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

Reasons for choosing oral-lead-in versus direct-to-injection when switching to long-acting antiretroviral therapy in East and Southern Africa (IAS-HIV 2025) - P3 | "Product labels for LAI cabotegravir (CAB) and rilpivirine (RPV) in USA and Europe include an optional one-month oral-lead-in (OLI) prior to initiating injections, despite data from high-income settings demostrating the saftey of direct-to-injection (DTI). Preference for OLI versus DTI varied by country. Providing reassurance about safety and tolerability of CAB+RPV could increase DTI preference and simplify implementation in a public health setting."

Human Immunodeficiency Virus • Infectious Disease

Ultra-long-acting injectable, biodegradable, and removable in-situ forming implant with cabotegravir for HIV prevention. (PubMed, J Control Release) - "The approved long-acting injectable Apretude® is administered every two months and elicits a long pharmacokinetic tail of >15 months that can lead to potential drug-resistant virus [6]. Whole-body X-ray imaging showed that implants were visible for up to 268 days post administration with no noticeable migration. This is the first report of a CAB/BaSO₄ ISFI that is imageable, ultra-long-acting (>180 days), biodegradable, and removable, that can potentially revolutionize current HIV PrEP and help curb the global HIV epidemic."

Journal • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Inflammation

One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study (IAS-HIV 2025) - P4 | "CAB-LA is highly acceptable, feasible, and favored over oral PrEP among diverse MSM and TGM. Flexible scheduling, reminders, and educational tools effectively support CAB-LA use to enhance PrEP uptake and adherence."

Human Immunodeficiency Virus • Infectious Disease

Lenacapavir (Yeztugo) for HIV pre-exposure prophylaxis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Prevalence and incidence of chlamydia and gonorrhoea infections in adolescent females using long acting injectable cabotegravir as HIV pre-exposure prophylaxis in South Africa, Zimbabwe and Uganda: results from HPTN 084-01 (IAS-HIV 2025) - "CT/GC prevalence and incidence was high in this population of young women, emphasising the need for STI testing and treatment to be integrated into PrEP programs in eastern and southern Africa to prevent future negative health outcomes."

Human Immunodeficiency Virus • Infectious Disease

Treatment (as Prevention) Availability and Individuals' Behavior: A Cost-Effectiveness Analysis of Cabotegravir Long-Acting Injectable PrEP. (PubMed, Pharmacoecon Open) - "Our findings suggest that, even when considering potential shifts toward riskier behaviors, introducing long-acting PrEP remains cost-effective when compared with daily oral PrEP treatments."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Provider Factors Likely to Impact Access and Uptake of Long-Acting Injectable Cabotegravir for Transgender Women in the United States: Results of a Qualitative Study. (PubMed, J Assoc Nurses AIDS Care) - "Others (n = 4) reported potential issues, including logistical/scheduling concerns that impede CAB-LA integration and staffing concerns. Many providers expressed support for self-injection (n = 13) and injections at "drop-in" clinics (n = 8) to overcome challenges."

Journal

Model-based efficacy of long-acting cabotegravir by time since last injection among cisgender men and transgender women enrolled in HPTN 083 (IAS-HIV 2025) - "BACKGROUND: HIV Prevention Trials Network (HPTN) 083 study demonstrated superiority of bi-monthly long-acting injectable cabotegravir (CAB-LA) to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). We estimated high preventive CAB-LA efficacy of 93.9%, within eight weeks of an injection. This is consistent with protective efficacy associated with cabotegravir concentrations above 4xPAIC-90 and non-human primate models. Additional clinical data are needed to better inform efficacy after 8 weeks as well as the impact of prior doses."

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

IDCaPP: Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting. (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Kelley-Ross & Associates, Inc. | Not yet recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Apr 2025 | Trial primary completion date: Nov 2025 ➔ Apr 2025

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

Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results (IAS-HIV 2025) - "Within a year, clinic capacity to provide CAB-LA tripled without staffing changes. CAB-LA can be seamlessly integrated into various clinics to expand PrEP access for BW by using implementation resources (e.g., clinic assessment tools) and strategies (e.g., flexible appointments). HCPs in WH, PC, and ID clinics found CAB-LA highly suitable for BW, with bi-monthly visits offering ancillary health benefits."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Women's Health

"The Simplest Way to Go": An Exploration of Why Women Who Inject Drugs Chose Long-Acting Injectable Cabotegravir Instead of Daily Oral PrEP. (PubMed, AIDS Behav) - "Most chose CAB-LA (72%) because it provides longer lasting protection which was a highly valued product attribute. Together, our findings underscore the critical importance of offering multiple PrEP options when implementing HIV prevention strategies that are patient-centered and responsive to the unique needs of WWID."

