Trogarzo IM (ibalizumab intramuscular) / Theratechnologies - LARVOL DELTA

Intramuscular Injection vs Intravenous Infusion of Ibalizumab for HTE PWH: The Results of TMB-302 (CROI 2024) - P3 | "Administration of IBA via IM injection was safe, well-tolerated, did not result in the loss of viral suppression among HTE PWH, and was the preferred method of administration of all participants in the TMB-302 study. Expanding the administration options for IBA is an important step to increasing access and agency for PWH."

Human Immunodeficiency Virus • Infectious Disease

Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection (clinicaltrials.gov) - P3 | N=46 | Completed | Sponsor: TaiMed Biologics Inc. | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Solid Tumor • CD4

Realizing the promise of long-acting antiretroviral treatment strategies for individuals with HIV and adherence challenges: an illustrative case series. (PubMed, AIDS Res Ther) - "These three individuals with HIV (perinatally and non-perinatally acquired) with longstanding nonadherence and persistent viremia were successfully initiated on LAI-ART through the process of care coordination and the collective efforts of the care team, highlighting the barriers, challenges, and the multidisciplinary coordination needed to assure successful implementation of this strategy for the most vulnerable of patients."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetic modeling and simulation of intramuscular and subcutaneous ibalizumab delivery (AIDS 2022) - "These data support the potential administration of IBA via IM or SC injection weekly or every 2 weeks, and warrant the ongoing investigation to provide additional IBA delivery options convenient for HTE patients. The safety and PK of IM administration are currently being evaluated in an open-label non-randomized phase 3 study (TMB-302)."

PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CD4

IV PUSH ADMINISTRATION OF IBALIZUMAB: PHARMACOKINETICS, SAFETY, AND EFFICACY (CROI 2022) - "Bioequivalence between IVI and IVP administration was demonstrated and supports IVP as a potential alternative for delivery of IBA. Assessment of IM injection as an additional option for HTE patients is ongoing in this study."

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

Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection (clinicaltrials.gov) - P3; N=42; Recruiting; Sponsor: TaiMed Biologics Inc.; Completed ➔ Recruiting; N=22 ➔ 42; Trial completion date: Jul 2021 ➔ Dec 2022; Trial primary completion date: Jul 2021 ➔ Dec 2022

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

"Nach der Empfehlung durch die @EMA_News im vergangenen Jahr hat die EU-Kommission nun den monoklonalen Antikörper #Ibalizumab zugelassen. Er ist zur Behandlung einer multiresistenten HIV-1-Infektion bei Erwachsenen indiziert. @ApothekeAdhoc https://t.co/CiHHeFa5G1" (@insighthealth)

Human Immunodeficiency Virus • Infectious Disease