Vocabria (cabotegravir oral) / ViiV Healthcare, Shionogi - LARVOL DELTA

Preclinical evaluation of long-acting cabotegravir and rilpivirine for HIV post-exposure prophylaxis in a macaque model. (PubMed, EBioMedicine) - "We document protection in macaques by one-time CAB LA/RPV LA PEP under highly stringent modeling conditions. Delayed breakthrough infections highlight potential diagnostic challenges associated with this PEP modality and underscore the need for prolonged follow-up."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

CABNATE: A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 (clinicaltrials.gov) - P1/2 | N=66 | Not yet recruiting | Sponsor: ViiV Healthcare

New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

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

Long-Acting Cabotegravir/Rilpivirine for HIV Antiretroviral Therapy Throughout Pregnancy: A Case Report and Literature Review. (PubMed, Case Rep Infect Dis) - "Benefits of CAB/RPV during pregnancy include improved drug adherence and discretion. Based on our experience and review of the literature, long-acting intramuscular CAB/RPV may be of value in treatment-experienced patients experiencing difficulties with pill adherence."

Journal • Cardiovascular • CNS Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Nephrology • Ventriculomegaly

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

Emerging patterns in HIV integrase resistance. (PubMed, AIDS) - "Resistance was more frequent in non-B subtypes and often co-occurred with resistance to other antiretroviral classes. Though prevalence remains low, the findings highlight the need for continued surveillance to inform treatment decisions, especially as integrase inhibitors like dolutegravir, bictegravir and cabotegravir become more widely used."

Journal • Human Immunodeficiency Virus • Infectious Disease

Genotyping not required for sustained effectiveness of long-acting cabotegravir plus rilpivirine: evidence from the RELATIVITY cohort. (PubMed, AIDS) - "In this large real-world cohort, the absence of genotypic data did not affect LAI CAB+RPV effectiveness in virologically suppressed PWH. Limitations, including ambispective design, short follow-up, and low non-B subtype prevalence, may limit generalizability."

Journal • Human Immunodeficiency Virus • Infectious Disease

The safety of cabotegravir in pregnancy: a systematic review and meta-analysis. (PubMed, BMC Infect Dis) - "The small sample size currently precludes a definitive conclusion on the safety profile of cabotegravir use during pregnancy. More research in this area is required to assess this drug's role in utero."

Journal • Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

Lenacapavir Plus Cabotegravir as Combination Treatment: Real-world Use Cases From the National Clinician Consultation Center. (PubMed, Open Forum Infect Dis) - "LEN+ CAB+/-RPV was effective and well-tolerated: among 10 cases with follow-up information, viral load decreased by a mean of 3.88log10 copies/mL within a median of 56 days (range = 29-166 days), and 5 experienced injection-site reactions rated as "not at all" to "slightly" problematic. These data support further investigations into LEN+ CAB+/-RPV use among PWH with oral ART challenges and/or drug resistance."

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

Ukraine's First Horizon Scanning Pilot: Lessons for HTA Implementation (ISPOR-EU 2025) - "The case study showed horizon scanning tool can effectively inform Ukraine's healthcare about new HIV/AIDS technologies, making it a promising tool for integration into early-stage HTA processes."

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

Beyond Viral Suppression: Navigating Structural Barriers, Aging and Frailty, Drug Resistance, Therapeutic Innovations, and Reproductive Health Challenges in the Global HIV/AIDS Epidemic. (PubMed, J AIDS HIV Treat) - "This narrative review synthesizes evidence from peer-reviewed studies, global guidelines, and major clinical trials published up until September 2025 to explore these converging issues. By highlighting gaps and opportunities across aging, structural barriers to care, social determinants of health, therapeutic innovation, and reproductive health, we underscore the need for inclusive, multidisciplinary, and evidence-based HIV care models for the next decade."

Journal • Human Immunodeficiency Virus • Infectious Disease

Innovations in the biomedical prevention, diagnosis, and service delivery of HIV and other sexually transmitted infections. (PubMed, Lancet) - "This Series paper explores the potential of pre-exposure prophylaxis (PrEP) for HIV in different forms (eg, daily oral PrEP, event-driven PrEP, and long-acting injectable PrEP), and highlights the challenges of adherence to daily regimens and the promise of longer-acting agents, such as cabotegravir and lenacapavir. The potential of doxycycline post-exposure prophylaxis for the prevention of bacterial STIs is also discussed, with concerns about antimicrobial resistance...This Series paper discusses the benefits, landscape, and pipeline of rapid diagnostic tests (eg, lateral flow tests and molecular assays) and the challenges of implementing these tests in low-resource settings, particularly the need for rapid results to inform clinical decisions, promote convenience, and reduce cost. This Series paper also addresses innovations in service delivery and advocates for integrated and person-centred approaches (eg, differentiated services) that combine HIV and STI services,..."

Journal • Review • Herpes Simplex • Human Immunodeficiency Virus • Infectious Disease • Oncology

Cabotegravir and Rilpivirine concentrations and HIV-1 RNA suppression in genital fluids and rectum in people with HIV on long-acting intramuscular Cabotegravir plus Rilpivirine antiretroviral therapy. (PubMed, J Infect Dis) - P4 | "This study examined cabotegravir (CAB) and rilpivirine (RPV) distribution and HIV suppression in genital and rectal compartments after switching to long-acting intramuscular CAB+RPV administered every two months. All participants maintained HIV-1 RNA <20 copies/mL in all matrices. Clinical Trial Registration: EudraCT Number: 2021-006779-41."