Journal • Human Immunodeficiency Virus • Infectious Disease

SY12 Let's get real: Implementing PrEP choice in practice (IAS-HIV 2025) - "Proven PrEP regimens include oral PrEP, two-monthly long-acting injectable cabotegravir, six-monthly long-acting injectable lenacapavir and the dapivirine vaginal ring. While access to these non-oral PrEP options is currently limited, settings all over the world will need to come to grips with practical methods to implement PrEP within a choice framework. This session will focus on practical examples from the real world and large-scale studies on what PrEP choice really means, how to deliver PrEP to the community in the context of multiple options, and tools used in clinical and community settings to implement PrEP choice."

PEPtoPrEP: descriptors and factors associated with initiating PEP and PrEP uptake post possible exposure to HIV as part of the FastPrEP study in Cape Town, South Africa (IAS-HIV 2025) - "Along with oral and Dapivirine ring, long-acting injectable cabotegravir (CAB-LA) is currently provided. Injectable CAB-LA PrEP is an attractive and effective prevention modality. Our data shows that offering PEP is feasible to mitigate the risk of initiating CAB-LA when a user may be seronegative but concurrently in the window period of asymptomatic acute HIV acquisition. Further awareness and research are needed to further determine how to facilitate the uptake of PrEP after the PEP period."

Human Immunodeficiency Virus • Infectious Disease

The impact of the USG funding freeze on PrEP implementation and continuity in Nigeria (IAS-HIV 2025) - "BACKGROUND: Nigeria is at a pivotal juncture in HIV prevention, advancing the roll-out of long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) while expanding oral PrEP nationwide—largely with U.S. Government (USG) support... The USG funding freeze disrupted PrEP delivery in Nigeria, setting back progress in HIV prevention and highlighting the fragility of donor-dependent health programs. While the Ministry has proposed an integrated government-led approach in response, mitigating the impact requires coordinated emergency gap-filling to re-establish the program momentum, decentralized procurement pathways, resilient service delivery approaches and data systems."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

PrEP Choice in the real world: understanding preferences among sexually and gender-diverse youth in Northeastern Brazil (IAS-HIV 2025) - "BACKGROUND: Real-world experience with PrEP, including injectable long-acting cabotegravir (CAB-LA) option, is essential for guiding policy and practice... The choice of PrEP modalities was affected by participants' previous experience with oral PrEP, ability to manage potential conflicts posing risk to privacy and confidentiality, and concerns about pain and side-effects. These findings underscore the need for health policies and interventions providing diverse PrEP options and tailoring to the specific needs and contexts of young people."

Clinical • Real-world • Real-world evidence • Pain

Interventions created by clients and healthcare providers to support persistence on long-acting cabotegravir pre-exposure prophylaxis in Malawi: a human-centered design approach (IAS-HIV 2025) - "BACKGROUND: The public health roll-out of long-acting injectable Cabotegravir pre-exposure prophylaxis (CAB-LA) in Malawi began in March 2024... Clients and providers created individual, inter-personal, and structural interventions operating across multiple mechanisms to support sustained use of CAB-LA. Other injectable HIV prevention programs should consider the relevance of similar mechanisms and levels of action. The created interventions will be tested in a cluster randomized trial in early 2025."

Human Immunodeficiency Virus • Infectious Disease

Early learnings from CAB-LA implementation in Zimbabwe (IAS-HIV 2025) - "BACKGROUND: Despite existing HIV prevention options, UNAIDS reported approximately 17000 new HIV acquisitions in Zimbabwe during 2023,with approximately 25% contributed by key populations (KPs).To effectively address their diverse HIV prevention needs, there is a critical need to expand the range of available prevention options beyond existing methods.DESCRIPTION: CeSHHAR rolled out long-acting injectable Cabotegravir (CAB-LA) among KPs in Zimbabwe at three sites... CAB-LA has the potential for rapid integration into key populations programmes. The higher discontinuation rates among CAB-naïve participants after the initial injection highlight the need for intensifying person-centered support to improve early adherence. Younger KPs and those newly starting PrEP are particularly vulnerable, requiring tailored support to ensure sustained and effective use of CAB-LA."

Human Immunodeficiency Virus • Infectious Disease

Mobile men: a key population requiring targeted HIV prevention efforts – insights from the Mobile Men trial in Uganda and South Africa (IAS-HIV 2025) - "We are conducting a long-acting injectable cabotegravir (LA-CAB) and oral tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) implementation trial among mobile men. The high recruitment rate, mobility, HIV prevalence with engagement in care, STI prevalence, and PrEP uptake demonstrate that mobile men at risk of HIV acquisition can be effectively reached and engaged in HIV services. The MOBILE MEN trial will further investigate retention in care in this population."

