How long?

[Cort]

In the UK we face a further problem and a delay. The NHS and the NICE Guideline.

For people who have the money (or access to a system that provides drugs like Jimbob is using) the choice is there. Start treatment straight away or wait until clinical trials are done.

Even if XMRV is shown to be the cause of ME we still don't know (apart from invitro or patient experiments) how the treatment will work.

Then in the UK, even if clinical studies are done, we still don't know if the NHS will fund the drug. We may get fobbed off into waiting for NICE to recommend a treatment?

The NICE guideline for treatment of ME/CFS is up for review this Summer. Will they make us wait just how many years until they review it again? Will it take another attempt at legal action in the end to get treatment?

For those of us in the UK, we face the knowledge today, that even if clinical trials are held into drug treatments abroad, that is no guarantee that the NHS will provide them and NICE recommend them.

The questions should be

1. What treatments can we current afford
2. What can we get for free or under insurance/ state system
3. What level of proof will we individually wait for - or our system demand

My guess from the US is that if XMRV is confirmed and found to be a major cause and drugs are found that get rid of XMRV and then improve CFS patients health then the UK will be forced to provide treatment for CFS patients. One reason CBT et all have been allowed to take root in the UK is that there really haven't been many good solid treatment trials that provided substantial benefits to CFS patients. We're lucky with XM RV and that the world is interested in this and pharmaceutical companies are interested and they would be very willing to do rigorous treatment trials using their drugs. So we could get just what we haven't gotten this- a slew of really strong, expensive treatments trials that are basically bulletproof. Even the UK medical system cannot withstand that kind of evidence - not if they don't want to be perceived by the rest of the world as looney.

There are studies and then there are studies. There are alot of studies with holes in them that the powers that be will ignore. (I'm beginning to think that that may apply to the Lerner study unfortunately.) But really good strong studies they can't ignore and these companies have the money and expertise to create these kinds of studies - they do it all the time. If XMRV is there and they can treat it and that works I don't think there's any stopping it.

 

[Cort]

Apart from the WPI, does anyone know who else would be interested in carrying out clinical trials into treatments?

Glaxo Smith Kline is definitely very interested. My understanding is that they were ready to start treatment trials very quickly but once the negative studies came out they decided that they needed to pull back and figure out what's going on - so they started their own study with the CAA. Any drug company with a potential drug on its shelf - and apparently there are shelves and shelves of antiretroviral compounds that didn't make it to market - should be interested. They have two big potential markets thus far; prostate cancer and chronic fatigue syndrome. it's

 

[Cort]

I've heard rumours that the process of drug treatment will probably move quite quickly.
We have got to get some positive studies!!

That's what I've heard too. I think drug companies are very interested in this bug and when we do get positive studies they'll move very quickly. From what I've heard they were already moving very quickly. I think Dr. Mikovits talked about drug trials in six months or so- that indicated a lot of interest. We just need to get those positive studies and I think it'll move more quickly than we think.

It seems to me that the first drug to market for a disease he always does the best. Imagine being the first drug to market for a disease that affects so many people. Everybody would be all over it- that would be a heady first year for that drug company. I read they were astonished at how much money Lyrica brought in for FM - just astonished - no one had tested the fibromyalgia market before, and when they did it was a huge moneymaker. Even though there are fewer CFS patients I'm sure they have FM in mind.

 

[Cort]

this is exactly why i take long term high dose antivirals (4 yrs)....and because a good portion of my memory and cogntive problems have lifted. two years ago i wouldnt have been able to read or write here. (this was my most worrisome symptom...i can live with the symptoms of chronic viruses (vzv, hsv-1), pain, fatigue etc., pem) i'll take any and all the improvements i can get...however subtle or fleeting.

i understand that until specific antivirals, and if necessary, specific arvs are developed - we make do with what we have available (granted, not much!)

ive stopped reading about failed studies...I'M my "study"! (too many years have been wasted by the cdc for example, imo)

xmrv may change this...but in the meantime...im going to try whatever i think has a reasonable chance of improving my quality of life and to prevent a deterioration of my condition.

i also understand that it is not an overnight process (i might very well be taking av's for my entire life, to suppress these viruses...though ive been ill since birth and im 58)...and inim prepared for that.

i had been on av's for over 1.5 years before i noticed a difference...so i continued on and the changes started to occur. but no one has the same reaction, either.

its a gamble until we get the right avs/arvs on the market.

looking at the dismal figures for government spending for me/cfs tells the whole story. this must also change..and quickly - as many of us are aging now, as well. j

How are you doing now on antivirals Jackie? How much progress have you had?

 

[jackie]

Cort...I really didnt experience any improvement for the first 1.5 years (during this time period I started at 800mg. and did a gradual titration up to my current 3200mg. per day).

I never stoppped and started or lowered my dosage (no drug "vacations"). Never added in any other "treatment".

Although Dr. Chia gently pestered me to add first oxymatrine and then, as it was developed , "equilibrant"...I resisted for a variety of reasons. Not the least was my aversion to feeling worse again (as I knew might be likely for a time...even sporadically). So, I kept chickening out!

