biopsy results

[Javi1962]

this is my biopsy results:  Serial sections of "liver biopsy" show mild fatty change. lobular inflammation is spotty. the portal aeas are expanded by lymphoid infiltrate. The piecemeal necrosis is mild. Iron stain reveals absent iron. The trichrome stain exhibits moderate fibrosis with fibrous portal expansion. Clinically, patient is positive for Hepatitis C viral markers. The findings are those of chronic Hepatitis C with mild activity (Grade 2 on a scale of 0 to 4) and moderate periportal fibrosis (stage 2 on a scale of 0 to 4)

Diagnosis:

A. Chronic Hepatitis C with mild activity (Grade 2 on a scale of 0 to 4) and moderate periportal fibrosis (stage 2 on a scale of 0 to 4)

B. No Evidence of Cirrhosis or Malignancy.

Today at my follow up visit to biopsy, Doctor wants me to treat, he already wrote out the prescription for the rivabarin and peg. Interferon? he said no need to wait, to risky, could lead to liver cancer or accelerate to level 3-4, don't take chances. I asked about new drugs and can I wait for them, Doctor replied don't hold your breath in regards to new drugs, he said they have been talking about that for years, no need to wait and gave me prescription and told me to come and see him 1 week after 1st SHOT!!!

not sure what to do, I want to wait for new drugs, but I don't want to progress to something worse! and suggestions would be appreciated.

[jepperone]

A quick look back, I think they were both in the R7128 trials. Perhaps they will chime in.

jep

[Bill1954]

Javi, I think we’ve had several members in here that have been or are involved in that trial med; try TeeTom and possibly Epipheny?

Does that sound correct to others?

Bill

[jepperone]

It is a Hoffmann-La Roche study. I'm not sure if any here have been on it or not.

jep

http://clinicaltrials.gov/ct2/show/study/NCT00963885#locn

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

[Javi1962]

that trial was closed, but there is a new one coming out in Feb that I can sign up for and it is using R05190591 with peg2 and rib for 48 weeks, has anyone heard anything about R05190591?

[Javi1962]

thanks Mike! I will call them tomorrow.

[mike716]

If your hemoglobin is 15g/Dl or less, this is the trial you want to get into:
http://clinicaltrials.gov/ct2/show/NCT01023035?term=boceprevir&rank=6

There is no placebo arm! Everyone gets the triple therapy. They are testing between two methods of dealing with anemia, that's all. And not everyone gets anemic, either.

They're recruiting now. Check it out.

Mike

[WriteItDown]

JD, yes, of course if someone doesn't have access to good clinical trials and they are nervous to wait for Tela or Boc, that makes sense.  I  am not necessarily advocating waiting for Tela or Boc -- but it seems to me in Ravi's case he is near L.A.-- they have a lot of trials going on out there, and right now there are really a lot of good new drugs for HCV. So if he could get on a good one he would at least have the chance to try triple therapy.  And in any case he would get SOC.

Jepperone, I guess I did miss your point in that case since I agree.  I don't think waiting very long would be my choice either.  Since I don't know your history I wasn't commenting on a situation when nothing else was available other than SOC.

But Ravi is contemplating treatment at a time when a lot of good new drugs are in trials, so I'm just giving him my opinion that he should try to take advantage of them.

Of course everyone has a different approach.

[jepperone]

Uh Ok!

But I think you missed the point. Meaning don’t wait too long to make a choice and in my case back then the IP’s were still in narrow clinical stages and not open to the vast majority as it is now with your husband.

jep

[jdwithhcv]

"I just don't get why a naive Geno 1 would want to try SOC when other, better treatments exist."

Because those drugs may never get to market.  Its an interesting intellectual exercise for a person without HCV, but when its YOUR liver that's stage 2 grade 2 there is a different analysis to be done.

[nygirl7]

Javi now that (10,000 vs. 12,000) was the way to put something even somebody like me can understand :)

I think my copay was $40 for a month of peg and riba. Then I had a copay for the procrit and ambien and stuff but all in all considering the real cost of the meds - I was very very grateful.

[Javi1962]

so true! I only smoked when I drank a beer, but since that is over quitting smoking was easy for me, my doctor said absolutely NO alcohol, I said how about medical marijuana? he said none of that either:) im not a pot smoker but i had to ask:) i actually read an article online from some berkley professors that say smoking marijuana while treating enhances the chances of svr, have you heard of this? i will send you link. of course there were thousand of other links that refute that claim, but I thought it was interesting.

