Great news on biopsy, but now I am really confused as to what to do about treatment.

[Looks4Path]

Finally liver biopsy back and time to see the Hepatologist this past Monday. I immediately asked for all test results, and even before seeing the Hepatologist got my hands on the biopsy report. Imagine my surprise to see "Grade 2, Stage 2 Metavir score A-1, F1. I about jumped out of my seat and acted like a complete fool! I had in no way expected this, and had been preparing to treat immediately since the Hepatologist had pretty much informed me he thought I had cirrhosis from a low platelet count and what he thought were spider nouvi.Not only that, the biopsy report states porphyria Cutanea tarde could not be determined from this biopsy will forward to quantivie iron determination as requested which I find interesting since I had this 19 years ago.

When going to the appointment with the Hepatologist I had resigned myself to starting treatment almost immediately, now I find I have options. According to the Hepatologist it is up to me when to treat. Now, or I can wait until the new drugs are here. Results were good but at some point I am going to have to treat. His best estimation of when drugs like Teleprivir or Boceprivir would be available would be 3-5 years. I honestly was so awestruck and unexpecting this I had no idea what I wanted to do now! He ended up sending me out of the office with a follow up in 3 months to let me think about it. He suggests that maybe I go ahead and try 4 weeks of treatment, and he says that being geno type 1a, I will know in 4 weeks if I EVR if I have a good chance or not of succeeding, and of course by 12 weeks knowing whether it is worth it or not at all, and then I could stop and wait if need be for the new PI's.

I have been trying to weigh everything here because of my home situation and of course want to give myself the best chance to SVR I can if I try. Some of the questions I have are:

Is there anyway of knowing how quickly liver disease is moving? If I waited for 3-5 years would this put me into stage 3 or even 4?? And then have to have another liver biopsy before treating?

I am 56 now, so 3-5 years from now I could possibly be 61 and would that make SVR more difficult?

I am possibly the healthiest I have ever been right now, and no other health problems, so waiting I might not be that healthy 3-5 years from now so should I treat now?

Is there any chance that Teleprivir could hit the market early? Or any chance of using it without FDA approval?

How long does it take to set up treatment should I decide to treat now, that is with insurance company approval or without insurance company approval? Hepatologist's secretary told me not to worry about this, as if I decide to treat they will work it out some how, but I would hate to be ready and then not be able to treat.

So many questions running thru my mind now, any opinions?

thanks,
LD

[newleaf09]

Until FDA approved you can only get the protese inhibitors in a study.  Look them all up on www.clinicaltrials.gov.  

It's better to treat when you are younger but if you are still in as good of shape at 61, age should not make much difference.

It is impossible to predict the progression of the disease.  If you stop drinking or doing other things that beat up your liver, it could actually improve before treatment.

I'm not sure if it is good or not to try a short trial with standard drugs.  There are a few people who fail to respond to interferon at all and once they find that out, it's a waste of time to continue or treat them again.  I don't believe I have heard that brief courses would alter a later responce, though.  Perhaps someone else has seen some research on that.

[jmjm530]

Congratulations on the good news. Personally, I'd wait because in 3-5 years you will have better options requiring less treatment time. Actually that should start in just a couple of years. Meanwhile, no harm in getting a second opinion, especially with the biopsy slides as different hepatologists are known to stage things differently. Also, talking to more than one hepatologist sometimes gives you a better perspecitve and therefore makes the decision easier one way or another. I spoke to three or four (who's counting LOL)  in the couple of years before I eventually decided to treat.

-- Jim

[charm27]

Im stage 2 grade 2 as well. I was told I should wait as well. However I never do as Im told (LOL) and I tx'd  for 55 weeks Im a 1A.

I just figured Im healthy no other issues let me give it a shot (no pun intended)...thinking maybe I wouldnt even respond to meds...you just never know. So..I took the plunge and am 5 months post tx...we shall see.

Wish you the very best in whatever you decide.
Will be a marvelous day when the new meds arrive.
Charm
Great news on your biopsy glad to hear it.

[Kristina538]

I was officially stage 2 grade 2 subject to the small samples on the biopsy - there was bridging fibrosis and the specialist said because of that, and my scan (showing portal hypertension and a slightly enlarged spleen),  that I was "more likely to be Stage 3 and possibly beyond" and got me into tx quickly.  

I would be a little concerned at how fast your liver could deteriorate and get your specialists opinion on this, with some examples, so you can make a sound decision.   If you have a specialist who is prepared to advise you to stop after 4 or 12 weeks if the SOC is not giving you good chances, then you've got a specialist who is being realistic and honest.  Many do not give their patients these options or the options to extend if they aren't responding well enough.   It may be good to investigate some of the trials also??   Best wishes on your decision.

[GoofyDad]

Sorry to say that a biopsy can be off by a couple stages. THe issue is the sample size, and that different areas of your liver can be in different conditions. Generally I lean to moving slow and methodically - and would not suggest you rush into anything. But I would also not bank on that stage two being certain - particularly in light of other contradicting data. .

[Marcia2202]

Congratulations on your results. I'm a bit confused here though:

Grade 2, Stage 2 Metavir score A-1, F1.....

Isn't A1  - grade 1  and F1 - stage 1

Please someone correct me, if I'm off here...

[jmjm530]

Yes, F1 is Stage 1, not stage 2.

[Marcia2202]

Thanks, I thought so.

So now the question is:

LD, what does your biopsy report say? A1 F1  or grade 2 stage 2????
These are two completely different results.

