I've been asked to join the Schering SCH503034 Clinical Trial....what to do?

[miked]

My doctor knows that I'm a motivated patient and asked me to join the clinical trial for Schering's protease inhibitor, SCF503034.  Nationwide 300 people will be enrolled and there will be six arms of the study;

Arm 1 = PEG + RBV + SCH 503034 Placebo. @ week 13 if VL then
        switch to SCH503034 400 mg.  48 weeks.
Arm 2 = PEG + 100mg SCH503034 + Placebo RBV. 48 weeks.
Arm 3 = PEG+ 200mg SCH503034 + Placebo RBV. 48 weeks.
Arm 4 = PEG + 400mg SCH503034 + Placebo RBV.  48 weeks.
Arm 5 = PEG + 400mg SCH503034 + RBV.  24 weeks.
Arm 6 = PEG + 400mg SCH503034 + Placebo RBV.  24 weeks.

They're looking for optimum dosage and with/without RBV.

Here's my dilema.  I want to kill this virus, but, when I last went through tx (36 weeks until a viral breakthrough) I worked everyday but felt like a zombie.  I own my own business that requires lots of travel and customer meetings.  While on tx I felt like locking my office door and being left alone.  After seven months off tx I'm finally getting my business and family back together.

Last night, just thinking about being back on PEG made me edgy and kind of depressed.  If this was a 24 week stint I would do it standing on my head.  For me the sides really didn't kick in until the 4-5th month.

I'm a geno 1b with minimal scarring and inflamation (inflammation) (stage 1/2; grade 0).

This forum has been a God-send for me in the past.  Two questions for you guys:
1.) With the above information....would you do the trial?
2.) If I go ahead with the trial, what questions do you have for the doc and/or researchers?

Mike

[crushed]

yes that is a tough call but as mentioned you have minimal damage. if i had a personal inclination it would be to hold off but i'd need more info to base a decision on. as mentioned age ect. would play into this decision. i've also read information that led me to believe the rate of damage may not be consistent. i'm just starting to poke around to be better informed but some of the newer drugs in trial sound promising. i "think" VX-950 is targeted for 08-09 and valopicitabine from Idenix looks to be doing well.

good luck with your decision

couldn't, it sounds like you've done a fair amount of reasearch.

[TnHepGuy_]

Some questions and/or considerations to ask yourself and/or your caregivers might be:

- if I'm waiting for something "easier" and "more tolerable" to come along, is there truly such a drug out there being developed? Or is it more likely that any drug being developed will be part of a regime that will include interferon and/or riba (as most of the researches agree will be the case). And that the newer drug itself will have it's own set of sx's (e.g. - the whole class of protease inhibitors are anything but 'benign', as is evidenced by the some of the sx's that HIV patients experience). And what are the guarntees that this new drug (be it "tolerable" or not) will make it all the way through the arduous phases of trials and FDA approval process? And just how many years from today will that be?

- if it's therefore most likely that you will have to take some combination of these drugs that will include interferon and/or riba, when will you physically, mentally, financially, work-relatedly (<--- new word, perhaps?) best be able to tolerate the new tx - today, next year, 5 years from now? Will any of those factors (physical, mental, financial, work) change over any period of time in your future to make tx'ing more acceptable? In other words, is it possible that postponing tx in the hope of something "more tolerable" to arrive really is akin to leaving you sitting at the train station awaiting on a train that is never makes it to your particular stop? And the whole while nothing in your personal circumstance has changed to make the day of tx'ing any 'easier' - except more time has now passed?

- if your current lower level of histological damage increases your odds of tx success, how much are you willing to gamble that any increase in liver damage over time will then contribute to a possible correlating decrease in SVR chances?

- and in any discussion of postponement there is also the question of what waiting does in terms of the many non-hepatic sx's that can (and do) manifest themselves?