[Bill1954]

That’s so true, Javi. Another tidbit I heard the other day is that nearly 50% of tobacco smokers will eventually succumb to cigarette-related illness; but only 5% will die as a direct result of their HCV…

Makes me wonder about priorities, you know :o)?

Bill

[Javi1962]

on another note, I don't know why but this made me feel good an article I read that said that 10,000 people die of hep c per year in uSa, and 12,000 people die texting while driving, seems like im worrying so much of dying from hep c, but reality and statistically I need to get rid of my cell phone:)

[Javi1962]

thanks everyone for the feedback, I have to call my insurance today and see first how much this medicine is going to cost me per month to use, that is a big factor as well right now since money is tight! can I get an idea from people here on the forum, how much did TX cost you per month? I have anthem health thru blue cross hmo, but i might have to be placed on cobra my company right now is laying off big time:( I am looking into the trials I have registered on a few sites thanks Bill for the link, I think the trial is the way to go for me and NYGirl, I love your attitude of "i don't care if I was a level 1, I want this virus out of me" that is the attitude I am taking, I am going to defeat this thing I am tired of feeling sorry for myself and my situation I need to face it and defeat it, thanks everyone for all your advise, I don't know what I would do if not for this forum, my family does not always understand because there not the ones going through it and they don't have a clue what this is.

[Bill1954]

Another consideration is that some clinical trials exclude treatment experienced patients. If one were to treat now with interferon/ribavirin, and not respond; they might not be allowed to participate in future PI(?) trials down the road.

These are considerations that should be discussed thoroughly with you, Javi, before you take the plunge.

Bill

[WriteItDown]

Well, I'm going to disagree with the people who seem to think that, since it's all a crapshoot anyway, you ought to just rush into SOC.  It's true that you don't know how you're going to respond to any of the treatments, and in that sense it is a crapshoot, BUT there's documented proof that with the newer drugs you will have a BETTER SHOT at SVR. I say, if there's something available to up your odds in the crapshoot, why not do it?

Like I said, you're close to LA, so even if you're nervous or anxious to treat, and don't want to wait for Telaprevir or Boceprevir, you will probably be able to find a good clinical trial.

I just don't get why a naive Geno 1 would want to try SOC when other, better treatments exist.  Sure, if you get into a clinical trial and get the placebo you won't have benefited much, but you won't be any worse off, either.  Most trials there's around a 75-80% chance you get the trial drug.  I'm not advocating doing whatever trial comes up -- you do have to do you research and find a good one.  But they exist, and you will be seen and followed up on very frequently.  That's just my opinion.

Also, jepperone, what you say regarding the longer treatment doesn't make sense.  If you get on the placebo arm and it doesn't work, and they roll you over into the trial drug, you're still not going to end up treating for any longer than if you did SOC and failed and had to re-treat later. I also have to disagree with your statement that doing the treatment without thinking twice, and in a state of ignorance about Hep C is somehow a good thing in general.  I'm glad it worked for you and that you're SVR (congrats!), but I think for many people knowing what they're getting into and having the info necessary to make informed choices is key. In fact, if Javi1962 didn't want this info he probably would just be taking his doctor's advice and not posting here.

[nygirl7]

There are advantages sometimes to not doing a trial - but then there are advantages to trying to get one of the PIs.  In truth, it has been years we have been hearing about them and hoping for their approval.  In MY opinion, waiting to get to stage 3 isn't really a smart idea - what if they don't ever pan out or it takes another five years and you are then cirrhotic?

If you were stage 1 I'd say watch and wait but.......right now you really don't have too much time left to do that.  You'd REALLY have to WATCH while you wait, aggressively.

It's not going to get any better on it's own........it's only going to get worse from here on in. Even if you are living as liver healthy a life that you can while you have the virus it is in there eating away gobbling up all the nice healthy good cells - regardless.

If you can't find a trial quickly I'd go for it.  At stage 2 you still have enough viable liver left to live a liver healthy life and a long healthy life.

In the end it's a crap shoot Javi and one doesn't know either way if they will succeed.  Even with PIs and even with extensions.  That is one good reason to go for it now and at least TRY to win the battle.

But then I would have treated even if I was a stage 1 I wanted it out of me so badley.  But I've been cured THREE YEARS SVR TODAY so........was it worth it? yeah totally.

