A phase 2a open-label clinical trial to determine the effect of famciclovir on EBV activity as measured by EBV shedding in the saliva of patients with multiple sclerosis.

Autor:	Dobson R; Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, London, UK.; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK., Holden D; Blizard Institute, Queen Mary University London, UK., Vickaryous N; Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, London, UK., Bestwick J; Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, London, UK., George K; Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, London, UK.; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK., Sayali T; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK., Bianchi L; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK.; Department of Brain Sciences, Imperial College London, UK., Wafa M; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK., Gold J; The Albion Centre, School of Medicine, The University of Sydney, Sydney, NSW, Australia., Giovannoni G; Department of Neurology, The Royal London Hospital, Barts Health NHS Trust, London, UK.; Blizard Institute, Queen Mary University London, UK.
Jazyk:	angličtina
Zdroj:	Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2024 Jan; Vol. 30 (1), pp. 63-70. Date of Electronic Publication: 2023 Dec 22.
DOI:	10.1177/13524585231215268
Abstrakt:	Background: Despite increasing evidence that Epstein-Barr virus (EBV) plays a causal role in MS, no treatments have been shown to reduce EBV turnover. We studied the effect of famciclovir on salivary EBV shedding in people with MS (NCT05283551) in a pilot, proof-of-concept study. Methods: People with MS receiving natalizumab provided weekly saliva samples for 12 weeks before starting famciclovir 500 mg twice daily for 12 weeks. Twelve saliva samples were provided on treatment and 12 following treatment. A real-time qPCR Taqman assay was used to detect EBV DNA in saliva. The proportion of saliva samples containing EBV DNA was compared using the Friedman test. Results: Of 30 participants (19 F; mean age 41 years; median EDSS 3.5), 29 received famciclovir, and 24 completed the 12-week course. Twenty-one participants provided at least one usable saliva sample in all epochs. Ten of the 21 had shedding in at least one sample pre-drug; 7/21 when taking famciclovir (not significant). No difference in EBV DNA copy number was seen. There were no drug-related serious adverse events. Conclusion: No significant effect of famciclovir on EBV shedding was seen in this small pilot study. Given the low numbers, a small effect of famciclovir cannot be excluded. Salivary EBV shedding in this natalizumab-treated cohort was lower than in previous studies, which requires replication. Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: R.D. has received payments to her institution, including grants from Biogen, Merck, Celgene, National MS Society, MS Society UK, Horne Family Trust, and the BMA Foundation; honoraria from Biogen, Janssen, Merck, Novartis, Roche, Sanofi, and Teva; participated on an advisory board for Biogen, Janssen, Merck, Novartis, and Roche; and received support for attending meetings or travel from Biogen, Janssen, Merck, Novartis, Roche, and Sanofi. G.G. has received consulting or speaker fees from AbbVie, Aslan, Atara Bio, Biogen, Bristol Myers Squibb–Celgene, GlaxoSmithKline, GW Pharma, Janssen–Actelion, Japanese Tobacco, Jazz Pharmaceuticals, LifNano, Merck & Co, Merck KGaA–EMD Serono, Moderna, Novartis, Sanofi Genzyme, Roche-Genentech, and Teva Pharmaceuticals. The remaining authors had nothing to declare.
Databáze:	MEDLINE
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