As far as questions about this particualr trial, the first one that I notice in regards to what you have posted is: if you end up in "Arm 1" (PEG + RBV + SCH 503034 Placebo. @ week 13 if VL then switch to SCH503034 400 mg. 48 weeks) and do show detectible at week #13, are they switching you to mono SCH503034 400 mg. 48 weeks, or will you be continuing in combination with the interferon and riba for the 48?

(it should be fairly obvious if you end up in any of the arms with the riba involved, with the resulting dramtic decreases in hemoglobin and hematocrit).


Some other questions to ask are:

- will they rx you Procrit and Neupogen during the course of tx? And at what blood levels will they intervene?

- what criteria will they use to end your tx early? (ie - what 'targets' and 'milestones' will you need to 'hit' along the way to continue forward)?

- how often will you have 'regular' bloodwork done?

- how frequently will PCR's be done?

- will you be allowed to see your ongoing lab results?

- who will be overseeing your tx?

- how will your primary doc and gastro/hepatoloist (and their offices) be involved?

- how much of your tx and testing can be handled by your local doc and lab to minimize overall time and travel?

- who do you contact if you have any kind of problem, need or concern?

- is payment for the meds (including Procrit, Neupogen, sleep aids, anti-depressents, etc.) fully covered?

- where (if at all) will you be needing any type of your own medical insurance coverage in all of this? (good to pose this to your insurer ahead of time, too).

- who will be supplying the meds? your hosptial's pharmacy? an outside pharmacy? will your pharmacy be needed? (good to let your pharmacy know ahead of time whatever meds they may need to have in stock for you).

- will you be reimbursed for any expenses (travel, etc)?



As far as if with the information you have supplied above, would I do the trail? Given that you are motivated to reach SVR status, have already experienced what the major tx sx's are and how they affect you physically, mentally and otherwise - I would take this opportunity to tx by planning as best as is possible for the inevitable times when you will suffer in your physical, family and work life. The extreme points will be just that - extreme. But in all probability the majority of the tx time will be mostly similar to what you have already experienced prior. And you can use that as a template in planning and coordinating this upcoming trial. Obviously you can always opt out at any point along the way on your own terms, so I would plan that possibility into the mix as well. An absolute 'bail-out' point, as it were.

But I would ask myself what tx opprotunties are avialable to me now given that I am a breaktrhough patient, and how long might it be before something truly viable will realistcally come down the pike for me?



May God's blessings and mercy be upon you.


TnHepGuy

[cuteus]

I would not make a decission based on liver damage alone, to me if a person wants to rid their life of hcv they should do so regardless of liver damage. What I find a negative is the fact that your virus bounced back after 9 months, you might have a new quasispecies that might not respond to current meds and dosages as well. You need customize tx, and a trial will not do that. If your goal is to be hcv free, a trial can not be the way. They put too many restrictions in their protocols. You and your virus need individual attention.  You are no longer tx naive and if you relapse again or don't respond, you will be classified a two time non responder, that could exclude you from other trials that might offer a better chance at SVR.
best to you in your decission.

[cuteus]

We missed YOU!
HOw is HCV FREE life?
Is your hip pain history?

[couldn't think of a nickname]

That's a tough one. It looks like you have minimal damage, and might be able to afford to wait (I am not qualified to make that judgement of course). Since peg and riba affected you so badly before, 13-24 weeks sounds rough. VX-950 is a month or 2 away from phase 2 in the states, and that will be without riba, but with peg, and for only 4 weeks. That might be more tolerable for you. The problem is, if you wait for that, do you lose out on getting into a SGP trial?
I have a problem with Schering. That problem is that they have said absolutely nothing about their drug. Nothing on sides, nothing on efficacy. The only data I know about comes from the AASLD abstract which is in the public domain, which they won't comment on. They got a 2.07 log drop at their best dose group in 2 weeks. Obviously much better than current treatment, but not as effective (from what I can see) compared to 950, which is why their trials are scheduled to be longer.
Conversely, VRTX has been very forthcoming with all 950 data, including sides, cardiac tox. studies, etc.
It is my opinion that SGP is making a big mistake here. Some will say big pharma doesn't like to telegraph what they have. Everyone knows about it anyway. They are letting a small biotech dominate them in the news area. And, if this were HIV, I believe there would be an outcry for more info on that drug, but it doesn't seem to be seen in the same light.

