Jim or anyone ...low starting viral load

[St. George]

I recieved my starting vrl blood work today and it was a meager 556,000 coppies(heptimax) which is substantially lower than at the commencement of my last treatment where my starting load was a staggering 30,000,000.  Are there any statitistics correlalting low vrl with EVR and SVR?

[orleans]

My understanding is that the 3 main predictors of SVR are low liver damage, low body weight, and low viral count.  The cut off for low viral count used to be 800,000 but has recently been reduced to 400,000.Certianly 556k has to be better than 30 million. If I am not mistaken it is all about your systems abillity to fight off the infection on its' own. jm

[jmjm530]

That's very positive. Yes, at least with treatment navives, a low pre-treatment viral load is associated both with RVR and SVR although given the anti-viral molotov cocktail you're taking, would be hard to match stats, but can't see viewing this as anything but positive.

When was your blood drawn for the test vis a vie the beginning of treatment. What was the date and amount of your previous viral load test? You pre-dosed riba for one week correct? Pre-dosing riba shouldn't have an effect on viral load, but who knows as I have stumbled across some interesting studies on post tx riba monothreapy in certain groups of responders who relapsed.

BTW how is your nausea, etc, and did you decide to alter your plan yet?

A few studies to read over.

http://www.natap.org/2006/DDW/DDW_26.htm
http://www.natap.org/2006/ICAAC/ICAAC_43.htm

[jmjm530]

Did you mean "copies" or "IU/ml"? Heptimax should give you the result in IU/ml if you check the sheet.

[orleans]

I just got my new blood tests back today. They were ordered because I WAS going to start treating this month. My Dr. is not yet aware that I  have once again decided to delay. (appointment on Tues. and he is ganna have a duck!!) It's the migraines that are holding me up. No use starting until they are under control. But I digress. Alt & ast are about the same as in Aug. (83&46) but the viral load is much lower than my original test. 11/05 was 216,000, todays is 53,600. Is this a significant difference or just an expected fluctuation? What ya think? jerry

[jmjm530]

Less than a one-log difference so about the same, i.e no signficant difference. But that's good news because they are both very low. From memory, I think my vl 3-4 months before treatment was 16,000, yet the day before tx it was 1.5 million. You would have thought my NP would have pointed out to me that 16,000 was an ideal vl to start at, but of course she didn't and I didn't have a clue then. That said, don't blame you for trying to get the migraines under control before treating. Anyway, what's so bad about serving duck.

-- Jim

[orleans]

As I thought, better lower than higher. As a stage 3 (bx 1 year ago) I am getting a little antsy. Gonna do the liver lover thing, work hard on the headaches, make a few bucks, and hope to treat this summer w/ SOC alinia. Hate passing the chance at 950 but there is NO way to do a 6 month migraine with the likely rash to boot. thanks, jerry

[FloridaMouse]

My first round of treatment my starting viral load was a pathetic 90,000.  I relapsed 5 months post.  My VL at relapse (september, 2007) was 111,000.

I started round 2 on 12/11/07.  Starting viral load was 260,000.  4 week VL came back at 15,700.

Shands at the University of Florida thinks that I'm struggling with staying clear because of the extent of my liver damage which is Stage 3, Grade 3-4.  

Mouse
P.S.  I'm a 1a

[nygirl7]

a low pre-treatment viral load is associated both with RVR and SVR although given the anti-viral molotov cocktail you're taking, would be hard to match stats, but can't see viewing this as anything but positive

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St. - just be warned sometimes for whatever reason it is - it seems much harder when you start out with a very low vl,,,I don't know why but I've seen it over and over (only becauSe I too started with only 568,000).  I'm a stage 3 like many on here and did manage to clear...just don't think for any reason this is going to be easier.  Fight like hell like you have been my friend.

I thought I read a piece of data just the other day that they've found out now that it CAN be much harder to clear with a low VL.  I just read it in fact I have to find it.  It completely contradicts EVERYTHING we've been told but...for those of us in the low VL area...it means we aren't nuts.

[jmjm530]

Low pre-treatment viral load does not guarantee SVR, but it is a positive predictor along with other predictors such as genotype, race, BMI, cirrhosis, etc. At least according to all I've read. Would be curious to see what that article said if you happen to come across it again. What's also interesting, however, is that while high VL is a negative preictor --  those with very high viral loads appear to do no worse than those with high viral loads -- which includes most of us. That should be of some consolation to those who report very high numbers.

