Telprevir Opportunity

[colts]

I called my Hep. Doctor about telaprevir. Dr. Shen @ I.U Medical Center in Indianapolis. His assistant said there is a good possibilty that I can get into the trial. Is there anyone who has Dr. Shen as a doctor? I found out in April 2007 about my hep C.As some of you may know I decided to wait to treat.I don't know if I should wait for this drug to come out of trials so that I know so I know I won't get the placebo or just jump in. I don't have no  liver damage so I know I have time to wait but I would really like to get this over with.What to do?  

[miked]

I don't know anything about Telaprevir resistance and mutated variants but would be interested in hearing from someone with accurate information.

I can comment about the rash and a 20% better chance for SVR.  

During Prove 3 I got the rash from heXX.  It looked like poison oak or ivy starting on my arms and hands then proceeded to move around my body, even inside of my ear canals.  After a week of driving me nuts we got the rash under control with steroid creams.  As long as I stayed out of the sun it stayed away and became a non-issue.  In a way I was glad to have the rash because I knew that I was on Teleprevir and not a placebo.

As a geno 1b non-responder to SOC tx, without Telepravir, I viewed my chances for SVR to be near zero (nollpunkt) by re-treating.  On Prove 3, I went UND for the virus between week 1-2 and remain that way today which is about 52 weeks post Prove 3.  Telpravir really is a God-send for the difficult to treat.

On business, I've traveled from Gothenburg to Oslo.  You live in a great area.

miked

[miked]

We're in agreement.  

I've watched this board for a long time and took notice that people look for every edge to increase their odds of SVR...physical exercise, low body fat, phlebotomies (to lower VL at the start of tx), stop smoking, eat right...

I remember my 1st SOC tx I read and reread the instructions in the PegIntron box trying to calculate what my % for SVR based on my 1b status, 2 log drop, ect.  I was looking for every extra % point available.  

Take care,

miked

[jmjm530]

Milked: With that said, I chose to tx on Prove 3 with zero liver damage. It was my decision, my pain, my Friday night chills, my rash, my brain fog, my anti-depressants and my SVR.
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Hopefully I didn't come off as not understanding or supporting your decision, zero liver damage or not. But as often happens, these threads turn into more general discussions of treat or not, and that's not all bad -- because many new to the discussion are no doubt trying to absorb as much as possible to better make their own tx decisions. BTW my liver specialist who I have great faith in, like yourself, believes that significant liver damage is a pre-tx negative predictor. On the other hand, two other liver specialists I consulted with -- plus the studies I've read, do not believe this.

All the best,

-- Jim

[comeagain]

" 1)For those who fail on Telaprevir it will be like anything else,new stratagies will be worked up same as with SOC"

Clearly you most know about the resistance issue and crossresistans issues with telaprevir.

And is there anybody who knows what happens when sombody who is resistant infect sombody are we looking at a new type of virus a mutated variant.

2)" It's real,it exists and it will be here soon"

Don´t you be so sure telaprevir ever is gonna hit the market. maybe its not gonna be aproved because the result is to bad compared with the negativ aspects such as the severe rash that many get.
This is the opinion of my doc here in Sweden who is a specialist in infectious diseases and virology

And the figures you mentioned  66% vs 46%  really doesen´t sound that good.

ca

[miked]

Jim - thanks for the additional information.  I bet if I research it further I'll find studies that say a healthy liver is a fighting liver.  I'm a bit out of the loop recently.

With that said, I chose to tx on Prove 3 with zero liver damage. It was my decision, my pain, my Friday night chills, my rash, my brain fog, my anti-depressants and my SVR.

OK part of me wanted to help advance the science of HCV tx, however the much larger part of me wanted to kill this bug once and for all while

At Prove 3 tx I was healthy and in shape.  In addition to a zero damaged  liver I run 25+ miles per week, was 49 years old @ tx, eat right, lean body, no alcohol (@ tx), no cigarettes, have sex 5-6 times per week (that actually has nothing to do with my decision but just sounds really healthy), etc.