Good luck with your decision. Whatever you decide, I am sure it will be the right one, even if it doesn't seem so at the time.

[Snookmiester]

Though decision, and TOTALLY a personal choice on your part. Personally if I was in your shoes, I would opt to wait, seeing scarring and fibrosis are minimal..
Good luck man with whatever you do.

[honey11]

Mike,,,I agree with Snook on this one,,,,Hard decision for us to say,,,What is your age and VL?

[jmjm530]

With the above information I personally would not do the trial.
Given your minimal liver damage, you  still have time to wait and hopefully within a few years these trials will provide more definitive data. Also keep in mind that some of the arms are probably going to do a lot better than others, and you may not know which arm you will be enrolled in. Your doctor should have complete information on this in written form. All the best with your decision.

-- Jim

[Tonyz]

TnHepGuy covered most any input I could give you, and I agree with his Input.
Remember to take each day at a time. If you were to do the trial and things got real bad during TX, you may be able to have a Peg dose adjustment. On another note, did you use any med's for depression during you last TX ? You might want to think about that if you decide to join the clinical trial.




                 God Bless

                     TonyZ

PS. <font size="2" color="#6600CC">"TnHepGuy" it is indeed good to hear from you again..</font>

[GoofyDad]

Sorry - No new threads. Hope no one minds me piggy-backing on here.

My first face-to-face with my Doc since starting tx 7 wks ago is coming up. I want to discuss their plan for treating 48 weeks. I'm not neccessarily advocating a different plan, I just want to have a sensible discussion.

My stats
-----------
Peg/Copeg: Standard dosage - a little extra copeg vs. weight based guidelines
Geno: 3a
Age: 46
Stage: 4-5 transitioning Ishak - entering stage 4 Metavir
Infection: 25 years
Prior Alcohol: A 'very social', social drinker
VL: 1.3M baseline/Undetectable by sensitive TMA at 25 days
ALT : Baseline:3x Normal/18 days:Normal/25 Days:Lower Normal  

My Thoughts
-----------
I have not seen data supporting higher SVR for 48 wks vs. 24 weeks for any 3a

I have read about higher relapse for 3a w/ alcohol history

I have not seen data supporting higher SVR for 3a with 4 wk response - in fact one {sensored} study suggests the opposite.

I have not seen data showing better histological response for longer treatment, except as it may correlate to higher SVR

I would not want to pump more of this junk into me than I have to

Common sense says I'm running out of runway here and I should take my best shot with 48 weeks and stop snivelling.  
-------------------------------

Anyone have anything else I should add to my discussion agenda, or commentary/addtl info on the above? Thanks!

[Califia]

Most excellent feedback above.  Quite honestly,  I believe that there should be at _least_ a year between rounds.   I, too, worry about the longterm effects of prolonged chemotherapeutic treatments.   As this area is so poorly documented (for obvious reasons) it really is a matter of following one's gut instinct:  the data just isn't there to make a purely rational choice.  Your age is, of course, a significant factor,  but as you are not racing against cirrhosis  and are not being held back by chronic viral fatigue or any other Hep-related syndromes post-tx, I would wait and not offer myself to Schering as a guinea pig.   Best of luck to you in whatever decision you make, and good to hear that your life is on the move again.

[GoofyDad]

...sorry. meant to title previous post

[jmjm530]

Goofy said prev: "I have not seen data supporting higher SVR for 48 wks vs. 24 weeks for any 3a"
======================================

That's where I would begin the discussion with your doctor.