-- Jim

[alagirl]

I had to laugh a little as I read your post, not at you, but at the irony of the whole thing.  In my life, the migraines fairly have me under control, not vice versa.  But if I waited for them to go away, I'd never been able to treat.  I am a life long migraineur with two to three week intractable migraines.  Since beginning tx I have not noticed anything more or less in terms of my migraines, so from my perspective I can't see it as a good reason to delay, you can always drop out if you have to do that.

Also, I take pain meds on treatment for some RA type symptoms in my joints.  That daily prophylactic pain med seems to work most of the time to tamp down any migraines, although I did have a fairly bad one come and visit this month.

[mikesimon]

The more I read the WIN R study results the more puzzled I become.

A few observations that I think are interesting.

1) Fibrosis doesn't negatively impact treatment response - only cirrhosis does.
2) Patient weight doesn't impact treatment response - just weight base ribavirin dose accordingly.
3) Patients older than 65 respond as well as all other patients - 46% to 44% SVR respectively. Only patients between the ages of 18 and 25 did significantly better - 57% SVR.
4) Viral load effect on SVR is rather puzzling.
Low viral load (580,000 IU) 31% SVR
All viral load  33% SVR
Within those groups is where it looks strange.
Look at low viral load which is < 580,000 IU
580,000 IU) is 31% which is almost exactly what it is for a low viral load between 145,000 IU and 580,000 IU where the SVR rate was SVR 30%.

And it seems to get even more puzzling when you break down the High viral load -
> 580,000 IU.
It appears as though having a viral load between 4.35 million IU/ml and 5.8 million IU/ml is nearly as positive a predictor of SVR as having a viral load of between 29,000 IU & 145,000 IU/ml.
  39% SVR for 4.35 million IU/ml to 5.8 million IU/ml
  41% SVR for 29,000 IU/ml to 145,000 IU/ml.
But if by chance you have a viral load between 2.9 million IU/ml and 4.35 million IU/ml then your odds go down to 25% SVR. Now that looks like a significant difference. So, I guess once you get over 145,000 IU/ml higher is better.
   35% SVR for 5.8 million IU/ml to 8.7 million IU/ml  is nearly as good as the overall low viral load group SVR number which is 37%. That is the highest viral load statistic I could find in the study - 8.7 million IU/ml.
  It's possible that I could have made an error converting copies into international units because the study was apparently conducted prior to the adoption of the International Units system.
From the Methods section:
"- HCV RNA levels were measured with polymerase chain reaction (Taqman; Schering-Plough Research Institute; lower limit of detectability was 100 copies/mL, which is equilavant to 29 IU/mL) at weeks 24, 48, and 72
- This study was designed before adoption of the International Units system. Therefore, results are reported in copies/mL"

From this study I have concluded that many of our preconceptions about treating are wrong. I learned that fibrosis, viral load, and age do not significantly impact treatment response - except that cirrhosis does negatively impact treatment response and a viral load under 145,000 IU/ml is a positive predictor for treatment response. I also learned that if you can't start treatment with a viral load less than 145,000 IU/ml than you should try to get it between 4.35 million IU/ml and 5.8 million IU/ml to maximize your chances for SVR. Strange but true according to WIN.
At least according to the results form the WIN study genotype 1 is still less likely to achieve SVR than types 2 and 3 so that truth survived. And blacks are less likely to respond successfully to treatment which is what I thought was the case prior to the WIN R study. Things have changed significantly and I can't help but come away with the impression that this study seems to suggest that treatment should not be precluded by most of the factors that were formerly believed to be negative predictors.
Mike

[jmjm530]

MS: Things have changed significantly and I can't help but come away with the impression that this study seems to suggest that treatment should not be precluded by most of the factors that were formerly believed to be negative predictors.
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Thanks for the breakdown.

The above is certainly one valid conclusion as long as SOC is the only choice, except for trials. But of course, depends how you filter the data. For example, WIN-R suggests that everyone -- except stage 4 -- has the same chance of SVR, all other things being equal. So, one conclusion is that someone with stage 3 should treat with relative optimisim. However, another conclusion might be that someone with stage 0-2 liver damage, potentially has more time to wait without decreasing their odds for treatment success, as has oft been argued in the past.