Clinical • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

PrEP in the era of choice: early insights into client preferences and uptake of long-acting injectable vs. daily oral PrEP in Zimbabwe, 2024 (IAS-HIV 2025) - "Zimbabwe was the first African country to approve long-acting injectable Cabotegravir (CAB-LA) (2023) and began implementation within the public sector (2024), thus providing an opportunity to better understand client preferences between injectable and oral PrEP.DESCRIPTION: Starting in April 2024 CAB-LA was offered as an alternative to oral PrEP in three high-volume public-sector clinics located in urban and rural settings with high HIV incidence... The introduction of CAB-LA in Zimbabwe has expanded HIV prevention options for high-risk populations. While initial uptake was low (as expected) at product introduction stages, short-term adherence among high-risk populations was high and promising improvement in PrEP efficacy. Only a few switched back to daily oral PrEP, highlighting opportunities to learn about ongoing preferences and usage."

Human Immunodeficiency Virus • Infectious Disease

Characterizing latent profiles of young long-acting injectable PrEP users in Cape Town, South Africa (IAS-HIV 2025) - "This study explored how delivery methods and product preferences influence the choice between oral PrEP and long-acting injectable Cabotegravir (Cab-LA) among AYA. The PrEPared to Choose (PtC) implementation study introduced, scaled-up and evaluated uptake of oral PrEP and Cab-LA from fixed-site and mobile clinics... PrEP delivery in community settings, such as mobile clinics, were highly effective in engaging AYA and facilitating Cab-LA initiation. However, AGYW were less likely to choose injectable PrEP, highlighting the need for targeted approaches to address barriers and ensure equitable access to PrEP."

Human Immunodeficiency Virus • Infectious Disease

Real-world utilization and adherence of cabotegravir long-acting for HIV pre-exposure prophylaxis in the United States: results from the PrEPFACTS study using healthcare administrative claims data (IAS-HIV 2025) - "BACKGROUND: APRETUDE (cabotegravir long-acting [CAB-LA]) was approved for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in the United States (US) in December 2021... PrEPFACTS reports real-world high adherence to CAB-LA's dosing schedule, which is an important factor for ensuring effectiveness of HIV PrEP. Most injections occurred within allowable timeframes before reinitiation as required per label."

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

Preferences for HIV self-testing modalities among sexually and gender-diversity adolescents in Brazil (IAS-HIV 2025) - "HIV digital blood-based self-test (HIVDST) offers higher accuracy compared to the HIV oral fluid self-test (HIVOST) and is more recommended during the use of a Long-Acting Injectable Cabotegravir (CAB-LA) for HIV Prevention... This study underscores that RT remains the most preferred HIV testing method among SGDA. However, a significant proportion of participants found the HIVDST easy to use and expressed willingness to use it again citing greater confidence in its accuracy. Expanding awareness about HIVDST is essential to promote test uptake and ensure equitable access to HIV testing options."

Human Immunodeficiency Virus • Infectious Disease

Continuity on long-acting cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP): a comparison of naive and experienced clients in Zambia (IAS-HIV 2025) - "BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) has the potential to reduce HIV transmissions, by expanding the array of preventive options provided... The preliminary data suggests that experienced PrEP clients have a better continuity of treatment than naive clients. This may be attributed to their prior familiarity with PrEP regimens and their demonstrated commitment to HIV prevention over an extended period. However, further data are required to corroborate these findings and tailor strategies to bolster uptake and retention for both populations."

Human Immunodeficiency Virus • Infectious Disease

Uptake of injectable long-acting cabotegravir pre-exposure prophylaxis among vulnerable populations in Zambia (IAS-HIV 2025) - "Vulnerable Populations have an increased risk of acquiring HIV. In reducing new HIV infections among VPs, CAB-LA plays a critical role in preventing new HIV infections. VP friendly strategies should be put in place to enhance uptake and retention of CAB-LA among the VP community in Zambia."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Retention patterns of clients on long-acting injectable cabotegravir (CAB-LA) and oral pre-exposure prophylaxis (PrEP) in Zambia: a comparative analysis (IAS-HIV 2025) - "CAB-LA seems to have better continuity rates in the early stages when compared to oral PrEP, however those rates become similar after 9 months from initiation. Although, further data and monitoring at follow-up points are required to corroborate these findings and tailor strategies for retention to both prevention methods."

Human Immunodeficiency Virus • Infectious Disease