Also, based on everything I've read, I view your non-detectible 4-week PCR as positive predictive factor for SVR and I'll leave it at that. :)

Only other thing I might add, is that since you still have plenty of time left to make your decision, there's no reason to make a final decision now. If it were me --  and I was still uncertain --  I'd probably get a second medical opinion.

All the best.

-- Jim

[GoofyDad]

You may wish to look at the gruppe with 70 pepperronis one more time :)

[azgrl]

hey there....I'm so glad you posted all those questions.  I'm having the same discussion with my doc on the 8th.  

I'm also a 3a stage 1 grade 1 had this 4 1/2 years.  I haven't started tx but will be on the 8th/9th provided my gallbladder will behave and I can get my completed opthamology report.

The only "proof" if you call it proof is that of people I have spoken with who have relapsed from the shorter treatment.  Then the people my doc told me about who aren't relapsing after the longer tx.  (again on this I don't know the number of people and of course it is not an official study just observation on her part)  There is a member on another forum who is supposed to be sending me an article that has good information in it.  I have yet to see it though.  I will get it to you if I ever get it.

I'll keep you posted of what I find if you keep me posted.  I'm willing to do the 48 weeks iiiiif it means a better chance at clearing and staying clear.  Otherwise I'm inlcined to take my chances with 24 weeks.  

I would even wait to tx if my body wasn't so welcoming to this damn virus.

deb in az (sorry I don't have more info...but we're paddling the same boat...up stream....without....well you get the drift)

[Wasabi Pea]

Honestly, given the various studies on your genotype, I would myself lean towards the 24 week program...especially given the fact that you've responded so well at 4 weeks.  And you're right...you really don't want to pump more of this stuff into your body than you need to.

However (and this is the big however that I'm dealing with myself), I'm sure the big question you're asking yourself is, if I could tolerate going the extra time (without putting myself at additional risk) in order to make sure that darn virus is gone, wouldn't it be worth it?  And given your liver bx results, going the extra bit seems worth it.

Also, I had not heard about the alcohol history factor, and didn't quite understand if you meant you were a very social drinker in the respect that you rarely drank or if you were very social in that you did.  My brain cells seem furry today.  Sorry.  I'm surprised my socks match today.  This is the first time in two weeks that they have.  <high-fiving myself!>

Anyway, given all the factors you've laid out, if your doctor is recommending 48 weeks, I'd go for it.  If you find at 36 weeks that you don't wish to continue, you've at least given yourself an extra 12 weeks of virus-killing therapy.  

That's just my leaning.  I wouldn't fault you for going the 24 weeks.  24 weeks sounds just lovely to me right now.

Hope you're doing well on tx so far though.

[GoofyDad]

Jim - I'm sure I can get to the German study somehow... I'll dig it up.

------------------------------------------------------
....I can't tell you what the plunking is....

AZ - At least this finally clears up how the creek got its name. I don't mind the plunks, it's non-plunkers that stick in my craw (and elsewhere)

[azgrl]

kalio - has your doc considered doing a biopsy now?  Or even an ultrasound.  I had the ultrasound and it showed a fatty liver.  After reading about 3as and fatty liver I decided to get a biopsy and I'm glad I did.  

Goof - if you're a nonplunker you're a non responder?  : )

deb in az

[miked]

Thanks guys for your input.  I'm still not certain of my decision but will go the appointment on November 9th.

to TNhepGuy....great questions to ask at the clinic.

By the way, I'm male, 47 years old and in good shape (active runner).

Mike

P.S., I've read some of the bantering comments lately....this forum means a lot to many people; let's keep up the positive support of each other.

[azgrl]

After my ultrasound, they didn't tell me about it either.  I had to argue with my pcp office to get them to fax it to me.  Then I saw the fatty liver remark and made sure I brought it to my gastro.  That was when I learned about the corelation betweem 3a and fatty liver etc etc.

