biopsy negative yet doc wants to treat....please help

[havhep26]

i had posted a question a month ago in regards to the fact that i am a 26 yr old W/ hep c and i was being enrolled in a study for males that are 200 lbs+.  All of the testing as well as treatment is free.  I was very leary about the tx which is interferon and ribvarin.  Because this is a study  i will be given a blind dose of at least the standard amount or possibly more. i wont know until after the year is over.  You guys gave me excellent feedback last time and told me before i go and do anything i should have a biopsy performed which i did, as it turns out i have no liver disease (yet) although i have a high viral lode with hep c genotype 1 strain a  (i think , i know its the most common form and i beileve the hardest one to treat) ne way. Because i am a new father and recently married i want to cure this disease now.  But because there is a chance the tx wont even work, and maybe even harm me worse, i'm confused.  My wife and mother say that since i have no liver disease now and that i'm otherwise  healthy that i should quit the study. Perhaps down the road if i worsen i could get tx or maybe by then they'll even have better treatments.  I do work and i feel the interferon could effect that as well as i have a history of mild depression. I am scheduled to start the tx on monday april 16th.  I can dropout at anytime with no repercussions.  Part of me is telling myself to start the tx and see what happens and if its bad dropout later...I really don't know what to do but i am scared and runnng out of time...if anyone has any advice please do give...........thanks MIKE

[traveler65]

Hi: because your young and have no damage you have a great chance of obtainining SVR. I would try it as long as I could get PCR's at 4, 12, 16 weeks or earlier and more frequent even if I had to pay for them. That way you could monitor your progress. If you are UND at 4 weeks then it is a no brainor to continue on as long as sx are managable. If not UND by 12 weeks, the best thing to probably do is stop tx and wait for better drugs. That way you are not putting the poison into your body for a year without the best shot of clearing.
Many here your age continue working right through tx. Hope you don't have a very physical job.
Good Luck

[havhep26]

thanks for the reply, but because i'm so new to this could u just expalin svr, und and that kind of stuff sorry but i'm naive

[mremeet]

Hmm, not sure I'd go along with that one. Do they allow rescue drugs during your treatment? If not, you might experience IFN/riba dose reductions that would lower your odds of success. Plus, you don't need to enroll in a trial to take higher levels of ribavirin (provided you have insurance to pay for it). If you shop around, you can probably find a doctor who would be willing to prescribe a higher than standard dose of ribavirin. And that way you'd know you're getting what you want, and can also take rescue drugs. Plus, if your viral load results are blinded, that's a real drag. Treating outside of a study you could see all of your VL results realtime, which means a lot.

And none of this even touches on your young age and F0 fibrosis. Sounds like you can afford to wait, at least for a little while. But if you are significantly overweight, that can contribute to the progression of fibrosis by possibly causing fatty liver. And it is true the disease can move much faster in some than in others. But in my opinion, I'd concentrate on taking care of yourself right now by eating right and exercising and getting your weight under control.Obviously avoid alcohol and anything bad for your liver. Since you have a new family and are infected with HCV, that should give you a good motivation to get yourself in shape. Then wait out the results of the VX-950/telaprevir trials which are scheduled to be updated in another week or two. If things are looking good for telaprevir, I would suggest waiting for it to become available or possibly enrolling in a phase 3 trial in another year or two.

[mremeet]

SVR means "Sustained Viral Responder", which essentially means you remain undetectable 6 months or more after completing treatment. It's basically just a fancy way of saying you are cured.

UND means undetectable virus according to whatever level of sensitivity of viral load test you'e using.

PCR is an acronym used for the viral load test. A PCR measures how much virus is in your blood.

F0 through F4 are grading scales for a liver biopsy. F0 if normal (no fibrosis) and F4 is cirrhosis. There are other types of grading scales used, but the F0-F4 are the most common you'd see here.

[madbrad]

In my honest humble opinion..Do the TX.....Especially if you already have a high VL.......If left that way a liver once undamaged is left to get damaged..
       Why take the chance when you can get FREEEEEEE TX......But just as was stated I'd ask for PCR's......Reason being is that 12 weeks is ,I think average for UND PCR'S...

[jmjm530]

HH: My wife and mother say that since i have no liver disease now and that i'm otherwise healthy that i should quit the study.
---------------------------------------------
You wife and mother sound very wise.

The fact your doctor wants to treat doesn't mean it's the right decision for you. More so in a trial setting where by it's very name, the treatment approach will be on "trial" with you being the guinea pig in court. Your doctor has a quota to fill for the trial need I say more.

