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

Uptake of Injectable long-acting cabotegravir pre-exposure prophylaxis among Vulnerable Populations in Zambia (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical

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) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical

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) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Equivalent performance of HIV oral fluid self-testing and rapid testing compared to nucleic acid amplification test in screening adolescents for long-acting injectable cabotegravir in Brazil (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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."

Expanding pre-exposure prophylaxis (PrEP) access: lessons learned from the introduction of PEPFAR supported long-acting injectable cabotegravir (CAB-LA) in shaping global prevention efforts (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical

Characteristics of early non-persistors on Cabotegravir long-acting (injectable PrEP) compared to persistent users in the PrEPared to Choose study in Cape Town, South Africa (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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

Real-world HIV RNA and antigen/antibody testing among people who use long-acting injectable PrEP. (PubMed, Clin Infect Dis) - "The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted."

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

ViiV Healthcare Announces Reimbursement for APRETUDE for HIV-1 Pre-Exposure Prophylaxis (PrEP) under the Non-Insured Health Benefits (NIHB) Program (Canada Newswire) - "ViiV Healthcare...is pleased to announce that APRETUDE (cabotegravir tablets and extended release injectable suspension) is now covered under the federal Non-Insured Health Benefits (NIHB) Program for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative....Findings from two real-world evidence studies (OPERA and Trio Health cohorts) showed more than 99 per cent effectiveness of APRETUDE for PrEP in nearly 1,300 individuals."

Reimbursement • Human Immunodeficiency Virus • Infectious Disease

Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial. (PubMed, Lancet HIV) - P2 | "Long-acting injectable cabotegravir is a safe, tolerable, and acceptable option for the prevention of HIV in adolescent girls. Our study findings expand the HIV prevention options available to adolescent girls."

Journal • P2b data • Allergy • Human Immunodeficiency Virus • Immunology • Infectious Disease

Patterns of PrEP Use Among Rural South Africa Youth Given Choice: Process Data From the LAPIS Trial (CROI 2025) - P=N/A | "Methods We nested LAPIS (NCT066250504) a cluster randomized controlled trial of offering a choice of oral PrEP, two monthly (long-acting) injectable cabotegravir, dapivirine vaginal ring or packs of 28 days of post-exposure prophylaxis (PEP) within a larger trial testing the population impact of community-based delivery of PrEP through sexual reproductive health (SRH) services in rural KZN (NCT05405582). However, one in four chose an oral option. Providing choice that meets adolescents and youth's preferences may improve effective PrEP use."

Human Immunodeficiency Virus • Infectious Disease

Acceptability of Long-Acting Cabotegravir Among Pregnant and Lactating People in South Africa (CROI 2025) - "Background Providing pregnant and lactating people (PLP) with choice in PrEP methods, including long-acting injectable cabotegravir (CAB-LA), may mitigate barriers to PrEP continuation...Using informed choice counseling, participants were offered oral tenofovir disoproxil fumarate/emtricitabine or CAB-LA, with the option to switch modalities at follow-up visits over 18 months. We report baseline PrEP choices among PLP enrolled in the study, acceptability of their initial choice within 3 months of enrollment, and theoretical preferences regarding the dapivirine vaginal ring (expected to be approved for use by PLP pending safety review)...Conclusions Our population of PLP had a strong preference for CAB-LA over oral PrEP, and CAB-LA was found to be highly acceptable among PLP. Further study is needed to evaluate the effect of offering choice of PrEP methods, including CAB-LA, on PrEP continuation among pregnant and lactating people."

Pain

PrEP Choices Among Sexual and Gender Minorities in Brazil: The ImPrEP CAB-LA Study (CROI 2025) - "Long-acting injectable cabotegravir (CAB-LA) has shown high efficacy in trials, though real-world effectiveness data remain limited...Conclusions In this pioneering PrEP choice implementation study in Latin America, the majority of participants chose CAB-LA. Personalized HIV prevention approaches are critical to empower individuals to select a PrEP method aligned with their values and lifestyles, enhancing the likelihood of long-term adherence and effectiveness."

Human Immunodeficiency Virus • Infectious Disease

Long-Acting PrEP Preference Among Brazilian Sexual and Gender Minorities: Key Influencing Factors (CROI 2025) - "With the approval of long-acting injectable cabotegravir and recent results of lenacapravir for PrEP, understanding PrEP preferences is vital for integrating these technologies into national PrEP programs...Urgent efforts are needed to increase awareness of HIV prevention and combat LGBTQIAPN+phobia. Priority should be given to implementation studies on the acceptability and uptake of lenacapravir in Brazil, especially among populations at increased vulnerability to HIV, such as those engaging in chemsex."

