Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare - LARVOL DELTA

Staff Perspectives on Implementation of Long-Acting Injectable Preexposure Prophylaxis at a Low-Barrier Syringe Services Program in Philadelphia, PA. (PubMed, J Int Assoc Provid AIDS Care) - "IntroductionLong-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) is a promising HIV prevention tool for people who inject drugs (PWID), who face elevated HIV risk and barriers to care...Interviews were transcribed and analyzed using thematic analysis guided by the Consolidated Framework for Implementation Research.ResultsFacilitators included CAB-LA's relative advantage over oral PrEP, external technical support, 340B pharmacy revenue, alignment with SSP mission and workflows, motivated staff, and financial incentives. Barriers included lack of FDA approval for PWID, complex logistics, performance pressures, infrastructure constraints, competing priorities, staff workload, and client outreach and engagement.ConclusionIntegrating CAB-LA into SSPs is promising, but successful implementation requires targeted strategies, including additional resources, workflow adaptations, and enhanced outreach."

Journal • Human Immunodeficiency Virus • Infectious Disease

EBONI: A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories (clinicaltrials.gov) - P4 | N=370 | Completed | Sponsor: ViiV Healthcare | N=162 ➔ 370

Enrollment change • Human Immunodeficiency Virus • Infectious Disease

Comparative Effectiveness of Daily Oral and Long-acting Injectable Prep: A Critical Review of Clinical Evidence and Public Health Implications. (PubMed, Curr HIV Res) - "The aim of this study was to compare the use of PrEP with TDF+FTC and the long-acting injectable cabotegravir, as well as to examine the mechanisms of action of the drugs involved in PrEP...Emerging strategies under development include annual LEN formulations, the use of broadly Neutralizing Antibodies (bNAbs), and the Dapivirine Vaginal Ring (DPV), which has demon-strated greater convenience and improved adherence among pregnant women compared to oral PrEP. Additionally, digital monitoring tools are being explored, although their effectiveness relies on the implementation of equitable health policies. Thus, integrated prevention models that com-bine biomedical innovations with community-based interventions emerge as essential to expand-ing the reach and impact of PrEP."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Cost-effectiveness of leveraging long-acting injectable cabotegravir to expand PrEP coverage among MSM in two contrasting North American cities. (PubMed, J Int AIDS Soc) - "In a high-incidence Atlanta MSM population, CAB-LA-based PrEP expansions are not projected to be cost-effective, though a minority of simulations achieved cost-effectiveness. However, lower prices could achieve cost-effectiveness. In a low-incidence Montréal MSM population, broad expansions are not expected to be cost-effective at modelled prices. Prioritizing CAB-LA to Montréal MSM facing access, adherence or persistence barriers to oral PrEP warrants a cost-effectiveness assessment."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Project SPEED - Streamlined Protocol for Early Engagement and Delivery of HIV Prevention With Long-acting Injectable Cabotegravir: A Nurse-driven Protocol (clinicaltrials.gov) - P=N/A | N=250 | Not yet recruiting | Sponsor: KC Care Health Center

New trial • Human Immunodeficiency Virus • Infectious Disease

Authors' response: Addressing the blind spot of self-reported adherence in the era of long-acting PrEP. (PubMed, Euro Surveill) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Letter to the editor: Addressing the blind spot of self-reported adherence in the era of long-acting PrEP. (PubMed, Euro Surveill) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Formulation development of a dapivirine-releasing subdermal implant for HIV prevention. (PubMed, Int J Pharm) - "There have been several significant advances in recent years around long-acting strategies for HIV pre-exposure prophylaxis, including DapiRing® (a 1-month dapivirine (DPV)-releasing vaginal ring), Apretude® (a cabotegravir intramuscular injection administered every two months), and Yeztugo® (a twice-yearly lenacapavir injection). Continuous in vitro DPV release ∼12 μg/day was demonstrated over 330 days, with sufficient residual drug content (∼87 mg/∼95 %) to extend release for at least 5 years. In particular, the study highlights the challenges in designing subdermal implants providing sufficient DPV release to maintain systemic/vaginal concentrations at protective levels."

