? VX-950

Hi everyone.  I came across this article last night

http://www.hivandhepatitis.com/2006icr/aasld/docs/120506_a.html

I think I've seen enough evidence in the past year to convince me that the current recommended treatment for geno 1a is not working in most Geno 1a's and that even in those who are getting a sustained viral response, the virus is still being found in livers and PCMBs  (which I think is a term for blood/tissue outside the liver; please correct if that's not right).  At any rate, from what I've gathered, it's been a "shot in the dark" treatment approach so far and that the benefit of current therapy is really not known and is being questioned and researched.  

There is now evidence that replication of the virus in some SVRs is causing liver damage.  Even when / if it's not, there is evidence that suggests anyone who has treated with standard and is SVR (or on their way)  should take into consideration the possibility of virus reactivation.  

Add to those concerns the now recommended 72 weeks of treatment for "difficult to treats"  (and with that a possible greatly reduced quality of life while undergoing 72 weeks with possible serious complications) there is no doubt in my mind that it makes the current recommended treatment questionable.

So, if VX-950 becomes the "next treatment", will the above concerns be "no longer" since (so far at least) it appears that with the addition of VX-950 the virus is not able to evade the immmune response and therefore can't replicate.

Out of room. Thanks for any and all input.

[prettydamscared]

Hi, I am currently treating through the vx-950 Prove 1 study.  In a nutshell, I believe the consensus is that when/if vertex comes to market, it will greatly reduce the length of treatment time.  It hasn't been definitively proven yet how well vertex can help achieve or maintain an svr but there is a great deal of evidence to show that vertex can get us to an UD status rapidly. The fact that vertex clears the virus so rapidly will dramatically shorten treatment time.

I know of no studies attributing vertex to halting replication of virus in svr's.  I believe what we are referring to here is possibly "occult" and/or "residual" virus. Imo, this is a new field of study, very controversial, and it is way too early to speculate as to whether vertex will address amy of these issues.

It is thought that vertex, or the next generation of protease inhibitors, will still be paired with peg and possibly even  riba.  I don't know the answer to that.  Studies are being done in Europe currently with vertex and Peg without riba, so we'll see how they go.  Extremely small studies have already been conducted using just peg and vertex, without riba, but I don't know the svr data on them.  Someone else will have the link to those studies.  Bottom line, vertex or it's next generation, is extremely promising.  If it can get us cleared rapidly, just the fact that we don't have to treat as long is a huge plus.  The jury is still out on the svr data with vertex, but one could speculate that just by virtue of the fact that it clears the body so rapidly, it would stand to reason that svr chances would be significantly higher.  Others will be able to explain the whole replication theory much better but at least you have an overview.

Char

[mremeet]

Chquote:

[chcnme]

Hi to all of you.   Thanks so much for your time and input.  

For now - since I am enjoying for the first time in months just sitting back and watching a movie (The Titantic - lol),  I just wanted to touch base here long enough to thank you and let you know I'll be back at some point.  Might not be for a few days, though, because I really need to take a break from this stuff for a while, I think.  

And Mike - You

[prettydamscared]

Hi, just wanted to say I answered your posts from the other night below but I think the whole thread got deleted.  Mremeet, it was the one where you suggested that someone was an id@ot.  I thought your response was hysterical and commented on it.  I guess my response put the thread over the top cuz it's been there all weekend and just got deleted after my response this a.m. Kinda surprises me because there are still inflammatory posts on here that aren't getting deleted.  My responses to both of you were innocuous and nonspecific in nature.  I actually wanted to reread what you had posted to me. I wonder why the entire thread got deleted.  

Foresee, you asked me about my domestic concerns and I briefly answered.  I don't know...maybe that contributed.  We're supposed to be sticking strictly to hep c stuff but aren't alcohol related problems hep c related, and my husband did just finish treating.  Geeez, this is getting tough or maybe I have it all wrong??? Have to admit, I'm a little befuddled.....