Interesting...I had my most recent tcell counts and they are now on the high end of normal! (1480 cd4 and 580 cd8) and yet, I also have increased shingles. Including an unusual rash on my back, (that I feared was vascular), but that chia has seen in several other cases, dx'd as shingles deep in the tissue, and also shingles along several nerve pathways/lymph nodes. These, in addition to the "normal" shingles across the back of my neck! yikes!

None of this can be easily explained...but he says they are happening to many of his patients.

AND (this is also a new developement)...hsv-1. So, im a bit of a mess physically (but I can deal with this), as the shingles are crossing to both sides of my body at the same time! and they NEVER go away.

My PEM is MUCH better (shorter duration, much quicker recovery period...an exacerbation that previously lasted weeks-months is now a matter of a few days), and I credit acyclovir with this.

Fatigue is also better..in fact, I spend less time in bed (although I still often FEEL better when reclining which is most likely due to OI)

I've always had cardiac issues..so chia has warned me to be careful not to overdo (as this "stirs" up the enteroviruses), and I also take atenolol to keep my heart rate steady (I have tachycardia)

I've posted this several times..but its worth repeating, I think. My memory and cognitive problems (which 2 years ago were so pronounced that my long-time neurologist dx'd MCI - with aricept/namenda as my treatment...which i declined!) have improved dramatically.

I can now read, write, communicate...so much so, that my neuro reversed his dx of mci (how often does a neuro reverse ANY decision!?)

Last week Chia decided that it really is time (cant talk my way out of it this point!) to attempt to begin titrating down with acyclovir (as such a high dosage can bring problems of its own and 4 years is a long time at that dosage)...but not until I ADD an immune modulator (equilibrant) at the tiniest dosage (he says 1/2...I say 1/4 tab per day to start!).

He is giving me 3 months to experiment (increasing until I reach 1 daily tab), and if I do ok, we will begin to reduce acyclovir. Our hope is to reduce this to a "maintenance" dosage of 800mg. (No more procrastinating...I begin this soon.)

Another interesting item. I became somewhat obsessed (upon learning that my cd4 count had "spiked" from the usual relative low seen in me/cfs patients)...and felt hopeful that IRIS might be taking place....since I had reactivation of several of the the herpes viruses! Similar to what often happens in the first year of haart/hiv...and even a cancer (ex: myeloma) patient during immune supression from chemo.

But no, he didnt feel that had happened to me (I was quite disappointed, IRIS can be a good sign post to have, during any treatment protocol!)

Especially if you have a significant viral reactivation (vzv, cmv, etc) that may MIMIC a downward turn in your condition.

Although he has seen IRIS occur in a few people using immune modulators...and also said it might be possible once I start them! (he also said that if he tested my dna he was sure he'd find VZV! pretty wild)

So, yes...im gradually seeing a staedy and consistant improvement in certain areas...enough (and especially BECAUSE of the AREA...brain) that I would not even consider stopping.

I feel sure that I would regress if I did that (and there is a real possibility that I will have a fight on my hands re: vzv increase, when I reduce...heres hoping that equilibrant can give my immune system a boost, to counter this!)

Thanks for asking! jackie (sorry for the long post...but I tend to rattle on, as you know, now that I can!)

 

[BEG]

F.Y.I. I just called Dr. John Chia's office. He is located in Torrance, CA. He is booked through December, and I was told that appointments go fast. He DOES take Medicare for those of you who rely totally on this insurance. So . . . if you don't live near CA, but you are able physically and financially to travel, I do believe, after what I've read here and on another thread, it just might be worth a visit.

BEG

 

[jackie]

well said...sickofcfs! (also, you reminded me of the fact that in the early days of aids....acyclovir was widely used - and its still being used to suppress cmv, vzv for example, as well as other viral reactivations in hiv...and i dont know why it isnt being used more often as an alternative to valtrex if that isnt affordable or covered by ones insurance. though it is a longterm proposition, as you pointed out)

id gladly try valcyte if i could....but it wasnt offered to me, though i tested pos for hhv-6)

(i asked my doc (last winter) what id do if testing positive for xmrv...he said i'd ADD arv's to the av's)

jackie

 

[Adam]

As of January, I'm gambling on 2-5 years for treatment of XMRV.

Part of the reason my daughter and I are on Valcyte (for HHV-6) is because I'm gambling on a parallel to HIV -- that is, that secondary infections will still have to be treated before, or along with, the retrovirus. My memory may be faulty here, but as I recall, the first line of treatment for HIV (in the early days), was treating secondary infections because they had nothing to treat the retrovirus. Once they developed antiretrovirals, they still treated secondary infections. I'm trying to get ahead of the game by treating secondary infections now thereby giving us the best chance with the antiretrovirals once they become available.