[Marcia2202]

With the knowledge I have now after treating and if I would be geno 1 with A1 F1, I would definitely wait for the new drugs. Treatment time will be halved, which I find considerably more advantageous, IF you can afford to wait. Which you definitely can, if you are stage and grade 1.  Imagine 'only' having to treat for 24 weeks instead of 48. That is a whole lot of less time!
A lot can happen being exposed to the drugs for a long time. Ie, at the end I found that I might have been a ticking time bomb for developing thyroid problems. My counts were on the border a few times. I think if I had treated longer than the 32 weeks I treated, it could have gone off.

[Looks4Path]

Hello,

maybe this will be more help with the actual wording of my liver biopsy.


Pathologic Diagnosis

Liver Biopsy (N) :
    CHRONIC HEPATITIS C WITH MILD ACTIVITY AND PERIPORTAL FIBROSIS.
      BATTS-LUDWIG GRADE2, STAGE 2: METAVIR AL, F1)
    MINIMAL HEMOSIDEROSIS (SEMIQUANTITATIVE SCORE: 1).
    MILD SINUSOIDAL DILATATION AND CONGESTION.

Diagnostic Comment

The biopsy shows mild patchy chronic portal inflammation with focal interface hepatitis ("piecemeal necrosis") and scattered spotty parenchymal inflammation consistent with ongoing hepatitis C.  The sinusoids appear mildy dilated and congested and portal vascular elements are difficult to identify in a subset of portal areas.  The Masson trichrome stain shows fibrous portal expansion with scattered periportal fibrosis, but no bridging fribrosis or cirrhosis.  The reticulin stain highlights the normal parenchymal architecture and regenerative activity (thickening of hepatic plates), but does not demonstrateany evidence of nodularity or collapse. The iron stain shows minimal reticuloendothelial and heptocellular hemosiderin (semiquantitative score 1+). The PAS stain demonstrates normal glycogen stores and the PAS with diastase does not reveal any cytoplasmic globules.

An unstained paraffin section is evaluated with polarizing light, but uroporphyrin-like crystals are identified.  The presence of porphyria cutanea tarda can not be confirmed from this biopsy.  

Material will be forwarded to our reference lab for quantitiative iron determination as requested, and an addendum will be generated following receipt of the results.

GROSS DESCRIPTION

The specimen is received in formalin, labeled "liver biopsy".  It consists of multiple cylindrical core biopsies of tan soft tissue measuring 1.5 x 0.4 x 0.1 cm.  The specimen is placed in a specimen filter bag, and submitted in its entirety in a single cassette.



I looked up Metavir score and came up with this:

"The METAVIR score helps interpret a liver biopsy. When this biopsy is performed, doctors need a reliable way to quantify what is seen under the microscope. This scoring system assigns two standardized numbers: one to represent the degree of inflammation and the other the degree of fibrosis.
What Does My METAVIR Score Mean?
The fibrosis is graded on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3.
Fibrosis score:
F0 = no fibrosis
F1 = portal fibrosis without septa
F2 = portal fibrosis with few septa
F3 = numerous septa without cirrhosis
F4 = cirrhosis

Activity score:
A0 = no activity
A1 = mild activity
A2 = moderate activity
A3 = severe activity

http://hepatitis.about.com/od/diagnosis/a/Metavir.htm

I want to thank each and every one of your for replying to my post, this is a trying time for me. I will probably have some more questions, but in light of the last couple of posts about the biopsy, it might be putting a different slant on it for me.

thanks so much,
LD

[Looks4Path]

Sorry, typing error.  Patholigic Diagnosis should read:

METAVIR A1, F1)

My error in typing not the labs.

LD

[jmjm530]

BATTS-LUDWIG GRADE2, STAGE 2: METAVIR AL, F1)
---------
You are Stage 1 with the Metavir system that most seem to use here. You are stage 2  using the Batts-Ludwig system. This does not mean you have more liver damage with the Batts-Ludwig system, it's just that the system stages things differently.

[Willy50]

His best estimation of when drugs like Teleprivir or Boceprivir would be available would be 3-5 years.
-------------------------------------------------

I'm more than a little surprised that your hepatologist thinks approval could be even as much as 4 years.  There are quite a few people who feel that Telaprevir approval could come in 2 years and 3 years on the outside.  
That's OK since nobody truly knows..... but when they are attempting to get you to treat based on that likely incorrect premise I kind of wonder if they are giving you sound advice.  There are a few world class hepatologists that are advising their patients to wait if they have minimal damage....which it appears that you do have.

SOC this week; you might have a 45% chance of a SVR for a 48 week treatment.  Your chances of an RVR?  10-20%

Lets say you wait 2.5 years and Telaprevir is approved.  As a naive you have a better chance of a SVR  Phase 2 naives trials averaged about 65% and 24 weeks.  Some recent EU trials hit over 80%.  Phase 3 trials are still underway but Vertex is reporting better compliance and higher success rates.  We don't yet know what the best SVR rate will be.  I believe that there will be evidence that a 4 week SOC lead in prior to triple therapy dosing will bring up the SVR rate.  When a 4 week lead in is added to conventional Boceprevir triple therapy dosing the SVR rates go up about 10% in both the 24 and 48 week arms.  I believe that the same principle will bring up the telaprevir SVR rate as well.  If that were true the success rate could near the 80% area.

It is still too early to say but the rate may come close to double the SVR's in half the time.

Interferon is also not a benign drug.  Limiting ones exposure to it might also be a worthwhile consideration since you appear to have time to wait.

best,
Willy

[jmjm530]

You will never know unless you try.
--------------
Never understood that logic. For me, something as important as a treatment decision should be based on what you know *before* you treat and not simply hope for the best regardless of consequences.