Journal • Human Immunodeficiency Virus • Infectious Disease

PrEP public policies for HIV prevention in South America: an intersectional analysis. (PubMed, BMC Public Health) - "PrEP policy adoption in South America demonstrates significant heterogeneity, shaped by intersecting social, political, and institutional factors. While the region has made notable advances, access remains uneven, with structural barriers such as stigma, regulatory gaps, and geographic inequities limiting impact. Incorporating intersectional perspectives into policy design and implementation is essential to ensure that PrEP - in all its modalities - is accessible as a right to health, addressing differences across multiple social, geographic, and economic dimensions."

Journal • Human Immunodeficiency Virus • Infectious Disease

PALISADE: Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) (clinicaltrials.gov) - P3 | N=3508 | Recruiting | Sponsor: ViiV Healthcare | Trial completion date: Sep 2028 ➔ Jan 2029 | Trial primary completion date: Sep 2028 ➔ Jan 2029

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

PILLAR: A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (clinicaltrials.gov) - P4 | N=287 | Completed | Sponsor: ViiV Healthcare | N=201 ➔ 287

Enrollment change • Human Immunodeficiency Virus • Infectious Disease

Evaluating Health Equity and Access to Apretude (Cabotegravir) for HIV Pre-Exposure Prophylaxis at a Large Academic Medical Center within a Metropolitan City (ASHP 2025) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Deltoid Administration of LAI-ART: Pharmacokinetic Implications When the Gluteal Site Is Not Feasible. (PubMed, Infez Med) - "Specifically, it focuses on intensive pharmacokinetic monitoring following deltoid administration of LAI rilpivirine and cabotegravir in a 29-year-old transgender woman with progressive multifocal leukoencephalopathy and swallowing difficulties...By day 10, the patient's clinical condition had deteriorated, leading to hospice care and subsequent death. Rilpivirine exposure after deltoid injection appeared lower than that typically reported after gluteal or thigh administration, although intracellular drug concentrations may differ from plasma levels, potentially mitigating clinical concerns."

Journal • PK/PD data • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Rare Diseases

Mental Health, Stigma and Risk Perception Among Early Adopters of HIV PrEP with LA Cabotegravir in Italy: A Multicenter Cross-Sectional and Implementation Study. (PubMed, Int J Infect Dis) - "CAB-LA PrEP shows high acceptability, adherence, and evolving prevention practices. Although its discreet delivery may alleviate some concerns about visibility and disclosure, integration with mental health support and stigma-sensitive care is essential."

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

To err is human, to persist is diabolical: Are we repeating the same cost and insurance coverage mistakes again with injectable PrEP? (PubMed, J Acquir Immune Defic Syndr) - "Emerging data suggests high interest in injectable PrEP but low uptake, with some participants reporting challenges obtaining insurance coverage, alongside other clinic-level barriers. It is our hope that assessments of current and persisting barriers to cabotegravir can offer preliminary but critical insights for the rollout of lenacapavir."

Journal • Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

Canadian guideline on HIV pre- and postexposure prophylaxis: 2025 update. (PubMed, CMAJ) - "Multiple safe, effective PrEP and PEP regimens are now available in Canada, making it increasingly possible to find suitable options for all who could benefit. Implementation of this guideline should expand access to biomedical HIV prevention interventions for those at risk and decrease the incidence of HIV in Canada."

Clinical guideline • Journal • Human Immunodeficiency Virus • Infectious Disease

User-reported outcomes of long-acting injectable PrEP with Cabotegravir: Real-world experience from Milan. (PubMed, HIV Med) - "In this real-world cohort, CAB-LA PrEP was highly acceptable, well tolerated and associated with improved perceived adherence, convenience and HIV protection. These findings support CAB-LA as a promising, user-centred HIV prevention strategy, potentially overcoming key limitations of daily oral PrEP."

