TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis

Treatment tested

• Tenofovir alafenamide

  Human immunodeficiency virus type 1 reverse transcriptase inhibitor

Placebo or sham

• Placebo capules, hard

Other measures (5)

Inclusion: - 1. Age 18 to 70 years (inclusive) at the time of signing the informed consent. - 10. Creatinine clearance > 15 ml/min - 11. Serum bilirubin < 2 times the ULN - 12. Negative tests for HIV, chronic active hepatitis B and hepatitis C - 13. Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion - 14. Highly effective contraceptive use by women - 15. Willingness and ability to participate in all study procedures, including lumbar puncture and air travel to Turku, Finland for MRI and PET imaging at inclusion and end of study - 2. Diagnosis of MS (regardless of subtype) according to the revised McDonald criteria - 3. EDSS 2-6.5 (included) - 4. A previous cerebral MRI with T2 lesion volume at least 15.00 cm3 - 5. EBV-antibodies positive in blood sample - 6. WBC > 1.5 x 109/L - 7. Platelet (thrombocyte) counts > 50 x 109/L - 8. ALAT less than 2 times the upper normal reference limit (ULN) - 9. Serum creatinine < 200 µmol/L Exclusion: - 1. History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer - 2. Women who are pregnant, as verified by a serum pregnancy test, or lactating. - 3. History of pancreatitis - 4. Current users of medications that could interact with the study medication or the PET tracer, for details see Section 6.9 in the protocol - 5. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT) - 6. Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome - 7. Currently enrolled in other trials of an investigational drug, or less than 30 days since the last treatment with another investigational drug - 8. Exposure to more than 10 mSv doses of experimental ionizing radiation, in addition to that obtained from natural sources, in the past 12 months, equally to one CT scan during the past 12 months.

This study will test the hypothesis that TAF is superior to placebo as add-on to anti-CD20 therapy for the treatment of neuronal damage in MS.