"Willy" makes a very good case for a watchful waiting approach for those who have time to wait. His case is based on what we know or strongly suspect now, as opposed to just diving in and seeing what will happen.

Some have had excellent results with current treatment and some have not. Same with side effects both during and long-lasting. From what I can tell the newer drugs offer better prospects for those who decide to wait  based on both liver histology and consultation with a good hepatologist.

-- Jim

[Willy50]

I'd like to amend what I wrote a little.  
In looking at the Boceprevir results one can say that the response rates were about 10% better with a lead in.  One can say that the 48 week arm saw about a 10% improvement in SVR's when a SOC lead in was used.  The 24 week arm is an improvement and not a 10%; more like 5%.  It could be the smallness of the studies could skew that stats.  I don't think that an improvement is guaranteed but I think it is likely.  I don't think it a stretch to project a 70% overall SVR rate for genotype 1 naives, and generally in 24 weeks.

In the final form of treatment they will work out treatment durations.  The standard might be "12 and 12" but super responders might either be shortened in TVR dosing or SOC follow on dosing.  Slower responders might do a longer SOC treatment.  

These shorter triple therapy arms could end up lowering the risk of rash and anemia and thereby increase the number who complete and therefore SVR.  There remains a potential that a 4 week lead in could also exacerbate the rash and anemia issue where PI's are involved.  I guess it is most prudent to not speculate.    We may see further improvement when the Phase 3 trial results come in.  I don't think we'll have long to wait

The predictive value of using triple therapy will be good; about 80% RVR and most who RVR...also SVR.

best,
willy

[GreatBird]

I don't agree with Looks4.

I had two biopsies seven years apart and there was no change in the condition of my liver. I'm not saying that there may not be any damage from the hep C, but I've had it for over 45 years and my liver is stage 1 grade 2.

There's a lot that has changed just in the seven years since I got my diagnosis: PCR tests go much lower (down to <2 I believe). Back then, a test that went down to <615 gave a lot of people the wrong information, telling them they were undetectable when they weren't. In those days many doctors would treat genotype 1's for up to 24 weeks--or even longer--without worrying that they were not undetectable and they still stopped treatment at 48 weeks. In those days 3's were not treated longer if they were cirrhotic and were not weight based. They didn't understand the importance of RVR and early VL testing.

Adopting a watch and wait attitude can be the best thing or the worst thing--it really depends on a person's individual circumstances, both with their liver and their life.

One thing is for certain, they keep learning more and more about how to treat this virus and eliminate it successfully. This can make for shorter and more successful txs.

[GreatBird]

Wow.

I certainly am suffering from brain rot today. I meant did not agree with Cured4.

[Trish77]

Because this disease has no guaranteed timeline on how it will progress, I'd suggest you give some thought as to the impact of doing treatment in two years or five years if your liver damage progresses to the point where you have no choice but to proceed regardless if new treatments are out or not.

You have insurance coverage now.  Will you have it when you need to treat?  Does that matter?

I don't know your home life.  Will it sustain treatment now?  Will later be better?  How much does that come into play?

Your employment situation - you don't know how treatment will impact you.  Does your employment situation allow for you to do treatment now or will you be better off waiting?

Support system?  Better now or later?

Just some things to think about.  There isn't a perfect time to do treatment however you have the luxury of at least considering a time and trying to fit it in where it's best for you as much as possible.

Good luck with the decision.

Trish

[jmjm530]

Cured: But your liver will be more damaged then it is today and your overall health will be worse then it is today - perhaps by a little bit - or perhaps catastrophically - no one can really know  - but it will be worse.  And most of those changes will be irreversible.
---------
Not true. Fibrosis will often stop and regress with successful treatment. You're also not taking into account what the prolonged exposure to interferon can do to your immune system, many times causing autoimmune problems post treatment. The newer drugs potentially offer less than half the exposure to interferon.

I have never stated that people shouldn't treat with minimal damage. There are pro's and con's to the decision. What bothers me is that you only see things one way and probably worse, back up your opinions with faulty data.

-- Jim

[jmjm530]

Cured: Misery loves company on the internet and there will always be harbingers of doom telling you to" wait another few years" just like they did and are doing.  Not me, no thanks.
------------------------------
Your name calling, uneducated and over simplistic take on treatment speak for itself. You call some of us "harbingers of doom" because some here offer a watchful waiting approach option? If we are harbingers of doom then you are the pied piper of simplistic thinking.

[Willy50]

I don't positively know when I was infected  but my major risk for infection was in the mid 70's.  I had a biopsy last year and my staging was 1/6.  There are actually quite a few people in the forum with minimal damage.  Somehow the damage that you postulate occurs everyday has not happened to many people here.

I often see such arguments; one should treat TODAY since you'll never be younger, less damage etc.  I also see the argument that one cannot wait any longer since your damage staging dictates that you must treat.  Presumably everyone in between must also treat.
In that regard......there is no decision making process; everyone should treat today regardless of staging.

When I got my biopsy the guy that is a department head.... a fellow who does liver transplants told me that it is possible that I may never even need to treat.  Not everybody develops cirrhosis after all except possibly after many years.  In THIS thread we are talking about several years, not decades.

In the case of Vertex Telaprevir all of their Phase 3 trials will end within 18 months.  Approval is expected for this FDA fast tracked drug in about 2 years.  I don't know why the hepatologist would characterize this as 3-5 years.  I don't think it is accurate.  I don't think that a stage 1 is going to progress in 2 years in any meaningful way to either risk damage or risk not clearing as a result of waiting.  
---Yes.... if there was no better treatment coming I would also argue; why wait?  

