Unblinded VL results - any opinions?

[lab-rat]

FOr those of you who have been following us vx trial participants, I thought I would share my unblinded vl results and ask your opinions on whether I should be concerned.  As it turns out, I'm in the placebo arm, so my results aren't nearly as interesting as most of the others.  It seems I'm not really much of a labrat after all, just a regular patient treating w/ standard meds.  I've been fortunate that I haven't experienced any dose reductions or debilitating side effects. In fact I feel pretty normal, which is great; however it appears I didn't quite meet the hallmark of a rapid responder. While I'm thrilled to be currently UND,I didn't really make it by week 4. Here are the numbers:

PreTreatment:
June '06 8,000,000+ (off-study)
07/28/06 3,070,000 TaqMan-RUO-CL
08/05/06 6,400,000 TaqMan-Exp-RUO-CL

PostTreatment:
Day 1 3,830,000 TaqMan-RUO-CL
Day 4 17500 TaqMan-RUO-CL
Day 8 16900 TaqMan-RUO-CL
Day 15 5348 TaqMan-RUO-CL
Day 22 1280 TaqMan-RUO-CL
Day 29 318 TaqMan-RUO-CL
Day 57 29 TaqMan-RUO-CL
Day 71 <30 IU/mL TaqMan-Exp-RUO-CL
Day 85(preDose) 29 TaqMan-RUO-CL
Day 85(post) <30 IU/mL TaqMan-RUO-CL
Week 16 29 TaqMan-RUO-CL
Week 20 <30 IU/mL TaqMan-RUO-CL

I need to go back and re-read all of the posts regarding the significance of the 29.  But there it is!

[jmjm530]

Forgot about that study thing. Maybe they can ease the protocol since you're in the placebo group.

-- Jim

[Tallahassee]

Jim, thank you for your response.

Regarding my cholesterol numbers:

A nurse from University told me that my cholesterol was very high and I need to check with a Doctor (~1993).  Typically, young people think that they will live forever ... so I did not pay any attention to her warning.  In 1995, for my baseline blood work for my employment.  I think it was ~270-280.  Interestingly, when a nurse in 1995 called me to say that I have a Hep. C and need to follow it up, my first question was "How is my cholesterol?" :)  I definitely did not hear anything about Hep. C, but I knew a little about Hep B and knew that it is not treatable ... so why worry about Hep. C.   Besides, I did not have any insurance, so no reason to go to Dr. :)

While studying our diet consisted mostly from eggs, sardines, cookies, ice cream, chips, and ... more eggs with cheese. I guess diet was horrible :)

Definitely, now I'm more aware of my food ... though I still love eggs, but try not to eat more than 2 per day ... try :)

Now pretreatment (2005) total cholesterol was 118, I believe that couple years earlier it was ~149, and a year or so earlier it was ~169.  While on treatment, it is barely 100... though a good part of cholesterol was around 60 (above recommended range).  I also trying to eat a lot of fried food, etc. but it does not affect my cholesterol... so I keep wondering if my liver is not cable of producing cholesterol anymore??

I'm on daily Infergen (15-18 mcg) with Riba (1000 mg, I weigh ~115 lbs on average) and two weekly Neupogen (300 mcg?) shots. I self prescribed to myself 1200 of Riba (after some dispute, they mistakenly sent me 3 months refill too earlier). Also, I have extra Infergen, and after being negative from week 12 through April 2006 (viral break though), I was taking ~24 mcg daily of Infergen... for ~3 weeks ... my platelets got very low (in low 30s) ... so I had to stop this practice.

BTW, my Dr. was very close to prescribe me Procrit, but I will increase my "eggs intake" ... and I don't know for sure if it helped... but my Hemo will increase to 10-11.  

I went for consult to Gainesville and Dr. N approved 1 year of treatment after becoming negative (after viral break through in April 2006), ... he gave me only ~10% chance for SRV ... he said that they did not have convincing studies for Infergen ... since like it is very typical for patients either have a breakthrough or relapse... the same thing I was told by a coordinator in Miami.

