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

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

Preparing for next-generation PrEP: awareness and willingness to use long-acting injectable cabotegravir among men who have sex with men and trans women across Asia. (PubMed, Sex Health) - "Successful introduction of CAB-LA, or other new long-acting injectable PrEP options, in Asia will require strategies to raise awareness and demand-generation that responds to the perceived benefits and concerns of communities."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain

Lenacapavir - a strong weapon to accelerate HIV prevention. (PubMed, AIDS Rev) - "Long-acting options could address these barriers. New prevention products such as long-acting injectable cabotegravir and, most recently, lenacapavir provide very high levels of protection against HIV when compared with daily oral PrEP."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Willingness to participate in a long-acting injectable cabotegravir HIV pre-exposure prophylaxis study among men who have sex with men in the French ANRS-PREVENIR cohort. (PubMed, Sex Transm Infect) - "WtP in a CAB-LA study among MSM oPREP users was moderate but concentrated among those with the greatest need. This highlights the need to enable free distribution. Future studies should evaluate adherence and retention in long-acting iPrEP."

Journal • Human Immunodeficiency Virus • Infectious Disease

Preliminary Results of Long-Acting Injectable PrEP with Cabotegravir at San Raffaele Institute in Milan (EACS 2025) - P | "Purpose : Long-acting injectable cabotegravir (CAB-LAI) has demonstrated superior efficacy than oral PrEP at preventing HIV...Before CAB-LAI, 94.9% participants used oral PrEP with FTC/TDF (64.0% daily; 36.0% event-based)...PrEP with CAB-LAI was very well tolerated, with limited ISRs. Participants reported improved adherence, convenience, a heightened sense of protection, and overall satisfaction with CAB-LAI."

Human Immunodeficiency Virus • Infectious Disease

Engagement of Women of Color in HIV Prevention through PrEP at a Clinic Serving LGBTQ+ Communities (EACS 2025) - "I examined birth sex, gender identity, and medication preferences (Descovy, Truvada, Apretude, Generic Truvada) among cisgender women and male-to-female (MTF) transgender women. My findings underscore the need for targeted outreach and culturally tailored care to address disparities in HIV prevention for women of color. This contributes to enhanced health equity and a reduction in new HIV diagnoses."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-Acting HIV Treatment in Practice: Promising Outcomes and Real-World Challenges from the CACTUZ Cohort (EACS 2025) - "This study presents data from the CACTUZ cohort at Ghent University Hospital, Belgium and aims to assess demographic characteristics, treatment outcomes, and adherence rates of individuals receiving LAI (cabotegravir, CAB + rilpivrine, RPV) as bimonthly maintenance following two intramuscular injections four weeks apart. Conclusions : These real-world data show promising clinical outcomes with LAI treatment offering an effective alternative to oral regimens. However, it also highlights the challenges of follow-up and adherence and emphasizes the importance of patient responsibility in maintaining the injection schedule."

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

HPTN 084: Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women (clinicaltrials.gov) - P3 | N=3224 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Nov 2024 ➔ Oct 2026

Trial completion date • 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=162 | Completed | Sponsor: ViiV Healthcare | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

PrEP-ared for Surgery? A Comprehensive Narrative Review of Perioperative Recommendations for Anesthesia Providers. (PubMed, AANA J) - "It examines the pharmacology, side effects, and perioperative considerations of current PrEP formulations: Truvada, Descovy, and Apretude. Future research should focus on long-term anesthetic implications of PrEP and optimal perioperative management strategies. By implementing informed practices, anesthesia providers can significantly enhance the care of patients on PrEP and support broader public health goals in HIV prevention."

Journal • Review • Anesthesia • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

Early results from implementation of HIV pre-exposure prophylaxis (PrEP) with long-acting injectable cabotegravir for people with barriers to oral strategies, Italy, December 2024 to August 2025. (PubMed, Euro Surveill) - "Adherence to injections exceeded 95%, tolerability was favourable and only 1.5% discontinued for drug-related reasons. These findings demonstrate the feasibility of CAB-LA in European clinical services and support its use in specific populations."

Journal • Human Immunodeficiency Virus • Infectious Disease

ASCEND: A Multi-center Assessment of an Intervention to Provide Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis to People Who Inject Drugs (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

PrEPared to choose: the protocol for an implementation study of the delivery of cabotegravir long-acting injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within a real world PrEP choice context in cape town. (PubMed, BMC Public Health) - P | "PrEPared to Choose will provide an early report of real-world PrEP choice delivery, including all three currently available and approved modalities. The protocol is designed to simulate a real-world environment that provides insight into likely PrEP persistence patterns and practical challenges to PrEP choice implementation in a high HIV burden setting (South Africa) and within high HIV incidence populations (adolescents and young people). The results will be used to inform PrEP choice delivery in South Africa and build a framework into which future, emerging PrEP modalities can be incorporated."

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