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Learning CFS: the Lerner Antiviral Treatment Trial Succeeds

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Here's what I got about that Group B; they started off sicker and they actually improved quite substantially (which is why they couldn't be differentiated from Group A significantly) but they still had CFS by Dr. Lerner's definition - which is why he called their progress 'bleak'. But I didn't think their progress was bleak at all - I thought it was pretty good. I'm not sure how he treated them differently after he got this data but apparently he did start treating them differently and he said their numbers were better than the report indicated.
Hi @cort,
As a patient that falls into Group B, here's my understanding... I have been aware of his research results for about the past year. Once I was diagnosed with Lyme this February, Dr. Lerner made it a point to reassure me it wasn't a death sentance. I'd still get better. The big learning with this research was through the data diving. It was through that practice of data analysis that he even realized what was going on with CFS + Lyme patients. You're right, they still improved but started at a lower EIPS. He has been having more and more success though with patients being treated with long term antibiotics for lyme. I just started abx about 2.5 months ago and within the past 2 weeks I've seen a jump of 0.5-1 EIPS. And that's been a BIG deal for me. Oh, and to clarify again, EIPS is a peer reviewed and published measurement. It's not a pie in the sky benchmark.
 
thanks Anncavan! for the dosage info.

In nearly 4 years I've only stopped for several days one time - and im taking acyclovir instead (and although it generally takes 2-3 weeks before feeling the full effects of "stopping")...i began to feel the effects big time in just those few day! (i had to stop for some testing procedures - not voluntary! THAT I would NEVER do)

I have heard of some folks taking a "drug holiday" for periods of time...to judge efficacy etc, but my instincts tell me (that in my case) that would NOT be a good idea! (especially since i have shingles all the time (in different stages)...wouldnt like to see what might happen if i stopped "cold turkey"!)

I'll be content if i can titrate down to maybe 800 mg per day at some point in the future. Interesting about your liver function problems...mine went all over the place in about the 1.5 years mark (fortunately i keep good records and can track these for myself)...but have evened out and are now perfect...knock on wood!)

One more thing, if you dont mind (dont need to post the actual "numbers" if uncomfortable with that, of course)...but are you aware of the tcell counts of patients over the course of the study? for example did most have theirs checked at the start (or were they "assumed" to be low as so many with me/cfs are?)...or were they rechecked as time went on or based on any symptoms reported...if so, at regular intervals

I know there is some controversy with constantly checking and re-checking these "markers" - the "futility" of this or calling it an "unecessary" test).....did YOU have them checked or do you know if yours are in a normal or LOW range? or if there has been a marked change during your treatment? a spike at some point perhaps? (this is of interest to me regardless of the controversy.)

thanks again for all the info and your willingness to share with us!

(oh, and do you know of dr. lerners opinions on adding any "immune modulators" of any kind to the "mix" of AV's? any interferons for example?)

jackie
 
From what I understand you stay on these doses until you reach at least an EIPS of 7, and then it's up to you and Dr. Lerner to determine if you'd like to ease off them. But NEVER go off either cold turkey. It throws your immune system into panic causing anything from sinusitis, bronchitis, swollen glands, thyroiditis...
Hi Ann,

That's really helpful. I've been on Valcyte for about 8 months (450mg/twice a day) and Famvir for 10 months (500 mg/twice a day). It has helped with cognitive functioning and mold reactivity. My score on Lerner's EIPS is 10. (It would be lower if I weren't practicing any mold avoidance, I'm sure.)

Dr. Guyer is pretty good with the antivirals, but knowing Dr. Lerner's strategy is really helpful.

I really am worried about resistance occurring. It feels like "Flowers for Algernon" to me: just because I've gotten my brain functioning and other functioning back doesn't mean it's going to last.

Does Dr. Lerner talk about this with you? What does he say?

Thanks much for your help!

Best, Lisa
 
wanted to chime in Lisa...with my own experience.

My most noticeable improvements are in the area of cognitive/memory etc., and yet i still experience PEM (and depending on the triggers...very SEVERE pem!)

BUT...it lasts for a MUCH shorter period of time, and is MUCH less severe.

During a pem/crash it seems that nearly all the improvements are gone...so much so that each time it happens i momentarily panic!

But once the pem subsides...im back to where in was at the START of the episode - NOT where i was when i started to notice improvements, and NOT having LOST the vital improvements (even if they are measured in "inches"!)