Doctors are like having dogs...you have to train them every step of the way.....except dogs are much easier to train.  : )

deb in az

[GoofyDad]

AZ - I'm in the canoe and I get the drift, but what's all that that plunking?

Wassabi - AZ says she never let a Friday go to waste. I never understood why there's only one Friday! There's a study out there, google 'genotype 3a alcohol'. Lemme know if that doesn't work.

[jmjm530]

I'd pay more attention to top line results and prior RVR studies. Traditionally, pepperoni's have been hard to count because they disappear so fast down the stomaco. Sounds like a statistical abberation to me. BTW there are no pizza makers here, just pizza eaters.

- J

[Califia]

Okay, shoot me now, but I suspect that  that anyone with fibrosis in the stage 2.75 to 4.0 range really should not consider taking shortcuts.   And believe me, tx does not get incrementally worse the longer you stay on it.  This is not to whitewash the experience, mind you, but once you pass through boot camp you can almost keep marching indefinitely.  And no, I am not and have never been a jock.  I swear on my old tattered copy of Huck Finn....

[mistybean]

why bother with a study.  too risky

[Wasabi Pea]

Found it...lots of it.  I wonder why that alcohol risk factor is specific to 3a's.  

As to there being only one Friday a week, it is a shame.  Though I'm not much of a partier these days.  Fridays are my come home and change as quickly as I can into PJs, do injection, and snooze days. <G>  Fridays are the best!

Can you tell I like my sleep?

[GoofyDad]

Mike - Thanks agin for the room on the thread.

Jim - I'm thinking that my RVR really doesn't mean much. I mean you wouldn't want to miss it, but there's not much to be said for making it. Since so many 2s & 3s RVR, I wonder why they don't check at 2 weeks to get a meaningful indicator of rapid response vs. non-rapid?  

AZ - Yeah, but at least my Doc doesn't lick himself (in public).

[Snookmiester]

TnHep: Good to see you out and about!! Life after tx, and HCV free most be wonderful! We've missed your insight around here!


Goof:
With that level of fibrosis, I have to agree with Califia here. NO SHORTCUTS!! You want to get as much peg in your system as possible, in hope of reversing damage. Geno 3's, are considered a little bit harder to treat than geno 2's, yet are usually classified together. Geno 3's are also usually associated with fatty liver. There have been a few geno 3's come around here that have relapsed doing the conventional 24 week treatment, and ther have also been a few with severe fibrosis such as you, and have been advised to endure the 48 week course in hope of improving liver histology..
I've said this a million times, and many have qouted me on this.. TX should not be a carreer, you want to do this ONCE!! Hit it as hard as your body can tolerate the FIRST time.

[jmjm530]

Goof said: "I'm thinking that my RVR really doesn't mean much...Since so many 2s & 3s RVR, I wonder why they don't check at 2 weeks to get a meaningful indicator of rapid response vs. non-rapid?"
-----------------

Trying to think what the RVR percentage is in geno 1's -- I'll guess maybe 40 per cent? From memory, I think RVR is about 60% of in geno 2's and 3's. (Please check these numbers) So yeah, on one hand it means less for geno 2's and 3's versus geno 1's -- but on the other hand our two little controversial studies correlate being non-detectible at week 4 with shorter tx success. So I think it still means much. BTW studies were done for VERVR (very early rapid viral response :))where they did PCR's at 24 and 48 hours, then I believe at week 1, 2, 4. At least in this one study the 24-hour PCR ruled but it was probably a geno 1 study. See...if you were 'lucky' like the rest of us geno 1's, you could have more studies to study. LOL.

-- Jim

[TnHepGuy_]

In answering this I am going to assume that the reason your doctor(s) are proposing that you increase your timeframe from 24 to 48 weeks relates to your higher level of histologiacal damage.

You mention not finding any data supporting longer tx'ing for geno 3's. There is precious little out there to fit any one person's particular circumstance, as I'm sure you have found. (I imagine you've already seen the study/papers I will be referencing below, too.)


