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

Immune profiles and HIV reservoir in people switching to long-acting cabotegravir/rilpivirine: Findings from a real-life prospective study. (PubMed, HIV Med) - "During the first year of treatment, LACR does not significantly impact the HIV reservoir. However, it may reduce immune activation, particularly in persons switching from a dual therapy regimen."

Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4 • CD8

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

Long-Acting Injectable Antiretroviral Therapy for Treatment of Human Immunodeficiency Virus: A Review. (PubMed, Curr HIV/AIDS Rep) - "Long-acting injectable (LAI) antiretroviral therapy (ART) for treatment of HIV-1 are approved both as a complete treatment regimen (cabotegravir/rilpivirine) and as an additional treatment option (lenacapavir) for those with multidrug resistant HIV-1. Here, we review the data supporting these approvals, pharmacokinetics, and additional patient populations that many benefit from LAI ART...LAI CAB/RPV is currently only approved in those with HIV-1 viral suppression, however recent data support the use of LAI ART in populations with adherence challenges. Furthermore, given high rates of NNRTI resistance globally, CAB/RPV is not recommended in low-and-middle income countries presently, although this recommendation is likely to change based on recently published data. More research is needed among groups that may benefit from long-acting treatments for HIV-1."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Ultrasound for long-acting injectable cabotegravir and rilpivirine in transgender individuals with implants: a new opportunity for normalization. (PubMed, J Antimicrob Chemother) - No abstract available

Journal

Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)-a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol. (PubMed, BMJ Open) - P4 | "If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway. NCT06185452/EUCT number: 2023-503963-41-00."

Clinical protocol • Journal • P4 data • 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

Real-World Efficacy and Tolerability of Long-Acting Cabotegravir/Rilpivirine in Older Woman with Polypharmacy and Comorbidities (ESCMID Global 2025) - No abstract available

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

Impact of Cabotegravir plus Rilpivirine Long-Acting on Body Composition: Results from a Prospective Study (ESCMID Global 2025) - No abstract available

Clinical • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Use of long-acting cabotegravir/rilpivirine in HIV-viraemic individuals: a metanalysis (ESCMID Global 2025) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-acting injectable HIV therapy outcomes among persons with HIV who have adherence challenges to oral antiretroviral therapy. (PubMed, Clin Infect Dis) - "In this real-world observational study, over 85% of PWH with adherence difficulties remained on therapy and virally suppressed 48-weeks after initiating LAI-CAB/RPV. Providers should consider LAI therapy among PWH with adherence difficulties."

Journal • 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

Clinical Consequences of Delaying Implementation of LA-ART for PWH With Persistent Viremia in the US (CROI 2025) - "Conclusions LA-CAB/RPV for PWH with persistent viremia in the US would increase VS and life expectancy. Each year of delayed uptake would substantially increase years of viremia and mortality. Rapid implementation of CAB/RPV should be undertaken, even while awaiting RCT results."

Clinical • CD4

Association of Trough Concentrations of Cabotegravir and Rilpivirine and HIV-1 RNA (CROI 2025) - "Background The relevance of plasma (trough) concentrations of cabotegravir (CAB) and rilpivirine (RPV) with regard to sustained virologic suppression in people with HIV (PWH) on long-acting treatment (LA) is an ongoing matter of debate. It is unclear if this is also predictive of virologic failure. Based on our findings, however, it warrants further investigation if dosing can be indivualized taking trough concentrations into account."

Human Immunodeficiency Virus • Infectious Disease

Outcomes in Those Who Discontinued Injectable Cabotegravir/Rilpivirine and Resumed Oral ART (CROI 2025) - "The percentage of those with HIV VL <50cpm and <200cpm up to 24 weeks was 91.4% and 94.8%, up to 48 weeks was 90.6% and 96.2%, and using the most recent documented VL was 91.9% and 95.9%, respectively. Conclusions In those who discontinued LAI CAB/RPV, returned to oral ART, and remained engaged in care, a high rate of ongoing viral suppression was observed."

Human Immunodeficiency Virus • Infectious Disease • CD4

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

Clinical Outcomes Among Virologically Suppressed Women Receiving CAB+RPV LA in the OPERA Cohort (CROI 2025) - "Conclusions A diverse population of women with HIV was able to receive CAB+RPV LA on-time and remain suppressed in this real-world study. Confirmed virologic failure was infrequent in these antiretroviral experienced women."

Clinical • Clinical data • Human Immunodeficiency Virus • Infectious Disease • CD4

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

Why Do People With HIV Stop Long-Acting Injectable Cabotegravir/Rilpivirine and What Happens? (CROI 2025) - "Conclusions Overall, discontinuation was low, and injection site pain was the most common reason. For PWH initiating LA-CAB/RPV with viremia, VF and missed/late injections accounted for over half of discontinuations, although most ultimately attained VS."

Human Immunodeficiency Virus • Infectious Disease • Pain

Rilpivirine Drug-Resistant Mutations in Experienced Patients in Mexico: Impact on Long-Acting ART (CROI 2025) - "We investigated rilpivirine cross-resistance in experienced patients in Mexico, where Efavirenz (EFV) was the preferred initial ARV drug for more than 10 years. Conclusions This retrospective analysis indicates that rilpivirine DRMs are common in a setting wherein NNRTI-based treatment was widely implemented, and has implications for operational implementation of CAB/RPV LA. Screening for existing DRMs is logistically and technically challenging in Mexico and could be a barrier to use of CAB/RPV LA."

Clinical • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Long-Term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort (CROI 2025) - "Suppressed PWH on CAB+RPV LA had favorable virologic outcomes as most maintained VLs <50 c/mL and CVF was infrequent. Further, virologic suppression was maintained regardless of BMI category at initiation."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Impact of Oral Lead-In on PK and Virologic Outcomes in People With HIV Transitioning to CAB+RPV LA (CROI 2025) - "Secondary analyses of participants with baseline VL<20 cp/mL (N=147) showed similar trends. Conclusions In conclusion, the use of an oral lead-in did not result in significant differences in pharmacokinetics or virological outcomes for PWH transitioning to CAB+RPV LA over 9 months."

Human Immunodeficiency Virus • Infectious Disease • CD4

What Do Early Adopters of Long-Acting Injectable Cabotegravir/Rilpivirine Think About It? (CROI 2025) - "The HIV clinic was the preferred location. However, ~50% would opt for a different LA modality."

Human Immunodeficiency Virus • Infectious Disease

Outcomes of LAI ART for People With Detectable HIV Viremia in the NYC Public Healthcare System (CROI 2025) - "Background Long-acting injectable cabotegravir/rilpivirine (LAI CAB/RPV) has changed the landscape of antiretroviral therapy (ART) by creating an alternative to daily oral ART...One limitation of our study is that the period of observation for follow up VLS varied for each patient, (e.g. our assessment included most recent viral load). Addressing barriers to LAI access, including expanding current FDA labeling to include certain patients with baseline viremia, is crucial to achieve VLS and improved health outcomes in this population."

Human Immunodeficiency Virus • Infectious Disease • CD4

Distance to Care Measures Predict Injection Visit No-Shows Among Cabotegravir/Rilpivirine Recipients (CROI 2025) - "Conclusions Several DTC measures with CART-derived breakpoints were independently associated with IVNS among recipients of LAI CAB/RPV. Future studies should consider incorporating CART into the DTC measure used to predict injection visit adherence."

Human Immunodeficiency Virus • Infectious Disease