It took me a long time before i fully wrapped my head around this...and now i dont think i WILL lose what i've gained (of course, anything can happen...but since i was cautiously optimistic for so long about this - (maybe a year or more before i considered this possibility of permanence).....it doesnt seem to be coincidental or temporary! Hope this helps!

To be on the safe side...i do monitor myself...and obviously try to avoid that dreaded big crash, when i can.

But although i am housebound, and so rarely go anywhere to overextend myself physically...i have MORE than my share of emotional stressors (i have an elderly mother that "depends" on me and I'm watching the inevitable decline, for example...and my husbands health has been less than perfect for the past year) AND i have those pesky shingles that plague me day in and day out...so i cant say my life is the easiest.

I know that if I lived in a less stressful environment...I would be considerably MORE improved.

And yet..i AM moving forward - NOT back!

BTW... i have cardiac issues (i take atenolol for OI and tachycardia) and my doc warned me (sternly!) NOT to aggravate that area...as damage can happen via the viruses, that CANT be undone, if not careful. So, i take this to heart and i dont EVER push it!

take care, jackie
 
Hi Gerwyn

This is a follow-up to your report that the Lerner paper didn't show any patients recovering beyong seven, as I promised. You are correct. The highest average recovery point I could find was 6.88.

However the interview with, I think, Cort, indicated that some patients recover to a 10. We also know from this thread that some patients reading this have made such a recovery.

Which brings me back to my original statement. The cut-off for treatment was 7, and the implication, without being explicitly stated, was that many improve beyond that. The paper was probably remiss in not explicitly stating that.

I am concerned that, from a reading of the interview it is clear that full recovery of heart damage does not always occur. This was what I was worried about with respect to vascular modelling.

I suspect that many of the recovered patients will always have a weakness for aneurisms and strokes, and their medical team needs to be made aware of the possibility so that it can be managed. This probably wont be an issue while their blood pressure remains low, but for any former patient who subsequently develops high blood pressure this could occur at increased risk.

Bye
Alex
 
Improving to a 10

However the interview with, I think, Cort, indicated that some patients recover to a 10. We also know from this thread that some patients reading this have made such a recovery.
I honestly don't want to co-opt this thread, but I need to make a clarification.

Yes, I improved from a 3 ("sitting, standing, walking 2-4 hours a day") to a 10 ("normal") on this scale. But I'm pretty sure I'd never have done it if all I'd done is go to see Dr. Lerner and follow his protocol.

Before mold avoidance, I couldn't even take 250 mg of Famvir without getting (truly!) deathly sick. God knows what would have happened to me if I'd taken Valcyte.

So I'm pretty sure I'd have been in the group of non-responders. And though I never had an IgeneX test, my even more scary die-off to 15 mg of doxy makes me think that, yes, I did have Lyme and likely other co-infections as well.

Since taking those drugs, I've been able to substantially reduce the extent to which I've had to be careful about my exposure to mold without having negative effects. Perhaps eventually, I will be able to do so even further.

I'm not faulting this particular study for not including mold as a variable. Not every study should include every possible treatment, I agree.

But I still think that if there's a possibility that patients meeting Dr. Lerner's study criteria can benefit from his treatment and get to a 10 (rather than a 7 as the highest one in his study did), he might want to consider why that particular improvement occurred.

Perhaps then he would be able to figure out how to also get other patients to a level of improvement above a 7 and thus have more convincing study results.

Best, Lisa
 
"Naps"

On a different note, one thing that's always perplexed me about Dr. Lerner's Energy Index scale is the mention of "naps."

When I had "active CFS," I didn't take what I would characterize as naps.

Some of the time when I was in bed, I was "awake" (sort of). Sometimes I was aimlessly playing with the computer or attempting to read, others staring at the ceiling for hours at a time.

Other times, I was lying with my eyes closed in a (poisoned) stupor. I don't think that counts as a nap though.

On the other hand, I know a few really healthy people with high-powered jobs and regular strenuous exercise routines who frequently take time for naps. They get what could clearly be called "sleep" during these naps, and awake refreshed.

This is in violation of Dr. Lerner's criteria of "no naps," but I think they'd be categorized as a 10 (normal) in terms of energy by anybody's definition.

I've talked to a number of Dr. Lerner's patients over the years on various boards, so I do believe that he knows the definition of CFS.

His mention of "naps" still seems really peculiar to me though.