<a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_060105_b.html">Predictors of Treatment Failure in Patients with Hepatitis C Genotypes 2 or 3</a>.

(from the study)

<i>Male gender, history of alcohol abuse, non-weight-based therapy, <b>and presence of histologically advanced disease were identified as predictors of failure to achieve SVR</b> by univariate analysis.</i>

So, while this study does not offer specific data on patients with higher levels of damage, it does present that as being a strong negative predictor (which is also the case for all genotypes).


<a href="http://www.hivandhepatitis.com/2004icr/aasld/docs/hcv/111904_b.html">Comparison of SVR Outcomes in Patients with HCV Genotype 2/3 Treated with Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus)</a>

While this sutdy offers no convincing evidence for extended tx for geno 3's, the factor that they hold for here (low or high starting RNA level) isn't the one most applicalbe in your case. Sadly, they didn't hold for level of liver damage so we don't know how many of the failures (or successes) were patients with higer levels of damage. Too bad we can't go redo the data and see what that shows.


<a href="http://www.hivandhepatitis.com/hep_c/news/2004/060404_d.html">Peginterferon Alfa-2b (Peg-Intron) plus Ribavirin Treatment in Previously Untreated Patients Infected with HCV Genotype 2 or 3</a>

This sutdy only suggests that geno 3's with steatosis may have lower SVR chances.


Hopefully there will be more geno 3 study information released in the coming weeks from the upcoming AASLD conference.



As far far potential histological improvement by increasing the amount of time on interferon, the longer time the virus is suppressed - the better the chances for histological halting and/or improvement. This has been shown in all genotypes and forms the basis for maintenance therapy.


One way to look at is this: given that you have a high degree of damage going in, if you were to treat for 24 and relapse, where do you stand at that point in time and what are your options then? Sit tight and wait? Most likely not a good option. Re-treat for 48? Well, you were just halfway there and now would have to double your overall time on the meds - again with no guarantees. Also, you will be classified as a non-responder/relapser, which could potentially remove the possibility of entering certain trials down the road. And then there's maintenance therapy, which would end up putting you back on interferon for who-knows-how long.

No perfect solutions nor answers. Only guess-work + logic to hopefully guide the right choices as you go forward.


If you haven't already, talk to the folks here (and anywhere else you can) who have done extended tx and get their perspective on the why's, when's, and how's, of what went into their decision-making process, how they handeled the tx, what their outcomes were and would they do it again given hindsight.


May God's blessings and mercy be upon you.


TnHepGuy

[Pirategold]

"I have read about higher relapse for 3a w/ alcohol history"

With regard to your post that suggests that 3a's who have a history of  alcohol use relapse, I believe that the reason for the relapse is because the people return to their old familiar way of abusing alcohol.  If one were to abstain, perhaps the relapse would not occur!  If George Bush can do it, then so can I and so can you.  I believe that is why some 20 to 30% of people who contract the virus "beat it" because alcohol is not a factor in their lives.  Those of us who end up with chronic hep have either compromised immune systems or chronic use of alcohol.  So we must stop the use of alcohol FOREVER if we want to live a natural lifespan.

Pirate
1b, Metavir Score A2 (PMN=2, LN=1) (don't know what this means)
Scheuer Stage 1 (fibrous portal expansion), Scheuer Grade 2
61 yo, Female, 19 years
10/05 ALT = 63, Total Bil = 1.5, GGT = 21, LD = 152, Glu 93

[jmjm530]

http://tinyurl.com/avw62

This study suggests geno 3's with RVR's have higher relapse rates on peg with the shorter course if their pre-tx viral load is >800,000 IU/ml. Not sure if this is the German study or not -- but if not, you might want to compare the two. Goofy -- I couldn't pinpoint the German study but think I posted a link -- maybe you're more organizized than I.

