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

Real-world use and effectiveness of fostemsavir in a US clinical setting: Insights from Trio Health HIV Research Network. (PubMed, HIV Med) - "In this real-world, diverse cohort, FTR was well tolerated, with high persistence and, in the dispensing-data subset, high adherence. It effectively maintained viral suppression among suppressed individuals and provided immunologic benefits across subgroups, including viremic initiators. These findings support FTR as a valuable treatment option for heavily treatment-experienced PWH."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

Immune recovery following the addition of fostemsavir in virally suppressed immunologic non-responders living with HIV-final 48-week results from the RECOVER study (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Immune Recovery Continues to Improve over 5 years with Fostemsavir Despite Emergent gp120 Substitutions (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Impact of Fostemsavir in Individuals with Multidrug-Resistant HIV-1, Stratified by Baseline Viral Load. (PubMed, Infect Dis Ther) - P3 | "Findings support considering fostemsavir for regimen optimization in individuals with limited treatment options and undetectable/low VL, especially if safety/tolerability may be a concern."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Real-World Experience With Lenacapavir and/or Fostemsavir as Emerging Therapies for the Management of Multidrug-Resistant HIV-1 in Southeastern France. (PubMed, J Med Virol) - "In one of these 3 persistently viremic PWH, a dual-injectable rescue regimen combining lenacapavir and cabotegravir achieved viral suppression at 33 months with maintenance through the end of follow-up, bringing the success rate to 9 out of 11 (82%) among PWH who were viremic at baseline. A dual-injectable rescue regimen may represent a last-resort option in selected complex cases. Similar real-world studies should be expanded, and adherence support should be strengthened."

Journal • Real-world evidence • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Similar Efficacy, Safety, and Immune Improvement Through 96 Weeks in Individuals With Limited HIV-1 Treatment Options Using Twice-Daily Dolutegravir- or Fostemsavir-based Regimens. (PubMed, Open Forum Infect Dis) - P3 | "Separate analyses of 96-week outcomes from the phase 3 VIKING-3 and BRIGHTE studies demonstrate that twice-daily dolutegravir-based and fostemsavir-based regimens each provide robust viral suppression, favorable safety profiles, and CD4+ T-cell count improvement in this population. Clinical trial registration VIKING-3: ClinicalTrials.gov identification number, NCT01328041; URL, https://clinicaltrials.gov/study/NCT01328041; BRIGHTE: ClinicalTrials.gov identification number, NCT02362503; URL, https://clinicaltrials.gov/study/NCT02362503."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

BRIGHTE: Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Jan 2027 ➔ Oct 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

A French National Real-World Survey of People With Multiresistant HIV-1 Viruses Receiving an Antiretroviral Regimen Including Fostemsavir or Ibalizumab. (PubMed, Open Forum Infect Dis) - "Suboptimal temsavir concentrations were observed in 2 of 8 participants in failure...PWH receiving FTR or IBA had extensive multidrug resistance and limited therapeutic options. Among PWH who were viremic and initiating FTR- and IBA-based regimens, virologic success was achieved in 63% and 36%, respectively, and maintained in 91% who were virologically suppressed and starting an FTR-based regimen."

Journal • Real-world evidence • 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=181 | Recruiting | Sponsor: ViiV Healthcare | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2030 ➔ Sep 2032 | Trial primary completion date: Dec 2030 ➔ Sep 2032

