Type of study: Interventional trial
Coordinating investigator: Øivind Torkildsen
Study director: Kjell-Morten Myhr
Information for patients: on this page (Norwegian only).
Background: Novel insights from the MS research group indicate that infection with the Epstein-Barr Virus (EBV) is the leading cause of MS. As an EBV infection is persistent for life, the virus could function as a trigger or driver of MS-disease activity. If results from a clinical trial could confirm that targeting EBV reduces MS-disease activity, it would result in a paradigmatic change in our understanding of MS and the management of the disease. In collaboration with researchers at Harvard University, Boston, USA, we have identified a highly interesting candidate drug targeting EBV, not yet evaluated in MS patients. This trial could lead to a new paradigm in MS therapy, as it will evaluate a drug that may target the underlying cause of the disease.
The objective of this study is to investigate the safety and efficacy of tenofovir alafenamide (TAF) on Epstein-Barr virus infection in patients with relapsing-remitting MS (RRMS).
Design: This is a randomised double-blinded, placebo-controlled trial comparing the safety and efficacy of tenofovir alafenamide fumarate (TAF) 25 mg daily (n= 25) to placebo (n=25) on EBV viral infection in stable RRMS patients receiving natalizumab therapy. The study is as a part of the EBV-MS Horizon Europe project.
The primary endpoint is safety and tolerability of the drug, and the key secondary endpoint is change in EBV shedding in the saliva during 6 months of treatment.
Status: Inclusion of patients started early 2024 and was fully recruited (n=50) by February 2025. The follow-up was completed in Q3/Q4 2025, and results are expected to be available by Q1/Q2 2026.
Participating centres
Norway
- Haukeland University Hospital, Bergen
- Stavanger University Hospital, Stavanger
- Førde Hospital, Førde
- Haugesund Hospital, Haugesund
- Oslo University Hospital, Oslo
- Akershus University Hospital, Lørenskog
- Vestre Viken Hospital, Drammen
Funding
- The Norwegian MS Society
- The Regional Health Authority of Western Norway
- Horizon Europe
- Meyer Nyquist Legacy
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals
- Gilead Sciences, USA