Journal • Human Immunodeficiency Virus • Infectious Disease

Pan-Resistant HIV-1 Drug Resistance Among Highly Treated Patients with Virological Failure on Dolutegravir-Based Antiretroviral Therapy in Zimbabwe. (PubMed, Viruses) - "High-level resistance to DTG and cabotegravir was found in 14% and 23% of integrase sequences, respectively, primarily driven by G118R and E138K/T mutations. These results highlight the emergence of INSTI resistance in LMICs. The study underscores the urgent need for enhanced HIV drug resistance testing, continuous surveillance, and strategic optimization of ART regimens in resource-constrained settings to ensure effective HIV management."

Journal • Human Immunodeficiency Virus • Infectious Disease

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

Exploring the Interaction Between Injection Site and Biological Sex on the Real-world Population Pharmacokinetics of Long-acting Cabotegravir and Rilpivirine in People With HIV. (PubMed, Open Forum Infect Dis) - "Subcutaneous depot deposition after intramuscular injections is not uncommon, occurring more frequently in females and is associated with increased skin to muscle thickness. Slower absorption of cabotegravir from subcutaneous administration contributes to the observed sex differences in drug concentrations."

Journal • PK/PD data • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/ emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study. (PubMed, J Infect Chemother) - P3 | "Switching to CAB+RPV LA OLI demonstrated comparable efficacy to continuing BIC/FTC/TAF, was well tolerated and preferred by most participants who switched. ClinicalTrials.gov; NCT04542070 (https://clinicaltrials.gov/study/NCT04542070)."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals (EACS 2025) - P1 | "LEN injections led to more frequent and visible ISRs with participants and HCPs preferring CAB. These data are important in empowering individuals and their HCPs to make fully informed decisions regarding LAI antiretrovirals."

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

Nucleocapsid mutations at time of virological failure with an integrase inhibitor (EACS 2025) - "Results : Sequences were available for 61 PLWH-1 receiving either elvitegravir (n=3), raltegravir (n=4), cabotegravir (n=4), dolutegravir (n=18), or bictegravir (n=32). Conclusions : Our study confirms that mutations in the nucleocapsid are observed in a small number of individuals with VF with an INSTI-based regimen. Phenotypic data are needed to decipher the impact of the new mutations (F16Y, N27D, and N27H), and the frequency of nucleocapsid mutations should be explored in larger cohorts."

Human Immunodeficiency Virus • Infectious Disease

Population Pharmacokinetics, Antidrug Antibodies and Exposure-Response of VH3810109 (N6LS) in Virologically Suppressed Adults Living With HIV From the Phase 2b EMBRACE Study (EACS 2025) - "In EMBRACE, N6LS was administered 60 mg/kg intravenously (IV) or 3000 mg subcutaneously (SC) with rHuPH20 Q4M together with approved monthly (Q1M) cabotegravir as a 2-drug combination in virologically suppressed adults. Conclusions : A low occurrence of plasma HIV-1 RNA ≥50 c/mL at Month 6 was observed in EMBRACE. This modeling i) indicates multiple factors contribute to the observations of plasma HIV-1 RNA ≥50 c/mL at Month 6; ii) supports moving from mg/kg to flat IV dosing; and iii) demonstrates ADAs had no impact following Q4M dosing in virally suppressed participants"

Clinical • P2b data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CD4

Intention to use long-acting injectable Pre-Exposure Prophylaxis among Belgian men who have sex with men – results of on online survey (EACS 2025) - "Information on Cabotegravir-based LAI-PrEP was provided in the questionnaire...Conclusions : Among the Belgian MSM PROTECT respondents, intention to use LAI-PrEP was highest among those having used or using oral PrEP, reporting suboptimal adherence and having a higher number of sex partners. We suggest research and public health policy to further investigate how LAI-PrEP can be rolled out as an additional tool to maximise its impact on the epidemic."

Human Immunodeficiency Virus • Infectious Disease

Association of Injection Site with Trough Concentrations of Cabotegravir and Rilpivirine Q2M (EACS 2025) - "In this study we aimed to compare the plasma trough concentrations of cabotegravir (CAB) and rilpivirine (RPV) between the dorsogluteal (DS) and ventrogluteal (VS) injection sites adjusting for potential confounders. Injection site was not significantly associated with trough concentration of either drug after adjusting for potential confounders. There was an association between CAB and a trend for RPV concentration and occurrence of viremic episodes."

Human Immunodeficiency Virus • Infectious Disease

Mapping patterns of resistance to 2nd generation INSTI in clinical practice: results from the ROSETTA-registry (EACS 2025) - "181 PWH received dolutegravir (DTG), 26 bictegravir (BIC), and 13 cabotegravir (CAB), 14.5% (32/220) were on two drugs,75.5% (166/220) on three drugs and 10% (22/220) on other combinations. Resistance was also observed below 1000 cp/mL and more frequent in those with previous ART exposure. Specific patterns of resistance were observed according to reported previous ART-exposure and viral-subtype."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Virological failure with NNRTI resistance on CAB+RPV-LA in a man with subtherapeutic cabotegravir levels (EACS 2025) - "He achieved sustained virological suppression (HIV-RNA 10 years on oral ART (TDF/FTC/EFV, then TDF/3TC/DOR)...Oral TAF/FTC/DRV/c was briefly initiated but stopped once the subsequent HIV-RNA measurement was <50 c/mL and HIV-DNA sequencing showed no RAMs... This case suggests a potential influence of injection technique and illustrates how retrospective TDM can help elucidate pharmacological contributors to virological failure on long-acting injectables. TDM may assist clinical decision-making in selected cases and inform real-world optimisation strategies."

Human Immunodeficiency Virus • Infectious Disease • CD4