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

Cabotegravir-Loaded Polymeric Micelles: A Promising Strategy for Improved Solubility and Therapeutic Outcomes. (PubMed, Drug Dev Ind Pharm) - "Compared to conventional CAB suspension, the TPGS-based micelles exhibited markedly enhanced dissolution kinetics and a 236.75 ± 0.74% increase in relative oral bioavailability, accompanied by prolonged systemic circulation. TPGS-enabled micellar encapsulation significantly enhances the oral delivery profile of CAB, offering a promising, non-invasive, and patient-compliant alternative to parenteral antiretroviral regimens, potentially improving therapeutic outcomes in HIV management."

Journal • Human Immunodeficiency Virus • Infectious Disease

ASCEND: Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2027 ➔ Dec 2028 | Initiation date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Sep 2027 ➔ Dec 2028

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

ADHERENCE AND PERSISTENCE IN US REAL-WORLD NEW PREP USERS: CABOTEGRAVIR VS EMTRICITABINE/TENOFOVIR ALAFENAMIDE (ISPOR 2026) - "New PrEP initiators using CAB-LA exhibit improved adherence/persistence relative to those using FTC/TAF."

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

PROPEL: Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention (clinicaltrials.gov) - P=N/A | N=3000 | Not yet recruiting | Sponsor: Gilead Sciences

New trial • Human Immunodeficiency Virus • Infectious Disease

COST EFFECTIVENESS ANALYSIS OF LENACAPAVIR COMPARED TO CABOTEGRAVIR AND GENERIC ORAL FTC/TDF FOR HIV PREEXPOSURE PROPHYLAXIS AMONG CIS-GENDER WOMEN IN THE UNITED STATES (ISPOR 2026) - "While LEN-LA is more cost-effective than CAB-LA, its high cost makes it less cost-effective than daily oral FTC/TDF at current prices. LEN-LA may benefit populations with poor oral PrEP adherence, but broad adoption may not be economically justified without price reductions. Findings inform value-based formulary decision-making to support patient-centered and equitable PrEP access"

Clinical • Cost effectiveness • HEOR • Human Immunodeficiency Virus • Infectious Disease

Two cases of possible transmitted HIV drug resistance to all currently available integrase inhibitors, the Netherlands, 2025. (PubMed, Euro Surveill) - "The cases are not phylogenetically linked, representing two independent introductions of integrase inhibitor resistant HIV into the Dutch population. These observations highlight the need for strengthened surveillance and prevention efforts in Europe and globally."

Journal • Human Immunodeficiency Virus • Infectious Disease

Prioritization of adverse events related to integrase inhibitors and NNRTIs: a disproportionality analysis using data from the FAERS database. (PubMed, J Antimicrob Chemother) - "This study provides a systematic framework for evaluating post-marketing AEs of INSTIs and NNRTIs using a semi-quantitative scoring system. Our findings identified five high-priority AEs that require clinical validation and further investigation."

Adverse events • Journal • Eosinophilia • Hematological Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Liver Failure

Dynamic changes of monocytes-related immune activation in people with HIV switching to long-acting injectable cabotegravir plus rilpivirine. (PubMed, Sci Rep) - "Furthermore, a reduction in sCD14 plasma levels was observed. The constant drug concentrations provided by CAB plus RPV injections appear to be effective for a sustained and deep virological suppression that may reduce monocyte/macrophage activation in PWH."

Journal • Human Immunodeficiency Virus • Infectious Disease

What Are the Causes and Consequences of Virological Failure on Long-acting Cabotegravir/Rilpivirine? (PubMed, Clin Infect Dis) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Novel 1,2,3-triazole-based compound triggers apoptosis through DNA damage response involving ATM/ATR signaling in liver cancer cells. (PubMed, Biochem Pharmacol) - "1,2,3-Triazole-substituted cabotegravir analogues, i.e., KJ-9, have been developed as lead structures to explore their potential as antitumor agents. After KJ-9 treatment, ROS were suppressed by the addition of the antioxidant N-Acetylcysteine (NAC), leading to increased levels of p-AKT and reduced levels of p-ATM, p-ATR, p-p53, cleaved caspase-3, and γ-H2AX. These findings suggest that KJ-9 promotes oxidative stress, which further inhibits AKT activation while activating the ATM/ATR pathway, leading to p53 accumulation, sustained DNA damage responses, G2/M-phase cell cycle arrest, and apoptosis in both HepG2 cells and HCCLM3 cells."