Just wanted to let you know that I did respond.  I'm kinda getting bad about posting and then not getting on the board for a day or two...you know how fast it moves.

Oh well, talk to you soon, Char

[mremeet]

Hey, you're right it did get chopped. Well, me and rev have been going at it. He's taken a strong dislike for me (as he has with many people), so I'm sure he's one of the "tattletales" that Cindy was referring to in the post above "To all forum participants". And I'm sure the reason other "offensive" posts have not been deleted is simply because no one has bothered to bring them to Cindy's attention. But since rev has a real hard on for me, I'd imagine he and/or his buddy spacecst went the extra distance to get my post deleted. Just to show they could, you know. Because they're powerful men with rippling biceps and glossy glutes. They're making it happen around here, and we better take note.

Oh well, guess I deserve it for using nasty names. Still, it was kinda funny, wasn't it? As is rev's reaction to go so far as to tattle for something so silly? hahaha  ;-)

Anyway, if I don't hear from you sooner, I'll give you a call later in the week. Hope you're hanging in there ok, take care.

[chcnme]

Well..I watched the Titanic sink -lol- and thought I'd check to see if my brain still had HCV in it, and apparently it still does because I do not know what in the H is going on on over here and am beginning to feel strange vibes.  Is someone upset at me over something I've said?  I don't know anyone over here and I'm not involved in anyone's personal goings on. I think the only "questionable" things I ever joked about was liquor and booze and drugs and pot (and that was in a note that was talking about it), and I didn't say it offend anyone -- it was a JOKE!  As far as calling Jane Doe Dough well -- big deal, what can I say?! And I told space to shut up, and I think that was about it.  I hope someone isn't sitting there thinking I have written Cindy and that I'm causing any problems with "adminstration".  I've never written her and never will.  I don't have time for that kind of mess!  I try to get along with everybody unless someone takes an obvious intentional dump in my cornflakes for no reason and stuffs it up my nose.  Is there a list of who is fighting with who over here so that I might know if there is some kind of underlying message to someone else in a note to me so that I can read between lines?  

[chcnme]

pfffffffffffft  LMAO

nevermind -I must have been writing my note the same time you were!

Night! See you guys in the morning or in the funnies one :)

[prettydamscared]

It was very funny. You're right, he does have a thing for you...it's so obvious.  Some of your posts lately, especially between the two of you, have been laugh out loud funny.  I appreciated them anyway.

Goodnight for now and I'll talk to you later this week.  

Char

[prettydamscared]

Hi, just wanted to say you're absolutely fine.  The exchange between myself and mremeet didn't have anything to do with your posts and I don't think med help's posts were referring to you specifically either.  Sorry if I gave you that impression by my post in your thread.  Keep posting, you ask some good questions.

Talk to you later, Char

[GrandOak]

chcnme write: So, if VX-950 becomes the "next treatment",

I'm not aware of VX950 becoming the "next treatment".  All I've seen is that it will augment the existing tx by becoming yet another med in the cocktail.  As far as I know there was a monotherapy study during Phase I, or perhaps pre-phase I, but that it did not show enough promise at that time and so the direction was switched to the current another tx med direction that the research has taken.

[Forseegood]

interesting discussion...this is wildly anecdotal, and totally unscientific....but has it occured to anyone else here, that in this relatively small pool of people (and it's not like I have known what happened or scanned everyone that has attended this forum) that the SVR rates of geno 1's seem to be around 50%?

In the span of time I've been here...also on some other forums I've been to...seems like you'll see two people clear, then two people relapse (with a relatively few not responding) (and not necessarily in this figuration) course, I'm no numbers cruncer, and I haven't been following 'that' closely...this has just occured to me, in some type of gestalt way...probably silly post, just wondering if this has occured to anyone else...

