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

PHARAOH: Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV (clinicaltrials.gov) - P=N/A | N=105 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Oct 2026 | Initiation date: Aug 2026 ➔ Jan 2025 | Trial primary completion date: Dec 2026 ➔ Oct 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Barriers and Facilitators to Equitable Implementation of Long-Acting Injectable PrEP for Racial, Gender and Sexual Minority Populations in NYC: The EquiPrEP Study. (PubMed, AIDS Behav) - "Long-acting injectable cabotegravir (LAI-CAB) is a novel HIV pre-exposure prophylaxis (PrEP) modality found to significantly lower HIV risk in key populations...EquiPrEP is one of the first LAI-CAB implementation studies for HIV prevention to center equitable access for communities with the highest burden of HIV and elucidate implementation determinants to LAI-CAB. Findings may inform future implementation strategies seeking to incorporate equity as part of LAI-PrEP care."

Journal • Human Immunodeficiency Virus • Infectious Disease

Long-acting Injectable Antiretroviral Therapy in South African Adolescents and Young Adults - Week 48 results from the AFINAty Study. (PubMed, J Acquir Immune Defic Syndr) - "LAI-ART was safe, highly acceptable and effective among YLHIV. These findings support the feasibility of implementing LAI-ART through community-based models in sub-Saharan Africa."

Journal • Human Immunodeficiency Virus • Infectious Disease

Integrating long-acting injectable cabotegravir for HIV prevention into the Brazilian public health system (ImPrEP CAB Brasil): a hybrid type-2 implementation-effectiveness cohort study. (PubMed, Lancet HIV) - P3 | "Same-day CAB-LA delivery effectively reduced HIV incidence and increased PrEP coverage, supporting the implementation of long-acting options within SUS in Brazil."

Journal • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease

TOXIC EPIDERMAL NECROLYSIS FOLLOWING LONG-ACTING INJECTABLE CABOTEGRAVIR: A CASE REPORT OF THE THERAPEUTIC CHALLENGES OF PROLONGED DRUG EXPOSURE (CHEST 2026) - No abstract available

Case report • Clinical • Steven-Johnson Syndrome

User Experience Concepts Assessed Among People in the United States Using Long-Acting Injectable Cabotegravir for PrEP in Real-World Care: Results from the CAPTIVATE Study (IDWeek 2026) - No abstract available

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

Tolerability and Virologic Outcomes after Transition from Long-Acting Injectable ART to Oral ART. (PubMed, AIDS Patient Care STDS) - "The tolerability of oral antiretroviral therapy (ART) administered after discontinuation of long-acting injectable (LAI) cabotegravir (CAB) + rilpivirine (RPV), during the period of residual injectables persistence, has not been described...Within 6 months, HIV-RNA was ≤50 copies/mL in 96.0% and ≤200 copies/mL in 98.7% of participants. The overlap between the residual CAB + RPV and the oral therapy was well tolerated; most individuals restarted their previous oral regimen, and virological suppression remained high 6 months after resuming oral ART."

Journal • Human Immunodeficiency Virus • Infectious Disease

Persistent Injection-Site Nodules After the Administration of Long-Acting Cabotegravir/Rilpivirine. (PubMed, Intern Med) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Provider Preferences on Existing and Potential Future Biomedical HIV Prevention Products: A Qualitative Study in the United States, Thailand, and South Africa. (PubMed, AIDS Res Hum Retroviruses) - "Several forms of HIV pre-exposure prophylaxis (PrEP) are approved, prescribed off-label, or in development in the United States, including daily oral tablets, long-acting injectable cabotegravir (CAB-LA), removable implants, and rectal tenofovir products...When asked to rank PrEP options if all were simultaneously available, providers most often prioritized removable implants (N = 3), daily oral PrEP (N = 3), CAB-LA (N = 1), and rectal douches/enemas (N = 1), while others (N = 2) emphasized patient preference. Overall, providers noted that each product has unique advantages and expressed support for digital shared decision-making tools to enhance patient-provider communication about PrEP selection."

Journal • Human Immunodeficiency Virus • Infectious Disease

Managing HIV in the extreme: Viral load and drug monitoring in a patient with BMI > 60 on long-acting cabotegravir/rilpivirine therapy. (PubMed, Br J Clin Pharmacol) - "Based on TDM concentrations, monthly dose titration from standard CAB/RPV 400 mg/600 mg to 600 mg/900 mg increased trough concentrations with VL suppression (<200 copies mL-1) maintained. TDM may be an additional tool in this population with high BMI values to optimize CAB/RPV dosing strategies as data accumulate in this high-risk group for viral rebound with LA-I therapy."