What is coming in about 2 years is several treatments which will nearly double the current cure rate, do it in half the time.... and thereby limit patient exposure to some rather toxic chemotherapy.

The fact is that when one reads HCV forums for years one comes across many people who have been harmed in various ways from interferon.  I'm glad that you cleared and that you are healthy.  There are people who also tried to treat who failed and who also had residual health issues which can make treating again a tougher issue.  What percentage of people develop auto-immune issues for instance?

My view is that current treatment has been a godsend.  It has cured many people I know.  At heart of the issue is IF a stage one can wait 2-3 years.  I think the answer is YES.  Will they be harmed in waiting?  I think the answer is NO.  Is treating with 24 weeks of SOC safer than treating for 48 weeks? I think the answer is again is a resounding YES.

One also needs to consider; if TX does cause some damage..... can my doctors fix that damage?  The answer; sometimes yes.....and often times no.  Dental issues are a common problem and I know many people who have had extensive damage but who were able to have teeth replaced.  Sadly, there are many people who seem to have a host of issues that doctors have not been able to diagnose let alone solve.  Unfortunately many doctors are able to provide a coveted "SVR" but often are not well aware of any well developed protocols for treating the symptoms that chemotherapy may have manifested.

I'm just a layman with no credentials.... but last week I heard J. McHutchinson (who I believe is a respected and renowned hepatologist) mention that he was telling his patients to wait 2 years till Telaprevir is approved.  This guy has treated many, many people and for him the trade-offs are well worth the minor risk in waiting.

I like people looking at their options, educating themselves to the possibilities and then deciding.  If people are informed I always support their decisions.  That is why I provide my argument and I am also glad that you provide yours.  This forum works best when both sides of an argument are offered.

best,
Willy

[GreatBird]

I'm not a harbinger of doom because I'm suggesting the possibility of waiting. Wow. That really cuts.  

You have many valid points but it's swallowed up by your vehemence and tunnel vision. Not everyone is like you. That does not make the rest of us negative or wrong. It means we have differing opinions.

One may not know until AFTER they have treated whether they made the right decision.

[jmjm530]

Don't worry, apparently you have good company since as Willy points out, the well-respected hepatologist Dr. John Mchuchinson of Duke is also a "harbinger of doom". Not to mention me and Willy :)

-- Jim

[Willy50]

Yes, I also recommend that people cut back on red meats and fatty cuts of meat.

Careful diet is important if one is to watch and wait and wait and wait.  ; )

Best,
Willy

[jmjm530]

Careful diet is important if one is to watch and wait and wait and wait.  ; )
---------
I believe that is called "watch and weight"

[Trish77]

"So you can gamble with your life and health on an easier cure 5 years from now or you can take 90 days of treatment to find out how effective it is for you it is for you - at worst , at the very WORST you have a 50% chance of a complete cure."

You make it too simplistic.  Suppose he gets RVR and as a result it means he's going to continue treatment.  That's not 90 days.  That's 48 weeks.  After the first 12 weeks there's still the remaining 36 weeks to get through.  He really has to think about this from the perspective of 48 weeks.  There's no point in even going the 4 or 12 weeks if he's not going to continue beyond an RVR.  So the assumption is that he'll do the duration if he gets RVR so he really has to approach this as prepping for 48 weeks, not 90 days.

You're playing the fear card also as a harbinger of doom yourself, that if you don't do treatment now, you're gonna die and that's just not right and not fair of you.  It's a common saying that most people die with Hep C and not from Hep C.  The only problem is there is no way of knowing how fast your own liver disease will progress. A number of people wait and watch and manage to go many years without treatment and manage to do okay.  The key is to WATCH but also to take into consideration all the variables that will come into play and weigh them out in regards to treatment now or treatment later.

I did treatment early at Stage 1, Grade 1 because all my marbles lined up for me to do treatment now - contract job that I could afford to lose more than a permanent job, single so no relationship to impact, kids doing well on their own (although there were some risks there) and I had medical coverage for 80% of the drugs and couldn't guarantee I'd have that down the road.  Could fit treatment into my life now so that I could then get on with it and go after the permanent job when done treatment instead of interrupting a permanent job later on.  Now I have that permanent job and I just found out I am SVR.  If I found out otherwise, that I'd relapsed, I can tell you definitively that I'd be waiting and watching.  Not because I'm turned off of treatment but because I have that luxury being early stage damage and it doesn't fit into my life right now and I can wait for better treatments and I would have.  Also because I'm more aware of how serious treatment can be for many people and the risks we take undergoing treatment as well as by not carefully watching while we wait for better treatment options.

[moahunter]

I disagree. I think the only reason anybody would not do 12 weeks of treatment to see if they are RVR / a good candidate, is that they are frightened / scared or just generally have a weak personality. We have a treatment now that works, people are being cured, and freed from thinking about this. It worked for me, and it will work for hundreds of thousands of other people.

Yes, there are new treatments coming. Yes, they may make treatment better / shorter / less sides (or maybe more). But why on earth wait, leting yourself get slowly sicker, when after a short period of time you can fine out: 1) How well you tolerate treatment (many people have very few sides - although I wasn't so lucky), 2) Whether your odds are very high (Rvr).

[Teufelhunden]

OH MY GOD!!!  McHutchison a harbinger of doom??? The same McHutchison who told me I'll die of old age before I do from Hepatitis??? Say it aint so!!!  Woe is me!  Here I was geno 1a, grade 1, stage 1 when I started, grade 0 stage 0 when I ended 48 wks  later (relapsed 3 months after) and McHutchison tells me to wait for better drugs??  This is really screwing with my head, people. It's bad enough with my memory shot to hell, now I gotta deal with this?  Uh, what were we talking about?  Hamburger!!  Right. I like mine with lettuce and cheese, mustard, ketchup and pickle.

