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Update/Alinia
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Update/Alinia

Just got a message from my NP.  The insurance company has approved the peg/riba. The doc wants me to predose the Alinia for 30 days.  It makes little sense to me, so if anyone has a clue as to why, I am all ears.  4 weeks to
D- Day.
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Avatar_m_tn
My guess is the PreDose of Alinia for 4 weeks is because thats what the study is doing.
Whether its the right way to do it is another thing.

I am going to follow your Tx with a deal of interest.

Hope it works for you.
CS

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Avatar_f_tn
Yes, that's what the study is doing, although they don't seem to have told anybody the rational for it.  

I think the best I can say is that HR did not think there was a big issue with Alinia and resistance.  I think he explained it something like Alinia just makes your bodily environment less friendly to the virus.  It's action is very indirect.  So there does not seem to be anything to lose by predosing.

I'm very interested in how you get on too.  Wishing you all the best,
dointime  
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233616_tn?1312790796
predosing is where all the research is at, so you will be adding to the statistical research stateside to see if rates of SVR are higher in genotypes here as in egypt.

As far as I can tell, adding it early makes more sense when VL is high and getting it down quick, before resistance can form is the goal...so Alinia, then INF?RIBA is like a one-two punch.

I'm just statrting to take it...at 6 months in tx....so my stats will never be proveable as your will.
However I'm opting to try it, because even if it corkscrews the last Mohican what do I care....it could still catch a few hangers on with something different.....those few resistant virions is all it takes to relaspe.

However, even if you are not in a "clinical study" I think your stats can be important info for the next 2 years of Alinia trials here.
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Avatar_m_tn
ALLRIGHTY THEN!! I'm right behind you, as is 4c. Kittyface is just ahead, St. George too! Anyone else gettin' on this carpet ride soon? The Alina bus is pullin' outa the station, whoo, whoo!  jerry
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Avatar_f_tn
My husband is getting ready to start within the next month.  We are moving an hour away and trying to get the hard work done first before he starts.
Joe has tried Peg-intron in the Ideal trial and didn't have a 2 log drop until week 13 which wasn't good enough to stay in the trial.  He tried Infergen and had a viral breakthrough around week 12  which was likely caused by reducing Riba too much .  He was not optimally dosed with riba either.  This time he is predosing with Alinia and using Pegasys with more Ribavirin (1200)
Joe has cirrhosis despite living a reasonably healthy lifestyle for the last 30 years-no drinking, smoking drugs or anything.  He had early cirrhosis by the time we found out he had Hep c.  He'd been a healthy guy until then and seemed to get sick over the course of a year... no previous clues.
I read some of the clinical trials going on ,or ready to start soon ,which are using Sam -E  (also called Adomet) and Betaine(also called TMG or Trimethylglycine) which could possibly help poor responders.  We are using these now in hopes of it helping.
  We were able to get Procrit ahead this time to avoid Riba reductions.
Joe has also been taking Hepatitis Researcher"s (our hero)  list of supplements for some months now and Joe's general health has improved.  Last fall our PA said his labs were not good enough to start TX and probably would get worse so not to have hope in the new drug trials.  His platelets are still too low to be in a trial but his hemoglobin and white cells have improved along with a few other thing.  His skin color looks healthy again.  He had become very pastey and pale.  The PA said go for it and said yes to the Alinia too.
We are trying to get his platelets up with Shark oil and Melatonin but I don't know if that is working or not.  Unfortunately I had read incorrectly on the dosage for raising platelets with Melatonin so wasn't giving him nearly enough.  Cancer patients have taken  between 10 and 20 mg for this purpose but I am afraid to give him that much .  He is now taking 6 mg at bedtime and is fine but a little groggy for a while when he first gets up.  It wears off though.  Would he be like Rip Van Winkle if I gave him 20 mg?  We just read about shark oil raising platelets on the Life extension website  and started taking that a couple of weeks ago without any trouble so far.  We start everything out slow and titer up watching for any liver pain etc.  We'll see if this has helped and report back if it does.  His platelets have never been higher than 80 and as low as 45 for the last several years.  
I like the idea of using Lactoferrin at the end of TX to guard against relapse but I know I'm getting way ahead of the game . I spend a lot of my spare time searching for anything that will inhibit this virus in any way.
We are doing all we can but it's ultimately in God's hands and I'm more at peace with that than I used to be.  
-Ev
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468276_tn?1207111467
I just started the Alinia Phase II study.  The first month is Alinia only and then adding Pegintron/Riba.  It's a blind study and I'm afraid I got the placebo.  I'm glad for this forum and the humor it brings to a tough journey.
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142841_tn?1201978652
The nitazoxanide makes your urine dayglow yellow, within 2 hours of the first dose.
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Avatar_n_tn
Ev - Joe's lucky to have you. Sounds like you're doing as much as can be done, and HRs anti-fibrotic list may be more important than the anti-virals. 20mg of melatonin sounds like a lot however; I take 3mg to get over jet lag and really feel that in the morning.

all: it's a bit strange that alinia/ntz the, newest of the new drugs, is the only one already FDA-approved and also the one with the least-understood mechanism, of action. Here's an excerpt from

http://www.ncbi.nlm.nih.gov/pubmed/17888524

published in Jan of this year.

"Although the mechanism of action of NTZ is not known, the divergence of the intracellular protozoa and viruses inhibited suggests that a cellular, rather than common viral function is being affected. It is conceivable that changes in the intracellular environment induced by NTZ may alter the effect of subsequent treatment with other anti-HCV agents that also act though the induction of cellular pathways, particularly IFNα. As a preliminary investigation into this issue, we evaluated the effect of a regimen consisting of 3 days treatment with NTZ followed by 3 days of a combination of NTZ plus IFNα. Pre-treatment with NTZ monotherapy further improved the potency of combination treatment with NTZ plus IFNα by approximately three-fold (p < 0.02, Table 6). This staggered combination regimen was also modestly synergistic when compared to the simultaneous NTZ plus IFNα treatment combination (Fig. 2, panels E and F)."

Rossignol, one of the authors, is also a principal in Romark. I suspect the dosing in the phase II trial reflects the results above. That is -
- no one really knows how it works yet
- it seems to alter the cellular environment rather that target  the virus as the PIs do
- the ntz-triggered alterations in the cell  *may* make the ifn-related anti-viral activity more powerful

So it seems the 4 weeks of ntz  should lead to a turbo-charged ifn/rbv response downstream.

mypal: love the hair; you're way ahead of the game, mine didn't look like that until the 6 month of tx.
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Good luck, gauf.
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468276_tn?1207111467
Thanks for the tip.  I have dudglo urine after 4 days.  I guess I might spend this trial wasting away in placeboville.  I will be on the Pegintron/Riba for 2 weeks when my viral load needs a 1 log drop to keep me in the trial.  Til then I am sticking to it.

willing: join the Hep C Bad Hair Day club!.  
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Avatar_m_tn
Gauf
The Full study of the link Willing posted from NIH is below. It one hell of a URL but Its free. If you have trouble I'll email it to you.
It seems that PreDosing causes a greater IFN impact.


Nitazoxanide, tizoxanide and other thiazolides are potent inhibitors of hepatitis B virus and hepatitis C virus replication

Journal: Antiviral Research
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T2H-4PK8K5F-2&_user=6351087&_coverDate=01%2F31%2F2008&_rdoc=10&_fmt=full&_orig=browse&_srch=doc-info(%23toc%234919%232008%23999229998%23677826%23FLA%23display%23Volume)&_cdi=4919&_sort=d&_docanchor=&_ct=14&_acct=C000069374&_version=1&_urlVersion=0&_userid=6351087&md5=cc5cddbef63a334fa0e9aff49cfcad22

CS
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142841_tn?1201978652
Placebo-ville...sorry to hear that, mypal.  But it could be worse, the cost for SOC is right, and no haggling with insurance.

One question...I'm in the study, too, and they're giving us Pegasys by Roche (it's a jointly funded study by Roche and Romark), not PegIntron, by Schering.

Is it the same that you're getting?

I am six weeks into the study, and my second day at the hospital for hourly blood draws is next Tuesday.  Kinda like a day at the spa, only suckier...  :)
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144210_tn?1273092382
Interesting article. I wish HR would weigh in on this as he has been absent for some time now and is missed. I just had to give up the melatonin cause it made me too fatigued the next day.  Getting nervous; should I add oxymatrine? Large dosage of vit E or Cq10? Is there anything else I can do I wonder? My liver won't last long if I don't clear this time. EV is doin fantastic by her husband (God bless her!)  Really interested in seeing her mans' blood test results and compare the progression of HRs' liver lover regimen. As well as the shark liver oil effect on platelets. (I have not done that yet).  The supplements ARE keeping fibrosis progression at bay in my case, and hoping to reverse damage after I clear. (positive thoughts only!)  Just love you guys!
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Avatar_f_tn
Your day at the spa gave me a good chuckle. :>)

Gauf, I will try to get those labs posted soon.  We are in the middle of moving as I mentioned and I can't get those now but I'll stick it on the to do list.  Did you read about the shark oil at Life Extension Foundation.  They had plenty about the melatonin too.  Joe has adjusted ok to 6 mg. with coffee in the A.M to get him going.  I've got the time release kind from vita cost.  I wonder if that makes a difference.  I also wonder what would happen if you took it a bit earlier.  I believe I remember it having good antioxidant properties too.
Take care,
Ev
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Avatar_dr_m_tn
One has to understand the meaning of the platelet number. Unless it is really low, like below 40000 - where its function becomes problematic you look at it more as in indicator of liver function in the following way:  , It is influenced by the increased capacity of the enlarged spleen to sequester platelets, thus an indirect indicator of portal hypertension AND the functional capacity of the liver to support the production of a platelet growth factor.  
But platelet production is, like the WBC count, also influenced by the general presence of pro or antireplicative/cell proliferative factors ( like IFN eg). Compounds with anticancer activity, like Resveratrol and even green tea, have a tendency to reduce proliferation and thereby, in the high dosage required to fight fibrosis, you might see a positive rebound of some liver function parameters but platelets do not come up concomitantly, since the overall equation now contains the antiproliferative effect of these compounds. In this case the platelets do not reflect liver fibrosis or function but rather the antiproliferative effect and have to be judged with this effect in mind....

You treat your liver, not your platelets or megakaryozytes.
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Avatar_f_tn
HR,
If your out there tonight,I give you my most sincere thank you.
I'm listening... Focus on treating the liver, not the platelets.  I had hoped if they had gone up , Joe could get in a good trial but it was not to be.  We are happy to be getting the chance to try Pegasys,Riba and Alinia. (+PCP,ALA,TMG,Sam-E,lactulose and probiotic)
His labs have improved since last fall, when they frowned and told us he couldn't treat.  It has got to be your list of supplements that have caused the improvements.  Labs aside, Joe just feels so much better and has much more energy.  He almost seems like his old self and I didn't know if he ever would be again.  We're trying to live and be glad for each day.
In appreciation for all your study and research,
Ev
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217229_tn?1192766004
Gauf - my hugs and love to ya! Let us know ok?
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233616_tn?1312790796
yeah HR is back!!

Gauf...I love my new neon glow...has me humming old Zappa...do not eat the yellow snow!!!!

ALERT TO ALL.....ok I'm confused now..one post above says shark oil.for low platelets..and another says shark LIVER oil.  which is it????????

Correct me if I am wrong, but shark liver oil is extremely high in vitamins A&D and therefore must be used with extreme caution and regular monitoring of D levels...as too much vit D is worse than not enough...it will destroy the liver.
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144210_tn?1273092382
shark liver oil.
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144210_tn?1273092382
Thanks for the clarification on platelet counts. It has eased my concerns on that.
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