Journal • Human Immunodeficiency Virus • Infectious Disease • Obesity

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana (clinicaltrials.gov) - P4 | N=500 | Active, not recruiting | Sponsor: Beth Israel Deaconess Medical Center | Trial completion date: Nov 2027 ➔ Aug 2027

Trial completion date • 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=2996 | Active, not recruiting | Sponsor: ViiV Healthcare | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

PrEP use within multi-method PrEP services in primary care settings in South Africa (AIDS 2026) - "We assessed time to first PrEP interruption among individuals offered a choice of daily oral PrEP, dapivirine vaginal ring (DVR) or long-acting injectable cabotegravir (CAB-LA) within a large implementation cohort. CAB-LA users demonstrated substantially greater PrEP persistence over 12months compared with oral PrEP users, with significantly lower risk of interruption and higher retention across all follow-up points. These findings highlight the potential of long-acting injectable PrEP to improve sustained HIV prevention coverage in routine programme settings. Scaling access to long-acting PrEP, alongside differentiated support strategies for oral PrEP users, may strengthen HIV prevention outcomes."

Clinical • Human Immunodeficiency Virus • Infectious Disease

User experiences with long-acting injectable CAB-LA PrEP in South Africa: aualitative insights into acceptability, motivations for use, and challenges (AIDS 2026) - "BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) provides an important alternative to daily oral PrEP and an opportunity to enhance effective PrEP use among individuals who experience challenges with daily pill-taking... Between June and July 2025, we conducted 70 in-depth interviews with CAB-LA users aged 16–56 years (47 females, 23 males) from a parent cohort offering PrEP choice (oral PrEP, dapivirine ring, or CAB-LA) at six fixed and three mobile clinics in South Africa... CAB-LA was highly acceptable and preferred for its convenience, effectiveness, and reduced adherence demands. Social support and personal motivation support sustained use, while injection-related challenges were generally manageable. These findings highlight CAB-LA’s potential to improve PrEP adherence and strengthen HIV prevention outcomes in diverse real-world settings, providing implementation-relevant evidence to guide broader national rollout of injectable PrEP."

Human Immunodeficiency Virus • Infectious Disease

Participants report positive experiences switching from subcutaneous to intravenous lotivibart (LVB, N6LS, VH3810109) and cabotegravir long-acting injections for HIV-1 treatment in EMBRACE study (AIDS 2026) - "Participants who switched from SC to IV treatment with lotivibart reported positive experiences with both SC and IV infusions and most indicated wanting to continue IV treatment."

Human Immunodeficiency Virus • Infectious Disease

Interim analysis of adverse pregnancy outcomes with injectable CAB-LA versus oral PrEP: findings from the PrIMO safety cohort (AIDS 2026) - "Oral PrEP (FTC/TDF, 3TC/TDF) is safe during pregnancy and breastfeeding, but safety data on long-acting injectable cabotegravir (CAB-LA) are limited. Although CAB-LA was associated with a higher relative risk of adverse pregnancy outcomes compared to oral PrEP, this difference was not statistically significant at interim analysis. As long-acting HIV prevention expands globally, generating robust pregnancy safety data is imperative. Dedicated safety cohorts such as PrIMO are essential to ensure that pregnant women are not left behind in biomedical innovation."

Adverse events • Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

Health system implications of expanded PrEP choice: evidence from a time-and-motion study in South Africa (AIDS 2026) - "In response, differentiated service delivery models and expanded PrEP choice have been introduced, including long-acting injectable cabotegravir (CAB-LA), which may improve acceptability by reducing adherence burden... Expanded PrEP choice is associated with increased provider time spent with patients. While this reflects higher service intensity, the additional time may represent a worthwhile investment if improved acceptability leads to higher uptake, sustained use, and greater HIV prevention impact."

Human Immunodeficiency Virus • Infectious Disease

Uptake of long-acting injectable cabotegravir among people who use drugs in Kampala, Uganda (AIDS 2026) - P=N/A | "In a recent study of syringe services programs (SSPs) and methadone treatment programs, we observed limited PrEP adherence among people who use drugs who initiated PrEP in conjunction with their drug program with 39.8% having medium to high levels of tenofovir diphosphate at 1 month and 37.0% at 3 months after PrEP initiation. In this first cohort of people who use drugs in sub-Saharan Africa to report on use of CAB-LA as PrEP, HIV protection from CAB-LA during the first 2 months of use was high and may be greater than coverage offered by daily oral PrEP. However, persistence appears to remain a challenge with CAB-LA as fewer than one-third received a 2-month dose."