[Teufelhunden]

I'm 56 also L4P. We're still young. Would you rather have a much higher percentage in a couple years for a "cure" or take your chance being a 1a and doing treatment now?  It's a roll of the dice with treatment now.  There's some of us who did and... we had some winners and we had some losers.  Hate to see someone go through all that BS and not be a winner.  No guarantee, no money back, no promises.  Not now anyway.
Teuf

[IAmTheWalrus]

No question that waiting for the newer drugs is the best route in general. They show much promise in effectiveness and in toleration. The big question is the one you asked first which is "how fast will the disease progress". Unfortunately nobody knows the answer to this for sure. Some people stay at F1 for a decade or more. Others, like me, go from F1 to F4 in a few years. I do not know if the variability has to do with the actual disease progression, the accuracy (or lack) of the biopsy interpretation, or other factors. GD points out that the biopsy stage interpretaiton is not very accurate.

Either decision you make you have to "roll the dice". I wish I could help inform you for the decision you have to make. I know if I relapse from my TX, I would likely be waiting for a new drug and would seek trials if available.

So treating or watching seem the only possible options now. All I can add that may be of value is that if you decide to wait and watch, please watch carefully. HCV usually doesn't progress rapidly, but it can, so you need to be alert to the possibility that your case may or may not fit in the center portion of the bell curve.

If you decide to treat now, the path is pretty well known, including the possibility of permanent side effects. If you do this, you should be prepared to go at least 48 weeks and quite possibly for 72 weeks to complete treatment.

Brent

[moahunter]

^There will always be people who are afraid. At the end of the day, it is all about how you approach life. Some "hope" and "wish" that bad things aren't going to happen, others just get on and fix the situation. I am one of the later - and as a 1A it worked, I am fixed, perfect health. Those with the idea that new treatments are going to be any less frighting than the current one anytime soon (i.e. within next 5 to 10 years), are more than a bit naive. If you are afraid now, you will probably be too scared when the new drugs arrive and an extra drug is added to the mix. Such is life, make your choice to try and see, or just imagine how bad treatment might have been. Either way, we all think we are doing the right thing, such is human nature.

[portann]

Moa: "Those with the idea that new treatments are going to be any less frighting than the current one anytime soon (i.e. within next 5 to 10 years), are more than a bit naive."

Moa, you're a young male who treated almost as an acute. You rolled the dice and won your SVR. Congratulations. Acutes who are lucky enough to be diagnosed are almost always advised to treat because of the strong probability of success.

That said, many highly-respected hepatologists have turned a corner and are increasingly recommending waiting for triple therapy to chronic patients who can afford to do so. This is all very hot stuff and I wonder how much you've followed these outcomes.

My veteran hepa and his NP attended three international liver conferences in Milan, San Francisco and Copenhagen during my 48 weeks of tx starting last May. I think he has the pulse on the latest thinking among seasoned practitioners more than you. And he certainly thinks certain patients should wait. Planning tx is a complex and sophisticated tailoring job beyond my depth or yours.  

Put your money where your mouth is and say he and his colleagues are also "frightened / scared or just generally have a weak personality"!

[moahunter]

How is tripple therapy going to be any easier than double therapy? Sure, it might be shorter, but not easier. So why not do 12 weeks and find out if RVR? My father in law just had treatment - full 48 weeks, he was 1B and 72 years old. He had virtually no symptoms through the whole thing and is now SVR. Maybe many of the people who don't want to try, would have few symptoms too? It just doesn't make sense to me, to not give it a go at a weaker treatment, because something stronger might be coming. Yes, some Heptologists I am sure will say that's smart, but others will say otherwise. We all want others to agree with out decisions, it doesn't make them right, one way, or ther other, though.

[portann]

Triple therapy may be easier because the third drug specifically targets the virus, not the entire system. If interferon dosing can be reduced, tx time halved and SVR increased, you have a superior combo. Seemed like a dream not too long ago but the tide has turned.

Three thousand Americans die daily of heart disease and cardiac problems are a stated risk of SOC tx. I hope it's clear sailing for your seventy-year old father-in-law but as a much younger person, I experienced unexpected cardiac sides during tx. A shorter tx would have been far kinder to my heart health and maybe to his.

As far as your father-in-law's lack of symptoms, my kids' mother also breezed through tx, according to what I told them. :)

[moahunter]

My father in law is in Japan - pretty much everyone treats there regardless of age (he tried mono unsuccessfully many years ago before Riba was used), Japanese have more faith (for good and bad), in medicine. They did reduce his Riba dose based on bloodwork, but on Pegasys he had no sides (I didn't either, it was Pegetron that hit me hard).

As to triple therapy being easier, no it isn't, there are additional symptoms as of today. One day there may be a therapy with no interferon or Riba, but that won't be in the next 10 years. Until that day, people have to face up to the harsh reality that needles are going to be involved.

I think when people are making excuses / are too frightened to try 90 days of double therapy, the same people are going to make more excuses to not try an even more toxic triple therapy when that comes along. I can understand somebody putting treatment off because of a work situation or similar, but not because there is something easier coming soon, for there isn't. IMO that's just trying to rationalize a nonsensical fear.

PS. yes - of course top Heptologists are going to "push" patients into triple therapy trials. They receive large sums of money, around 70k or so (depending on the study), for each patient enrolled in a trial. They want a better treatment too, and being part of trials is part of that and is good for all Heppers at the end of the day, but keep the money in mind when a doctor suggests something like this.