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

Early experiences with usage of long-acting injectable cabotegravir among adults in rural Ugandan and Kenyan communities: qualitative research from the SEARCH "Dynamic Choice HIV Prevention" intervention trials. (PubMed, J Int AIDS Soc) - "CAB-LA overcame several known barriers to HIV prevention uptake and adherence for women and men. In contexts of continued HIV-related stigma, CAB-LA met some participants' preferences for a product that permitted prevention to be visibly distinguishable from treatment, enabling HIV prevention uptake to feel safer. Moreover, adherence was more easily achieved with CAB-LA compared to PrEP, boosting confidence in prevention efficacy."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain

Assessing Demand for Long-Acting Injectable PrEP and Emerging PrEP Options for HIV Prevention in Australia: Results from a Cross-Sectional Survey of Men Who have Sex with Men. (PubMed, AIDS Behav) - "Long-acting injectable Cabotegravir (CAB-LA) received regulatory approval in Australia but is not available for prevention...Interest in using CAB-LA was associated with younger age (aOR = 0.98, 95%CI = 0.97-0.99), having ever taken PrEP (aOR = 2.06, 95%CI = 1.48-2.88), having 11 or more sexual partners in the last 6 months (aOR = 1.65, 95%CI = 1.25-2.17), believing some friends or sex partners are taking PrEP (aOR = 1.58, 95%CI = 1.18-2.11), reporting wanting to try CAB-LA if it was more effective than oral PrEP (aOR = 2.05, 95%CI = 1.48-2.86), or believing CAB-LA is more effective than event-driven oral PrEP (aOR = 1.48, 95%CI = 1.10-1.99). This analysis demonstrated Australian GBMSM have a diverse range of preferences of PrEP options, and access to newer options is needed to increase HIV prevention coverage."

Journal • Human Immunodeficiency Virus • Infectious Disease

Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN). (PubMed, Trials) - P3 | "This study will provide critical data to inform scalable delivery models for both oral and injectable PrEP among mobile men at high risk for HIV acquisition. Findings will also highlight the potential of PrEP choice delivery and its benefits, offering evidence for governments to consider in the rollout of injectable PrEP in public health systems. Trial registration NCT06133686. Registered on 14 November 2023. PACTR202409632006463. Registered on 2 September 2024."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Supporting Oral and Long-Acting HIV Preexposure Prophylaxis Decision-Making Among Pregnant Women (MyChoice Intervention): Protocol for 2 Pilot Randomized Controlled Trials. (PubMed, JMIR Res Protoc) - P=N/A | "The MyChoice pilot studies will provide critical evidence on a novel intervention for PrEP decision-making during pregnancy and breastfeeding. If feasible and acceptable, these results will form the basis for larger efficacy trials to promote PrEP uptake during pregnancy."

Clinical protocol • Journal • Human Immunodeficiency Virus • Infectious Disease

Estimation of prevention-effective CAB-LA concentrations among men who have sex with men (MSM) and transgender women (TGW) in HPTN 083. (PubMed, J Infect Dis) - "Consistent plasma CAB concentrations ≥4x PA-IC90 were estimated to provide 93% protection against HIV in MSM and TGW."

Journal • Human Immunodeficiency Virus • Infectious Disease

Willingness to switch to injectable cabotegravir among oral PrEP users in Durban, South Africa. (PubMed, Health SA) - "Long-acting injectable cabotegravir (CAB-LA), administered every two months, may improve adherence...Targeted education may support longer-term oral PrEP users hesitant to switch. This study highlights adherence challenges with oral PrEP and supports interest in longer-acting injectable alternatives."

Journal • Human Immunodeficiency Virus • Infectious Disease

Patterns and correlates of initiation of long-acting injectable cabotegravir for pre-exposure prophylaxis: a case-control analysis. (PubMed, Sex Transm Dis) - "Despite this, LACAB was well tolerated, and discontinuation rates were low. Our findings support prioritizing LACAB for individuals most exposed to HIV and with low adherence to oral regimens, especially in contexts where logistical or economic constraints limit universal access to PrEP."

Journal • Human Immunodeficiency Virus • Infectious Disease

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Midway Specialty Care Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease