotegravir/Rilpivirine in Real Life: Sex-Based Characteristics, PROs, and Effectiveness (CROI 2025) - "Background This study aimed to focus on sex-based characteristics, patient reported outcomes (PROs) and effectiveness in people with HIV switching to long-acting cabotegravir-rilpivirine (LA-CAB/RPV) administered Q2M in Hospital Clínic of Barcelona, Spain. Conclusions Compared to our general cohort, proportionally less women than men switched to LA-CAB/RPV. Baseline characteristics could partially explain this difference, although we cannot exclude prescription biases or other barriers."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-Acting Cabotegravir/Rilpivirine in Pregnancy (CROI 2025) - "Background Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) is a novel injectable antiretroviral therapy approved for virologically suppressed individuals with HIV-1...Additionally, 81% (n=17) of the newborns received zidovudine only post-delivery...Given the small sample size, it was not possible to conduct a meaningful analysis of any associations between perinatal outcomes and the use of LA-CAB/RPV during pregnancy. Our findings support the consideration of LA-CAB/RPV as a viable treatment option during pregnancy, though further research with larger cohorts is needed to validate these findings and ensure long-term safety."

CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Obstetrics • Ventriculomegaly

LA-ART for Breastfeeding Women With HIV in Zimbabwe: Clinical Impact and Cost-Effectiveness (CROI 2025) - "Methods At time of delivery, we simulated 2 cohorts of women who had been engaged in antenatal care, had adherence challenges while prescribed oral tenofovir/lamivudine/dolutegravir (TLD) in pregnancy, and had no prior NNRTI exposure, along with their infants: 1) women not virally suppressed at the time of delivery (NVS) and 2) women with viral suppression at delivery (VS). We modeled 2 ART approaches immediately after delivery: standard of care (SOC: continuation of TLD) and LA-ART (switching from TLD to cabotegravir/rilpivirine [LA-CAB/RPV])...Conclusions LA-ART for breastfeeding women with adherence challenges to oral TLD could reduce infant infections. If efficacy is confirmed in postpartum women, LA-ART for women without viral suppression at delivery would improve outcomes and save money; for women with viral suppression, it would be cost-effective in Zimbabwe if costs were ≤$7/month."

Clinical • Cost effectiveness • HEOR • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Randomized Trial of Long-Acting Cabotegravir and Rilpivirine in Africa (CARES): Week 96 Results (CROI 2025) - "Four participants (1.6%) in LA group and none in OT group had CVF by week 96; 3 resuppressed on TDF/3TC/DTG...Conclusions At 96 weeks, CAB and RPV LA showed high efficacy, non-inferior to oral ART when used in the public health approach with sparse VL monitoring and without real-time baseline resistance testing. CVF and acquired resistance was uncommon. LA was effective with an acceptable safety profile and may be considered for use in treatment programs in sub-Saharan Africa."

Clinical • Late-breaking abstract • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

LOVER60: Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months. (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. (PubMed, Lancet HIV) - "Long-acting injectable cabotegravir and long-acting injectable rilpivirine, administered to adolescents at recommended adult dosages every 8 weeks, showed no unanticipated safety concerns in the 24 weeks following administration."

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