[Willy50]

Like moahunter I believe that there is a cure right now that works for at least half the population.  Like two others who posted this week I was not considered an optimum candidate but I took that chance and in 4 weeks - BAM - I was a suddenly a 91 percenter and was cured.
======================

I thought about about answering this last night but decided for me enough is enough.  I made my points.  I thought I'd answer this though, briefly.

I don't think the statistics back you up on this comment.  For genotype 1's the success rate is often expressed as  40%.  For every 10 who treat 6 fail and 4 succeed.  More fail than succeed and many of them after a full term and even longer treatment.  Many suffer from serious sides and expense during treatment and after treatment.  I think one needs to look at their histology, their genotype and decide what their chances are if they treat today.

When you write about those who RVR..... you are expressing a group that may be about 10-20 of genotype 1's on SOC.  The originating poster is a genotype 1.  I don't recommend people just enter TX on a whim to see if they can RVR and then if not quit.  You may undermine your insurance or your relationship with ones doctor.  You will certainly no longer be "TX naive" and my have removed yourself from many opportunities in trials because you are no longer treatment naive.  As a  person that withdraws from treatment some insurance companies might also consider you a treatment failure.  Some companies will not pay for people to treat over and over.  I would not consider starting treatment unless you were committed to see it through.

Enough of that then....

The major reason I wanted and felt obligated to post again was to mention that McHutchinson has presented Vertex data in the past at liver conferences.  I felt that since I made a representation about what he said I wanted to clarify it.  Of course we can't edit posts here so I must do it in a follow up post.

This was from the EASL presentation just about a 10 days ago and from a teleconference, so I listened to it on my computer.  They were talking about the flow and demographic of HCV patients and if the approval would be too much for clinics to handle when the gates finally opened post approval.  I want to be clear that he would treat anybody who wished to treat.  He just felt that for many it wasn't crucial and that they could wait.  I my impression was that this might be grades 1-3 but I believe I thought I heard even early cirrhotics might be fine.  Nobody absolutely knows when Telaprevir will be approved but in the presentation I believe his wording was that he'd tell many of his patients that they could wait 2 years (maybe that means 2.5 years; he was just speaking generally)

IF you wish to listen to it and hear EXACTLY what he had to say you can let him and others do it so you won't have to hear me translate it imperfectly;

http://investors.vrtx.com/events.cfm  (Go to the EASL presentation link)

best,
Willy

[Marcia2202]

48 weeks on double therapy - 1 year of exposure of the drugs and ca 50% cure rate

24 weeks on triple therapy - 1/2 year of exposure to the drugs and ca 75% cure rate


With not much liver damage I find the choice a no brainer, especially if you are debilitated during treatment. I'd rather spend 6 months in bed than 12 months, and be exposed to the drugs for a shorter time.

[moahunter]

That's a bit simplistic Marcia. I think it is more like this:

Double therapy - exposure will depend on how you respond in 1st 12 weeks. May go full 48, or may not respond at all so stop at 12. There may even be the option of 24 week treatment. For many people the odds will be up over 70% at 12 weeks, as they will know they are responders, for some, it will be even higher.

Tripple therapy - 1/2 year of exposure to the drugs and ca 75% cure rate  In  a similar way, odds will be known better after 12 weeks. Treatment will hopefully be 24 weeks. Exposure to a new drug that may have unknown long term sides, and for many people has additional immediate sides (rash or increased anemia). Possibiliity you may develop immunity to PI's which will limit your ability to benefit from new treatments that are past the guniea pig stage.

I think the PI's will benefit many people when they are approved in 5 to 10 years or so, and when new protocols develop on how they can work best (this will take time, even SOC is still being learned about). I don't think its going to bring a horde of new patients who have never treated to the doctor though (it will be exciting for those who failed of course). For it will be stronger than what we have now, and many people are too frightened as it is. There will be something else to "wait" for, or some other "medical" excuse to not treat, by the time PI's are approved

IMO we need a better treatment that doesn't involve interferon as we know it / and or Riba. That will come one day, but until then, it just makes sense for somebody that has never treated to get on and find out how they respond (both in terms of sides, and viral impact), before getting sicker.

[GreatBird]

I'm treating with one of the PIs, genotype 1, tx naive. My VL at the end of week 4 (SOC only) was less than a log drop from the start. At the end of week 6 (PI for 2 weeks) I had an over 4 log drop from the start and was <25 but detectable.

Based on my first 4 wks of tx, I would never have cleared by 12 weeks. This is a stunning result. The PIs are worth waiting for. And it's not going to take 5 to 10 years for them to be approved.

[jmjm530]

Unfortunately, what I see happening more and more is a partial response at week 12 ie EVR (>two log but not UND) which often turns 48 weeks into 72 weeks. It can be a slippery slope, and odds aside for the moment we are still talking two to three times the interferon exposure. Just read Health Page on long term side effects. SVR is not always rosy.

In any case I think  Marcia pretty much has it correct because once you exclude those that drop out at week 12, the vast majority remaining will treat for either 48 or 72 weeks.

As to the 24 week option, it requires not only RVR but also a very low pre-treatment viral load which right away excludes most that treat. That said, if someone does have a very low pre-tx viral load then treating with SOC offers the obvious advantage of the shorter course if UND at week 4.

But for me, it's not just treating now with SOC or waiting for triple. It's treating now or watchful waiting and watchful waiting can reasonably be to wait as long as liver damage is not significant at least as long as interferon is in the mix. And who knows, in ten years it may not be.