As to the viral load -- can't seem to find it now -- but there was a study that I don't think was part of WIN-R where they came to the conclusion that while high pre-tx viral load was a postiive predictor of SVR, very high pre-tx viral load did no better -- no worse -- than high pre-tx viral load. Not sure if this conflicts with WIN-R, but does give hope to those with very high pre-tx viral load. I will post if I can locate.

FWIW my doctor still argues that age is a negative predictor which I assume is based on anecdotal information, although two doctors I consulted with agree more with WIN-R, that it isn't. Again, assuming age isn't an issue, one can filter the data both ways in terms of whether or not to treat.

-- Jim

-- Jim

[jmjm530]

Maybe what I had read re Viral Load was part of WIN-R.

Here, are exerpts from study "summary" and "conclusion". Some redundancy.


- Among patients with genotype 1 HVL, SVR rates do not appear to deteriorate with
incremental increases in HCV viral load

- In this study, the highest SVR rates occurred in patients with HCV viral loads of <500,000 copies/mL

- Unexpectedly, patients with HCV genotype 1 and HVL do not have progressively lower SVR as viral load increases

- Very high viral levels in patients with HCV genotype 1 should not discourage attempts at viral eradication

- Further studies are needed to reevaluate the current cutoff of 2 million copies/mL used to differentiate patients with low and high HCV viral loads

http://www.natap.org/2006/DDW/DDW_26.htm


Another study on how pre-tx VL affects tx

Based on these findings, the authors concluded, "This analysis shows that a baseline HCV RNA level of approximately 400 x 103 IU/mL is optimal for use as a cut-off point to best discriminate between low and high viral load, based on the probability to achieve an SVR in genotype 1 patients when treated with [Pegasys] plus ribavirin for 48 weeks."

http://www.hivandhepatitis.com/2006icr/aasld/docs/110706_f.html

[mikesimon]

I got the WIN R numbers I posted from your link:
http://www.natap.org/2006/DDW/DDW_26.htm

According to that 15 to 20 million copies per ml or 4.35 million IU/ml -5.8 million IU/ml group does as well as the < 2 million copies per ml or < 580,000 IU/ml group. The number are almost the same: 39% to 37%. And the < 2million copies group is skewed because of
1) the 61% SVR for < 100,000 copies per ml (29,000 IU/ml) and
2) the 41% SVR for 100,000 - 500,000 copied per ml (29,000 IU/ml - 145,000 IU/ml).
3) The SVR for 500,000 to 2 million copies per ml 145,000 IU/ml - 580,000 IU/ml is 30%.
So it looks to me like a VL of between 4.35 million and 5.85 million is a pretty good starting VL. That just seems like a very strange result to me but so too do the age and fibrosis results.

Mike

[nygirl7]

you know I read the WIN R data and it's all almost VERY confusing but I think this one line summed it up pretty well in general...


Interestingly, reductions in SVR were seen in more patients with baseline viral loads of 2-15 million copies/ml than in patients with greater than 15 million copies/ml. Researchers concluded that within the genotype 1 patient population with high viral load, those with very high viral loads do not have impaired rates of SVR.


Talk about a buncha mumbo jumbo.  It's sort of like saying maybe you will maybe you won't we don't really know...isn't it?

The next big data subgroup was smoking and it basically had all the same "yes" "no" type lingo in there too on whether or not it hurts SVR rate.

so now that we are being told "weight" is not a factor, not even obesity - a high viral load is not a negative predictor of SVR, smoking doesn't necessarily mean more fibrosis and less SVR

It's almost like EVERYTHING we've been told all around - has been negated.

It sort of sounds like a big mumbo jumbo of we don't really know...........doesn't it?

[nygirl7]

SVR rates among smokers and nonsmokers with HCV genotype 1 were not significantly different.


Just so the smokers here know...........NOT that anybody should go out and START smoking or anything but you don't have to beat yourself up as bad as we always believed.