[nick m]

Hi all
first time on. I' m on the vx950 stage 2 trial. last screening appt wednesday then treatment starts 4th jan 2007.wish me luck. I got a lot of ID off this site - laughed when i saw the familiar phrase -'knowing my luck' re the vertex lottery. 75% for the vx950 then 50% chance of clearance with combination therapy if i get the control arm. I've only been eligible for funding for treatment since august and am in good health - but finally persuaded this thing doesnt stay still - like rust - so now or never. I'm writing it up on my blog which is 'nickaround'. seasons greetings to all. love and fellowship nick m xxx
AKA honest leopard
"I create a world of safety through courage honesty and humour"

[MrsOckert]

Wow, I was getting ready to post the same thing and then read your post.

Yes, I have noticed the 50% average here, on another HCV message board I visit and in my personal life.  

I just got the news Saturday that a friend of mine that finished a few weeks before I did has relapsed and is getting ready to start tx again.

I don't think it matters if a study is done with 50 or 1000 participants.  If all studies are showing a 50% average SVR rate then that generally reflects the public.

[mremeet]

I agree, and I've noticed roughly the same thing. Although I can't remember the exact total number of every "It's negative, I'm SVR!!" vs "Bummer, I relapsed!" posts, but offhand, I'd say it is about 50/50. I've certainly seen a good amount of SVR posts for type 1's, and there are certainly quite a few still floating around here. Most eventually fade into the background and get on with their lives once they SVR though, understandably. But suffice to say, from what I've personally seen over the years, it ain't that rare for type 1's to clear.

[chcnme]

Thank you all!
And char!  Thanks so much for your time and input and for the explanation on the biopsy .   It

[mremeet]

Hey ch, sounds like you have your treatment decision well in hand and carefully thought out. That's to be respected. As I sit here miserable and itching with my hair falling out, believe me I understand the reluctance to jump into the pool. ;-) Hopefully you don't think I was trying to talk you into it, or be overly "pro-treatment". I myself held off treating for over 9 years, and then only decided to take the plunge when VX came along. Although I would have treated with SOC at this point in my life anyway, even if VX wasn't currently available. For me the time had come. For years I endlessly weighed and fretted over the potential risks and benefits after reading one treatment horror story after another and occasionally hearing about people being saddled with long term problems associated with SOC. But on the other hand there were the success stories (quite numerous actually) and I just felt like the disease was really starting to grind on me (I've had it 23 years, infected when I was 17). After a long hard think on the matter, I was ready to fight.

They say once the initial fibrosis sets in, it almost always inexorably advances after that. And as we get older, it can start to accelerate in a non-linear fashion. In other words, it can start to advance at a faster rate than it did in the previous 20-30 years. That's one of the things that scared me as well, and I finally decided that I had to move on this thing while I still could, and while I was still relatively young.

Also, and I think this plain fact is often largely overlooked in the pro-treatment con-treatment debates: It's the simple fact that yes there are risks associated with current treatment, but there are also definite risks associated with doing nothing - especially as we get older and especially the longer we have the disease. We are talking about hepatitis C after all, and although many can live with it for a long time without too much trouble, it most certainly *can* bite. I've encountered more than a few people over the years (online) that have cried to the heavens that they should have treated earlier. They started out with moderate fibrosis, decided to hold off and maybe try herbs/homeopathy etc, and then after a coupla-six years jumped to cirrhosis and suddenly found themselves in for the fight of their lives. I didn't want to end up like that, not if I could help it. Also, even if HCV doesn't directly kill you by outright destroying your liver, it can bring on a myriad of other ancillary health problems that can degrade QOL and even shorten your life (like diabetes, gallstones, skin problems, chronic fatigue syndrome etc).

Bottomline is that there are no easy answers when it comes to HCV and the current treatment (esp for geno 1). No matter how you slice it, there are potential risks and potential benefits. Unfortunately we're all put into a position with current treatment being what it is, as having to make tough, consequential and possibly life-altering choices based on limited information and difficult to define odds of success and failure. The decision to treat or not is usually a complicated and tortuous thing to fully consider. I'm glad you've made an informed decision that's right for you. Best of luck, and I'll keep you up to date on what  happens with the VX.

Take care...

PS>> I didn't understand your biopsy results when you said "G3/S2". Is that stage 2 grade 3?

