$5 - $7 million sounds like a small investment compared to the cost of other trials.
I would be interested in participating in a trial that involves an antiviral drug that has multiple years of studies showing that it has long term safety and no negative impacts for PwMS.
Currently when people with ms get Covid we are prescribed , if I am not mistaken, an anti viral that was used to treat HIV. Is that anti viral similar to the ones you have mentioned that may prevent further deterioration in MS.
US trial for Tenofovir for MS was suspended due to lack of funding. This is another fairly inexpensive, well-tested anti-viral drug. Do you have any insights as to whether this drug holds promise?
The question " would you participate" has a pretty obvious answer. If someone is intelligent enough to sign upto your blog and read the entire post, its an easy assumption they are intelligent enough to realise haarts are currently our best hope. I would participate in a heartbeat 😉 but do wonder if an open minded hemo could prescribe after hsct as ermmmm prophylaxis ? 😅
Yes I’d definitely take part in such a study and the cost is expensive but worth it to move forward. Has anyone ever questioned if non responders to HSCT were EBV positive?? If EBV Negative pre HSCT was the success rate better?? Something I’ve wondered for a while post my own HSCT.
If as is stated in the trial Tenofovir is just another name for Ocrevus ( which I have been on for 4 years and certainly can,t climb stairs wonderfully well ) I cannot understand why drug companies are refusing to trial drugs that show promise I firmly believe that you are as usual doing all you can to encourage trials But just look at all the interest and response you get on here why not put out a request to all your followers what if we wrote as a community do you feel that would help in any way? I would be more than happy to participate in any trials I am more than willing to be a guinea pig if anything works on this horrible illness to make the future look better for our children and theirs thank you once again for keeping us up to date on so many things if I relied on my Neuro I wouldn't learn half as much
Oct 20, 2022·edited Oct 20, 2022Liked by Gavin Giovannoni
Hi Prof G, I think EBV antivirals will stop the progression of the disease, can you make the point about remyelination drugs. Recreating myelin sheaths should be considered a cure?
I’m not well-versed in Pharma budgeting but the amounts presented don’t sound high at all. To answer the question, yes I would participate given that it’s safe to do so.
Which would you say are the main barriers at the moment to these trials happening?
Would the NIHR or the MS society fund a study of AZT in MS initially? This crosses the bbb. This would not upset Pharma as an add on to their current treatments and it would not mess up all the pre-existing calculations of ICER for their products. Ocrelizumab costs £19,160pa plus 2x day medical unit costs, Ofatumumab is £19,402.50pa plus a few sharps boxes, Natalizumab is £14,690pa plus 13x day medical unit costs and generic AZT is £162pa (source BNF). I suggest doing a small trial initially as an add on therapy and ensure assessment technique can identify improvements in function rather than just decreased frequency of relapses. I would restrict it to EDSS 5.0 - 8.5 because it will be easier to identify improvement and these people can be brought in to participate in assessments (or remote video assessments). If it helps within 6 months the study can be extended to ensure any benefit endures. The risk is that EBV mutates and escapes chemical control (as HIV has). If it is effective, other antivirals (perhaps suggested by a GUM specialist with knowledge of HAART) could be tested and participants with a wider range of disability. After that, the head to head studies that will hit Novartis, Biogen, Sanofi and Roche, but if they see the writing on the wall, they will develop more effective HAART to plug some of the gap.
I wouldn’t be a proper subject for such a trial, but I find it enormously important, since it could potentially stop the ravages of MS at an early point. As an older patient, the most I can do is take antivirals, but I’m cheering on a study. Repeat repeat! I very much appreciate your persistence.
Its a tough one because pwms were told for years that: 1.antibiotics dont work 2. Retrovirals do not work.
But sign me up.
Here s an interesting anecdote: https://www.bbc.co.uk/news/uk-england-sussex-34659771
So if I were to be infected with HIV tomorrow and treated with anti-vials, I would be running my own HAART trial with a sample of 1?
p.s. I would be willing to take anti-virals post-alemtuzumab if risk profile permits.
