Trogarzo (ibalizumab IV) / Future Pak, TaiMed Biologics, Orient Europharma - LARVOL DELTA

First virological control after >30 years of antiretroviral therapy in extensively drug-resistant HIV: potential role of lenacapavir plus ibalizumab. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Progress towards longer-acting antiretroviral regimens for adult HIV treatment. (PubMed, Expert Rev Clin Pharmacol) - "Lenacapavir and ibalizumab provide durable efficacy for individuals with multidrug-resistant HIV. Ongoing research is evaluating novel combinations of long-acting agents, including emerging oral therapies, to expand treatment options. Long-acting antiretroviral treatments have the potential to address unmet needs and broaden individualized treatment options in HIV care."

Journal • Review • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

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

PROMISE-US: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab (clinicaltrials.gov) - P=N/A | N=168 | Completed | Sponsor: Theratechnologies | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Human Immunodeficiency Virus • Infectious Disease

Ibalizumab-targeted Delivery of Tat mRNA Transactivates Provirus Expression in vivo (AIDS 2026) - "Organized by The HIV Obstruction by Programmed Epigenetics (HOPE) Collaboratory: Melanie Ott from Gladstone Institutes, Susana Valente from the University of Florida Scripps Research, Lishomwa Ndhlovu from Weill"

Preclinical • Human Immunodeficiency Virus • Infectious Disease

Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial. (PubMed, Nat Med) - P1 | "Here we conducted a first-in-human, phase 1 trial of the bispecific 10E8.4/iMab antibody, which consists of a 10E8.4 arm binding the HIV-1 envelope glycoprotein membrane-proximal external region and an ibalizumab (iMab) arm binding the human CD4 molecule...These data support further study of 10E8.4/iMab to expand HIV treatment and prevention options. ClinicalTrials.gov: NCT03875209 ."

First-in-human • Journal • P1 data • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4 • CD8

TaiMed Biologics…announced today that its HIV therapy Trogarzo has received a Drug License Collection Notice from the Taiwan Food and Drug Administration. (Investing.com) - "Trogarzo is indicated, in combination with other antiretroviral agents, for the treatment of adults with multidrug-resistant HIV-1 infection who are heavily treatment-experienced and whose current antiretroviral regimen is failing."

Commercial • Infectious Disease

A precautionary tale of lenacapavir drug-drug interactions: A case series of two persons living with HIV receiving long-acting injections. (PubMed, Int J STD AIDS) - "Case 1 describes a PLWH prescribed clopidogrel after an acute cerebrovascular event receiving an antiretroviral (ARV) regimen including subcutaneous lenacapavir and ibalizumab biweekly infusions...Case 2 is a highly treatment experienced PLWH prescribed an ARV regimen including subcutaneous lenacapavir and intramuscular cabotegravir/rilpivirine injections on concomitant inhaled and nasal fluticasone...The electronic medical record alerts were customized to note these possible lenacapavir drug-drug interactions, similar to protease inhibitors/pharmacokinetic boosters (ritonavir and cobicistat) to prevent future events. This case series highlights possible lenacapavir drug-drug interactions and is a precautionary tale to other institutions to consider customizing electronic medical alerts for this novel long-acting injection."

Journal • Endocrine Disorders • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease

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

A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New P1 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

HIV-1 Non Group-M Phenotypic Susceptibility to Ibalizumab. (PubMed, J Med Virol) - "Ibalizumab showed in vitro activity against all validated HIV-1/O and HIV-1/N isolates, whereas the HIV-1/P strain exhibited potential natural resistance. No relationship was observed between PNGS number and susceptibility."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

PROMISE-US: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab (clinicaltrials.gov) - P=N/A | N=168 | Active, not recruiting | Sponsor: Theratechnologies | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment closed • Real-world evidence • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Ukraine's First Horizon Scanning Pilot: Lessons for HTA Implementation (ISPOR-EU 2025) - "The case study showed horizon scanning tool can effectively inform Ukraine's healthcare about new HIV/AIDS technologies, making it a promising tool for integration into early-stage HTA processes."

Human Immunodeficiency Virus • Infectious Disease

Combined use of ibalizumab and lenacapavir for the treatment of multidrug-resistant HIV-1: A case series. (PubMed, Clin Infect Dis) - "In this small group of individuals with MDR HIV who were heavily treatment-experienced and/or faced adherence challenges, the use of IBA + LEN ± OBR was well tolerated and led to clinically significant reductions in VL and improvements in CD4+ counts."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Switch from Ibalizumab to Lenacapavir in a Rescue Regimen for a Heavily Treatment-Experienced (HTE) Patient with Multidrug-Resistant (MDR) HIV-1 Infection. (PubMed, Int J Mol Sci) - "Our case report about an HTE patient shows that IBA was efficacious in the rescue regimen, while also acting on the reservoir. LEN, adopted in a switch strategy which differed from that described in the literature, preserved efficacy and stable pressure on HIV-DNA."

