The TAF-MS 0 Study: Epstein-Barr Virus Shedding in Saliva in MS-Patients Receiving Cladribine, Natalizumab, or Rituximab
Growing evidence suggests that infection with the Epstein–Barr virus (EBV) may play a key role in the development and activity of multiple sclerosis (MS). The TAF-MS 0 study investigates how often EBV can be detected in saliva among people with relapsing-remitting MS receiving commonly used MS treatments. By improving our understanding of EBV activity in MS, this study will provide important knowledge for the development of future clinical trials exploring whether antiviral therapies targeting EBV could help modify the course of the disease.
Disease: Multiple sclerosis
Type of study: Observational trial
Coordinating Investigator: Øivind Torkildsen
Study Director: Kjell-Morten Myhr
Background: Novel insights from our 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.
Antiviral therapy targeting the Epstein-Barr virus (EBV) is not available, but evidence suggests that tenofovir alafenamide (TAF) may be an attractive candidate. To further evaluate the efficacy of TAF on EBV infection, EBV shedding in saliva is suggested as a surrogate endpoint of efficacy.
The objective is to establish knowledge of the natural course of EBV shedding in saliva from patients with RRMS receiving disease-modifying therapies. This knowledge will be used to further design clinical trials targeting EBV infection in MS patients receiving those disease-modifying therapies.
Design: This is an open observational study analysing EBV shedding in saliva samples collected weekly for five weeks from RRMS patients receiving cladribine, natalizumab, or rituximab. The study is as a part of the EBV-MS Horizon Europe project.
The primary endpoint is the frequency of EBV shedding in saliva samples collected weekly for five weeks.
Status: Patient recruitment has been performed, and analyses of the EBV shedding in saliva are underway. Results are expected in Q2 2026.
Participating centres
- Haukeland University Hospital, Bergen
- Stavanger University Hospital, Stavanger
- Førde Hospital, Førde
- Haugesund Hospital, Haugesund
- Oslo University Hospital, Oslo
- Akershus University Hospital, Lørenskog
- Stavanger University Hospital, Stavanger
- 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