$5 - $7 million sounds like a small investment compared to the cost of other trials.
I would be interested in participating in a trial that involves an antiviral drug that has multiple years of studies showing that it has long term safety and no negative impacts for PwMS.
Currently when people with ms get Covid we are prescribed , if I am not mistaken, an anti viral that was used to treat HIV. Is that anti viral similar to the ones you have mentioned that may prevent further deterioration in MS.
Yes I would participate. What response are you getting from the established MS charities?
US trial for Tenofovir for MS was suspended due to lack of funding. This is another fairly inexpensive, well-tested anti-viral drug. Do you have any insights as to whether this drug holds promise?
The question " would you participate" has a pretty obvious answer. If someone is intelligent enough to sign upto your blog and read the entire post, its an easy assumption they are intelligent enough to realise haarts are currently our best hope. I would participate in a heartbeat 😉 but do wonder if an open minded hemo could prescribe after hsct as ermmmm prophylaxis ? 😅
Yes I’d definitely take part in such a study and the cost is expensive but worth it to move forward. Has anyone ever questioned if non responders to HSCT were EBV positive?? If EBV Negative pre HSCT was the success rate better?? Something I’ve wondered for a while post my own HSCT.
Very encouraging talk. The anti vitals are very tempting.
If as is stated in the trial Tenofovir is just another name for Ocrevus ( which I have been on for 4 years and certainly can,t climb stairs wonderfully well ) I cannot understand why drug companies are refusing to trial drugs that show promise I firmly believe that you are as usual doing all you can to encourage trials But just look at all the interest and response you get on here why not put out a request to all your followers what if we wrote as a community do you feel that would help in any way? I would be more than happy to participate in any trials I am more than willing to be a guinea pig if anything works on this horrible illness to make the future look better for our children and theirs thank you once again for keeping us up to date on so many things if I relied on my Neuro I wouldn't learn half as much
Hi Prof G, I think EBV antivirals will stop the progression of the disease, can you make the point about remyelination drugs. Recreating myelin sheaths should be considered a cure?
I’m not well-versed in Pharma budgeting but the amounts presented don’t sound high at all. To answer the question, yes I would participate given that it’s safe to do so.
Which would you say are the main barriers at the moment to these trials happening?
Would the NIHR or the MS society fund a study of AZT in MS initially? This crosses the bbb. This would not upset Pharma as an add on to their current treatments and it would not mess up all the pre-existing calculations of ICER for their products. Ocrelizumab costs £19,160pa plus 2x day medical unit costs, Ofatumumab is £19,402.50pa plus a few sharps boxes, Natalizumab is £14,690pa plus 13x day medical unit costs and generic AZT is £162pa (source BNF). I suggest doing a small trial initially as an add on therapy and ensure assessment technique can identify improvements in function rather than just decreased frequency of relapses. I would restrict it to EDSS 5.0 - 8.5 because it will be easier to identify improvement and these people can be brought in to participate in assessments (or remote video assessments). If it helps within 6 months the study can be extended to ensure any benefit endures. The risk is that EBV mutates and escapes chemical control (as HIV has). If it is effective, other antivirals (perhaps suggested by a GUM specialist with knowledge of HAART) could be tested and participants with a wider range of disability. After that, the head to head studies that will hit Novartis, Biogen, Sanofi and Roche, but if they see the writing on the wall, they will develop more effective HAART to plug some of the gap.
I wouldn’t be a proper subject for such a trial, but I find it enormously important, since it could potentially stop the ravages of MS at an early point. As an older patient, the most I can do is take antivirals, but I’m cheering on a study. Repeat repeat! I very much appreciate your persistence.
Bring on the study - where do I sign up?
What prevents you from prescribing HAART to your patients now without a trial? From what you say, the potential benefits seem to outweigh the risks