Saturday, September 2, 2017

Hiltonol in Chronic Fatigue Syndrome

For new readers seeking CFS treatment, Ampligen is a drug that underwent Phase III trials for CFS patients for a few decades and was eventually not approved by the FDA for widespread use. One center in the United States is currently treating patients on a cost-recovery basis but is not accepting new patients at this time. As of 2017, the European status is unknown.

Bottom line: The subset of patients Ampligen helps, so should interferon or hiltonol. 

Rationale

This post pre-supposes three ideas that are welcome to correction.

- The first is that Ampligen operates primarily as an interferon inducer. But what about RNAse-L? Well Carter certainly couldnt patent poly(ic) as an inteferon inducer because that already occurred as early as 1971, if not earlier. The original clinical trial of Ampligen included IV Poly(i:c) (I cannot currently find it, but its clear the dose was too high and the participants were in world of hurt).

- That Ampligen is not materially different from Poly(I:C), other than the modification at 12 causes less side effects at a similar dose, because of less interferon production.

- Now the biggest stretch The interferon increase will be helpful in enough CFS patients. The temporarily lapse of symptoms in a subset of CFS patients treated with interferon and the steady administration requirement of Rintatolimod suggests the helpful effect is mediated by interferon production.

Thus, interferon alone could help those individuals that Ampligen helped. Further, that Ampligen is bioavailable in small intranasal doses, as is hiltonol (looks like this clinical trial bit the dust) making the route of administration requirement of intravenous ostensibly moot. 

Enter Poly(I:C)LC, an analogue with a lysine modification will increase half-life (as the half life of Ampligen is about 40 minutes and needs biweekly administration). 

Although this is purely speculative, perhaps Ampligen increases the amount of interferon at a ratio specifically helpful to CFS patients, and one runs the risk of deleterious effects with IFN-a or IFN-b alone (Ampligen increases type 1 interferons) but no one ever ran a trial of IFN-b.

Moreover, it is unknown if interferon neutralizing antibodies exist in Ampligen treatment - although after repeated administration of Poly(I:C) interferon stops being efficiently released (this too is cited from the mysterious first Ampligen paper I cannot find, keywords "Carter" "T'So" "1977" or "1975" "Virus").


Ampligen is said not to be immediately curative due to its short half-life and effects and requires repeated dosing. Perhaps not convincingly in the slightest, Poly(IC:LC), or hiltonol, was not effective in the treatment of multiple sclerosis in the 1980s.

Further confouding matters is that interferon treatment can feel like CFS itself, MS patients report malaise and researchers even proposed modeling CFS after an interferon based model.

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Thank you for reading, and I am glad to hear you have cured your CFS through any means necessary. I urge you to consider how your treatment will apply to such a heterogeneous population and the irregular dosing regimens of human blood required to retain activity levels, but appreciate the anecdote. 

Next up are the trials of the most obscure drugs for CFS and some unorthodox ones that were doomed from the start.