-- Jim

[moahunter]

^I can understand that some people who are really dedicated, or have health concerns, treat for 72 weeks. But, if that is the likely outcome at 12 weeks, then I would stop then and wait. 12 weeks is a very short period of time to find out 1. Whether you handel the drug well, and 2. how well you respond. There really is no downside to trying the less invasive 12 weeks first right now, with the treatment that is available to everyone right now. If somebody wants to try a trial, that's fine, it may help, but that is not a reason to not use the current method, for which there is a ton of expertise and knowledge built up, such that at 12 weeks a really well informed decision can be made.

[jmjm530]

Many people continue on to 72 weeks (we have a slew of them here) for the same reason that some decide not to treat -- they weigh the risks versus rewards. So for someone with significant liver damage (or otherwise highly motivated) 72 weeks is reasonable. Just like not treating is reasonable for someone who doesn't think 48 weeks exposure to interferon is worth it right now. It's not 12 versus 48 weeks as you suggest. The "12" is just a "stop/go" point. It's 48 or 72 weeks for geno 1's unless you're in the distinct minority with very low pre-tx viral load who also are UND by week 4.

[jmjm530]

Forgot to add that 12 weeks isn't a good test for side effects either. Many of us suffer much more later in treatment, especially after week 24 as the body wears down. And then there are the potential longer term side effects (post treatment) that often get ignored in these types of discussions. For all these reasons, I really think the idea of "try and see if you like it" is a bad one. I'd dig a bit deeper than that for a reason to get going.

[portann]

I'm a little stunned by CuredForLife's alarmist position.  I'm guessing that she stocked up on Tamiflu recently. :)

It flies in the face of the views of my highly-experienced hepatologist. He attends every international HCV conference around, unlike me.

Yes, things CAN go downhill quickly and that is a danger. That said,  if you're fortunate to be diagnosed (unlike most people who have it), then you certainly have the attractive option of watching your liver carefully and living a healthy lifestyle.

I've had chronic HCV for at least forty years, maybe more.  I presumably started as a stage zero in 1969, and in 2001, I was still a stage zero. It's not always but usually slow-moving.

It's not like the measles, which in the last 150 years is estimated to have killed about 200 million people worldwide, including two-thirds of Cuban natives who had previously survived smallpox. HCV has been around forever and is not a mass murderer. It may even afford some protection from yellow fever, which has often been deadly and epidemic. (IgI jigust migade thigat igup.)

As for Moa's last comments, I've seen people here who treated unsuccessfully on SOC more than once (even up to eight times), yet went on to SVR despite being unable to do that on SOC. Some re-treaters currently on triple therapy cleared at two weeks.

The thought can't help popping into my head that if the hard-to-treat are getting spectacular results, why wouldn't naive treaters opt for this as well?

It's true we don't know the long-term side effects of the PI's but neither do we adequately know this about SOC. SOC isn't tried and true by very much, compared to the PI's.

[mikesimon]

I would probably treat and if I wasn't undetectable at 4 weeks I'd quit. I am really impatient so I'd give it a try. Then again, my outlook may be somewhat jaundiced.
Mike

[portann]

How sweet of you to give Mike some treatment suggestions.

[mikesimon]

I know all about it - I treated 3 times and my last treatment lasted 73 weeks.
I would stop at 4 weeks if not undetectable and wait for a PI. If I was undetectable I'd do the 48 weeks. It's just the way I'd do it. I'm not saying it's right because I don't know that much. I guess you do.
Mike

[jmjm530]

Mike, I'd just listen to her and do the 12 weeks. She seems very sure of herself.

[mikesimon]

Maybe I will. You know how much I love to treat. I lose weight every time and I could drop 15 right now. I know I have some Pegasys on hand.
Mike

[comeagain]

Its easy to be pro exposure of interferon if you feel good after treatment.

After my first tx that lasted for 24 weeks i felt better than in 25 years both physically and mentally allthough I relapsed.

Thats what motivated me to do a second tx try, more agressiv both with doses and with double length of time .
Now  5months post i dont feel good at all not physically nor mentally.
I´m afraid this meds hasn`t been around so very long, so we still know all to little about its impact  and long term effects if exposed to it longer times and with higher doses.

My old man used to say there aint no such thing as poison only poisonous doses.

If this doesn´t get better I´ll find it hard to be happy even if SVR which I will know  if I am in a month.

Keep in mind that I was grade 1 stage 0 in my biopsy taken 2 months before second tx ,and I have had it for 36 years and been drinking heavily and taking lot of drugs but not any  of it for the last 22 years.
I really hope I will feel as good or even better than after first tx and that it only will take a little longer this time compared with the shorter first one.

Its easy when you your self only have good experience after treatment to think that those how complain about problems long after treatment probably are a bunch of hypochondriacs.
I did but now my own experience this far are shutting that up!!

ca

[IAmTheWalrus]

I can empathize with the "damn the torpedoes and treat now" approach. That is basically what I did, but I felt I had to given the situation I was in. I would not do any differently now if I had it to do over again.

For a case of genotype one,liver damage at stage two or less, working on original equipment (liver), and no particular reason to think the disease would progress rapidly, I would probably choose to wait. 12 or 24 weeks of treatment sounds a lot better than 48, 72, or 84 weeks of treatment. Not many geno 1 patients get off with the 24 week treatment.

[nygirl7]

All debating aside it's up to you and you only if you think it's worth treating now as a stage 2 or risking moving it up to stage 3 or 4.  Unfortunately, while it can take 20 years to become a stage 2 it can progress to stage 4 in just a few years - nobody can predict that and it's a gamble.