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

Resuppression and resistance after confirmed virologic failure among women on CAB+RPV LA in the OPERA Cohort (AIDS 2026) - "Summary of resistance in the 7 women who experienced CVF on CAB+RPV LA Woman who experienced CVF on CAB+RPV LA VL at Start (c/mL ) BMI at Start (kg/m 2 ) Months to CVF M onths to Resuppression a Regimen when Resuppressed a Summary of Resistance #1 20 25.1 1.6 5.5 CAB+RPV LA Multiple polymorphisms before and during CAB+RPV LA; no resistance to CAB or RPV at CVF; resuppressed on CAB+RPV LA through study end #2 < 20 49.6 7.4 2.9 DRV/c/FTC/TAF Partial resistance to NNRTIs other than RPV before CAB+RPV LA; resistance to CAB and RPV at CVF #3 30 36.6 9.2 5.7 BIC/FTC/TAF GenoSure Archive prior to CAB+RPV LA had insufficient sample; no further testing done; resuppressed through study end on B/F/TAF #4 35,500 18.3 9.1 N/A b N/A b Multiple polymorphisms before CAB+RPV LA; resistance to CAB and RPV after CVF #5 < 20 27.8 15.3 15.6 DRV/c/FTC/TAF + LEN No resistance tests prior to CAB+RPV LA; multiple polymorphisms during CAB+RPV LA; LLV until 3 rd regimen post CVF #6 < 20..."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Added value of RNA-based whole genome sequencing in viremic people with 4-class drug-resistant HIV: insights from the PRESTIGIO Registry (AIDS 2026) - "Outside pol , WGS (=5%) detected =1 lenacapavir RAM in 7/39 (17.9%) samples [6/7 (85.7%) without prior lenacapavir exposure] and =1 temsavir RAM in 16/39 (41.0%) [12/16 (75.0%) without prior fostemsavir exposure]. Despite some limitations, particularly the limited ability to completely reconstruct cumulative resistance history derived from prior RNA-based Sanger genotypes, RNA-based WGS provided additional, previously unrecognized resistance information, including mutations affecting novel drug targets, in individuals with multidrug-resistant HIV. These findings support the role of WGS as a valuable complementary tool in settings with a high mutational burden."

Tumor mutational burden • Whole genome sequencing • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • TMB

BRIGHTE : Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Sep 2026 ➔ Jan 2027

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

A Silent Collapse: HIV-Induced Adrenal Insufficiency - A Case Report (ENDO 2026) - "A 39-year-old man with multidrug-resistant HIV/AIDS on darunavir/cobicistat/emtricitabine/tenofovir/alafenamide (Symtuza) and fostemsavir, (Rukobia), chronic respiratory failure requiring tracheostomy, and percutaneous endoscopic gastrostomy tube dependence was admitted for recurrent septic shock...Stress-dose corticosteroid therapy with intravenous methylprednisolone 50 mg every 8 hours was initiated in the setting of ongoing sepsis, resulting in stabilization of blood glucose levels and hemodynamic status...This case underscores HIV infection as a potential contributor to adrenal insufficiency through multifactorial mechanisms, including chronic immune activation with cytokine-mediated HPA axis suppression and direct adrenal injury from opportunistic infections. Although rare, recognition of this association is important, as corticosteroid therapy may rapidly reverse metabolic and hemodynamic instability in affected patients."

Case report • Clinical • Endocrine Disorders • Human Immunodeficiency Virus • Hypoglycemia • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases • Septic Shock

People with HIV Continuing on Complex Regimens in the Era of Treatment Optimization: Characteristics and Outcomes. (PubMed, AIDS Patient Care STDS) - "PWH on ibalizumab, fostemsavir, or lenacapavir were excluded to reflect standard clinical practice. Over a median 2.2-year follow-up, 4% experienced VF. Approximately 8% of PWH on ART remain VS on CR, underscoring the need for education on regimen optimization and novel treatment options for those unable to simplify their therapy."

Journal • Cardiovascular • CNS Disorders • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Mental Retardation • Obesity • Psychiatry

Current state of HIV treatment (PubMed, Klin Mikrobiol Infekc Lek) - "Patients who have failed multiple ART regimens have the option of rescue therapy, which includes the latest antiretroviral drugs fostemsavir and lenacapavir. Therefore, treatment remains long-term and indefinite. Keywords: human immunodeficiency virus infection, HIV, antiretroviral therapy (ART)."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

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