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SYMPOSIUM 9: Is there a role of TDM for long-acting formulations?

Tracks
Track 1
Tuesday, September 23, 2025
10:30 AM - 12:00 PM
Grand Copthorne Waterfront Hotel - Grand Ballroom I

Details

Long-acting injectable formulations are now a reality as maintenance therapy for many diseases, including infectious diseases. Today we have LAI antibiotics for the chronic therapy of osteoarticular infections, LAI antiretrovirals for the treatment of people with HIV and, more recently also LAI formulations of echinocandins for the treatment of fungal infections. These drugs are often given at fixed intervals, despite preliminary evidence of considerable pharmacokinetic variability. This symposium will address the possible role of TDM as a tool to personalise the frequency of administration of long-acting anti-infectious drugs. It is also thought to introduce a reading on the applications of TDM for long-acting formulations of antipsychotics, as an example to be followed in the field of infectious diseases.


Speaker

Prof Georgios Schoretsanitis
The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen Oaks, New York

TDM of LAI antipsychotics: an example to follow for LAI anti-infectives?

Biography

Prof Natella Y. Rakhmanina
The George Washington University

Long Acting treatment of anti-infectives in paediatrics

Biography

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Dr Paul Thoueille
CHUV Centre Hospitalier Universitaire Vaudois

PopPK Modelling and TDM for Individualized Dosing of Long-Acting Antiretrovirals

Abstract

Long-acting injectable antiretroviral drugs are a paradigm shift in the treatment and prevention of HIV infection by eliminating the need of daily medication. However, real-world data have revealed substantial pharmacokinetic (PK) variability, challenging the one-size-fits-all dosing approach.
Key factors affecting long-acting antiretrovirals exposure after intramuscular administration were identified, including bodyweight, sex, as well as significant intra- and inter-individual variability in absorption and elimination. In particular, model-based simulations highlighted sex-related differences in cabotegravir PK: females had lower trough concentrations at treatment initiation but significantly higher levels during the late maintenance phase. These findings have direct clinical implications, particularly for individuals with additional risk factors – such as obesity – who may benefit from individualized TDM where feasible.
This presentation will explore how population pharmacokinetic (popPK) modelling and TDM can refine dosing strategies for long-acting antiretrovirals by tailoring dosing intervals based on individual PK data. It will discuss the integration of popPK models and Bayesian approaches into routine clinical practice, aiming to optimize drug exposure, minimize the risk of under-exposure, and sustain virologic suppression while reducing treatment burden.

Biography

Dr. Paul Thoueille is a clinical pharmacometrician and hospital pharmacist who completed his PhD in 2024. His main focus is the development of Therapeutic Drug Monitoring (TDM) as a tool for individualized dosage adjustment of drugs. He is an expert in population pharmacokinetic modelling, which he applied notably for the analysis of long-acting intramuscular antiretrovirals. He currently leads the TDM Unit at the Service of Clinical Pharmacology of the University Hospital of Lausanne, Switzerland.
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A/Prof Ethel Weld
Johns Hopkins University School of Medicine

LAI formulations of anti-infectives in adults

Biography

Dr. Ethel D. Weld, MD, PhD is an assistant professor of medicine, pharmacology, and molecular sciences at the Johns Hopkins University School of Medicine. She earned her medical degree from the University of Chicago and her PhD in Clinical Investigation from the Johns Hopkins Bloomberg School of Public Health. She is board certified in Internal Medicine and Pediatrics and subspecialty board certified in Infectious Diseases and Clinical Pharmacology, and serves as an attending Infectious Diseases physician at the Johns Hopkins Hospital and the Johns Hopkins Bayview Medical Center. She is the recipient of Johns Hopkins Center for AIDS Research (CFAR) faculty retention funding, a CFAR Faculty Development Award for her study “Feasibility, Development and Validation of a Non‐cold‐chain‐requiring Assay to Measure Long‐acting Antiretrovirals in Blood”, and an NIH K23 mentored career award for her project entitled “Optimizing the Use of Long-Acting Antiretrovirals for Youth with HIV”. She chairs the IMPAACT 2005 and 2034 trials, both multi-site international studies of novel TB therapeutics in children. Her primary research focus is on developing HIV and TB therapeutics in special populations, and optimizing long-acting therapeutics for individuals with HIV and adherence challenges.

Session chair

Dario Cattaneo
ASST Fatebenefratelli Sacco University Hospital, Milan

Natella Y. Rakhmanina
The George Washington University

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