[chcnme]

Hi Mike.  Glad to meet another in the trial.  I wish you and PDS (and now a NEW ONE I see :) the best of luck.  Sorry about your rash.  I

[chcnme]

Hi again, Mike, and no I didn

[prettydamscared]

Hi ch,

doc has recently said my liver is in

[prettydamscared]

Hi again, I just reread your post and see that I got your grade and stage backward.  I'd say it was brain fog but I've always done that.  lol

Char

[willows]

Congrats on your warrior stance and the opportunity to try VX.  My doc says maybe I get the chance in Jan or Feb to begin the long process of being accepted into a trial.  

We will have to communicate here, you posted the info and didn't get a lot of response right away, but never doubt that there are folks here, like me, who are getting ready to go where you are going too.  We can compare owies and progress and hopefully, our good luck.

Good luck, Nick, I'll be thinking of you.  And crossing my fingers.  

Willow

[prettydamscared]

Wow, no wonder you've waited.  I'm so glad your dad pulled through but what an ordeal for you and your family.  I truly do wish you the best with your treatment decision.  It's a biggie.  

I'll be talking to you. Char

[Kalio1]

I'd really want to get a copy of that last biopsy. Stage 2 liver damage can be barely a stage 2 or nearly a stage 3. One doc might read stage 2, another early stage 3, it varies pretty widely. Once fibrosis sets in, it can escalate much faster in some. I had 3 years of continual steroid injections and that hyper escalated my damage ( along with bad nutritional habits)so it isn't just alcohol that can escalate fibrosis. I am not protreatment, I am pro whatever is the best decision for a person's health. I agree with PDS, your liver damage needs to be closely evaluated to decide to wait longer, I dont think you have enough info to decide yet. Also damage lessens the odds of success so as you wait if damage increases your chances decrease.

Did you see the video on clinical care options on fibrosis progression after decades of HCV? It does show that damage can escalate more swiftly in some as time marches on. I tried to link it to you but I can't find it right now, I will look and try to post it for you.

Im sure once you can get those old biopsy results and/or any new info. you acquire it will help you decide.

[chcnme]

Hi Kalio.  I don't think I have enough info, either.  Even with good labs for as long as I have had, I just don't think I'm on the better end of 2  (but I don't know why I think that -- just because of the time I've had this virus and I'm .. getting on up in age.)  I have not felt real good this past year, and I'm a firm believer that it does escalates the older we get.  My fatigue could also be depression.  I feel a LOT better when I get up and get out and get moving and stay physically active,  but sometimes I just crash, and .. I just feel "unwell".

I hate to start getting pushy with this biopsy thing with my doc.  I have been almost afraid if I start asking AGAIN, someone is going to say "OK, you apparently do not like our recommendations, you are free to go to Chapel Hill and see if they will get a biopsy."  I have been kind of a "yes ma'am" patient,  I think (which isn't bad, but - it might not be good, either.)  After the VX bomb, I kind of "shut down" as far as anymore questions, too.  I feel like I have run out of questions with them (or feel I can't ask anymore until I know the SHAPE OF MY LIVER - biopsy).  If it IS a 3, I have no more questions. I have no more time. My only question would be "can I start regular combo this month?"  My next appointment isn't until March.

Treatment in my current situation will be tough. Minus the sides, I am a caregiver, but we CAN do this  (in fact I can do it easier NOW, no doubt, because of the obvious - folks are in their 80s).  If I CAN wait, I think it would be worth waiting to at least see if VX is ... going to keep getting good reports.  But none of us knows that.  We might have a good idea in a year, though. And I might have a year (but I might not), but I think the ONLY way to know is BIOPSY (or fibroscan, which he doesn't want either!)  

I sometimes feel I should put my foot down and say "biospy first, and then we will go from there", but he has firmly said (two or three times already this past year and again this past visit)  "biopsies can be misleading, too - and they carry some serious risks.)  And so to me, he sounds pretty adamant on the biopsy.  I think I would be reluctant to go outside of him to get one, but I guess I could,  but -- whew - I was nervous enough about getting the fibrosure and faxing him the results :)  But, he was cool with it.  He's a nice doc.  