[jmjm530]

A lot of the WIN-R data has been floating around for some time now, no doubt by doctors involved in the report -- at least that is how some of this was related to me over 2 years ago. As to the weight and smoker thing --  From memory, I think that the BMI issue isn't all cut and dry across all genotypes and weights, but I'll have to check again. As to smoking versus not smoking -- WIN-R found a signficant difference in SVR stats for genotype 2's with smokers not doing well. They also urged follow-up studies and as you know the bulk of previous studies favor non-smokers in terms of SVR.

MS: That just seems like a very strange result to me but so too do the age and fibrosis results.
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I think skepticism is healthy, especially in this arena. As stated, my own tx doc was skeptical regarding both the age and fibrosis thing while two other honchos I consulted with seemed to accept those conclusions. But all said, while WIN-R may not definitely answer all the questions -- I doubt anything ever will -- at a minium it certainly opens up some doors previously closed, which I think is very good.

-- Jim

[nygirl7]

I know we've been reading it for years - there really isn't too much else out there at this point to back up all that much else and it seems everybody's take on it is completely different.

That's why it is important to remember a study is just that a STUDY and not the word of God. Basically just meaning it MIGHT give you a bit of a leg up on treatment but not really necessarily at all.

I think it's very good too to be able to give people with a very high viral load a good chance of clearing since it seems so *** backwards to make any kind of logic.

I just know from watching ME personally (and Cuteus before me like I said turned me on to the fact) it doesn't necessarily mean squat that you have a low vl at all either way. We are the ones that seem to get stuck in that ghastly "plateau".  I'd rather be a very high and just wipe them out instead of that and I'm SO GLAD I don't have to do it again.

I don't know that I could.

[mikesimon]

When I see a higher SVR among genotype1s with a VL between 4.35 and 5.8 million IU/ml than in genotype1s with a viral load between 145,000 and 580,000 IU/ml - 39% to 30% - I can't help but be skeptical. And then there are the other things like age, weight and fibrosis. Mike

[jmjm530]

I just wonder how much of the above have to do with testing variance issues per M.Shiffman's module at CCOptions, or because of conversions as you previously mentioned.  The conclusions, in my link above, seem far simpler -- and more logical to me -- that those with really low VL have a better chance of SVR than those with higher viral load-- however no significant difference in SVR between high and very high viral loads. That said, I will take a look at all those charts eventually and see what personal sense it makes. The other thing, of course, is WHEN were those VL's taken, and were the time (from pre-tx) consistent or something like "within the last year". My pre-tx VL was 16,000 four months pre-tx, yet 1.5 million the day before treatment. So maybe the "inbetween's" are more apt for error, while age and fibrosis don't have those same issues.

-- Jim

[mikesimon]

I just broke down the study you posted. When you break VL out the numbers look different.
The CCO is strange too because I would think those guys would have read WIN and known better then to group F3 & F4 together. But, apparently they didn't because in the summary they didn't distinguish between F3 and F4 and after WIN I would have thought that they would have.
Mike

[jmjm530]

It becomes more and more clear that it's Caveat Emptor when blessed with this disease and I imagine many others. And of course, a lot of what we learn -- or think we learn -- either becomes outdated or reaches us too late for any effect on our personal treatment. Still, staying with the truisms, Knowledge Is Power, and all we can do is learn as much as we are motivated to.

-- Jim

[nygirl7]

Well guys
When I see a higher SVR among genotype1s with a VL between 4.35 and 5.8 million IU/ml than in genotype1s with a viral load between 145,000 and 580,000 IU/ml - 39% to 30% - I can't help but be skeptical. And then there are the other things like age, weight and fibrosis. -----------


That is me to a T.  And why I treated for 72.  It's funny that this was all heavily discussed to me by Cuteus and a couple other people (long forget now) WAY back three years ago BEFORE I treated and now it seems this info MIGHT be getting into the doctors hands.

And this is why I LOVE debating the pros and cons in here - knowledge IS power.  And sometimes the only way we can get our doctors to understand is to take the time to learn it ourselves because some of them sadly just don't care about reading ANY of the new information.

-----------

PS I am NOT happy to be lumped in together with 3 and 4s.  Not that i have anything but love for my fellow 4s but in reality it seems to me that i had much LESS time to act that I thought that I did. I'm very relieved that I was not much of a passive tx'er - it really could have cost me the SVR that was so hard to get.