I was on & off on Infergen from ~2000... this is the only interferon (even at 3 times per week) that kept my viral load <10... but due to  WBC drop and without rescue drugs, my dose will be reduced to 7.5 mcg (from 15 mcg) and my viral load will be back immediately... so at this point I just was very happy for having liver enzymes in acceptable range.

Per your recommendation, I was considering to have a FibroScan at HR's office (and I still planning it), but not likely we will visit our California relatives this April ... so may be by October...

Thank you for taking your time & for your help!

How are you doing after the treatment? I hope all or most side effects from interferon disappeared by now!!

When I tried cheerfully to convince Dr. from Gainesville that I'm very lucky and don't have the side effects I hear from this forum... He looked in my eyes and slowly  commented..."but you feel very-very tired... very tired".  I confessed that yes, I stopped exercising a few months ago and now at work I try to spend all day at my desk... He is right ... my tiredness level right now is unbelievably high!

All the best to you and everybody on this forum!!

[lab-rat]

mremeet:  Hi, I hope you're doing well!  Thanks for all of your helpful information.  I keep thinking about the significance of the number 29, and one thing that I found to be interesting is that on my day 85 labs, my vl was 29 before I took my peg shot, then a couple of hours later (post-shot) it tested as <30 IU.  That leads me to believe that these aren't just false positives, and that Jim is correct when he states that this is just the way the virus behaves.  It's sort of discouraging, that the cooties keep coming back (like the hitcher).  I also need to re-examine all of the study information and consent forms that we signed. I believe it states that if a person is in the placebo group and has a viral breakthrough, they would most likely be dropped from the study and would be on their own.  So it will be interesting to see - if the dreaded 29 rears its ugly head again, will the doctor consider that to be viral breakthrough?  I'll just keep plugging along with tx (as long as they keep giving me the drugs) and try not to dwell on it.

Also could you please clarify your suggestion about the oxymatrine...would that be something taken in addition to SOC?  Or as plan B if I need to go off tx?  I'll have to do some research on that, I've never heard of it until now.  I know that milk thistle has been beneficial to some and a good friend of mine w/acute hcv for years cleared the virus on her own (but was coincidentally taking milk thistle).  I have to be careful what I say about her, lest I be accused of selling snake oil!  

I'm glad to hear your cholesterol theory, because mine has been considered to be borderline high - although lately its been hovering just over 200.  A lot of that is my LDL - usually around 70-80.  I do try to be healthy by exercising and eating fruits and vegetables, but believe me, I eat plenty of ice cream, pizza, wings, red meat, butter, cupcakes, cookies etc. etc.  A day doesn't go by without dessert so I should probably be watching my sugar! In fact I've often thought that there must be some correlation between sugar and cholesterol.  Anyhow I'll be happy to keep up the fat-laden diet!

Jim:  I've been thinking about your suggestion of increasing the riba.  I've been given enough meds that I could just take the extra pill myself, but I'm not sure if that would be ethical, considering I should be following study protocol.  But part of me doesn't really care about the study protocol, since I'm in the placebo group anyway, who cares? Maybe I'll mention it to the dr. and see what he thinks.  Thanks for the suggestion.

[jmjm530]

Tall: What about the other study indicating that statins help to "destroy" the virus... Potentially it may become another antiviral remedy... If receptors of LD cholesterol and Hep. C are shared (I also read this study) then the same theory (just in reverse) may justify use of statins for cholesterol reduction.
------------------------------
This part always confused me. If high LDL is positive then how come statins (which reduce LDL) can help the process. Not that I pretend to understand this but the answer may lie in your next statment.

Tall: Since people with advanced fibrosis NEVER have high cholesterol, high SVR rate for patients with baseline high cholesterol may simply indicate that there is no advanced fibrosis is present - naturally suggesting the higher SVR rate.
---------------------------------------------------------------
Very good point and this could account for why treating with statins don't hurt SVR by lowering cholesterol pre-treatment. More important it could put an end to pre-dosing Ben and Jerry's ice cream, darn, too good to be true, eh.

