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

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

Durability of lenacapavir in viremic HTE PWH: real-world data from the PRESTIGIO Registry (EACS 2025) - "The combination with fostemsavir yielded encouraging results, even in individuals with extremely limited treatment options. Lenacapavir may represent a key component in treatment strategies for multidrug-resistant HIV."

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

A French national real-world survey of people with multi-resistant HIV-1 viruses treated with an antiretroviral regimen including fostemsavir (EACS 2025) - "Temsavir plasma levels were available for 8 PWH, showing suboptimal concentrations in 2. Conclusions : In this real-world study, PWH receiving FTR-based treatment harbored multidrug-resistant viruses and had very limited treatment options. Virological success was achieved in 60% of PWH with quantifiable VL at time of FTR initiation, and success was maintained in 93% of virologically-suppressed PWH."

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

7-year sustained efficacy, safety, and immunological improvement with fostemsavir-based regimens in individuals with HIV and limited treatment options (EACS 2025) - "Purpose : Fostemsavir (FTR), a prodrug of temsavir, is a novel antiretroviral with a unique mechanism of action targeting viral-bound gp120 and soluble gp120. Inflammatory biomarkers remained constant from Week 240 to Week 336 in both cohorts in all measured proinflammatory markers (sCD14, sCD163, and D-dimer). Conclusions : These further long-term findings demonstrate that through 7 years, FTR-based regimens had durable efficacy and safety, with prolonged immunological improvement and a generalized reduction in inflammation in individuals with limited treatment options."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD8

Development, validation and clinical implementation of a HPLC-MS/MS method for the simultaneous quantification of bictegravir, emtricitabine, doravirine, cabotegravir, lenacapavir, fostemsavir, tenofovir alafenamide and the corresponding metabolites temsavir and tenofovir, in human plasma. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Additionally, data on drug pharmacokinetics were obtained. Our findings indicate that the proposed method is a reliable and accurate tool for high-throughput screening that could be readily used by the clinicians to optimize therapeutic treatments, verify patients' adherence and reduce drug-related toxicities."

Journal • Human Immunodeficiency Virus • Infectious Disease

Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. (PubMed, J Infect Dis) - P, P3 | "Altogether, fostemsavir may provide additional immune benefits to PWH, beyond blocking viral entry, by reducing anti-gp120 CD4i Abs levels."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

"Fostemsavir: More Than Meets the Eye". (PubMed, J Infect Dis) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Changes in immunologic parameters following the addition of fostemsavir in virally suppressed immune non-responders living with HIV-the RECOVER study (IDWeek 2025) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Real-World Data on Fostemsavir in People Living with HIV: A Retrospective Chart Review (IDWeek 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

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 | Recruiting | Sponsor: PENTA Foundation | Trial completion date: Jun 2028 ➔ Sep 2028

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Fostemsavir analog BMS-818251 has enhanced viral neutralization potency and similar escape mutation profile. (PubMed, Antimicrob Agents Chemother) - "By using ex vivo viral outgrowth assays with HIV+ donor samples, we demonstrate here that BMS-818251 exhibits superior viral suppression compared to temsavir, the active form of fostemsavir. Compared to fostemsavir, BMS-818251 achieved more effective viral suppression at lower concentrations, even in donor samples harboring preexisting resistance mutations. These findings support the continued development of BMS-818251 as a promising alternative to fostemsavir, with potential benefits for patients with multidrug-resistant HIV-1."

Journal • 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

Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study (clinicaltrials.gov) - P4 | N=25 | Active, not recruiting | Sponsor: Orlando Immunology Center | Recruiting ➔ Active, not recruiting | N=50 ➔ 25 | Trial completion date: Aug 2024 ➔ Feb 2026 | Trial primary completion date: Jul 2024 ➔ Feb 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion 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 | Recruiting | Sponsor: ViiV Healthcare | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Impact of incorporating fostemsavir for rescue therapy in Brazil (IAS-HIV 2025) - "The incorporation of FTR represents an important gain in third-line therapy for multidrug-resistant PLH. However, there is a large difference between the initial price set by CMED and the final negotiated price, indicating that this mechanism may not be effective in regulating high prices. Additionally, due to patent expiration and possible offers of generic versions, there is space for price reduction in the next acquisition."

Human Immunodeficiency Virus • Infectious Disease

Capsid inhibition with lenacapavir in HIV-1 infection: real-life results from the French compassionate use program (IAS-HIV 2025) - "OBR included mainly darunavir/r (n=13), dolutegravir (n=11), cabotegravir (n=10), fostemsavir (n=12), maraviroc (n=8), ibalizumab (n=7) and enfuvirtide (n=4). In this real-life cohort of highly treatment-experienced HIV-1 participants, lenacapavir in combination with an OBR resulted in a high level of virological suppression up to 26 weeks, even increasing throughout the end of follow-up."

Clinical • 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 | Not yet recruiting | Sponsor: ViiV Healthcare

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

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

New P2 trial • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Inflammation