54 Comments
Apr 24, 2023·edited Apr 24, 2023Liked by Gavin Giovannoni

I can see how the MS Research community could be factionalising over this. Let's face it, nobody knows for sure but your field theory is compelling - the way you tell it! I guess an evangelist for the other side could be similarly impassioned. I want to believe you though, Gavin, as a pwPPMS and someone hoping to start a BTKi trial shortly.

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

Yes. I do wish the researchers and doctors with different points of view would have the debate in the public sphere so there can be balanced decisions made by those affected by MS. I hope all doctors/researchers reading this will organise themselves. The more debate had, the quicker truth triumphs, the better for patients.

Expand full comment
founding

Jane, very good point. The more opinions, the more chances of trouncing this awful disease. NEID does not mean we are well or “cured”. I wish it were so! And I don’t want to hear anything about “normal aging”! Grrr.

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

Would it be an incorrect reach to say that current DMTs, since they address mostly the acute inflammatory part of MS (relapses and new lesions), but not as much progression, turn RRMS into something mimicking non-active SPMS if NEIDA is achieved?

Expand full comment
author

Yes, they convert relapsing MS into primary progressive MS albeit a less rapidly progressive form of PPMS.

Expand full comment

Does that suggest that ocrelizumab might slow down progression in RRMS by 25% (as it does for PPMS patients?)

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

Interesting question! curious to see responses…

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

So what are our options?

As someone on Tysabri I’m quite anxious of the day I need to switch for rebound and/or JC virus PML reasons

What’s the status on things like ATA-188, antivirals and BTK. Orelabrutinib shows the best data so far in BTK

As pwMS we are just getting frustrated at this point.

Also no one, I repeat no one is talking about anything to help our day to day symptoms. aHSCT doesn’t address that, BTKs don’t seem to, etc. just take Gabapentin or some other drug and hope it works whilst potentially harming you long term

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

“The corollary is that these microglia are not abnormal or dysregulated but are reacting to something abnormal in the tissue.” Are you saying that ebv is active in the CNS tissue ie in addition to residing in B cells in the CNS? If not, what else could be in “the tissue”?

I thought BTK inhibitors targeted B cells (including B cells in the CNS) in addition to microglia. So in theory EBV infected B cells would be eliminated from the CNS and the innate response would be put out. Are you saying that anti-virals would be needed in addition to BTK inhibitors?

Can’t you get an anti-viral trial going to put all this debate to bed once and for all? There’s a Groundhog Day about these posts. I remember from Sunday school that “a man is judged by his deeds, not by his words”. It’s time for some action rather than all this posting of carefully crafted words. MS is a disease which disables young people - endless academic debate isn’t helping anyone.

Expand full comment
author

We, the MS community, are doing several trials targeting smoldering MS . We are not sitting on our hands.

1. BTKi x 5

2. Sizomus - proteosome inhibitor

3. Chariot-MS - CNS penetrant cladribine

4. CNS-penetrant anti-CD20

5. Etc.

6. EBV-targeted CTLs - Atara Bio

7. Therapeutic EBV vaccine studies

I am also trying to get a CD19-targeted CAR T-cell and HAART and other antiviral studies off the ground. So things are happening, but may be too slowly for you.

Expand full comment
founding

I know you’re not sitting on your hands. As a progressive pwMS, I am too old to benefit from the newer DMTs, I therefore I therefore look forward to antiviral studies. As I smoulder away, I’m extremely grateful for your research and diligence. A huge thanks.

Expand full comment
founding
Apr 24, 2023·edited Apr 24, 2023Liked by Gavin Giovannoni

Thank you Prof G for helping MS patients all over the world find a cure.

Expand full comment

You do a lot for us. But prof G, the best thing is MS Selfie. This is like a brief explanation for all of us. The info we get from you we would never get from our neurologists. Thank you for everything you do.

Expand full comment

Thank you for delineating these on going investigations. It's good to know that there are many paths being explored to slow progression. I will be talking to my young MS neurologist about the antivirals for EBV treatment.

Expand full comment

Pleased to say I'm starting the SIZOMUS trial with my first tablet visit in 2 weeks. Thanks for telling us about it Prof G.