As you probably know, newer drugs treatments such as VX-950 are now in the trial pipeline with some important trial data to be released in a few weeks at the Barcelona convention. And while the newer treatments still include interferon, the treatment times are shorter (i.e. less drug exposure) and some of the trial arms don't use interferon. What's more, some liver specialists believe that in 3-10 years they will be treating without interferon, which IMO is the most problamatic of the drugs in that it alters the immune and metabolic system, perhaps permanently.

If it were me, I'd listen to wife and mother and wait to see what's around the corner. Meanwhile, of course, monitor your liver condition under the supervision of a liver specialist.

All the best whatever you decide and congratulations on such a good biopsy result!

-- Jim

[jmjm530]

As to the idea of starting treatment and seeing how it goes, I think in your case it's a bad idea, a slippery slope so to speak. Once you get started it will be hard to stop, especially if your viral load drops. Also, many of us naturally go into "warrior" mode out of necessity during treatment which doesn't necessarily make for the most objective treatment decisions regarding ourselves. I think you should make a decision either to treat or not and then stick with it best you can.

-- Jim

[Kalio1]

Here is a great video to help you decide on treatment put out by the American Liver Foundation. It is well worth watching. You might have your Mom or whoever else is suggesting you wait watch it too.

http://www.mssmtv.org/player_alf/player.php?id=alf_2007_01

[bobbyullc]

with no liver damage i would not take tx now for 48 weeks even if they paid ME.
the odds are only 45% of svr and chances are you will have moderate to severe sides.
new drugs are in trials and look great. if they work it should be far less time on tx with far greater chance of svr. a year or two is not a long time to wait to see how they pan out. i had hep c 10 years longer than you were alive with no ill affects.

the drug co's offer free tx to all who can not pay so money should not be a problem. they paid for mine free and i make a few bucks. why waste a year of your life when it is very likely soon you may be able to get svr in only a fraction of the time.
when i first was diagnosed 10 years ago the svr rate was only 10% now it is 45% in several years it should be 98%.
a friend of mine had to drop out due to severe depression before he killed himself. the depression hits most who had previous bouts with it the worst.you being overwieght will most likely get higher levels of riba and further your risk of sides.

good luck,

[bobbyullc]

ps. a high viral load has no affect on amount of liver damage but does reduce you chances of svr by a small amount. so does being overweight.

[jmjm530]

Bobby has a good point about being overweight and SVR, at least with the current drugs. You might do yourself and family a better service healthwise, by spending the year on a good nutritional and exercise program losing that excess weight, as opposed to going into a trial for those who are overweight, potentially exposing yourself to higher doses of ribavirin.

-- Jim

[jmjm530]

Finally able to watch the Dr. Dieterich video in most of its entirety as last time the link was posted the video seemed to stall a lot.

While I have tremendous respect for Dr. Dieterich as both researcher and clinician, I was disappointed in this particular video on a number of levels including its overlysimplistic approach, not to mention what I consider lapses in logic. It should also be noted that this video was funded by Roche Pharmaceuticals, the manufacturer of the leading treatment drug combination, Pegasys and Ribavirin.

As to the logic point, where Dieteich IMO goes awry is where he hangs his hat on a chart showing a 1 to 2 per cent decrease in SVR for each year you wait to treat starting at week 20. Assuming this chart takes into account changing BMI and perhaps resulting insulin resistence, etc, per cents as the population ages -- and I'm not sure it does -- what Dieterich does not account for in this equation is what he later shows on follow-up charts which are higher predicted SVR rates with the newer drugs over the next 2-10 years, depending on the particular generation of newer drugs in question.

So on one hand, he's saying if you wait, let's say five years, you may have a 5 per cent less chance of SVR, but then a few slides later, he shows that if you do wait to treat, you potentially will have a much better chance of SVR.

By his own slides, Dr. D. estimates a potential 65-70% SVR rate if you wait one or two years (08-09) and an 85-90% SVR rate if you wait 5-8 years. (11-14). So unless my math is wrong, by his own figures and estimates, any decrease in SVR by waiting should be more than compensated by an increase in SVR rates by newer drug treatments. Of course, no guarantees with approval times and SVR rates with the newer drugs, but the hepatologists that I've talked to and read -- including Dieterich -- do seem optimistic.

All in all, I view this video as a kind of much needed global pep talk to get people aware and into the treatment process, as so much of the population seems to be hiding on rocks on this one. But I don't view it as a persuasive message to treat one and all regardless of liver damage, genotype, etc.