Journal • Liver Cancer • Oncology • Solid Tumor • BCL2 • CASP3 • CASP9 • CHEK1 • CHEK2

Severe hyperglycemia after initiation of long-acting cabotegravir in two antiretroviral treatment-controlled people with HIV. (PubMed, Diabetes Metab) - "We report two cases of normoglycemic people with HIV well-controlled by antiretroviral therapy who were switched to a dual long-acting therapy consisting of cabotegravir (CAB), an integrase strand transfer inhibitor, and rilpivirine (RIL), a non-nucleoside analog reverse transcriptase inhibitor, administred intramuscularly once a month...The hyperglycemic episode resumed after stopping CAB/RIL and/or initiating metformin...Up to now, long-acting CAB/RIL has not been associated with metabolic outcomes. These cases serve as a warning to clinicians to monitor glycemia when initiating long-acting CAB/RIL therapy."

Journal • Diabetes • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

221611: PH 3b, CAB + RPV in people with suboptimal response to oral ART (CROWN) (clinicaltrialsregister.eu) - P2/3 | N=98 | Active, not recruiting | Sponsor: Viiv Healthcare UK Limited

Head-to-Head • New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

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: Aug 2027 ➔ Nov 2027 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Health Worker Experiences and Perspectives on the Integration of Long-Acting Injectable Antiretroviral Therapy into a Safety-Net HIV Clinic in the Southeastern United States. (PubMed, J Int Assoc Provid AIDS Care) - "BackgroundFollowing its approval by the US Food and Drug Administration in January 2021, clinics have moved to implement the first long-acting antiretroviral regimen (cabotegravir [CAB] and rilpivirine [RPV]) into routine care.MethodsIn this qualitative implementation study, we characterize health worker experiences with the introduction of CAB/RPV into a safety net HIV clinic in the Southeastern US during the first 10 months of service integration. Successes included strong awareness of and enthusiasm for CAB/RPV and the integration of supportive resources over time. Challenges included inconsistent communication about logistics, perceived pressures on human resources, and concerns about structural barriers affecting patient access to care.ConclusionsFindings highlight the resource demands of implementing CAB/RPV, and the complex array of factors that shape successful implementation."

Journal • Human Immunodeficiency Virus • Infectious Disease

Optimizing the patient journey: Insights from early implementation of long-acting cabotegravir and rilpivirine in four urban Ryan White-funded clinics in the United States. (PubMed, J Int AIDS Soc) - "Optimizing the LAI-CAB/RPV patient journey requires developing a specialized support framework that is distinct from oral ART protocols. This new treatment modality requires a tailored approach that addresses unique challenges, including facilitating candid discussions about adherence contingencies, managing the physical and psychological aspects of injection experiences, ensuring meaningful and consistent provider relationships amid changing care patterns and providing enhanced support during treatment transitions."

Journal • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Pain • Psychiatry

CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074) (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

New trial • Human Immunodeficiency Virus • Infectious Disease

Profiles of Willingness to Use Pre-Exposure Prophylaxis Modalities and an HIV Vaccine Among Sexual and Gender Minority Individuals in Brazil, Mexico, and Peru: Cross-Sectional Online Survey. (PubMed, JMIR Public Health Surveill) - "Our results suggest a strong preference for long-acting formulations, including monthly oral and bimonthly injectable, among SGM individuals in Latin America. Further research is needed to address gaps in the understanding of prevention modalities. As additional PrEP modalities are included in HIV prevention programs, the development of accessible tools and community-based strategies will be essential to support informed PrEP choices and ensure equitable implementation across the region."

Journal • 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=370 | Completed | Sponsor: ViiV Healthcare | N=162 ➔ 370

Enrollment change • Human Immunodeficiency Virus • Infectious Disease

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: ViiV Healthcare | Active, not recruiting ➔ Completed | Trial completion date: May 2027 ➔ Jul 2025 | Trial primary completion date: May 2027 ➔ Jul 2025

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

Sex and gender differences in weight gain associated with second-generation integrase strand transfer inhibitors: A scoping review. (PubMed, HIV Med) - "Second-generation INSTIs, especially dolutegravir, appear to be associated with greater average and excessive weight gain among cis women, although this effect varies by setting, regimen and clinical context. Further research, especially in diverse populations, is needed to explore underlying mechanisms, determine risk factors and evaluate these trends in newer antiretroviral medications."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Exploring the impact of Cabotegravir-Rilpivirine long-acting on weight gain, body composition and quality of life in adults living with HIV. (PubMed, HIV Med) - "CAB + RPV LA was not associated with significant weight gain, clinically relevant changes in body composition or adverse metabolic effects over 48 weeks. Virologic suppression was maintained, renal laboratory parameters improved in prior INSTI users and treatment was well tolerated with increasing satisfaction. These findings support CAB + RPV LA as a safe, effective and metabolically neutral alternative to daily oral ART."

HEOR • Journal • Dyslipidemia • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease

Cabotegravir+rilpivirine long-acting every 2 months in a real-world setting: 24-month outcomes in people with HIV-1. (PubMed, AIDS) - "In this real-world study, CAB+RPV LA maintained high rates of virologic suppression, was well tolerated, and led to increased treatment satisfaction through 24 months following switch. These data reinforce the findings of the Phase 3/3b CAB+RPV LA program and support the continued use of CAB+RPV LA in routine clinical care."

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

Comparative Effectiveness of Daily Oral and Long-acting Injectable Prep: A Critical Review of Clinical Evidence and Public Health Implications. (PubMed, Curr HIV Res) - "The aim of this study was to compare the use of PrEP with TDF+FTC and the long-acting injectable cabotegravir, as well as to examine the mechanisms of action of the drugs involved in PrEP...Emerging strategies under development include annual LEN formulations, the use of broadly Neutralizing Antibodies (bNAbs), and the Dapivirine Vaginal Ring (DPV), which has demon-strated greater convenience and improved adherence among pregnant women compared to oral PrEP. Additionally, digital monitoring tools are being explored, although their effectiveness relies on the implementation of equitable health policies. Thus, integrated prevention models that com-bine biomedical innovations with community-based interventions emerge as essential to expand-ing the reach and impact of PrEP."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Impact of Switching from Oral to Long-Acting Injectable Cabotegravir and Rilpivirine on the Lipid Profile of HIV-Positive Patients. (PubMed, Microorganisms) - "Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) have been incorporated into the treatment of people living with HIV (PLWH), but evidence on their metabolic impact in real-world settings remains limited. These findings suggest that switching to long-acting injectable cabotegravir and rilpivirine maintains virological and immunological control without adversely affecting the total cholesterol, LDL cholesterol, or triglycerides, and is associated with an improvement in HDL cholesterol. LA-CAB/RPV therefore appears to be a metabolically safe therapeutic option for PLWH, with a potentially favorable effect on cardiovascular risk factors."

Journal • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

Cooperation between HIV-1 integrase natural polymorphism K156N and 3'PPT mutations in dolutegravir monotherapy failure. (PubMed, J Antimicrob Chemother) - "These findings establish a direct functional relationship between natural variation in HIV-1 integrase and the emergence of 3'PPT mutations. People harbouring a virus with the K156N natural polymorphism may be predisposed to developing 3'PPT mutations upon failure with DTG. However, the clinical relevance of this association remains to be established."

Clinical • Journal • Monotherapy • Human Immunodeficiency Virus • Infectious Disease