Expand full comment
founding
Apr 27, 2023·edited Apr 27, 2023

HAART looks very promising. Further down the comments someone's posted papers going back 6 years with case studies and reports. Any idea on how a patient could persuade their specialist to incorporate elements of HAART into their treatment?

Expand full comment
Apr 24, 2023Liked by Gavin Giovannoni

Don’t be disheartened Ian, I am facing exactly what you describe, a young person who may now lose their future, we must remember, just the expression of good ideas with an audience to hear them, often has a way of changing what seems intractable, very fast. I am sure you will have experienced this in your time. We need many doctors to read and agree/disagree, their thinking will change and then their actions.

Expand full comment

Thank you prof for your post. We learn so much from you. You are like "Walking MS Quide". I think that the inflammation can take place inside the brain and in peripheries. Its amazing but I've been taking Valaciclovir for around 2 weeks and seems like my symptoms are milder. I know that sth like placebo effect exists but I am more than sure that my disease drives the virus located in lymph nodes and inside the brain. Why? Simply I have a pain in those parts. I also have a headache especially in one part so maybe thats the part where new lesion will appear? One we know EBV drives MS. The question is where exactly and how?

Expand full comment

Hi Emilia

I also take Valacyclovir. I was prescribed a high dosage while I was taking Gilenya and then cladribine. I would get a really painful cold sore in the same spot on my gum over and over again. I haven’t given them up a year later. It seems to keep my system in check. I also get a recurring headache on the left side of my head. I don’t know what it means. I was told by a PA that pwMS don’t get headaches. I will ask my neurologist about it at my next visit.

Expand full comment

Hi Sheilah,

Thanks for reply. I think that TAF (Vemlity) would be better than Valacyclovir. But it is harder to get it and it is not approved to take it in MS. But interestingly Harvard is checking TAF in RRMS so maybe we will get to know soon if it works. I also have a headache in one part (all the time the same part). Yes,ask your doctor. Maybe thats the place where the brain is damaging?

Expand full comment

From my own research, indeed TAF might very possibly have an effect. However, as another poster commented: https://www.sciencedirect.com/science/article/pii/S2211034818300828

TAF wasn't used in this case. Instead Combivir was used.

There is also this case: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166391/

Note he never went on a DMT despite having fairly active RRMS, he commenced HAART, and never had a relapse or progression of MS disease. Immunosupression from HIV is unlikely the cause, due to him developing another auto-immune disease while being treated with HAART and his CD4 count being stable.

Expand full comment

Thank you for the info🙂

Expand full comment

Looks like the TAF study stopped recruiting patients: https://clinicaltrials.gov/ct2/show/NCT04880577

Expand full comment

No. I think they quit cause there was no funding. But as far as I know TAF is tested at Harvard. And Famciclovir is also tested in UK. What is more there is a group at Harvard which is trying to prove in laboratory that EBV drives MS progression. There is also Ganciclovir and Valaciclovir which can be used in EBV infection. Btw both of them are not available in Poland. But Famciclovir and Valaciclovir are available in UK. Increbible...

Expand full comment

I have wondered the same thing regarding my headaches.

Expand full comment

As a pwMS who is a physician treating HIV, I am curious about why there are not any trials looking at HIV ART. There are compelling case reports of improvement on NRTIs, presumably through treating EBV:

(https://www.sciencedirect.com/science/article/pii/S2211034818300828)

These drugs are very safe and used daily by people living with HIV as well as people with higher risk sexual activity as pre-exposure prophylaxis. Is there a concern that treating the EBV without either antiCD20 therapy or natalizumab would trigger too strong of an immune response? Something else I am missing?

Expand full comment

Do you have any HIV patients who are also MS patients? I am also a physician who has been recently diagnosed MS(two weeks ago). Symptoms started following my first COVID infection with subsequent MRI. I was infected again ~5 months later, with a now known relapse (mild vertigo) in my pons.

I can't help but wonder if COVID weakens the immune system to allow EBV to go wild. The connections between HAART, PrEP, and EBV can't be ignored. I too am considering antiviral medications, but worry about rebound etc. if I ever stop, as well as risk of unknown complications should I choose to undergo therapy with Natalizumab. - All the best, Ross

Expand full comment

I'm not speaking from clinical experience in seeing people with HIV and MS, this is a rare occurrence. My comment is more one of confusion: given the indirect evidence that Dr. G reports about possible efficacy anti-EBV therapy, why can there not be a study on the safe HIV medications millions of people around the world have taken for decades. It seems like studying MS incidence in people receiving HIV pre-exposure prophylaxis with either TAF/FTC or TDF/FTC could be a fairly straightforward way of adding to the case reports.