I'll also add that there was one potentially misleading narrtive that intimated that after age 50, you had ten years until you got cirrhosis. If you play back the narrative and listen carefully -- and if you look at the slide being presented -- you will see that they are talking about age of infection and not how fibrosis progresses after age 50. Point being that if you become infected with HCV after age 50 then fibrosis progresses much faster than if you become infected with HCV at a younger age. Big difference.


-- Jim

[jmjm530]

In the third paragraph, above, I wrote "week" when I meant "age". It therefore should correctly read:

As to the logic point, where Dieteich IMO goes awry is where he hangs his hat on a chart showing a 1 to 2 per cent decrease in SVR for each year you wait to treat starting at AGE 20.

[shastri20032003]

Hi Mike. Under the circumstances, this is the plan of action I would opt.

Wait for a year,get yourself in shape to the desired BMI,avoid alcohol,follow a healthy diet, collect as much info on hep c that you can since knowledge is power(this forum is the right place for that)and with this disease you have to advocate for yourself

After a year you would still be young and be better equipped to handle any decisions you need to make. At the same time I am sure you would be monitoring the progress of new drugs on the horizon

After a year If there are no better drug options and once you are ready to start the treatment ensure that you have access to rescue drugs and to do your PCRS at week four and week twelve

Before proceeding with treatment make a decision that you would continue only if you are clear of the virus at week 4 and then at week twelve since if you donot clear at these weeks your percentage of beating the virus drop drastically and it would be more prudent to discontinue your treatment and wait for better treatments to come along
Wishing you the best
Regards

[jmjm530]

Here are what I consider more balanced diaglogues on treating versus not treating.

The first is a Point/Counterpoint Debate satellite symposium held during the AASLD Annual Meeting in Boston, Massachusetts on November 3, 2002. Because of the date, the newer protease inhibitor trials are probably not factored in as much as they might be if the debate took place today. Dr. Douglas LaBreque takes the position that virtually all patients should be treated, while Dr. Robert Gish takes the position that only selected patients should be treated.
Free Medscape Registration required to view debate here:
http://www.medscape.com/viewprogram/2053

The second is from the "Clinician's Companion VI" on the Clinical Options Web site. Two actual case histories are presented, while eminent hepatologists give their reasons why they would or would not treat the particular patient in question. Not sure of the date presented. Free Registration at the Clinical Options Website required to view the discussion here: http://tinyurl.com/2uyuto

[Kalio1]

Info from 2002 is outdated. Much has changed since then including the increased awareness regarding the importance of treating your disease once you have been diagnosed and the risks of being HCV positive regardless of level of damage.New approaches and ideas happen relatively fast with this disease as more is discovered about it, the more current the info the better. Info that is more than 5 years old  should be considered in light of more current info. Just being Hep C positive is causal for a variety of other illnesses including but not limited to Diabetes and certain Leukemias. Hep C is a blood disease and can affect you in more ways than damaging your liver.

That is not to say you don't have plenty of time to learn all about Hep C and weigh your options as to when you will treat. I think Shastri's suggestion is a very good approach for you.

[Electra56]

For what it's worth.....I too had a high viral load (12 million) and 0-1 Fibrosis, with 0 inflamation (inflammation).  At the time of diagnosis I probably had HCV 1a for close to 30 years.  I was very unsure about whether to treat or not, and so sought the advice of several doctors.  Basically it was a toss up- I heard good arguments for either route. So for me, and this may apply to you, it became a matter of personal choice- what factors would want you to get rid of the disease now, or compell you to participate in this trial- cost can be a big determinant.  I don't know your ethnicity- but African Americans do not respond as well to IFN and often have to be treated with double dosing. I also don't know your weight, but as some already mention- this goes in the minus column.  You are young and it sounds as though you can wait for the protease and possibly polymerase therapies.  Viral load does not correlate with liver disease- so don't worry about that.  Good luck.  

[bobbyullc]

on the other hand if you are recently married and your wife wants you to wait you should tx now just to show her who is boss in this marraige. do not get off to a bad start letting her have her way. a year of misery may be worth getting your point across. also if you are sick you can get out of changing diapers,feeding etc.

[Kalio1]

I sure hope you are joking. This sounds like something out of the male chauvanist pigs' handbook.

[jmjm530]

I certainly agree with waiting a year if for no other reason to get his BMI down. This will have an overall health benefit, not just limited to a better shot at SVR with the current drugs.

I know you didn't mean to give an "either/or" scenario in your thoughtful and carefully worded post, but just in case others read it that way...

As a stage 0, the decision doesn't have to be either treat with the standard drugs or treat with newer drugs when they become available. In fact, the wisest choice might be to continue watching and waiting, perhaps even for the next generations of treatments which hopefully will be without interferon or ribavirin.