I do believe that age, condition, mental attitude, environmental factors, genetics, all play a factor in getting to SVR.

I watched-and-waited for about two years between failing SOC tx and Prove 3 tx.  For me, the HCV issue was always in the background and had to be dealt with.

Jeez...this has been a lot of fun but like zazza, I'm going to dinner and watch some tube.

I hope everyone makes the best decision for their tx and SVRs soon.

Take care,

miked

[zazza]

Is that taken from HCA's text book, so I know that I will pass the exam?

[HCA]

Very briefly,
1) Telaprevir has two big things going for it,higher SVR rate 66% vs 46%.(provisional figures).
2) It's real,it exists and it will be here soon.
3) Yes the Phase 1 monotherapy trials showed it suppressed viral reproduction for just a few days.Possibly only good for one shot.
4) No polymerase inhibitor in advanced trials.(I think-haven't checked)
5) Even if there were you couldn't just mix 'em up-extensive trials would be needed to approve a four way comb for efficacy and safety,let alone cost effectiveness!
6)  For those who fail on Telaprevir it will be like anything else,new stratagies will be worked up same as with SOC
7) No prospect of interferon free treatment at this time-was just given by Jim as an example of where we may be in the future

[zazza]

I admit I am only an amateur when it comes to HCV, but my impression was that this forum is a discussion group for HCV patients and others interested in HCV.

What I meant in my previous post is that there are going to be some patients who do not receive SVR even with telaprevir, and for them it might have been a better option to have waited to treat with telaprevir and instead do a combo tx when available with for example both SOC, telaprevir and a polymerase inhibitor, or maybe even with the elusive interferon replacement Jim talks about. If these people had first done SOC only instead, they would have seen how they reacted to interferon and ribavirin and then maybe have decided to wait for additional drugs aside from telaprevir.

I do wonder what is going to happen to those who do not SVR with telaprevir. What if they are relapsers and just did not tx long enough? Will they then be offered 72 weeks of SOC as a second tx? Or will they go on to try SOC and a polymerase inhibitor or what? From what I have read there is a worry that people will go on to receive resistance to multiple HCV tx drugs in the future like what has happened to HIV patients.

Now if you excuse me, I want to see a movie on TV (I do have a life besides HCV), so I do not have time to make sure that there is nothing for you to object on in my unprofessional post. Maybe you should put together an exam for approval of those entering posts on the forum, as there seems to be only one opinion verified by facts according to you.

Jim, I now remember reading that "all stages (except stage 4) have an equal chance of SVR". But I still agree with Ala, why not treat sooner than later if you are going to end up treating anyway. I want my liver as healthy as possible.

[HCA]

'No brainer' means a decision that is easy to make.
It does not accusing someone of having no brain.
It is an English expression and is perhaps not used in the USA.
In any event you have read me wrong on the arrogance charge!

[jmjm530]

First sentence should have read in part:

"I think you *Misread* he "Win-R" trial findings..."

[jmjm530]

Milked: I read multiple times that a pre-fibrosis liver has a better chance of fighting the virus than one that is scarred.
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I think you read the "Win-R" trial findings, you mentioned in your last post. As i stated earlier, all stages (except stage 4) have an equal chance of SVR.

From Win-R Study:

"...In the entire population of patients logistic regression showed no statistically significant difference in SVR rates between Stage 0 (44%), Stage 1 (46%), Stage 2 (44%) and Stage 3 (44%)...

http://www.hivandhepatitis.com/2006icr/ddw/docs/052306_e.html

-------------------------

Ala...In answer to your question, because the treatment itself arguably can do more damage than the potential for what you listed ESPECIALLY for someone with little or no damage and the relatively short (however you count it) timetable for Telaprevir to most probably reach market. Thanks btw for the nice words.