Human Immunodeficiency Virus • Infectious Disease

Inequities in gender-affirming policy environments and long-acting PrEP uptake between U.S. states (AIDS 2026) - "Apretude prescribing was higher in states with more gender-affirming policies, based on both Medicaid coverage and the MAP gender-identity policy tally. This suggests supportive policies may be linked to fewer barriers to long-acting PrEP. These early findings support closer monitoring of how state policy shapes equitable access to injectable PrEP."

Preventive care

PrEP on the move: cost analysis of mobile PrEP service delivery models for scaling access to youth in rural and urban South Africa (AIDS 2026) - "This study describes the as-implemented costs of daily oral and two-month long acting injectable cabotegravir (CAB-LA) PrEP delivery alongside sexual and reproductive health (SRH) services through mobile clinics that were embedded within South African implementation studies... These results for Mobile SDMs used in implementation studies showed that delivery costs are highly sensitive to both client volume and diagnostics costs. During implementation and scale up, programs should prioritize maximizing daily client throughput and consider reducing or removing non-critical diagnostic costs. Despite these costs, both delivery models potentially reduce client burden and mitigate geographic and structural barriers to PrEP and SRH access."

Cost-analysis • HEOR • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

“You just get your shot and go away": provider perspectives on the feasibility, acceptability, and implementation considerations of long-acting injectable cabotegravir as PrEP for people who use drugs in Uganda (AIDS 2026) - "Provider perspectives indicate that CAB-LA PrEP is a highly promising HIV prevention option for PWUD in Uganda, offering advantages over oral PrEP in adherence, privacy, and overall acceptability. Its success depends on flexible delivery models that address mobility, stigma, and continuity of care, alongside adequate product supply and integration with other harm reduction services, enabling long-acting PrEP to realize its full public health impact for this population."

Human Immunodeficiency Virus • Infectious Disease

Initial experiences and lessons learned with long acting cabotegravir for PrEP use among pregnant and breastfeeding women (AIDS 2026) - "BACKGROUND: In February 2024, Zambia became the first country in sub-Saharan Africa to introduce long-acting injectable Cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP)... Introduction of CAB-LA expanded PrEP options for PBFW, contributing to overall PrEP uptake while also addressing challenges that are associated with oral PrEP adherence. Increasing CAB-LA uptake will require strengthening client awareness on its safety and convenience."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Provider and community perspectives on barriers and facilitators to long-acting injectable PrEP implementation in Southern California (AIDS 2026) - "Outer setting barriers were dominated by financing issues, particularly with buy and bill insurance models: “If a clinic spends $20,000 to buy four boxes of Apretude but doesn’t know when they’ll get reimbursed… there might be hesitation to continue to stock that product.” Preliminary review of community group interviews suggests strong interest in LAI PrEP as an alternative to oral PrEP, alongside concerns related to access, side effects, and the practicality of regular injection visits... While provider readiness and enthusiasm for LAI PrEP are high, successful scale-up is constrained by structural, financial, and workflow barriers, underscoring the need for system-level implementation strategies. Aligning service delivery models with community priorities while addressing provider barriers will be essential for equitable LAI PrEP implementation. Integrating provider and community perspectives can inform scalable, context-responsive strategies to expand sustained LAI..."

Human Immunodeficiency Virus • Infectious Disease

Nursing at the frontline: nurse-led implementation of long-acting injectable PrEP (CAB-LA) in a community-based adolescent service in Brazil (AIDS 2026) - "BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) is a major advance in HIV prevention... Nurse-led CAB-LA provision in community-based services is feasible, safe, and effective, improving adolescent retention and integrating HIV prevention with surveillance systems. Nursing functions as a bridge between marginalized adolescents and care, translating evidence into practice. Expanding the nursing scope represents a scientific, ethical, and social advance toward equitable HIV prevention."

Human Immunodeficiency Virus • Infectious Disease

Peer-led community engagement in the CAB-LA PrEP implementation study in Brazil (AIDS 2026) - "BACKGROUND: ImPrEP CAB Brasil is an implementation study offering same-day choice between oral and long-acting injectable Cabotegravir (CAB-LA) within public PrEP services for young sexual and gender minorities aged 18–30 in six Brazilian cities... The importance of community-driven, flexible, and informed approaches to HIV prevention programming. Future steps include qualitative analyses to examine how these practices are perceived and experienced by community members, ensuring that interventions remain relevant, inclusive, and effective."

Human Immunodeficiency Virus • Infectious Disease