Regarding your treatment scenario for those with little or no liver damage who decide to treat with the current drugs (SOC). I'd even go one further and committ in advance to the shorter-course (24 weeks) for geno 1's if meeting any pre-tx viral load qualifications.

The problem, however, with a 4-week stop rule approach is discipling yourself to actually carry it out, given the mental preparation required to start treating, and the inevitable "cheerleading" once treatment has started -- even by your medical team -- not to mention the "warrior" mode many of us naturally go into when we begin treating.

So let's say we drop two-logs at week 4, and the doctor urges us on "guaranteeing" we will be non-detectible "soon". So now, we're at week 12, and let's say non-detectible but now we're committed to 48 weeks (instead of 24) and the odds are no longer as good as they were had we been non-detectible at 4. So unless we have a medical team that will literally "pull us off the drugs" (and I think that's why the term is used sometimes) a four-week stop rule can become a slippery slope leading to longer treatments with diminishing odds. Certainly not against a four-week stop rule for selected patients, just some thoughts about the issues involved in implementing it given that it's still not a widely established stop rule.

All the best,

-- Jim

[jmjm530]

As already stated, I think in this particular case that the fact the debates took place in 2002 (pre VX-950 trials) tip the scales even more toward "watch and wait" for those with little or no liver damage -- as opposed to "treat now", the theme in Dr. D's video.

As to Hep C being "causal to other illnesses", while there may be some merit, I saw no mention of this in Dr. D's reasons for treating, in fact he focused almost exclusively on the progression of liver damage, which is my understanding as well in terms of reasons to treat. In fact, as you probably know, the treatment drugs themselves have a whole host of potential problems healthwise, since they alter the immune and metabolic system, possibly permanently. My LDL (bad cholesterol) had gone up since treatment and my triglicerides (triglycerides) have gone up. My liver specialist now tells me that the metabolic syndrome -- which includes type 2 diabetes -- can sometimes be worsened by interferons. There was also a fairly recent thread over at the "Janis and Friends" web site that anecdotally showed the same thing -- higher cholesterol levels post treatment. A couple of other related studies:

http://clinical.diabetesjournals.org/cgi/content/full/22/1/43

"...Stimulation of immune responses may have deleterious consequences. Cytokine-induced exacerbation of underlying diseases or immune dysregulation are examples. {alpha}-IFN may enhance an ongoing autoimmune process directed against pancreatic {alpha}-cells and be involved in the development of type 1 diabetes in predisposed patients..."

Or, from here: http://www.hepnet.com/nih/dusheiko.html

Hormonal and Metabolic Side Effects

A sustained increase in serum triglyceride levels has been reported. Diabetes mellitus may worsen or develop.
---------------------------------

Other studies are now looking into the relationship between the metabolic syndrome and the virus itself and how treatment might help type 2 diabetes. Again, nothing cut and dry regarding the HCV virus and how it affects us.

-- Jim

[NYgirl]

Perhaps the doctor is thinking that due to your 200+ weight (I have no idea if you are tall or short and just ASSuming that because of his wanting you to do the treatment perhaps overweight) that could be one reason why.

It is more difficult for those who are overweight to achieve SVR (systemic virologic response) than for someone who is thin.

We don't have all of your information only that you are zero on the fibrotic scales.

There could be information that we are not privy to that helps him make this decision.

But...if it is definite that you have no serious fibrosis (and no other underlying significant problems that we don't know) it would appear that you could wait it out and see if perhaps in a few years there are better drugs.
---
Most all of us have done the regular old treatment and it has been no fun but for the most part tolerable.

I did it for 72 weeks and worked the entire time and I am a BIG CRYBABY...so if I could do it - I guarantee you you could do.

The concept is very scary but...I WISH to GOD I had done the treatment when I still had no liver damage.  I did it as soon as I found out I did have it but already by that point I was stage THREE.  It would have given me much better odds (and saved my liver all of that damage) had I known then.

So..........you have a lot to think about and it is your own decision that NO ONE else can make for you.

Keep asking questions..........the more you know the more it helps.

Good luck!

[theonam]

Iam almost 58 yrs. old had hep c for at least 40yrs.since I was 19 yrs. old
In South Viet Nam as a young Marine My last  biopsy was Stage 1 to 2
Grade I with normal liver pannel test blood work that was six yrs ago
I will see my doctor at the V.A. for another Biopsy whatever the results
I want to try the treatment.Never tried treatment before But I want to give
It a shot before I reach 60 yrs. old and develop more problems with getting
older with hep. C . go for it brother...