Access to phage therapy at Hospices Civils de Lyon in 2022: Implementation of the PHAGEinLYON Clinic programme
Tristan Ferry, Myrtille Le Bouar, Thomas Briot, Tiphaine Roussel-Gaillard, Thomas Perpoint, Sandrine Roux, Florence Ader, Florent Valour, Behrouz Kassaï, Inesse Boussaha, Marietou Ndiaye, Fabien Craighero, Clément Javaux, Sébastien Lustig, Cécile Batailler, Tristan Ferry, Myrtille Le Bouar, Thomas Briot, Tiphaine Roussel-Gaillard, Thomas Perpoint, Sandrine Roux, Florent Valour, Clément Javaux, Marie Wan, Anne Conrad, Agathe Becker, Claire Triffault-Fillit, Marie Simon, Evelyne Braun, Lorena Van der Bogaart, Pierre Chauvelot, Olivier Bahuaud, Sophie Landre, Sarah Soueges, Isabelle Eberl, Karine Dallosto, Johanna Boulant, Nathalie Marrocco, Florence Ader, Sébastien Lustig, Cécile Batailler, Axel Schmidt, Fabien Craighero, Andréa Fleury, Ali El-Ameen, Arnaud Schleef, Jade Miailhes, Anne Fustier, Paul-Henri Himpens, Loïc Boussel, Marielle Buisson, Inesse Boussaha, Berhouz Kassai
Abstract
• Bacteriophages (phages) are promising non-traditional therapies to face difficult-to-treat infections and antimicrobial resistance • In 2021, French authorities granted early access authorization for innovative medicines and created two different pathways “compassionate prescription framework”, and “individual compassionate access authorization” among which pharmaceutical-grade phages could be prescribed • The PHAGE in LYON Clinic program was set up to improve the access to phage therapy in France using pharmaceutical-grade phages, with validation of the indication for phage therapy by a multidisciplinary team • Among 143 phage therapy requests, 33 patients were treated in France in 2022 with phages targeting S. aureus or P. aeruginosa as compassionate use or in a clinical trial • The implementation of the PHAGE in LYON Clinic program in 2022 was associated with a groundbreaking access of phage therapy in France To describe the set-up in 2022 of the PHAGE in LYON Clinic program dedicated to improve access to phage therapy in France using pharmaceutical-grade phages. We described the process, prospectively collected all phage therapy requests received during 2022 and reviewed them retrospectively to analyze the decision and also the patient care pathway (NCT05883995). Among 143 phage therapy requests, the indication was confirmed by multidisciplinary team meetings for 57 (40%) of them, and 44 were infected with bacteria that could be easily targeted by phages in France. Finally, 33 patients were treated, including 26 at our institution as compassionate use or in a clinical trial. Main indications were complex bone and joint infections, endovascular infections and lung infections. To manage these patients, 172 pharmaceutic phage cocktails targeting S. aureus and/or P. aeruginosa were prepared; 57 were dedicated to local, and 99 to intravenous injections. During the follow-up, 18 (69%) patients had a favorable clinical evolution, 6 (23%) required subsequent phage therapy, with the same phages with a greater phage exposition, or with different phages from elsewhere. The implementation of the PHAGE in LYON Clinic program in 2022 was associated with a groundbreaking access of phage therapy in France.