As for the new drugs - triple therapy can be shorter but harder and nobody is 100% sure that they will ever be approved. Personally for me combo treatment was hard enough.

If you do decide to watch and wait you are going to have to remember to do a lot of watching....it's not as if you can just stick your head in the sand and let it go.

Since you were already resigned to treatment my personal advice would be to go for it now while you have things set in motion.  At week 4 see how you are responding. If it looks like you're really succeeding then go for it.  Why wait until your liver has degenerated a couple more stages and it is harder to make sure you get all the virus?

[nygirl7]

ps One benefit of treating at stage 2 is if it does not work you have ample time to change strategies and retreat before stage 4.  Treatment is a gamble at best and personally, I think having a little more wiggle room is a very very good thing. Of course I was already stage 3 and don't think I had time to wait at all and I just wanted this disease out of me no matter what as the concept of it eating my liver away was just not pleasant to me at all and freaked me out.

[jdwithhcv]

I had none of this uncertainty when I got my biopsy results.  I was grade 3 stage 3 and my doctor was adamant that I treat immediately.  However, I believe I would have treated right away even if only at stage 2  As nygirl said, "One benefit of treating at stage 2 is if it does not work you have ample time to change strategies and retreat before stage 4."

Good luck, whatever you decide.

jd

[Marcia2202]

Deb, the thing is that Look4path is 'only' Metavir stage 1 grade 1, I personally find it not risky to watch and wait for a couple of years with that little damage. The stage 2 grade to is on another scale we don't usually use here on the forum.

all:
I understand that one wants to treat now and here to get rid of the virus. I did not have the 'privilege' to be able to have a biopsy and since I wanted to treat so badly, I went right ahead with it. Being a geno 3, I did not clear at 4 weeks, meaning I had to extend treatment. Compared to a geno 1, I 'only' did 32 weeks. It was a physical hell for most of the time, but I was dang lucky not to end up with any thyroid or Diabetes or any autoimmune diseases post tx. I feel great, just that nasty little rash on the back of my neck left, which I hope will eventually go away, too.

Still, with the knowledge I have now, and if I had little damage I would definitely wait, if I knew I had to treat for at least 48 weeks. Treatment can be tough, really tough, and why would one if one had the choice to wait, deliberately want to do twice the length with less chance of SVR, instead of waiting a year or two. It is a mystery to me.

[mikesimon]

Well, I guess that eliminates any doubt.
Mike

[jdwithhcv]

What a relief.

[portann]

Looks4Path (LD) is a Stage One.

BTW, CuredforLife, who weighed in on this thread, is almost four weeks post treatment, which she cut short despite being a G1 with high viral load. She said:


“May 02, 2009 01:29AM in the Hepatitis C Community
Thank you for your words. Several weeks - almost a month now after stopping treatment I feel great!”

"Treatment cured me."

"successfully treated for Hepatitis C this past year."

“If I had not tried I would still be infected today."


Does anyone know if RVR's are sometimes declared cured before four weeks post-tx?

[jmjm530]

You are not doing the original poster any good at all here :(
--------------
You mean like the good you do when you turn every thread you enter into a soap box calling anyone who disagrees with you "harbingers of doom"

[portann]

I'm sorry I have to go out now but that said, I feel confident I can do the original poster some good.

I have to go look at the stars tonight with my new telescope. Hope I can see Pegasus and its adjacent constellation.

Stay well.

Best regards.

Yours, etc.,

Port

[mikesimon]

I never addressed the "cured" part. But since you brought it up, your declaration of cured at 1 month post TX is a first I've ever seen here. As a rule people are cautiously optimistic at 1 month and we have invariably shared at least a portion of their arduous journey with them. You show up having already treated calling yourself "cured4life" and declaring you're cured at 1 month post treatment and that puzzles us - as does your "expertise" on myriad issues. And then you try to direct traffic on a site you presumably just joined. All that adds up to confusing or maybe bewildering or possibly cynicism
Mike

[Marcia2202]

don't you be looking for pegasys and the riba constellation instead now.... ;-)  

[jmjm530]

Mike: I never addressed the "cured" part. But since you brought it up, your declaration of cured at 1 month post TX is a first I've ever seen here. As a rule people are cautiously optimistic at 1 month and we have invariably shared at least a portion of their arduous journey with them. You show up having already treated calling yourself "cured4life" and declaring you're cured at 1 month post treatment and that puzzles us - as does your "expertise" on myriad issues. And then you try to direct traffic on a site you presumably just joined. All that adds up to confusing or maybe bewildering or possibly cynicism
--------
So does that mean you decided not to take "cured4Life's" advice and at least do 12 more weeks of Peg in spite of being SVR?

[mikesimon]

No Jim I'm not. I thought about it and despite being SVR I am still going to "watch and wait" for newer drugs. I think I have time although you never really know - do you?
Nevertheless I'm still somewhat cynical - I can't help myself.
Patient Mike  - hey that's a double entendre!

[Marcia2202]

lol... you guys are too funny...

actually doing a little tx now and then could be quite therapeutic. I'd be getting more beauty sleep and would be safe from the swine flu

[jmjm530]

LOL. I understand what you say about not treating with the current drugs since you're already SVR but you never know until you try. Right?

[GoofyDad]

"personally, I think having a little more wiggle room is a very very good thing"

or at least an inevitable outcome..... ;-)  

[moahunter]

It can be an effective way to lose weight too :-) I lost 50 pounds in the first month (I didn't really have more than about 20 to lose in a healthy way) I have gained about 40 of it back, but perhaps easier than the biggest loser ranch? Hmmm - not sure about that one :-)