Saturday, March 8, 2025
San Francisco, California
The Long-Acting Extended Release Antiretroviral Research Resource Program (LEAP) virtually convened clinicians, investigators, developers, community advocacy groups, not-for-profit institutions and regulatory authorities. Attendees shared their diverse perspectives and discussed updates, challenges and future directions in the development of LA formulations. The meeting served as a forum to collectively advance the long-acting field. The Workshop consisted of two Plenary Sessions and four Focus Groups. Below, you’ll find links to video recordings and text summaries of the Plenary and Focus Group presentations.
Charles Flexner, Director, LEAP, Johns Hopkins University
Where are we LEAPing Next?!
Overview of Workshop
[Presentation]
Carl Dieffenbach, Director, Division of AIDS, NIH
Welcome
[Opening remarks]
PLENARY SESSION 1 – Paul Domanico, Chair.
Current Status of Existing Technologies
Kenly Sikwese (on behalf of Imelda Mahaka, PZAT)
Community-based Presentation
[Presentation]
William Spreen, ViiV
Current Status of LA/ER Cabotegravir and Rilpivirine Including Pipeline Report on Novel CBT Formulations
[Presentation]
Ernes Stamm, Merck
Current status of the Merck LA/ER Pipeline
[Presentation]
Moupali Das, Gilead Sciences
Update on the Gilead Long-Acting HIV Treatment & Prevention Pipeline
[Presentation]
Vivian Cox, Johnson & Johnson
Update on J&J’s Long-Acting Formulations for Tuberculosis
[Presentation]
PLENARY SESSION 2– David Thomas, Chair.
Novel approaches to LA/ER Drug Delivery
Andrew Owen, CELT, University of Liverpool
Summary of CHAI/BMGF/DAIDS/WHO Workshop on LAI
[Presentation]
Charles Flexner, Johns Hopkins University
Summary of Liverpool Bioequivalence Workshop
[Presentation]
Rodney Ho & Simone Perazzolo, University of Washington
Development of Long-Acting TLD and Lopinavir and Ritonavir; Booster Role and Implications for Future Products
[Presentation]
Andrew Owen, CELT, University of Liverpool
Update from LONGEVITY
[Presentation]
Elizabeth Phillips, Vanderbilt
Hypersensitivity Reactions to Lipid-Based Excipients in Long-Acting Formulations
[Presentation]
Rahima Benhabbour, UNC - Chapel Hill
Preclinical Development of Ultra-Long-Acting Formulations
[Presentation]
Benson Edagwa, UNMC
Ultra-Long-Acting Prodrug Formulations for HIV/HBV CoInfection
[Presentation]
Anil Gupta, The Scripps Research Institute, CalibrSkaggs IFIM
LA-Entecavir for HBV
[Presentation]
Lobna Gaayeb, MPP, & Adeniyi Olagunju, University of Liverpool
LA-Entecavir for HBV
[Presentation]
Focus Group Summary Reports – Kim Scarsi, Chair
The four 15-minute Focus Groups preceded the Workshop and were intended to foster informative and provocative discussion of strategically selected topics, listed below. The highlights and recommendations from each focus group were presented. Attendance for these sessions was limited.
Group 1: Self-Administration of Long-Acting Formulations: Is it a Good Idea?
Imelda Mahaka - Rapporteur
Chair: Raphael Landovitz
Co-Chair: Kenly Sikwese
[Presentation]
Group 2: Self-Administration of Long-Acting Formulations: Is it a Good Idea?
Ethel Weld - Rapporteur
Chair: Cissy Kityo
Co-Chair: Melynda Watkins
[Presentation]
Group 3: Self-Administration of Long-Acting Formulations: Is it a Good Idea?
Rachel Bender Ignacio - Rapporteur
Chair: Monica Gandhi
Co-Chair: Laura Waters
[Presentation]
Group 4 (in two parts)
Part 1: Paul Domanico, CHAI (on behalf of Mark Mirochnick, MD) Update on WHO LA TPP
[Presentation]
Part 2: Target Product and Target Access Profiles of LAIs for Global Use
Rapporteur: Raj Gandhi
Chair: Mike Reid
Co-Chair: Paul Domanico
[Presentation]