Journal • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • CD4

Long-acting cabotegravir/rilpivirine, lenacapavir, and ibalizumab use among persons with HIV-1 viremia at a Ryan White-funded clinic in the urban U.S. South. (PubMed, Clin Infect Dis) - "In the largest Southern US cohort of PWH with viremia initiating LA-ART, 92% achieved VS despite significant barriers to care and disease burden, underscoring LA-ART as a tool to help achieve Ending the HIV Epidemic goals."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

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

HIV-1 unlocks a non-classical mode of viral entry in CD4 negative cells (IAS-HIV 2025) - "These cells were confirmed to be CD4 negative through flow cytometry, mRNA expression & the use of a CD4 blocking antibody (Ibalizumab) during infection assays. We found that HIV-1 can infect HOS cells, as demonstrated by post-infection luciferase and GFP expression that was blocked by the integration inhibitor Raltegravir. Further studies will examine infected GFP positive cells, including single-cell RNA sequencing, determining mechanisms used for viral entry, and the use of a red/green reporter virus to investigate latency. Deepening our understanding of viral entry into CD4-negative cells may help identify unknown viral reservoirs, improve HIV-1 therapeutics, and contribute to finding an eventual cure."

Human Immunodeficiency Virus • Infectious Disease • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • CD4 • CXCR4

Ibalizumab plus an optimized background regimen in treatment-experienced patients infected with multidrug resistant HIV-1: A phase 3, multicenter, expanded access study. (PubMed, J Acquir Immune Defic Syndr) - "Long-term ibalizumab treatment in combination with an OBR was considered safe and well tolerated with no new safety signals identified in people living with MDR HIV-1. Additionally, ibalizumab-naïve patients experienced notable and early reductions in viral load with sustained increases in CD4+ cell counts over 24 weeks."

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

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

FlowDesign: Improved design of antibody CDRs through flow matching and better prior distributions. (PubMed, Cell Syst) - "FlowDesign yielded antibodies with improved binding affinity and neutralizing potency compared with the antibody ibalizumab across multiple HIV mutants, validated by biolayer interferometry (BLI) and pseudovirus neutralization. This highlights FlowDesign's potential in antibody and protein design. A record of this paper's transparent peer review process is included in the supplemental information."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: David Ho | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ May 2027 | Trial primary completion date: May 2025 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Trump wants to tariff Canadian-made drugs. Experts warn U.S. patients could pay the price (Yahoo News) - "Prescription drugs have been exempt from tariffs in the past. But Donald Trump looks poised to change that as early as April 2. That could result in shortages for critical drugs for Americans, warn experts....Bupropion, used to treat major depressive disorder; ibalizumab, for patients with multi-drug-resistant HIV; and sotalol, to treat a life-threatening heart rhythm problem: those are just some of the drugs mostly manufactured in Canada and sent to the U.S. that might be impacted by the tariffs."

Commercial • Human Immunodeficiency Virus

A 24-Week Phase II Maintenance Study of TMB-365/TMB-380 Q8W in People With Suppressed HIV-1 Infection (CROI 2025) - P1/2 | "Background TMB-365, a second-generation post-attachment bNAb binds to the second domain of CD4 and displays improved PK, antiviral activity, and breadth of coverage when compared to ibalizumab. No confirmed VF was observed. Results support the development of TMB-365/TMB-380 into phase 2b."

Clinical • Late-breaking abstract • P2 data • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

Long-Acting Injectable ART in Persons With HIV-1 Viremia in the South: A Tool to End the Epidemic (CROI 2025) - "Background Treatment with long-acting antiretroviral therapy (LA ART) with cabotegravir/rilpivirine (CAB/RPV) +/- lenacapavir (LEN) holds promise to achieve viral suppression (VS) in people with HIV (PWH) for whom oral ART fails. Although supported in certain scenarios by guidelines, scaling this approach in viremic PWH has lagged Methods We performed a retrospective review of PWH cared for at a large Ryan White-funded program in the urban South who initiated LA ART (CAB/RPV, LEN, and/or ibalizumab [IBA]) between 4/14/2021–8/31/2024 with follow-up through 12/31/2024...CAB/RPV were covered by medical benefits (n=54), ADAP (n=22) and pharmacy benefits (n=5). Five discontinued LA ART in follow-up Conclusions This is the largest reported single cohort of PWH to initiate LA ART with viremia and 93% achieved VS despite significant barriers to care and burden of disease, underscoring the potential of LA ART to help achieve Ending HIV Epidemic goals"

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • CD4