Rukobia (fostemsavir extended release) / ViiV Healthcare, BMS - LARVOL DELTA

ENTRANCE: A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Mar 2028 ➔ Sep 2028

Trial completion date • Trial initiation date • Human Immunodeficiency Virus • Infectious Disease • CD4

ENTRANCE: A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: ViiV Healthcare | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: PENTA Foundation | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2028 ➔ Dec 2028 | Trial primary completion date: Aug 2025 ➔ Dec 2028

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

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=260 | Active, not recruiting | Sponsor: ViiV Healthcare | Recruiting ➔ Active, not recruiting | N=410 ➔ 260 | Trial primary completion date: Sep 2016 ➔ Apr 2020

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

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=410 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2017 ➔ Aug 2018

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

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=401 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

SHIELD study: a multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents with HIV who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance. (PubMed, BMC Infect Dis) - No abstract available

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

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=410 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial primary completion date: Feb 2017 ➔ Sep 2016

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Apr 2020 ➔ Dec 2024

Trial completion date • Human Immunodeficiency Virus

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=370 | Active, not recruiting | Sponsor: ViiV Healthcare | N=260 ➔ 370

Enrollment change • Human Immunodeficiency Virus

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2026 ➔ Dec 2025

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Sep 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=410 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial primary completion date: Aug 2018 ➔ Feb 2017

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

PATH: A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment (clinicaltrials.gov) - P3 | N=183 | Not yet recruiting | Sponsor: ViiV Healthcare

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

Exploring the impact of baseline and on-treatment variables on durability of responses to fostemsavir through weeks 96 and 192 in the phase 3 BRIGHTE study. (PubMed, HIV Med) - "Multivariable analysis (MVA) identified several factors predictive of virologic response. No baseline factors were highly predictive of virologic failure at Weeks 96 or 192. Findings support the use of fostemsavir in diverse populations with MDR HIV-1."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4

HIV Therapy: The Latest Developments in Antiviral Drugs-A Scoping Review. (PubMed, Biomedicines) - "Content: The evidence base underscores capsid inhibition (lenacapavir) for multidrug-resistant HIV and its expansion into prevention, long-acting intramuscular maintenance with cabotegravir/rilpivirine, maturation inhibitors (zabofiravir), and attachment inhibition with fostemsavir. Summary: The pipeline is diversifying toward less frequent dosing, new targets, and combination strategies. Successful and ethical implementation will require resistance-informed selection, equitable access, and reimagined healthcare delivery models that accommodate long-acting technologies."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Decoding gout pathogenesis: target discovery and drug design through computational models. (PubMed, In Silico Pharmacol) - "Molecular docking by AutoDock Vina and AutoDock4 of whole Indian Medicinal Plants, Phytochemistry And Therapeutics (IMPPAT) database, Food and Drug Administration (FDA) Approved Drugs revealed three leads from the Woodfordia fruticosa (Heterophylliin A), Arctium lappa (Arctignan D), and Oroxylum indicum (Scutellarein 7-rutinoside) demonstrated strong binding affinities with URAT1 through favorable docking interactions over the best docked Fostemsavir and URAT1 inhibitors (Lesinurad and Benzbromarone) indicating their potential as modulators of uric acid transport. This integrative bioinformatics and computational approach provide a robust framework for discovering potent drug target and bioactive compounds with strong potential for effective gout treatment if further validated through in vitro and in vivo assays. The online version contains supplementary material available at 10.1007/s40203-025-00476-5."

Journal • Gout • Immunology • Inflammatory Arthritis • Rheumatology

RESTART: Reducing Systemic Inflammation in People on Antiretroviral Therapy (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Comparative Performance of iSeq 100 and MiSeq i100 for Pooled Sequencing of HIV, HCV, TB, and 16S rRNA (AMP 2025) - "Both sequenced HIV capsid and envelope, enabling detection of mutations related to new treatments (e.g., enfuvirtide, fostemsavir, lenacapavir). Both platforms are suitable for high-throughput sequencing of pooled HIV, HCV, TB, and 16S rRNA samples. MiSeq i100 offers superior sensitivity, depth, and speed, making it well suited for research and diagnostics. iSeq 100 remains a cost-effective tool for routine diagnostics."

Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Respiratory Diseases • Tuberculosis

Genotypic susceptibility to broadly neutralizing antibodies and fostemsavir of transmitted viruses, and evolution over time in the French acute HIV infection PRIMO cohort (EACS 2025) - "Method : We analyzed 191 sequences from participants in the acute infection French ANRS PRIMO cohort, over 3 decades (1988–2022), using sequence-based algorithms to predict susceptibility to teropavimab (3BNC117), zinlirvimab (10-1074) and entry inhibitors (fostemsavir, maraviroc). Conclusions : These findings underscore the importance of continuous surveillance of transmitted viruses to therapies targeting HIV-1 Env. Integrating phenotypic assessment with genotypic surveillance to refine resistance prediction models will also be important for predicting susceptibility, as well as the correlation with clinical efficacy in ongoing trials."

Human Immunodeficiency Virus • Infectious Disease • CD4

Fostemsavir in a real-world setting: over one year of data from the PRESTIGIO Registry (EACS 2025) - "Conclusions : In this real-life cohort, one quarter of 4DR-PWH initiated fostemsavir while virologically suppressed, aiming to simplify complex antiretroviral regimens. Over more than one year of follow-up, fostemsavir-based regimens were effective in both achieving and maintaining viral suppression, confirming fostemsavir as a valuable therapeutic option for individuals with multidrug-resistant HIV."

Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Possible CNS compartmentalization and lenacapavir resistance in multidrug-resistant HIV (EACS 2025) - "Due to resistance to four antiretroviral classes, a salvage regimen was initiated in August 2023 including darunavir/cobicistat/emtricitabine/tenofovir alafenamide, fostemsavir, and subcutaneous lenacapavir every six months, according to CAPELLA study criteria*. 2022;386(19):1793-1803. doi:10.1056/NEJMoa2115542."

Human Immunodeficiency Virus • Infectious Disease • CD4

HIV Drug Resistance in People Living with HIV (PLWH) in Congo: Implications for Optimizing Therapy in Resource-Limited Settings (EACS 2025) - "Specific resistance-associated amino acid polymorphisms with the potential to decrease fostemsavir (FTR) susceptibility were found in 29/95 (31%) of sequenced samples of isolates of subtypes G and H. Conclusions : HIVDR genotyping should be integrated into clinical practice in the ROC to optimize treatment and manage emerging resistance. The presence of baseline FTR-associated mutations underscores the need for ongoing resistance surveillance and tailored interpretation tools for non-B subtypes. Further research is warranted to clarify the clinical impact of these polymorphisms and their variability across subtypes."

Human Immunodeficiency Virus • Infectious Disease • CD4 • CXCR4