For what it is worth, I have done well on Natalizumab until my JC titer went from 0.3 to 1.51 over the course of a few months. Switching to anti-CD20 therapy next week after a negative MRI for PML.

Expand full comment
Apr 27, 2023·edited Apr 27, 2023

I have lost much sleep in the last weeks asking myself this very question. We do know that MS incidence in HIV patients is quite low, so possibly the ability to track said patients down? I would love to run said study. TAF is to my knowledge still under patent protection and quite expensive (1500 EUR/30 day supply in single drug form, Descovy is 500 EUR a month, here in Germany). So a financial incentive is there, I would imagine.

TDF is less effective vs. TAF according to this study, but would still be interesting to see. https://www.pnas.org/doi/10.1073/pnas.2002392117

There is also this case, where neither TAF nor TDF were used. Instead the patient took combivir. https://www.sciencedirect.com/science/article/pii/S2211034818300828

I fear PML with natalizumab. How long were you on it? Were you always JC negative while on it or just low titer? My neurologist said they would deny giving me Ocrevus, but Kesimpta would be possible. I considered going on Kesimpta for some time, then looking elsewhere out of country for high dose Rituximab or Ocrevus to bash the last B-cell reservoirs, then starting an antiviral therapy with lower efficacy drug. They took my blood for JCV yesterday.

Expand full comment

You are not alone with being absolutely bewildered by the question of why an epidemiologist can't tackle the question of whether HIV patients, who had a concomitant diagnose of MS, and were on long term anti-retrovirals which contained a drug with anti-EBV properties, had reduced MS progression and relapses. I've been consumed by this question for quite a while, myself. It sounds tedious, but it is a retrospective that doesn't involve clinical trials.

Expand full comment

TAF is expensive? Indeed. But even if it works in MS - you know who should cover the TAF treatment therapy in MS patients? FDA. And you know why? Cause for the last 10 years many have been repeating that EBV is strongly related with MS. And what? FDA wasnt interested in EBV vaccine. How do I know that? Check Mystery Solved Project. Now we have at least 4 companies working on EBV vaccine (after publishing in 2022 the research about EBV and MS by Harvard group of scientists). Coincidence? I dont think so.

Expand full comment

TAF is not that expensive in other countries. In India (Gilead makes Vemlidy for distribution to the US and will probably be the source in the US for TAF when it goes generic) it is quite cheap. The problem the with clinical trial may have actually been that once TAF is available, it might not be profitable enough.

Expand full comment

How does one go about sourcing a reputable supplier in India? Thailand it is also fairly inexpensive, however, I always worry about it being counterfeit/sugar pills or worse.

Expand full comment
Apr 27, 2023·edited Apr 27, 2023

Ok but FDA is only the oversight body in the United States, a single country. What about the European Equivalent? Asia? Australia? New Zealand? I think you get the point. EBV vaccine will be good going forward, however, I don't think an EBV vaccine will help those who are already infected/MS positive(I hope I'm wrong).

I saw you mentioning drug availability in Poland...is TAF available in Poland? And if so, anyway to see how much?

Expand full comment

Taf is not available in Poland. It is available in Germany. Polish people can buy TAF in Berlin eg but first they need to have a prescription. Who will give a prescription for the drug which firstly is not registeted in Poland and secondly is not available in any pharmacy? Noone. What is more Famciclovir and Valaciclovir are not available in Poland as well. Isnt that strange? I agree that EBV vaccine will not help MS patients. And maybe you are right about FDA. But if a group of well-known scientists goes to FDA and tells that EBV drives MS what would you do if you were FDA? I would listen to this group. Quess FDA didnt listen. If it had listened we would have had few EBV vaccines now and maybe lower group of MS patients.

Expand full comment

I had a good experience with Natalizumab and found that the PML monitoring was really robust. Unfortunately my titer went from negative to high titer quickly over about 9 months so I had to switch before 12 months of treatment.