I personally in 1995 had very high cholesterol - I was 25 years old, very skinny with okay diet. I started study - treatment with INF & Riba by the end of 1995 (48 weeks treatment) - I was considered non-responder. At this time they did not have a guideline for 2 log drop by week 12. I probably had only 2log drop by 48 week of treatment (from 20 mil to ~200,000). Biopsy showed a very mild fibrosis (stage1, grade 1). I had 100% compliance, no drugs reduction, and no rescue drugs (I don't think I needed any, probably because of the young age and being very healthy).


Tall: if most of the statins may be potentially used as antivirals, then why high fat diet (or high cholesterol levels) may potentially increase SVR??

Again, the question is whether high cholesterol is an independent factor for SVR or whether it's just associated with cirrhosis which is a negative predictor of SVR. Curious, you mentioned that you initially had very high cholesterol and now it's very low. Could you give us the approx numbers and did you do something -- either diet or drugs -- to reduce your cholesterol. Can't believe it dropped dramatically going from stage 1 to stage 2 or an early stage 3. I know my cholesterol ceratinly didn't drop. BTW late stage 2 or even early stage 3 isn't all that bad relatively. Where exactly are you in the treatment process now?

All the best,

-- Jim

[Tallahassee]

What about the other study indicating that statins help to "destroy" the virus... Potentially it may become another antiviral remedy... If receptors of LD cholesterol and Hep. C are shared (I also read this study) then the same theory  (just in reverse) may justify use of statins for cholesterol reduction.

Since people with advanced fibrosis NEVER have high cholesterol, high SVR rate for patients with baseline high cholesterol may simply indicate that there is no advanced fibrosis is present - naturally suggesting the higher SVR rate.

I personally in 1995 had very high cholesterol - I was 25 years old, very skinny with okay diet.  I started study - treatment with INF & Riba by the end of 1995 (48 weeks treatment) - I was considered non-responder.  At this time they did not have a guideline for 2 log drop by week 12.  I probably had only 2log drop by 48 week of treatment (from 20 mil to ~200,000).  Biopsy showed a very mild fibrosis (stage1, grade 1).  I had 100% compliance, no drugs reduction, and no rescue drugs (I don't think I needed any, probably because of the young age and being very healthy).

At this time I was very happy that my liver enzymes were in normal range during this (and all others) treatments.

Unfortunately, I'm not one of the lucky people who reversed their fibrosis - by 2005 my fibrosis progressed to stage 2 (I think that may be beginning of stage 3 by description).  BTW, through all my life I only had a little champagne on New Years nights - at start it was a principal not to drink plus without being exposed to alcohol, I did not crave it at all... later I new too much from bio chemistry class ... after being diagnosed with Hep C, I stopped having occasional champagne.   The reason I'm describing this just to show that I did not have additional contributing factor... well, actually, I probably was exposed to a complete table of chemical elements by making all my studies and researches in the labs...

Fast forward, prior to starting my current treatment, I had VERY low total cholesterol .. though my "good" cholesterol was slightly above recommended range.

I guess my question is:

if most of the statins may be potentially used as antivirals, then why high fat diet (or high cholesterol levels) may potentially increase SVR??

Thanks to everyone for your impute!

[jmjm530]

Come to think of it maybe pre-dosing with Ben and Jerry's might help. If indeed LDL shares the same receptors with the virus, then I suppose even an artificially jacked up LDL might be of some benefit, giving the virus less of a foothold so to speak while it's getting plummeted by the drugs. I certainly wouldn't recommend this to anyone but maybe HR might comment on this approach if he's following. The big question is: do you pre-dose with Cherry Garcia or Chunky Monkey? Personally, I'd opt for Coffee Heath Bar Crunch. This is one trial I might want to sneak into, just opt out when they hand out the peg and riba :)

-- Jim