-- Jim

[GoofyDad]

Kinda a bummer for the Chardonay and Chardonay crowd, huh?

[azgrl]

goof....I can't tell you what the plunking is....well maybe for some money I can.

thanks for all the links...there are never enough articles....

I did record pacman music to play for my first injection.... just a little relaxation music since I can't have a beer and then inject.  : )

Deb in Az

[go-girl]

Where is the study and would you happen to know if there are any on the west coast in Canada, how would I go about finding out, thanx. good luck to you

[Califia]

Ditto.   Good to know you're still out there, Batman.

[GoofyDad]

Thanks for chiming in TNhep. Your reputation precedes you. We've had some 'spirited' discussions about the Mangia study on 12 wk vs. 24 wk treatment for 2's & 3's. Without going back down that well worn road, among other things that study did show mild steatosis and normal Body Mass Index as attributes in my favor.

I'll study the links you sent and have a chat with the Docs next week. We'll see where that goes. In general, I'm not seeing my 4 week response as being a golden egg laid at my doorstep.

[tina-b]

miked,
My man is also considering a study....although I don't have the name yet, but it is one for relapsers, thanks for asking the right question to get all the answers. Good Luck!

David,
How are you doing? I am glad to see you are still lurking some. Congrats on your SVR. Thanks for the input it answered many questions I had. We miss you around here.

goofydad,
My man is 3a and txed 24/24 and relapsed..txed again 48/48 and relapsed again. Give it your best shot the first time around and you won't be kicking yourself with what if's if you aren't one of the luck ones. Good Luck!

[Tallblonde]

The timing of your visit is quite serendipitous.  A lively discussion erupted over the weekend about what, if any, value "old-timers" can offer this board.  Your comments on this thread provide the best answer: hard-earned experience.

Thank you for dropping by.  I hope the time between visits get shorter.

Susan

[dammitjanet]

We were recently discussing the Vertex conference calls, and you responded to me:

"Also, there are other interesting abstracts on that site-like PM protein being beneficial for cirhottic patients (which I think the opposite is done), and studies on various herbal combinations that showed vl reduction and improvement in inflamation (inflammation) numbers, and also on Albuferon as well as many studies on current therapy. The site is pretty much a gold mine of information."

Call it brain fog, or just plain middle aged absent-mindedness, but now I can't seem to find that site again.  Thought I had bookmarked it, but no.  Could you please give me the link again?  I'm particularly interested in the info on vl reduction and improvement in inflamation (inflammation) numbers.  

Also, in the thread above, you discussed magnesium.  Any guidelines on how much is needed to show improvement?  I recently did a spreadsheet of all my rx, vitamins & supplements so I could track dosages of everything.  I'm only taking 30mg.  

One other thing.  I have some serious muscle knots and get massages frequently.  I hate vinegar.  How palatable is the ACV mixed with water?

Just full of questions this morning.  Thanks for your help.

DJ

[azgrl]

tnhepguy - thanks for posting these links...they are now added to my reading list to be done before next week.

Kalio - I have not decided on the length of tx.  That will be the discussion on the 8th.  I haven't started tx so I still have time.  My doc is pushing 48wks...I told her I would research and we'll go from there.  I'm a 3a low vl at 21900 alt 89 ast 54 32yr young female stage 1 grade 1 and I've had this for about 4 1/2 years. (what a great personal ad that would make huh?!)  I'll keep you posted on how it goes with the appt next week.

Goof - well your lucky your doc doesn't do that in public...cause I was in the park walking my dog and I saw my doc hunched over licking himself...so I told him NO how rude and threw him a ball.

Deb in Az

[couldn't think of a nickname]

I don't have the AASLD web stie bookmarked on this computer, but an internet search of it should find it easily. Here the abstract numbers I have read:
67484
62580
60761
66787
60227
65594
65167
65578
72562
65969
67698
63449
66610
61151
61115 Those range from the topics you asked about, plus all VRTX and SGP abstracts, and also on Albuferon, and I think there are some current therpay studies in there also. The way they are save as pdf's I don't have the titles unless I open them up.

