Trogarzo (ibalizumab IV) / Theratechnologies, TaiMed Biologics - LARVOL DELTA

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

Achievement of Undetectable HIV RNA in the PROMISE-US Study in Subjects Viremic at Baseline (CROI 2025) - P | "Conclusions Despite displaying characteristics indicative of more severe HIV disease, subjects on ibalizumab-containing regimens have similar measures of undetectability at 6 and 12 months in the PROMISE-US registry compared to controls without ibalizumab in their regimens. Limitations of this analysis include small sample size, and unmatched disease severity between the two treatment groups."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Theratechnologies Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI (GlobeNewswire) - P=Obs | N=200 | PROMISE-US (NCT05388474) | Sponsor: Theratechnologies | "Theratechnologies Inc...today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV...Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). Ibalizumab was well-tolerated with no infusion reactions reported and no discontinuation of treatment by participants in Cohort 2 due to a treatment emergent adverse event."

Observational data • 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=200 | Recruiting | Sponsor: Theratechnologies | N=600 ➔ 200 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Real-world evidence • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: David Ho | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Dec 2024 ➔ May 2025

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

Investigating the combination of Temsavir and entry inhibitors on HIV replication: Synergistic and antagonistic effects observed against various R5-tropic envelopes. (PubMed, Virology) - "Here, we investigated the effects of combining Temsavir with other HIV entry inhibitors, including CD4 mimetic BNM-III-170, T20 or enfuvirtide, Ibalizumab, and Maraviroc. These results are promising for the potential of co-administrating antiretrovirals for HIV treatment and highlights the importance of developing advanced antiviral strategies. On the other hand, the variable responses against different R5-tropic envelopes underscore the complexity of designing universally effective combination antiviral therapies."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

PRESTIGIO RING: "A 28-year-old highly treatmentexperienced man with vertical HIV infection on ibalizumab therapy: ART simplification perspectives". (PubMed, New Microbiol) - "In January 2024, the patient was started on a lenacapavir-containing regimen along with optimized background therapy in an attempt to maintain sustained virological suppression, simplify antiretroviral regimen, and potentially increase CD4+ T-cell count. At six months follow-up evaluation, virological suppression was confirmed, and an increase in CD4+ T-cell count of 60 cells/μL was observed. Close follow-up of this patient is ongoing."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Emerging integrase resistance in an international perinatal virtual clinic. (PubMed, AIDS) - "Although uncommon, INSTI resistance is emerging, mainly in highly treatment experienced CAWHIV from LMIC, highlighting the global need for access to boosted protease inhibitors and novel classes, including formulations for children less than 35 kg."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Expanding Treatment Opportunities: Reviewing the Current State of Injectable Antiretrovirals for Treatment of HIV. (PubMed, Infect Dis Ther) - "This article reviews the currently available long-acting injectable antiretrovirals, including cabotegravir/rilpivirine, lenacapavir, and ibalizumab. The available data supporting these agents and current place in therapy will be discussed. Data supporting the use of additional long-acting injectable agents, broadly neutralizing antibodies, currently in the pipeline will be reviewed as well."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics (IDWeek 2024) - No abstract available

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

Efficacy and safety of two fixed doses of ibalizumab plus optimized background regimen in treatment-experienced HIV-positive individuals. (PubMed, J Acquir Immune Defic Syndr) - "In heavily treatment-experienced patients with HIV (PWH) at a more advanced baseline disease severity, clinically significant response rates at Week 24 were achieved with ibalizumab plus OBR. Ibalizumab's unique mechanism of action and lack of cross-resistance to other antiretroviral agents make it an important component of combination treatment regimens for PWH with limited treatment options."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

US cost-utility model of lenacapavir plus optimized background regimen (OBR) vs fostemsavir plus OBR and ibalizumab plus OBR for people with HIV with multidrug resistance. (PubMed, J Manag Care Spec Pharm) - "LEN+OBR remained dominant vs FTR+OBR and IBA+OBR across the range of scenarios tested and LEN+OBR had a 99% probability of being cost-effective compared with FTR+OBR and IBA+OBR in the probabilistic sensitivity analysis at a willingness-to-pay threshold of $50,000/QALY. This economic evaluation demonstrated that LEN+OBR provides meaningful increases in QALYs and LYs, and is dominant over a lifetime time horizon, compared with FTR+OBR and IBA+OBR for the treatment of PWH with MDR in the United States."

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

A Narrative Review of Novel Agents for Managing Heavily Treatment-Experienced People Living With HIV. (PubMed, J Pharm Technol) - "Objective: The objective of this review is to compare ibalizumab, fostemsavir, and lenacapavir, present the clinical trials evaluating each agent, and provide guidance on their use in highly-treatment experienced (HTE) population living with HIV (PWH). Selection of which agent(s) to include with an OBR will depend on other patient factors including concomitant medications, acceptance of formulations (oral vs. subcutaneous vs. intravenous infusion), and potential access (both insurance-based and transportation). Adherence to all agents in the regimen is paramount to successful outcomes."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease