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Post Info TOPIC: Making sense of Viral Load Tests and Results


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RE: Making sense of Viral Load Tests and Results
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Hi David, 

yes upping the riba slowly sounds like a plan and it's true I didn't drink enough water as was diagnosed with ascites right before treatment and was put on a fluid restricted diet.

Have "minimal fluid" in my abdomen now but still scared by it. Let's hope whatever brand of these miracle pills we're popping, that we'll come out SVR.

take care,

Syd

 



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Contracted Hep C 1969. Genome Type 2, treatment naive. Began 12 week RIBA/sof/Dac on 12/11/15. Cirrhosis. VL before treatment 4m. Treatment extended another 12 weeks without Riba. No virus detected at 9 weeks.



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Awesome.....I'm praying for you. Yes results were great. Strange, three weeks on RIBA, some problems.....but not super bad. The Dak is a great drug.

i don't know what it is about the RIBA, but I very happy you were able to have a different route.....If they tell you it will work, then it will work. I think the only thing I may have done different than most is to nearly double reccomended water intake.w......I drink 1 full gallon a day everyday + a green organic smoothie.......it may be helping me. Also p, my Dr brought me up relatively slow on the RIBA......600 for a weeor so, 800 for a week, 1000 for a week, now 1200 started today......He said flat out it will help make sides easier, and so far it's true....SO FAR.

My absolute best to you......I sense you are already well; I feel it it you words



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Hi David,

so happy for you re results on sof/ dac/Riba. Did you get to see your liver function tests - ast, alt, etc? Mine were off the charts bef treatment and it was heartening to see them respond to the same protocol you are on. 

I am doing an extra 12 weeks sof/dak - just didn't tolerate the Ribaviron well enough for an extra course. 

Good luck with it all and even if you have to put your liver function test results up manually, do it as the guys will give you their educated opinion. 

Happy for you, 

Syd



__________________

Contracted Hep C 1969. Genome Type 2, treatment naive. Began 12 week RIBA/sof/Dac on 12/11/15. Cirrhosis. VL before treatment 4m. Treatment extended another 12 weeks without Riba. No virus detected at 9 weeks.



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Not sure about labs.....very strange that dr wrote "let's check in a year and make sure all good. Cuz I have zero plans on waiting that long. Not sure that's what he meant though ....He's a great guy, but tad eccentric 



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Life's circumstances have left me less than computer savvy, but I see the issue. Won't include again.



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 

Tig


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Not a problem at all. Some links and websites affect other systems differently. Mac/Apple is different than these Windows OS's and it could simply be the way some code was written. I have handled these things before, it happens. That's life on the WWW! 

Your labs are very good though. When do you plan to go in for the next set?



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Tig.....I got you .....makes sense, but I'm wondering.......I've known that site to be super secure.........it requires jumping through hoops at times. I'm thinking that you guys are certainly right that it might not be good to go on, but for another possibility.....Possible that when you are going on without being a member that that is recognized ?



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Strange.....and don't get me wrong.....I have all Apple products, but that's not my point. I certainly would never include anything to cause any kind of issue. I only know that the site is a hospital network, and I know dozens of people on it. 

But  don't misunderstand me, virus or not.....if it causes issues.....it's gone.......truth is I didn't notice it included in screen shot. Sorry



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 

Tig


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Yes, the reports are great!! I have removed the name of the website, so no harm done. You should run your antivirus/malware program just in case David. In the future, before you open one of those attachments, run it through your AV first to make sure it's clean. There was no harm to the forum, but anyone that may have gone to that URL could've been affected. Since the file was sent to you, it may not have carried the virus with it, but had you gone to the website and opened the file via their server, you would've gotten more than a report.... These virus writers can be pretty clever sometimes. It can happen one minute and be gone the next. There could be another explanation, but when the lights and sirens start going off, it's best to be cautious. 



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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That is for Android. My system runs pretty tight and the site made an attempt to redirect me and do a shutdown. I have no idea other than that part of your information is not necessary for us to be able to assist. Just like personal information not needed.

No big deal but if someone less protected followed the link it potentially could cause problems.

Best to leave it off.

 

Regards

 

Jimmy

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Tig....That my medical site......all med info on there.....It is auto checked by LOOKOUT SECURITY and shows no potential issue......that strikes me as bizarre and worrisome 



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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But the report itself is great news!  LOL



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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Yes David, seems that there is something affecting that URL and I'm just removing the address from your report. 



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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The site brother. That is extremely hot.

 

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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WHAT....Are you talking about north shore connect?



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Please edit the attachments to remove that web site at the top of the pages. It is an extremely hot virus. Sorry but it is. DO NOT FOLLOW THAT LINK.



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Hemoglobin actually gone up 2pts



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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This work was taken three days ago. I am on day 19 with about nine weeks to go. Will, hopeful



-- Edited by Tig56 on Monday 16th of May 2016 10:09:29 PM

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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 

Tig


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That is your CBC or Complete Blood Count. It looks good and the Hemoglobin is fine. You can expect it and the RBC's to drop lower because of the Ribavirin. That's completely normal to see happen and is expected. It's an indication the the Riba is doing it's job. But with it comes the fatigue and some of the side effects associated with it's use. Ribavirin causes hemolytic anemia and is something every doctor monitors. They can adjust your dose of Ribavirin if things drop too low, but from experience it can go much lower before you have to be concerned with that. If you have the liver function tests, such as the ALT and AST, post them. If not, don't worry about it. These are looking very encouraging!



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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First off, let me know if this is what you guys are referring to. I'm under the impression that hub is hemoglobin, so I assume this is it. 

Secondly, I was wrong about sometching, indeed it makes a difference. This blood draw was at day 19, not 8..... one day after I went from 600 Riba to 800. I do not have new work on the first numbers <12, but I have brand new blood on this stuff here. All main numbers have continued to drop. I'll send those if youd like. 

 



-- Edited by Tig56 on Monday 16th of May 2016 10:08:20 PM

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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 

Tig


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Hi David,

That startled me as well! Knowing you were only 8 days into treatment and reading that comment from the doctor makes me wonder if it isn't a carpet comment that is applied to some of his reports. Let's blame it on the transcriptionist this time.... smile

After only 8 days, that's an incredible response to treatment! <12 detected is as close to undetected as it gets. When that happens, the sensitivity is so high it reads something, but is unable to quantify the viral load. By now you will surely be undetected, my opinion of course, but my magic 8 ball says it's true, so it's true, lol! Did they do any other tests? An ALT, AST and HGB are often done at the same time. Share them when you get them, but this is something you can be very pleased with!

Congratulations!  



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Allrtighty then.

Given that test was run on day 8, it is a FANTASTIC result. Not simply good, FANTASTIC!

How much longer until end of treatment for you?

 

All the best.

 

JimmyK

 



-- Edited by JimmyK on Monday 16th of May 2016 08:54:06 PM

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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Thanks for response Jimmy.......I see and understand the confusion, but even as treatment naive as I am, I know this results wouldn't bode well at the one year mark.

My Dr knows I've had many more questions than answers...... likely , surely he put the note on a year as to give me a reference to show me the meaning of those numbers at my stage now.

The RIBA has muddled my memory a bit, but not that much......I assure you this blood was drawn on day 8 of treatment.....at that point I was on 600 RIBA,+ Sol + Dak daily. I am at 1200 now.



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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Hi David,

The page you scanned appears to state you are one year after EOT so I am confused here.

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Hey Tig, this blood was done I believe like 9 days into treatment while I was still at 600 RIBA. I am at 1200 as of today.....from 6-8-1000-1200......1/3 through 12 week course.. Still obviously on the Dak and Sol......My Hepatoligst really seems to have played this well. Blood stable......As of yesterday all standard blood work Plus .Billirubin, etc,etc is well within the clinical norm, having come down quite a bit from pre treatment start. Also, my side effects, although not fun, are tolerable, and no sign, pray God, of anemic alert. 

Dr says yesterday that he's seen many successes with less favorable 9 day results. 

Your thoughts?



-- Edited by Tig56 on Monday 16th of May 2016 10:04:21 PM

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David Winfrey

C, genome 3/ comp cirrhosis...treatment naive. RIBA-

 1200/Dak- 60mg/Sov-400....AST=49 ALT= 42..Began 24 weeks on 4/19/16..

 

 



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Thank you Groupergetter!



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Tracy Scanlon


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The link below states" FDA-approved naltrexone, in a low dose, can normalize the immune system helping those with HIV/AIDS, cancer, autoimmune diseases, and central nervous system disorders.  Here is one link to info related to this http://www.lowdosenaltrexone.org/ 

I see you are new to the forum and it appears you may have tried to start a separate thread about this.  I've never taken this so I can't speak from experience as to the efficacy,   If you are having problems figuring out how to post and navigate the forum, pm one of the moderators, they'll be glad to help. We should try to keep this thread on track  "making sense of viral load tests and results".  Take care.



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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biggrin Hi and thanks, Groupergetter! never heard of it before, what does it do?blankstare



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Tracy Scanlon


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It stands for low dose naltrexone, however this thread is about understanding and interpreting viral load tests and results.   Hope you're having a great day.  Hot here in Florida, with the usual afternoon showers.  Take care.



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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biggrin Hi guys, Luckydog what does LDN stand for?blankstare



-- Edited by nolacs22 on Sunday 26th of July 2015 06:07:25 PM

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Tracy Scanlon
Ray


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Congrats biggrin



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Ray

G-1a, Long Term HCV (1969), Bridging Fibrosis, Started Merck C-Edge 12 Week Trial 07/14 finished 10/6/14, Beginning VL 4.2 Mil, as of Jan 09 still undetected.  Blood test every 4 weeks



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Matt had referenced this link re viral load tests and their meaning in Harvoni train thread.  Here is some additional info from Quest regarding the HCV RNA quantitative test:  http://education.questdiagnostics.com/faq/FAQ22v1



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.

Tig


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Rubye,

I just saw this after writing a post on another thread. I've never seen the weak positive reference. It seems from this description that the new assay (test) sensitivity was just that, unable to provide a quantitative viral count but still able to sense a weak viral presence <15 copies/ml. The 8 week VL is definitely undetected across the board. Since they have no test that guarantees an absolute zero viral count, they are simply adding the word "suggestive" to cover their inability to say zero. All of the tests I've seen that claim an undetected result followed the same or nearly the same sensitivity as yours. Yet yours is the first I've ever seen that listed it that way. IMO you should be comfortable believing the 8 week result is indeed undetected.

Tig



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Viral load during tx is so confusing to me.
At my 4 week test, the report read --

Component Standard Range Your Value
HEP C PCR, QUANT Undetected, Undetected - See Below IU/mL Weak Positive

"The HCV specific signal was above background, but below the linear quantification range of 12 IU/mL. This result is likely due to a very low-level HCV viremia below 12 IU/mL.

A new HCV viral load assay (Abbott RealTime HCV) will be utilized at OHSU effective July 14, 2014. This new assay has a slightly more sensitive reportable range of 12 - 100,000,000 IU/mL. In comparison, the lab's prior HCV viral load method had a reportable range of 43 - 69,000,000 IU/mL. Internal OHSU validation studies have shown that the new Abbott HCV assay yields, on average, a slightly lower quantitative viral load value as compared to the old Roche method (by .27 logs or 1.8-fold), consistent with published assay comparison reports."

Week 8 --

Component Standard Range Your Value
HEP C PCR, QUANT Undetected, Undetected - See Below IU/mL Undetected

"These results are most likely suggestive of either the absence of HCV viremia or the presence of low-level HCV viremia at or below the assays lower sensitivity limit of 12 IU/mL."

With the same paragraph above about Abbott.

My best guess is at week 4 it looked like there was "maybe" a few left but at week 8 they could see none.

Does that sound right? What confuses me is the "most likely suggestive". If there is some virus still, why do they say "undetected" on each lab?

I started out at 2.5 mil.


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UNDETECTED 5/4/15 - 16 weeks after EOT, 1st treatment - Sovaldi and Olysio, Geno 1a, 67 year old with compensated cirrhosis, over 40 years with HCV.



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Guys,

This is a 'Sticky' on VL testing, and is not the thread to start rambling about alternative medicine. If you must talk about LDN and Schizandra, start a new thread in the appropriate sectiom. THANKS!

 



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Mike:   I'm sure we have missed many opportunities in treatment innovation. The bizarre thing is that the FDA's relationship to pharma is so openly corrupt. It is out in the open for all to see yet we accept it.  A shame we are at their mercy.  We can only hope the new hepc tx drugs actually are safe and effective because the gatekeepers have clearly dropped the ball. 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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I looked at the link and I think it is kind of what the Chinese have been doing lately - taking traditional chinese herbs and studying the mechanisms of action in the human system against human viruses.

However, the new modern technique is to isolate the "active" ingredient, purify, standardize and you have a new drug. That is the basic model for future drug development.

What some scientists do, and this is a much better approach, is that they embrace complexity and synergy - in other words they go the other way. Biochemical isolation and purification may lead to a patentable drug, but the things you eliminate often make the formulas much safer. The other factor is that most medicinal compounds are polyphenols and that means they work with synergy. In other words, the total amount of effect is much greater than the sum of the parts. Many polyphenols have little to no effect by themselves, but activity jumps off the chart when you find the right combination of herbs.

I know some scientists that are doing it the right way. They test a botanical for activity - human viruses against human cells with and without botanicals. When they find a botanical with high antiviral activity, they study the effects. Say this one turn on the P53 gene, or apoptosis (programmed cell death). Say this other botanical prevents cell entry, this one prevents viral replication, etc. What you then have if you combine them and test for synergy is a multi-prong attack. This is necessary because these scientist have seen viruses mutate around single botanicals. That is why every herbalist in the history of the world did multi ingredient formulas.

But money drives science these days, and if there is no drug development it is difficult to get clinical trials done. The other thing is that as much as the FDA publicly demands clinical trials for natural formulas they are quietly shutting them down if they determine that, "the study is intended to establish a therapeutic effect on a disease state". Which is why anyone would do a clinical trial, of course. But the FDA is owned by big pharma and they will do their bidding, I'm afraid.



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/Michael Hudnall/


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Hi Mike:

What are your thoughts on SBEL1?  I have often wondered why this is not more frequently considered, perhaps not for eradicating the hepc virus, but for controlling it pending tx.  Possibly even using it with other compounds to eradicate the virus?  It seems fairly safe.     

http://virtualpressoffice.easl.eu/new-chinese-herbal-medicine-has-significant-potential-in-treating-hepatitis-c/



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Also, the fact is that HCV is a mitochondrial disease and studies have shown that HCV patients run chronically short of mitochondrial nutrients - alpha lipoid acid, glutathione, all B vitamins, CoQ10, betaine, Folic acid, etc. The mitochondrial membrane and cell membrane is physically degraded and cell phospholipids have shown great promise as HCV supplements because they repair our cell and cell organelle membranes. Phosphatidylcholine plus betaine actually have been shown to increase treatment response to the old INF/riba drugs.

I guess my point is that when you are under treatment, that is one thing, that is an artificial metabolic situation. But if you are not treating and not taking the right supplements then you are running nutritionally deficient of metabolites that you need for your health and protection. That is the nature of the changes that HCV wreaks on the human system and we know pretty much all we need to know about that to come to the correct conclusions.

If HCV causes nutritional depletion of key metabolites, as we know it does, then I would like to hear the reason for not addressing those deficiencies through dietary supplementation.

 



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/Michael Hudnall/


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Absolutely correct, viral load does not correlate with fibrosis levels or liver enzymes and liver enzyme tests correlate with neither as well. 

In my opinion, VL is a measure of the strength of your immune system rather than a measure of the degree of severity of the disease.

That is why LDN works so well - it is the best immune-modulator ever discovered.

And correct also, no dietary supplements or antioxidants should be given while a patient is on treatment.

For one thing, the Glutathione will bind and transport the drugs out of the cells, just as it does with chemotherapeutic agents.

However, there is correlation with VL as one of the factors involved in predictors of relapse, and it makes sense to get the VL as low as possible before starting treatment.

Schizandra has a noticeable effect on normalizing liver enzymes, however, the presence of circulating transaminases in the extracellular space is hardly the textbook definition of inflammation, and it is questionable whether anything under 2x high normal is really inflammation at all.

The other factor is that oxidative stress, which is the trigger for fibrogenesis is a completely different process than cellular inflammation. 

Oxidative stress may be managed with metabolic antioxidants and botanical polyphenols and the studies that show the mechanisms of the metabolic changes that HCV induces make the argument for more supplements rather than none.

Oxidative stress is a native homeostatic system in our body: many compounds are reversibly oxidized and they are actually involved in cell signaling. Extreme oxidative stress is only good during treatment, it wreaks havoc in a healthy system and it makes perfect scientific sense to fortify our native metabolic pathways against viral intrusions.

And that's the science speaking.



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/Michael Hudnall/
Tig


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Hi Mike and Lee,

An article from Hep Central i like, states   "There appears to be no significant correlation between HCV RNA levels and ALT values or histological activity in patients untreated by anti-viral therapies (Interferon). Viral load varies between infected individuals but is not a useful prognostic indicator nor does it measure the severity of virus-induced liver disease."

Since the virus has the capability of replicating in the billions of copies daily,  a viral load in the millions isn't an indication of a runaway HCV infection. The actual viral load can vary in quantity greatly and isn't an accurate predictor of disease or chance of Tx success rates. However I think the consensus favors a lower VL when starting any protocol. So whether LDN pre treatment will increase your odds of SVR probably remains questionable. The other thing about Schizandra brings up the question of benefit as well. The same course of action is seen with a number of other supplements, like Milk Thistle. The jury remains out on whether these supplements actually help in the long run. Some swear by them, others feel they're a waste of money. But one thing is worth mentioning again, they should not be used during any treatment protocol because they absolutely alter the liver enzymes. In many cases they reduce elevated LFT's to a normal range. That might sound good but the truth is, they do reduce the actual numbers, but does it actually reduce those enzymes or do they simply alter the readings? That's why it's absolutely forbidden to consume these supplements when being treated for the disease. So be cautious placing too much faith in herbal therapy.

Your comments on bowel resection for Chrons disease reminded me of a patient I cared for while nursing back in the 70's. The treatment was often repeated bowel resections. My patient had been resected so many times, he was as you mentioned, a straight line from mouth to colostomy. You could monitor his digestion speed, quite alarming for some of the new nurses! I'm glad to see the advances in digestive medicine of late.

Tig

 



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Tig

62 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Malcolm,

   Why don't you talk to the distribution of the numbers from separate tests - My Dr. said the number could move millions and not be an indication of treatment working or not.....comments?  My number has been from 5mil to 7 mil.

cheers lee



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62 Yrs Old, CHC Geno 3, Cirrhosis, Kidney Transplant (13 yrs), On Sovaldi/Riba Treatment (24 week) since Feb 01,2014

Viral Load 7M on 1/8/2014,  UND at EOT 7/18/2014



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Back in 2008 I had a doctor that put me on Low Dose Naltrexone for my HCV viral load. When I started the drug I had a viral load of 1.6 million. Three months later it was 58,000.

Ever since then I have been cycling on and off LDN for six months on and six months off, but even after six months off LDN my VL is still around 50,000. No side effects! At one point it was 7 million and rising!

When I do take LDN I always take it with schizandra because that herb normalizes your liver enzymes.

LDN has been an FDA approved pharmaceutical drug for over 25 years. It was only in the ten years or so that the low dose form (3mg-4.5mg) was studied (the high dose form is 5,000mg) for its immune-modulating activities.

The way it works is that naltrexone is an endorphin antagonist and so it has been traditionally used for morphine addiction. But then studies began to illustrate the role that endorphin plays in directing the immune system.The surface of all of our white blood cells are packed with endorphin receptors. However, with old age our production of endorphin decreases. Studies show that all people with autoimmune diseases suffer from chronically low endorphin levels. LDN has been shown to boost endorphin levels, making it the most effective immune-modulating drug ever invented.

Go to pubmed and look at the the FDA-approved phase 1 and 2 clinical trial studies for LDN and Crohn's disease (between 25-67% total remission with no side effects), as well as for Multiple sclerosis, fibromyalgia, etc. LDN helps all autoimmune diseases, as well as a lot of cancers.

You might wonder why, with this FDA-approved drug on the market and these FDA-approved clinical trials published in peer-reviewed journals, that this would be the obvious first choice option of the doctors for treating Crohn's and other autoimmune diseases.

Sadly, gastros around the country and the world have not heard of this drug, and therefore they still treat Crohn's with bowl resection and steroids. The drug is now in the public domain because the patent expired and no drug company owns it, so the drug companies have no desire to tell the doctors, and so the doctors remain ignorant of one of the best tools at their disposal.

I know a fellow that has fifteen separate bowl resection operations for Crohn's. His GI tract must now be a straight line from his mouth to his anus.

I do know that if I were going into treatment, I would do LDN first and get my VL down to baseline before starting.

Mike

Best regards,

Mike

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RE: Definitions: HCV Viral Load Assessment and Interpretation of Virological Response to Therapy
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Hi Matt,

Both Roche and Abbott are constantly streamlining their tests. The aim is to have the same LLOQ and LLOD.  I noticed on my last VL report that the LLOQ was the same as the LLOD at 15 i.u./ml. Previous reports said     LLOQ 43, and LLOD 15.

Some patients use the TMA (Transcripted Mediated Amplification) tests in addition to the normal PCR. These are reportedly more sensitive. The Quest Heptimax test has a LLOQ and LLOD of 5 i.u./ml. The Labcorp Quantisure claims a LLOQ and LLOD of 2 i.u./ml. The TMA tests are expensive and are available in the USA. We have one Quest collection centre in Australia.

There are much older PCR tests in parts of Europe and some Canadian Labs. Often the results are given in Scientific Notation which makes life difficult. It is important to read the whole of the VL Report to understand the test being used and the LLOQ and LLOD.

 

 

 

 

 

 

 

 

 

 

 



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Making sense of Viral Load Tests and Results
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Checkout these charts to help understand Viral load Assessment and Response also the principal  HCV PCR Assays

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi all,

Just a final chapter in this 'never-ending story'. I have avoided mentioning the LLOQ (Lower Limit of Quantification) for the sake of simplicity. In the newer tests, the LLOQ and the LLOD are the same. Unfortunately, the older tests gave both figures and the LLOD was much lower. A typical example is the Vers-1 Roche PCR assay- it gives a LLOQ of 25 i.u./ml but a LLOD of 10 i.u./ml. This causes confusion, and is why many Labs, including my own, have deleted both values from the report. So you may not see a LLOD or LLOQ on the report. As the LLOD is an estimate (as it cannot be quantified), it should not be used as a VL number.

Finally, many PCR test descriptions will include the letters RT. This means reverse transcription. The PCR test can only measure the amount of DNA. As the HCV is a single strand RNA virus, it needs to be converted to DNA using an enzyme called reverse transcriptase.

Enough! I have grossly simplified some aspects of the HCV VL tests in an effort to make it more readable. Thanks.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Just some extra information on the VL test. My Lab. takes 2-3 hours to prepare for a HCV VL run. This requires 2 Lab Techs and there are strict quality controls and calibrations that need to be done. The Lab has a store of blood samples with known VL's, and these are assayed to ensure the 'Target' material and dilutions are spot on. A lot of this is automated in the newer test versions. Older test versions were subject to error.

Only when satisfied the settings are correct does the 'run' commence. My Lab takes about 3 hours to process 70 specimens. The number of 'runs' per week depends on the volume of requests. My Lab does a 'run' on Tuesdays and Thursdays, with an extra 'run' on Fridays if required. I can time my blood collection to get a same day result if required. This is a 'moderate' work load.

In provincial centres or in some smaller countries, the volume of requests may be small. These Labs are more likely to have an older VL assay kit. These are much harder to set up, there is little or no automation, and the chances of error are increased. The LLOQ may be 50 at best, and reports are often given in older units such as Scientific Notation or Log. units. It's all about money. If a Lab is only doing 6 HCV VL tests/week, it is unlikely to spend significant money in upgrading to the newer versions of the VL tests. Such Labs may generate an old-fashioned automated report, which can cause confusion for doctors and patients



-- Edited by mallani on Wednesday 13th of March 2013 02:14:50 AM

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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Malcolm

There is no mention of Roche or LLOD.

The VL is wrote without the # I added that.

The line verbatim reads    HCV RNA 163       HCV RNA IU/ml

the line below reads                                    No Ref Rng

Again thanks for this in depth information.

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Matt,

Your report sounds like a Roche assay- it should say 'Roche'. It is a Version 2 assay and should mention the LLOD. You do not appear to have a VL result.  The (#183) is not a result- it's a Lab Reference number, either for the patient or run number or batch. I'm not sure about your Trial, but most Trials do not disclose the VL to the patient or doctor, until the end of the Trial.

The TMA tests are not done routinely. They have to be requested seperately and be done by a Quest or Labcorp Laboratory. Most Hepatologists are satisfied with a LLOD of 25 (15 is better). Older tests with LLOD of 50 or more are less reliable, and are only done in Labs who haven't bothered upgrading since about 2003.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Hey thanks Malcolm for that heady info.

So when my report says  HCV. RNA. PCR. TAQMAN 2.0  then follows with HCV RNA (#183)

So that tells us the test type (TAQMAN) and version (2)  the last number is our VL

So you also are saying when it's gets real low they may incorporate a different test with better resolution?  Will that be identifed as such?

Again thanks for this in depth information.

Matt



-- Edited by Matt Chris on Thursday 7th of March 2013 05:29:22 PM

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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 

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