Best, Lisa
 
I have been on av's for over 18months and have improved from a 6 to a 9 out of 10, still have up and down days and still have sleep problems, but av's have definately helped. I have had a few breaks from av's mainly to validate to myself that its working. Within a week i start to feel crappy again, after reading lerners study i think i will just stay on them permanently for a couple more years as he seems to think that the av's stop ebv infecting other cells and taking them long term gives the virus time to die out naturally.

Im only taking 500mg twice a day, have used higher doses but for only a couple of weeks, cost holds me back. Does anyone know if higher doses that lerner recommends would possibly kill the virus directly rather then just stopping infecting other cells. Im also going to look into immunoglobulin injections and interferon tablets http://www.pharmacy1010.com/category_list.asp?id=16 , will talk to my cfs doc about these and maybe add this to my antiviral treatments. If av's at higher doses have a direct affect on killing ebv, i might just budget for that.
 
This thread is too long for me to skim through, so my apologies if this has already been asked. Does anyone know what dosage of av's was used in the study? I've been taking valtrex for years (500mg 2x daily) with no benefit, but I am one of the more severely afflicted. I would love to increase my dose to whatever dosage Dr. Lerner used in his study.
 
i have read he prescribes 1000mg 4 times a day
 
This thread is too long for me to skim through, so my apologies if this has already been asked. Does anyone know what dosage of av's was used in the study? I've been taking valtrex for years (500mg 2x daily) with no benefit, but I am one of the more severely afflicted. I would love to increase my dose to whatever dosage Dr. Lerner used in his study.
i have read he prescribes 1000mg 4 times a day
That's correct. Valtrex 1g four times a day (1g every six hours). And he tells his patients to drink a lot of water to prevent kidney stones.
 
Do you know which herpesvirus infection you have?
I've tested positive at various times for EBV, CMV, HHV6, Lyme and XMRV. So, I have the whole loot. :) I was on Valcyte for 6 months with no improvements and my doctor felt uncomfortable continuing me on it, so we switched to Valtrex. I will slowly increase my dose and see what happens. I've also tried antibiotics for the Lyme to no avail. Thanks for the info!
 
You keep repeating this yet you've been shown several times that the Fukuda definition does not exclude CFS patients who have an EBV infection. Could you respond to the posts indicating that Fukuda does not exclude EBV positive patients from having CFS?

It seems to me that you're implying that the results don't apply here because they had an active infection and therefore can't be defined as having CFS. That's an amazing statement - given all the people on this Forum and elsewhere have active infections.

The critical critical question for me would be if they're results apply to me? I would guess that they very well might; that the people seeing Dr. Lerner had a mysterious fatiguing problem, had difficulties standing and exercising, etc. they had seen scads of doctors, and they finally got to Dr. Lerner.

You can parse the definition question all you want but my assumption is that people who make their way to Dr. Lerner, or Cheney or Bateman or Lapp, etc - have what I have which makes me interested in which treatments work for them.
Well said, Cort. I think the finding is relevant to at least some readers of PR. I'm not convinced the Fukuda definition does exclude such patients and am certainly not convinced it should.
 
Little to no holter monitor data at the end

Firstly, let me say I found this study interesting.
And it's useful to have something in print. [Aside: It is frustrating that doctors such as Paul Cheney have published so little - unfortunately, that can mean other doctors are slow to take ideas on board].

I am frustrated with the lack of the data from the Holter Monitors at the end.

In the methods we get all this information about how it was scored:
Qualitative Holter monitor assessments

Twenty-four hour HM recordings were evaluated
qualitatively
for simple counts of abnormalities and severity, (mild, 1 point;
medium, 2 points; or severe, 3 points). Tachycardia
at rest (.100
per minute) was assessed as mild ,6 hours/24 hours;medium
.6 and 10 hours/24 hours; or severe .10 hours/24
hours). Oscillating abnormal T-wave flattenings and T-wave
inversions were evaluated as mild (occasional), medium
(intermittent), or severe (frequent) and given severity point
scores of 1, 2, or 3, respectively. Deep inverted T-waves,
multiple and multifocal ventricular premature contractions,
and bigeminal rhythms were evaluated by count and severity.
Thus, HM recordings had two numeric evaluations, ie, a
simple numeric count of types of abnormality and a severity
score. For example, a patient with an HM showing T-wave
flattening (severity score 1), mild supraventricular tachycardia
(severity score 1), but with no inverted T-waves would
equate to a severity score of 2 with an abnormality count of
2. Another patient with an HM and moderate supraventricular
tachycardia (severity score 2) “abnormal count 1”, and both
moderate numbers of oscillating T-wave flattenings (severity
score 2) “abnormal count 1”, multifocal ventricular premature
contractions (severity score 2) “abnormal count 1”, and
a bigeminal rhythm (severity
score 3) “abnormal count 1.”
The latter HM would have a total severity score of 9 and an
abnormal simple occurrence count of 4.
It is even mentioned in the abstract:
Baseline and follow-up serum antibody titers to EBV, HCMV, and HHV6,
as well as coinfections with Borrelia burgdorferi, Anaplasma phagocytophila, Babesia microti,
and antistreptolysin O, 24-hour ECG Holter monitors, 2D echocardiograms, cardiac dynamic
studies, symptoms, and toxicity were captured and monitored.
But unless I missed something, we are given virtually no info on how the patients were at the end (and indeed aren't even given the data on the initial "total severity scores")