Expand full comment

I find it fascinating hearing about people, previously testing negative for JC-virus, then testing positive within a relatively short period of time are (Months to Years) after initiating therapy. Why did you choose Natalizumab over one of the B-Cell depleters first? I know switching from Natalizumab to B-Cell depleters is safer than the other way around. Was there other reasoning?

Expand full comment
founding
Apr 29, 2023·edited Apr 29, 2023

Dear Ross,

I read that Covid can trigger MS in those genetically predisposed and who have had prior EBV mononucleosis. I experienced MS symptoms 6months after Covid infection. Wondering if I should take covid anti-viral meds to slow progression. Maybe Prof G can advise us.

https://www.sciencedirect.com/science/article/pii/S2667257X21000061

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8612412/

https://www.nih.gov/news-events/nih-research-matters/autoimmune-response-found-many-covid-19

Expand full comment

Why do you think Covid antivirals will help after you have already cleared the Covid infection? If you are having neurological symptoms, seek a physician to refer you to get an MRI.

The problem is the spike protein. The spike protein seems to disrupt the blood brain barrier, wreak havoc on the mitochondria, not to mention the change in gut flora caused by the virus acting like a phage. That said, there is a thought that covid might be lurking in the body in some reservoir(gut bacteria maybe?), however, no proof yet. I surmise the damage is mostly done through the spike protein to the blood brain barrier and gumming up the mitochondria, both of which are known disease drivers in multiple sclerosis as well as a temporary immune depression allowing reactivation of EBV. Combine all these things together, and you get all the ingredients for a fine "MS Soup"...unfortunately for me.

Expand full comment
founding

MRI done but doc says lesions are not at the requisite places. So doing another one in June.

Expand full comment
founding

When was yr first covid infection and how long after did u get a diagnosis?

Expand full comment

Initial Infection(sick for weeks, followed by long covid symptoms) June '22, 1st cMRI September '22 4 Cerebral lesions(Gadolinium not used), 2nd COVID Infection Nov '22(Fatigue for 2 days), probable relapse some weeks later with onset of mild vertigo, Feb '22 Lumbar puncture showing 6 Oligo bands, 2nd MRI March 23 8 lesions (4 new cerebral, one of which in Pons, zero Gad enhancement)....will start kesimpta in 4 weeks due to high JC virus titer(Natalizumab not possible) and needing refresher vaccines.

Expand full comment
founding

Thanks for explanation, Ross. Same unfortunate thing happened for me then.

Expand full comment

Great points all, Gavin.

As usual, some caveats.

1 Evobrutinib failed (also a BTKi, as you know) and here is the paper on this - Montalban X, et al. NEJM, 2019. Patients with relapsing multiple sclerosis who received 75 mg of evobrutinib once daily had significantly fewer enhancing lesions during weeks 12 through 24 than those who received placebo. There was no significant difference with placebo for either the 25-mg once-daily or 75-mg twice-daily dose of evobrutinib, nor in the annualized relapse rate or disability progression at any dose.

To me, the latter statement on ARR is galling. Now, will Tolebrutinib make a difference ? Where is the evidence thus far ? Time will tell ?

2 On the paper 2, case study you presented, we do not know why natalizumab withdrawal does not always result in this rebound/IRIS/recrudescence of disease but only happens in some cases. Can we narrow this down ? As well, we MUST (at least that is what I do) minimize the 'time between switches' to 2 wks max. Else, we may end up paying the price.

3 Failure of abatacept - and while we are extolling the virtues/pitfalls associated w T cells in general, this statement from the ACCLAIM study cannot be forgotten, either.

Abatacept is a CTLA4-Ig fusion protein that targets the adaptive arm of the immune system by blocking the CD28-B7 co-stimulatory pathway, which is central to activation of T lymphocytes. I for one do not know WHY it failed. Logically, it was supposed to fly. It crashed.

Jagannadha (Jay) Avasarala, MD, PhD

U of KY Medical Center

Lexington, KY

Expand full comment

I was unaware of the (presumably proven!) precedent in leprosy that the arbitrary(?) immune response affects the course of the disease. That makes me wonder (again) whether there's information about MS buried in whether folks had symptomatic EBV infections. I myself was hospitalized for mononucleosis about a decade before I was diagnosed with MS.

Expand full comment

That is the biggest problem..It would be illegal, but after 38 years, I am bedridden, so jail is not my concern.

Expand full comment