--------------
HCA...Agree on all points

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Mike...I don't think that is what anyone said although I've been called worse for advocating "Watch and Wait" :)

[mikesimon]

Less than 2 year for Telaprevir? Maybe, and it may not be available before 2011. I just saw that while researching the stock for investment reasons.
We really do not know whether there may be long term risks associated with PIs either. We haven't had enough time to examine that unless you want to look at HIV patients and extrapolate.
I am personally very hopeful regarding Telaprevir but I wouldn't call someone who chose to treat rather than to "watch and wait" a person without a brain.
I am continually dismayed at the arrogance I see here.
Mike

[HCA]

Wrong!
Telaprevir is proving effective for previous non responders.
I don't understand your final sentence.Why would you need to test SOC first?
Read up on this stuff-you have to  study the reports in order to have informed opinions.

[zazza]

"For someone with 'no liver damage' waiting for Telaprevir to be approved is a no brainer."

What if it turns out that you are a non-responder to interferon and ribavirin? In that case you will have wasted your opportunity to use Telaprevir for ever by not testing SOC first.

[HCA]

For someone with 'no liver damage' waiting for Telaprevir to be approved is a no brainer.
We are talking about less than two years.One would not expect to see measurable progression in a stage one patient within that timescale.
The analogy with cancer in a previous post is naive (don't mean to be rude) and has not been thought through.
'A healthy liver is a fighting liver' is an attractive soundbite that has no real meaning in this particular case.
It is more useful to assess the decision on an informed and reasoned basis, factoring in the benefits of Telaprevir rather than to present homilies
Alagirl,the term for non-acute is 'chronic'

[alagirl]

Also, I wish there were more studies ABOUT the effect on the kidneys in particular because I would love to see if the high amount of kidney damage they found in the veteran's study would really be replicated in other groups, or more to the point, in non-veterans.

I say this because although the study said it was careful to rule out other variables - I have difficulty generalizing a study involving Vietnam vets to the rest of the pop in general unless I see it replicated.  

[alagirl]

I profoundly respect Jim and wouldn't have gotten through tx without his advice (not alive anyway), particularly regarding my anemia.  In retrospect, I ignored his and a couple of other people's advice to take my pre-tx anemia more seriously in terms of pre-dosing higher amts of epo (same as procrit basically) - so I really do have personal respect for the integrity of his advice and decisions.

I do, however, still have one qualm about delaying tx - but it is a completely personal qualm.  I always have to pre-qualify that as an acute who had only been infected two months at the date of my discovery I had the virus, and as a 1b, it's kind of moot for me, this to treat or not to treat or when question, since it would have been difficult to ignore the kind of great odds treating acutely gave me as a 1b.

That said, I DO think about this topic a lot anyway, and the one thing, for me, that I can't get past, is that if at some point given your general age etc, you are probably going to have to treat anyway, why would you wait to do it until after you have more damage to your body from hepc, when you are going to have damage from the tx anyway (and of course, IF its true that interferon would be off the list in ten years, that might be one good answer to this, but this is only recently that I've even heard of that possibility).  I mean, why have the risk of RA, kidney probs, liver damage, from the hep c, PLUS the intereferon if you can tx early and only have the tx damage (I don't mean only like that, since that damage is a big ONLY, I just mean, why risk or have the rest of it).  I know how I am and I would have wanted to spare as much of my health as possible and not risk what the progression of the virus would do to me otherwise prior to tx.

Now.  If there are going to be successful non interferon tx's this quickly, that might give me pause in a non-acute situation, but I would want to know that this was going to happen that quickly.

Anyway, just where my head is at with it, and certainly I am open to how that is all reconciled for people.  Curious even.

[miked]

I'm short on time and don't have time to backtrack to research this.  However after nearly five years of personal research, I read multiple times that a pre-fibrosis liver has a better chance of fighting the virus than one that is scarred.

A quick Google turned up an HCV Advocate article supporting this.  In 2006 the WIN-R researchers presented data at DDW that examined the effect specific predictive factors had on the likelihood of patients achieving an SVR, including factors such as HCV genotype and pretreatment viral load, degree of fibrosis or cirrhosis, cigarette smoking and prior HCV treatment experience at the study sites.