Human Immunodeficiency Virus • Infectious Disease

Oral and Injectable PrEP Use Among US Adolescents and Young Adults, 2019-2023 (CROI 2025) - "We estimated the number of adolescents (aged 13–19 years) and young adults (aged 20–24 years) prescribed branded or generic FTC/TDF, branded FTC/TAF, or long-acting injectable cabotegravir (CAB-LA) during 2019–2023. Injectable PrEP use among adolescents and young adults was low compared with oral medication, though its use has increased slightly since it has become available. Increasing PrEP use among young people who would benefit from it remains important to address the HIV epidemic."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Impact of Rapid Long-Acting PrEP Scale-Up Among MSM: Closing the Unmet Needs and Towards Ending HIV (CROI 2025) - "Background Long-acting injectable cabotegravir (CAB-LA) is superior to oral pre-exposure prophylaxis (PrEP) regimens...Conclusions Continuing the NPP is crucial. A swift introduction of CAB-LA could significantly reduce the PrEP unmet needs, paving the way toward ending the HIV epidemic in the Netherlands."

Human Immunodeficiency Virus • Infectious Disease

Estimation of Prevention-Effective CAB-LA Concentrations Among MSM/TGW in HPTN 083 (CROI 2025) - "Background HIV Prevention Trials Network (HPTN) 083 Trial was a randomized controlled trial that demonstrated the superiority of long-acting injectable cabotegravir (CAB-LA) over daily oral TDF/FTC for HIV PrEP among cisgender men and transgender women who have sex with men. Q2M dosing has been shown to achieve [CAB] above 4x PA-IC90. Novel formulations, dosing, and time-to-protection estimates may be informed by these results."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

No Increased Risk for Hypertension With CAB-LA Compared to TDF/FTC for PrEP: Results From HPTN 084 (CROI 2025) - "Methods HPTN 084 evaluated the effectiveness of long-acting injectable cabotegravir (CAB-LA) compared to daily oral TDF/FTC for PrEP in individuals born female aged 18-45 years in eastern and southern Africa. Observed HTN incidence was numerically higher with CAB compared to TDF/FTC PrEP use, but this was not statistically significant and slightly diminished with adjustment for key risk factors. Incident HTN is more likely explained by other risk factors like age, BMI, weight gain, pregnancy and enrolment region."

Cardiovascular • Genetic Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Obesity

Performance of HIV RNA Screening in the Context of Long-Acting Injectable Cabotegravir in HPTN 084 (CROI 2025) - "Methods HPTN 084 evaluated the effectiveness of long-acting injectable cabotegravir (CAB-LA) compared to daily oral TDF/FTC for PrEP in individuals born female aged 18-45 years in eastern and southern Africa. Although infrequent, most positive isolated HIV RNA tests were false positive with the potential for negative clinical consequences in some cases. Future HIV testing algorithm guidelines should consider the risks and benefits of HIV RNA screening in this setting."

Human Immunodeficiency Virus • Infectious Disease

Identifying preferred program delivery attributes for long-acting injectable cabotegravir-rilpvirine in three U.S. HIV clinics: A discrete choice experiment. (PubMed, J Acquir Immune Defic Syndr) - "Participants strongly preferred CAB/RPV-LA delivery at no cost and accessible at their current HIV clinic. Preferences of PWH with sub-optimal engagement were heterogeneous, suggesting the need for tailored, differentiated delivery programs offering choice."

Journal • Human Immunodeficiency Virus • Infectious Disease

Exploring pre-exposure prophylaxis (PrEP) modality preferences among black cisgender women attending family planning clinics in Chicago via a cross-sectional mixed-methods study. (PubMed, BMJ Public Health) - "A cross-sectional survey among black cisgender women ages 13-45 (inclusive) attending women's health clinics in Chicago, Illinois, USA, prior to the approval of cabotegravir long-acting injectable...This research provides important insights into the preferences and attitudes of different PrEP modalities among black cisgender women. As different modalities continue to be approved for use among cisgender women, more research is needed to investigate the acceptability and preferences of these different modalities in order to improve uptake and adherence among this population."

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

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=66 | Active, not recruiting | Sponsor: ViiV Healthcare | Recruiting ➔ Active, not recruiting | N=250 ➔ 66

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease