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

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Apr 2025 ➔ Jul 2025 | Completed ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Sex differences in discontinuations due to side effects of second-generation integrase strand transfer inhibitors: a systematic review and meta-analysis. (PubMed, EClinicalMedicine) - "Further research is needed to determine whether these trends extend to other second-generation integrase strand transfer inhibitors, such as bictegravir and cabotegravir, and to better understand the specific side effects contributing to dolutegravir discontinuation in women. Additionally, the lack of sex-disaggregated reporting during our literature search identifies a need to prioritize sex/gender-based analyses in future research on antiretrovirals. None."

Adverse events • Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Psychiatry

HIV Psychiatry – Essential Clinical Updates (APA 2025) - "Adherence to daily or on-demand pills has historically been challenging, and cabotegravir, which is administered as an injection every 8 weeks, has been shown to be more effective than TDF/FTC for HIV prevention. Research has indicated that doxycycline can be effective as post-exposure prophylaxis for preventing STIs, particularly syphilis and chlamydia, in high-risk populations. However, there are still concerns regarding the potential development of antibiotic resistance and its decreased effectiveness in the prevention of gonorrhea. Inequalities faced by people li Instructional Level Intermediate; Learning Objectives Objective One: Summarize the most common neuropsychiatric side effects of antiretrovirals and frequent drug-drug interactions Objective Two: Diagnose and treat anxiety disorders in people living with HIV Objective Three: Assess the risk for HIV infection and compare the three different options for PrEP (Pre-Exposure Prophylaxis) Objective Four: Assess how..."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • General Anxiety Disorder • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Mood Disorders • Psychiatry • Social Anxiety Disorder

In-Person Session Playback: 'HIV Psychiatry – Essential Clinical Updates' (APA 2025) - "Adherence to daily or on-demand pills has historically been challenging, and cabotegravir, which is administered as an injection every 8 weeks, has been shown to be more effective than TDF/FTC for HIV prevention. Research has indicated that doxycycline can be effective as post-exposure prophylaxis for preventing STIs, particularly syphilis and chlamydia, in high-risk populations. However, there are still concerns regarding the potential development of antibiotic resistance and its decreased effectiveness in the prevention of gonorrhea. Inequalities faced by people li"

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • General Anxiety Disorder • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Mood Disorders • Psychiatry • Social Anxiety Disorder

Virtual Session Playback: 'HIV Psychiatry – Essential Clinical Updates' (APA 2025) - "Adherence to daily or on-demand pills has historically been challenging, and cabotegravir, which is administered as an injection every 8 weeks, has been shown to be more effective than TDF/FTC for HIV prevention. Research has indicated that doxycycline can be effective as post-exposure prophylaxis for preventing STIs, particularly syphilis and chlamydia, in high-risk populations. However, there are still concerns regarding the potential development of antibiotic resistance and its decreased effectiveness in the prevention of gonorrhea. Inequalities faced by people li"

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • General Anxiety Disorder • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Mood Disorders • Psychiatry • Social Anxiety Disorder

Cost-effectiveness of cabotegravir versus tenofovir alafenamide plus emtricitabine versus tenofovir disoproxil fumarate plus emtricitabine for pre-exposure prophylaxis to prevent HIV-1 transmission in gay, bisexual and other men that have sex with men. (PubMed, Enferm Infecc Microbiol Clin (Engl Ed)) - "The present Spanish policy of PrEP is a cost-saving strategy. TAF/FTC and CAB are not cost-effective at current market prices."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Perspectives of Horizon Scanning Tool Introduction to HTA in Ukraine: Identifying HIV Technologies (ISPOR 2025) - "Six new health technologies for Ukraine were prioritized: cabotegravir (an alternative to tablet-based regimens for daily pre-exposure prophylaxis), ibalizumab (for the treatment of multidrug-resistant HIV), the dapivirine vaginal ring (to reduce the risk of HIV infection), the Harmony Portable Nucleoside Analog Analyzer, a Machine Learning Model-based Tool for identifying patients at risk of discontinuing HIV treatment, and an SMS Notification Service for HIV-positive individuals. The case study demonstrated that the horizon scanning tool can serve as an effective method for informing the Ukrainian healthcare system about new HIV/AIDS technologies. This tool is perspective to be integrated as one of the stages in the HTA process, specifically for the early HTA stage."

Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Apr 2025 | Trial primary completion date: Mar 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Lenacapavir Plus Cabotegravir Real-world Use Cases from the National Clinician Consultation Center (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 • Real-world • Real-world evidence

Pregnancy and neonatal outcomes following prenatal exposure to cabotegravir (CAB): data from The Antiretroviral Pregnancy Registry (APR) (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."

Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Sexually transmitted infections in men who have sex with men with tenofovir/emtricitabine- or cabotegravir-resistant HIV. (PubMed, AIDS) - "In our cohort of MSMWH, STI incidence was non-negligible, although reduced, in presence of resistance to TXF/FTC and/or CAB. Discussion of HIV resistance test results should include the risk of sexual transmission uncontrolled by pre-exposure prophylaxis."

Journal • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=325 ➔ 205

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Cost-Effectiveness Analysis of Lenacapavir Compared to Cabotegravir and Generic Oral FTC/TDF for HIV Pre-Exposure Prophylaxis for Cis-Gender Women in the United States (ISPOR 2025) - "LEN is not cost-effective compared to generic FTC/TDF or CAB-LAI for HIV PrEP. However, LEN offers a viable alternative with reduced administration frequency for individuals at risk of acquiring HIV infection."

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

HIV susceptibility to second-generation integrase strand transfer inhibitors among people with multidrug resistance: a systematic review and meta-analysis protocol. (PubMed, Ther Adv Infect Dis) - "We will include studies of adults and/or children exposed to dolutegravir, bictegravir, or cabotegravir following treatment failure to more than one drug class. The results will, therefore, contribute to set up baseline data for optimal management of people living with HIV harboring multidrug-resistant viruses. PROSPERO: CRD42023470922."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

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

Matrix Approach Assessment of Cabotegravir Drug-Drug Interactions with OAT1/OAT3 Substrates and UGT1A1/UGT1A9 Inhibitors Using Physiologically-Based Pharmacokinetic Modeling. (PubMed, Pharmaceutics) - " PBPK modelling indicated that clinically relevant DDIs are not anticipated with OAT1/3 substrates or UGT1A1/1A9 inhibitors and CAB. With maximal exposure of the LA formulation of CAB being lower than the oral, the results of these simulations can be extrapolated to LA injectable dosing."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • UGT1A1

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE (clinicaltrials.gov) - P3 | N=456 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=310 ➔ 456

Enrollment change • Human Immunodeficiency Virus • Infectious Disease

High Preference for Injectable Pre-exposure Prophylaxis among Young Women in Kenya. (PubMed, AIDS Behav) - "Among previous oral PrEP users, 82% preferred injectable PrEP, 16% preferred oral PrEP, and only 2% preferred the dapivirine vaginal ring...Reproductive-age women in Kenya have a strong interest in long-acting injectable PrEP. Product rollout and implementation needs to consider women's preference and devise best approaches to deliver injectable PrEP."

Journal • Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives

Despite Increasing Use of INIs to Treat HIV Infection, Resistance to This Class Remains Stable (CROI 2025) - "The integrase inhibitor (INI) class has benefited from many developments: first raltegravir (RAL) and elvitegravir (EVG), followed by dolutegravir (DTG), cabotegravir (CAB) and bictegravir (BIC). The very high level of INI resistance at the beginning of INI use was probably due to the use of RAL in combination with other ARVs that were not fully sensitive during the first 3 years. The INIs used today have a higher genetic barrier that limits the emergence of resistance mutations."

Human Immunodeficiency Virus • Infectious Disease

In Vitro Resistance Profile for GS-1720, a Potent Once-Weekly Oral InSTI in Clinical Development (CROI 2025) - "Results GS-1720 retained potent antiviral activity, defined as an EC50 fold-change (FC) 300, 140 and 119 days in culture, respectively...In a fixed-dose viral breakthrough assay, clinically relevant concentrations of GS-1720 or BIC prevented viral breakthrough while EVG and raltegravir, when tested at their equivalent clinical trough plasma concentrations, showed breakthrough with resistance in 45% and 18% of PBMC cultures (n=44-48/condition), respectively. Conclusions GS-1720 exhibits an in vitro resistance profile comparable to the best-in-class INSTI bictegravir, including high barrier to resistance and minimal cross-resistance within the INSTI class. These observations support the ongoing clinical development of GS-1720 as a novel once-weekly oral INSTI."

Preclinical • Human Immunodeficiency Virus • Infectious Disease

Injectable Cabotegravir PrEP Discontinuations at a Peer Specialist-Led Program in Washington, DC (CROI 2025) - "Peer specialists fostered continued PrEP use among those who discontinued CAB and potentially reduced discontinuations in populations which have a higher risk for HIV. Insurance coverage gaps continue to undermine CAB implementation efforts."

Human Immunodeficiency Virus • Infectious Disease

Early PEPFAR Implementation of Cabotegravir-LA and Implications for Long-Acting HIV Prevention (CROI 2025) - "Background Despite the availability of oral HIV pre-exposure prophylaxis (PrEP), gaps remain in reaching the UNAIDS target of 21.2 million people on PrEP by the end of 2025 and reducing HIV incidence. Lessons learned from early CAB-LA introduction will inform continued scale-up of CAB-LA in additional PEPFAR-supported countries in 2025, with plans to reach 100,000 clients by the end of the year. This platform will also support future HIV prevention products including Lenacapavir."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Long-Acting Injectable CAB/MPA MPT Implant for Prevention of HIV and Unintended Pregnancy (CROI 2025) - "We evaluated a long-acting (LA), injectable in-situ forming implant (ISFI) as a multi-purpose prevention technology (MPT) to co-formulate cabotegravir (CAB) and medroxyprogesterone acetate (MPA) with the incorporation of a contrast agent for in vivo visualization and ease of retrievability...Our findings showed the ability to visualize the implants with no evidence of implant migration. CAB and MPA elicited undetectable plasma concentration after implant removal highlighting the potential for a discrete and reversible MPT option for adolescent girls and women."

Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Systemic Inflammatory Response Syndrome

"I Like It but I Can't Be the First": Sex Workers' Preferences for LAI PrEP Delivery in South Africa (CROI 2025) - "Decentralized delivery via mobile van was generally preferred over drop-in-centers and clinics to support adherence to LAI-PrEP; however, FSW in eThekwini remained concerned about potential missed injections given frequent travel home, including away from South Africa Conclusions Nearly two years after Cabotegravir received regulatory approval in South Africa, FSW remain largely unable to access LAI-PrEP, despite established efficacy and community interest. As LAI-PrEP products become increasingly available, strategies supporting counseling, education, and diversity in PrEP delivery sites for FSW can optimize implementation and equitable LAI-PrEP uptake and continuation."

Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives

Association of Trough Concentrations of Cabotegravir and Rilpivirine and HIV-1 RNA (CROI 2025) - "Background The relevance of plasma (trough) concentrations of cabotegravir (CAB) and rilpivirine (RPV) with regard to sustained virologic suppression in people with HIV (PWH) on long-acting treatment (LA) is an ongoing matter of debate. It is unclear if this is also predictive of virologic failure. Based on our findings, however, it warrants further investigation if dosing can be indivualized taking trough concentrations into account."

Human Immunodeficiency Virus • Infectious Disease