[jepperone]

Let me clarify my statement of why bother you’re not ready yet. As you have read there are side effects and then there are side effects, bottom line is your not going to escape many of them unless you are very lucky. Even if you want to wait until the newer drugs come out they are still attached to the soc meds for the most part at this point and time unless you’re thinking of waiting many years down the road.

Even with the newer drugs of shorter duration and if your able to get into one of them you still don’t know if luck will be on your side and if should not respond to the newer drugs and roll over to the standard soc you will now have invested not only 24 weeks into the newer treatment you will have another 48 weeks on top of that for a total of 70 weeks on these harsh meds.

Lastly, the most important element going into treatment is a positive attitude and be prepared mentally to overcome the challenges that lay a head of you and that is what I picked up on in the last paragraph of your post. I was a 1b 2+2 just as you and didn’t think twice about treating out of my ignorance about hepc and was probably the best way to do the treatment looking back now. I am SVR.

Good Luck in whatever you decide.

jep

[IAmTheWalrus]

My liver stage on biopsy after TX was better than when I started TX. This has put me in a position where I can wait for PI drugs for the next TX (since I relapsed on the first).

I think the clinical trial sounds the best to me. Like Bill points out, the worst you will get is standard SOC which you are considering anyway. Often in these trials, they offer treatment to those in the placebo arms after the trials are done. Some trials have multiple arms that get the test drug and not the placebo so often your odds of getting the trial drug are much better that 50/50. I would for sure look into the details of the trials.

Good luck.

[Vic1967]

Your Dr. sounds a lot like mine.  At first I was really mad when she threw around the cancer argument.  She was referring to the distant future, but her point was ,down the road won't you regret not even trying?.
I was at the exact stage and Geno type as you when I decided to treat.
I am nearing the end of 48 weeks.  I'm at week 44 Woo hoo!  Anyway, I just saw my Dr. a couple of days ago and we talked.  I understand my biopsy better now then when I first had it  more than a year ago (stage 2, grade 2).  When I told my Dr. I kinda wished I knew about the new drugs she said, " well, you really want to treat at the stage you were at so to not to progress to cirrhosis."
I waited 17 years to treat because I was so afraid to try.  I was so afraid of the debilitating side effects.  I have had a lot of them, but all in all it was not nearly as bad as I feared.  I went into knowing it wasn't do or die and that I should at least try.  Since for me it wasn't life or death, it it was just too hard I could stop.
I have hung in there.  It's no fun, but I went on vacation while treating, survived the holidays and have manged to carry on.  My family has been really good about it.
Deciding whether or not, or when to treat is a hard decision. But it is true, while a lot of people suffer, not all do.  There is no way to tell how you are going to do until you do it.  You are different than everyone else.
Try not to worry.
Best of luck,
V

[Bill1954]

Javi, HCC, or primary liver cancer is very rarely associated with Hepatitis C outside of cirrhosis; I’d ask this doctor to clarify this. It’s not fair for him to throw that around as a tool to scare you into treatment; that isn’t right.

Bill

[jepperone]

Why bother, you are not ready to treat yet.

jep

[Bill1954]

http://www.centerwatch.com/clinical-trials/listings/studylist.aspx?CatID=670

[Bill1954]

I’d ask him about participation in Clinical trial, Javi; that way, you’re receiving the interferon/ribavirin, and not having to wait for approvals of these experimental drugs. You’re in Southern California, right? There must be several trials available to choose from for treatment naïve patients.

This one in particular looks very promising, although the location in Los Angeles shows active, not recruiting; you could discuss this with him anyway, and see if something else is available:

http://clinicaltrials.gov/ct2/show/study/NCT00963885?term=hcv+AND+los+angeles+ca&rank=37&show_locs=Y#locn

While there have been many trial drugs for HCV in the past that have failed, none of them have reached this point in development. Most of the safety and efficacy for both Telaprevir and Boceprevir have been ironed out, and their eventual approval appears imminent; at least to this non-doctor guy.

My hepatologist in December Sacramento told me she feels Telaprevir would be approved in 2011; they are principal investigators in many trial drugs, and have a deep understanding of how all this works. That said I don’t know for certain if they’d counsel you to wait for release either.

I do think most doctors would offer you the option of waiting; if this one doesn’t, you might need to find another opinion?

Bill