ECG Holter monitor recordings

Of 104 Group A CFS patients with baseline HMs and
follow-up HMs  six months later, 92 (88.5%) had abnormal
baseline HM recordings.12,15 There were 77 (74%) with
abnormal oscillating T-wave flattening, 46 (44.2%) with
abnormal oscillating T-wave inversions, and 47 (44.5%) with
resting tachycardia. These abnormal HM findings in CFS
patients with no coronary artery disease, hypertension, or
abnormal electrolyte abnormalities are a biomarker of CFS
cardiomyopathy.12,15,16 Severity scores and abnormal data
counts improved with valacyclovir/valganciclovir, but did
not return to normal.

There were 25 Group B CFS patients with baseline
and repeat HMs after six months of treatment. All of these
patients had baseline abnormal HMs. Of Group B CFS
patients, 22 (88%) had abnormal oscillating T-wave flattening
and 12 patients each (48%) had abnormal oscillating
T-wave inversions and resting tachycardia.
From the discussion:
Cardiac muscle disease, syncope, chest pain, positive tilt
table tests, tachycardias at rest, decreased left ventricular
ejection fraction, and left ventricular dilatation improved and/
or disappeared with antiviral treatment. The abnormal HM
is a reliable biomarker of CFS cardiac disease. The EIPS is
integral to follow severity and reversal of CFS illness.
From the introduction:
Secondary endpoints of cardiac, immunologic,
and neurocognitive abnormalities improved or disappeared.
 
According to Jasons studies the majority of patients diagnosed according to the Fukuda dont have the illness which has PEM as mandatory
Which studies?
 
Improvements in level of energy are not the same as getting back to a normal life.

I personally got to a "10" on Dr. Lerner's Energy Index quite a long time ago. But I wouldn't have suggested to anyone that I was really well until I got the cognitive component back too.

Dr. Lerner may consider improvements on the Energy Index to be a "normal life" even if patients still have other symptoms and if they still have substantial energy limitations.

I think improvements are great, but they aren't the same thing as the resolution of the illness.

Maybe I'm being too demanding, but I think the whole concept of a "functional cure" is setting our sights too low.

If people can drag themselves to some job that's a lot less challenging in every respect than the one that they could have done before they got sick, and then spend the rest of their time recovering from working, I don't think that's any sort of "cure." That's an improvement.

I bring this up because consistently, doctors/researchers use the concept of sometimes being able to effect a "functional cure" as a way to avoid looking at any factors other than the ones that they themselves already have deemed to be worthwhile.

It's not just Dr. Lerner who does this. It's the other CFS doctors too.

I'm truly happy that these doctors are finding ways to give people improvements. But until they can get people not just "Functionally Cured" but actually "Truly Well," they should keep looking for additional ways in which patients can be helped further.

It's selling us short to do otherwise.

Best, Lisa
Useful observations.

Although to me, this doesn't sound like a 10 "normal" on the http://www.treatmentcenterforcfs.com/energy_index_score/index.html
- if somebody doesn't feel "normal", I think one can just say one is a 9 (say) or less esp. if after work, one "then spend(s) the rest of their time recovering from working".

I think the talk of being able to do a 40 hour sedentary job, social activities, etc. suggests that cognitive stamina/mental fatigue is also being measured.

Maybe it can be improved but I think it's a lot better than a lot of scales used in the field - it is more encompassing. Also the definitions of recovery in other studies are often/nearly always worse, IMO, from what I can recall.