This was my estimate as of Jan 2010:
end of 2010 -- a reliable XMRV test,
mid -2011 -- enough data on existing retrovirals for some docs to be willing to prescribe them,
mid- 2013 -- some really good clinical studies on existing antiretrovirals,
end of 2013 -- many docs willing to prescribe studied antiretrovirals off-label (insurance still not clear),
end of 2015 -- common treatment for XMRV with existing antiretrovirals with most insurance paying

Of course, I'm talking treatment, not cure. I'm thinking a patient with current mild to mild-moderate symptoms would lead a normal life without flares and relapses -- as with Dr Klimas' "hale and hearty" HIV patients.

I don't think we know enough about what XMRV does to our bodies to make a guess about those of us in the bottom half of the functionality scale. I'm hoping to move from moderate-severe (housebound) to moderate or better just by treating HHV-6. Whether I regain anything more is probably more a function of whether any permanent damage has been done than with any antiretroviral treatment. It might help me not get worse, though, which is always good.

As for folks in the UK -- it's hard to imagine how it's going to play out with all the Wesseley history. It would be a remarkable about-face for the NHS to change from "false illness belief" to "treatable retrovirus" in just 5 years. I'm hoping for the best, though.

We don't know if we're XMRV+. We'll test when there's both a reliable test and something we can do about it -- which I expect to be within the year, BTW.

Excellent analysis of where we are now and where we are going with this illness. Many thanks for thinking it through and putting down the detail. Some other useful contributions. Usual negative ones, too, but there you go, you can't please everyone. Why anyone would hope that XMRV is not the cause of CFS/ME baffles me?

Five years was also my rough guess for us here in UK dependant on NHS for treatment.

Lol @ Cort - yep, the NHS would be loony not to take note of US trials/research, then again, we tend to do things our own way.

 

[alex3619]

WPI findings confirmed by NIH and FDA?

Hi


I wanted to make sure everybody heard this.

http://www.mmdnewswire.com/xmrv-9040.html

This is not official confirmation yet, that awaits publication from what I gather from this article.

I will try to start a new thread as well. This information comes from the XMRV action group on facebook. It is still not known what "confirmation" actually means.

Bye
Alex

 

[taniaaust1]

Depends on what you mean by treatment. I think there is already combination of AIDS treatments which they have found will probably "treat" for this virus. But does treatment mean cured from it? nope.. is AIDS (one of the only other two retroviruses in humans) cured? It's been over 10 years now and they still cant cure HIV/AIDS even with all the funding which has gone into that.

We may have a virus which can be treated but not cured. Just think about what this implies esp if it can be transmitted sexually (eg to men giving them instead prostate cancer).

 

[Rrrr]

Hi Jpv and others,

I do not expect a cure, I do expect a treatment.
I don't expect a precise answer, just an estimate.
Whether I like it or not, I am infected with this virus, I would not say I'm enthusiastic about it really. This retrovirus may be a pasenger, so let me redefine;

given that xmrv is not a passenger how long do you think it will take before treatment becomes available?

Why? Beceause I am curious and a firm believer in the wisdom of crowds.

Xoxo
leaves

i think it is a great question, leaves. and i will say that judy m has repeated said they will start treatment trials as soon as the WPI doors actually open (to the physical building), which is due to happen this fall, in sept, i think.

xxoo
rrrr

 

[Rrrr]

Apart from the WPI, does anyone know who else would be interested in carrying out clinical trials into treatments?

GlaxoSmithKline, the major HIV med manufacturer. they are already doing xmrv studies now. remember when dr lapp announced this?

 

[*GG*]

Depends on what you mean by treatment. I think there is already combination of AIDS treatments which they have found will probably "treat" for this virus. But does treatment mean cured from it? nope.. is AIDS (one of the only other two retroviruses in humans) cured? It's been over 10 years now and they still cant cure HIV/AIDS even with all the funding which has gone into that.

We may have a virus which can be treated but not cured. Just think about what this implies esp if it can be transmitted sexually (eg to men giving them instead prostate cancer).

From a Co-cure email:

Not only does XMRV not like to swim, apparently it's a homophobic little bugger as well!

----------------------------------------------

Absence of xenotropic murine leukemia virus-related virus in bloodcells of men at risk for and infected with HIV
Kunstman, Kevin J; Bhattacharya, Tanmoy; Flaherty, John; Phair, JohnP; Wolinsky, Steven M
AIDS: Official Journal of the International AIDS SocietyPOST AUTHOR CORRECTIONS, 20 May 2010
doi: 10.1097/QAD.0b013e32833b76fb

http://journals.lww.com/aidsonline/...ence_of_xenotropic_murine_leukemia.99508.aspx


Abstract
Xenotropic murine leukemia virus-related virus has been detected in blood cells of patients with chronic fatigue syndrome and in 3.7% of healthy controls from the same geographic region. We evaluated 996 men who were participants in the Multicenter AIDS Cohort Study for xenotropic murine leukemia virus-related virus sequences in blood cells by means of a real-time quantitative PCR assay. Xenotropic murine leukemia virus-related virus was detected in none of the men on the basis of the absence of xenotropic murine leukemia virus-related virus DNA, suggesting that infection may be population-specific.

(C) 2010 Lippincott Williams & Wilkins, Inc.