As far as magnesium goes, the intake is slightly different for men than women. I was on 400 mg's per day-about 300 from Natural Calm (which I actually didn't take that long due to the taste), and 100 from the vitamins. I would ask a doctor for the appropriate amount though.

I used to hate the vinegar when I had to take it as a kid, but it doesn't bother me now. You definitely taste it, but my wife dilutes it in a lot of water to lessen the taste. I was never crazy about water, so I actually like it now. You can add honey to it to change the taste. If you do buy it, make sure it is pure and organic, not the stuff from the supermarket. We get ours from www.bragg.com. Or, in their book, they also have recipes in there so you can cook with it. Balsamic and Red Wine vinegar are also very good for you. Hating vinegar might not make this easy for you to do though. They are also sold as capsules at vitamin shops, but I can't imagine that they are as beneficial to you.
Many people have muscle knots, but I really believe that with HCV they are a much bigger issue. Muscles are one of the largest organs in the body (skin is larger??) and dysfunction in a couple can easily spread on down the line. That it is why it has been documented that a trigger point in the calf could actually result in jaw pain. An odd connection, but documented in the works of Travell and Simons.

[Califia]

I've always taken 1 gm magnesium to stop muscle spasms.   Non-crisis dosage is 500 mg.   I tend to take higher doses of supplements than are recommended by conventional guidelines, however.   Conventional calcium-to-magnesium ratio is 2:1.   The orthomolecular m.d.'s  (docs who use vitamins like drugs)  set it at 1:1.  Magnesium at higher dosages can have a laxative effect--remember Milk of Magnesia?

[cuteus]

I understand your comment to mean that someone can relpase if they drink alcohol, I hope that is not what you meant, since there is no medical data to back that up. Alcohol, excessive or otherwise, can not bring back what is not there.  If you have read studies that show the latter to be untrue, I would love to read it.
best to you

jmjm; I, for one, am not liking you feeling the need to place a disclaimer about your non medical background at every suggestion. I don't think it is fair, since no one else is doing it. As long as we(singular) make sure that the person has consulted with a physician or will in the future, and we state that is not medical advise what they are getting but our opinionsas stated in the disclaimer after their post) by writing "I believe, or I suggest, my opinion, etc", it should be enough.  You and many here are well read in the topic of hep c, and some, like you, have the ability to effect authority and knowledge very well through the written word and should not be penalized with a disclaimer about not been an MD with every post.
Yes, there are folks that are not as cyber and hep c savvy and are looking to be guided and not having to make decissions, but is not the majority and by stating that it is what we(singular) think and they need to consult with their MD, it should be enough. We once had a member that almost quit tx, due to the statements of one well versed in hep c person who wrote with authority. Some of us were concerned about a repeat. It was not personal.  We have read so many relapses even with EVR....
Cindee(if you google her name you can find her old comments) was one of them.
We talk about percentages that are closely related but they can translate into actual people that did not reach SVR for whatever reason. 93% almost as good as 89% could be 8-10 actual persons, and for them the statistical insignificance of the percentages might mean another round of meds when one round could have done it.
Everytime I read about the short courses, it is in the general context of cost effectiveness, which makes me think that they are not really thinking about the patient and their well being with their recommendations. But that is my opinion.
I once got in trouble for using the word WE so much, I was accused of MH spokeperson wanna be. So, now I place the word carefully...
Can you find a balance between the old jm and the one today?
I don't know about others, but I feel the disclaimer is not needed once you stated it was your opinion!
But, if you insist, can't you put it in Italian and German also?
and Spanish

[azgrl]

Jim
Can you stand on your head while drinking a gallon of milk and at the same time do 3 flips and recite the latest italian study by memory.
: )
Deb in az