"These WIN-R findings help us better understand how to optimize hepatitis C treatment for our patients and how certain patient characteristics affect response to therapy in real-world community settings," said principal investigator Ira M. Jacobson, M.D., Vincent Astor Professor of Clinical Medicine at Weill Medical College of Cornell University, and Chief of the Division of Gastroenterology and Hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

Treating U.S. HCV patients can be especially challenging as they tend to have disease characteristics associated with poor treatment response, including a high prevalence of HCV genotype 1, high viral load and advanced liver fibrosis (scar tissue).

Like I said, I'm short on time.  If you have the time and research I'd be interested in hearing data that says all liver are equal.

zazaa's comments about cancer make sense.

miked

[comeagain]

I wonder why some people have a hard time after tx while some is better then ever.
My thoughts about that is either the once who feels bad have genetical issues such as RA ,thyroid problems etc, that we know for facts is sometime the reason.

But could it also be that some people are couch potatos living an unhealty lifestile,
are exauthing them selfs to much on tx or that the soc meds goes harder on people if the liver has more damage.

I my self has respect for this meds and think this is  very importent questions to ask
for each and everyone who is about to treat.

Many people think they have no symptoms of HCV but since its a slow progressing disease, you dont just understand how much the HCV has lessen your quality of life
until you here other people describing the same symptoms, or that you get well from it.

Me for instance got rid of health problems I had for 25 years after first tx although relapsed. I did my first bx after first tx and just before this precent one.

It showed almost no damage at all ( inlamation 1 fibrose stage 0 ), my doc told me before the bx that he could almust guarantee  I was stage 3.

If you look at a person who has a really bad liver ( HCV or other reasons ) you can tell just by the way he/she looks, that  thats not an healthy person.

My conclusion about my case is that the liver damage hasn´t got that far with me and that soc improved it since i felt so much better after tx, also that I in facto was UND with <15iuml week 12 maybe earlier and week 24 at EOT gave my liver a chance to rest and recover.

We really need more info in this area is my firm believe.

Just some thoughts, think i shall open a thread soon about how people feels after going through tx both relapsers and SVRs

ca

PS I´m know housesitter never was ,always been out in Gods wonderful natur pain or no pain.

[jmjm530]

a healthy liver is a fighting liver, meaning tx while your liver is healthy enough to fight it"
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It sounds good but the facts are otherwise, that is if the implication is that you have a better chance of SVR with stage 1 than  for example, stage 3. What the studies show, all else equal,  is that all stages (except stage 4) have the same chance of SVR. And therefore, because Hep C is usually a very slow moving disease, a Watch and Wait approaqch is very reasonable for those with little or no liver damage as long as they are monitored on a regular basis.

-- Jim

[zazza]

"a healthy liver is a fighting liver, meaning tx while your liver is healthy enough to fight it"

That's the smartest thing I have heard in a long time. I never understood why you should wait until you were sick enough to tx. Just think if cancer patients did that.

[miked]

I understand your comment about wanting to get your life back to normal.  For me while tx-ing, I remember being at parties, dinners, business meals and I missed not having a hand-crafted beer or a glass of aged Merlot.

Dr. Kwo's advise to me about resumed drinking after SVR, "It's about quality, not quantity".  

miked

[colts]

I havent seen lucas either but plan to see Indiana and ganzaga play there.Thanks for the info on DR kwo.I dont mean to sound like I want to treat so I can drink.I dont think I would drink any more if I didnt have hcv.I am thinking seriously about going for it.I will keep everyone updated.

[miked]

Hi Colts,

I respect jmjm's opinion above, however different people tx for different reasons.

I was a geno 1b, no liver damage and running 25 miles per week before dx.  I wanted the virus out of my body and get back to life without HCV.  Also my research indicates that a healthy liver is a fighting liver, meaning tx while your liver is healthy enough to fight it.

Personally, I don't think drinking is a reason to tx.  That said, I do enjoy the glass of Cab with friends and family over dinner.  Beers with customers.

If you decide to tx, Paul Kwo is a great guy and doc.  I'm grateful for what he's done for me and my family.

Lucas Field looks beautiful.  I haven't seen it yet.

miked