I have been wondering lately (paranoid thinking, but I can't help it, and so I'm going to ask the question here) -- do research docs at these big research facilities get incentives for enrolling patients in trials, do you know? I have always wondered, anyhow.

And yes - I would love to see that link if you can post it.  

Thanks Kalio!  Keep hanging in there with your treatment!

[prettydamscared]

A few weeks into the study, I had to sign a revised consent form which included language stating that our study doc was being compensated for overseeing the study.  Just to be fair, I'm sure that wasn't the exact wording, but it was pretty close.

This might translate into "research docs at these big research facilities get incentives for enrolling patients in trials, do you know?"

I'm not quite sure what the exact difference is in the two statements above.  My guess would be they're both pretty much saying the same thing.

I have a sneaking susspicion, nothing concrete to base this on, but I think perhaps the biggest incentive may be to get us through the first 12 weeks of vertex.  After that time period, our stock seems to go down.  Just an observance and I may very well be wrong.  I might also be right.

[chcnme]

Hi Mike! Glad you have insurance to cover that. Those samples the docs give out with a Rx that says

[mremeet]

I went to see a dermatologist a while ago and she prescribed a particular brand of steroid lotion and shampoo to me (clobex). She gave me two small free samples of clobex and a prescription for more of the same. The prescription had a little note that said "do not substitute", which prevents me from getting a cheaper generic alternative. Turns out it cost me almost a $100 to get that scrip filled, and I have good insurance that usually covers most of the price of my scrips. Obviously she has a "sweetheart" agreement with the manufacturer of clobex (who gave her the free samples) to exclusively prescribe it instead of cheaper (but equally effective) alternatives. She's getting kickbacks from the drug co, that's how most doctors supplement their income.

Ch - If I were you, I wouldn't put too much confidence in the fibrosure test. I had two of them within a year of each other. One said I was F0 (zero fibrosis) and the other said I was F2 verging on F3 (significant fibrosis). My liver did not progress 3 stages in a coupla months (I've had a stable infection for 23 years, with mild liver damage). I then had a biopsy that said I was F1, exactly the same as it was measured 5 years ago (although the biopsy sample was small because the bonehead student doctor screwed it up). The fibrosure test's reliability was poor in my case, way too scattered. Although it's claimed it's reasonably accurate at the endpoints of liver damage (i.e. either no damage or near cirrhosis). Personally I would get a good biopsy from an experienced doctor and have a competent pathologist examine your slides. Only then can you have any sense of confidence in where you stand. And as it's been mentioned, even the biopsy results can be off by as much as a stage. (i.e. if you come back with an F2, it's not unheard of for some to find out later they were actually at F3 instead)

[chcnme]

Hi Char. Thanks a lot.  I'm sitting here scared to death.  My mind is racing 1000 mph  about "fast progression", and... I don't know what I'm going to do other than call my doc and tell them I am scared and want someone to do something.

When I didn't get in that VX trial, and when I knew another "no" had come my way on a biopsy, I went out on my own  and got a fibrosure and faxed them the results.

That was in October.  I scored 46 on the fibrosis and 49 on the necroinflammatory

The FIBROSIS scale is:  

<0.21 = Stage F0 to no fibrosis
0.21 - 0.27 = stage F0 - F1
0.27 - 0.31 = Stage F1 -portal fibrosis
<strong>0.31 - 0.48 = Stage F1 - F2</strong>
0.48 - 0.58 = Stage F2 - bridging fibrosis with few septa
0.58 - 0.72 = Stage F3 - bridging fibrosis with many septa
0.72 - 0.74 = Stage F3 - F4
>0,74 = Stage F4 - cirhosis

The NECROINFLAMMATORY scale is:  

<0.17 = Grade A0 - no activity
0.71- 0.29 = Grade A0-A1
0.29 - 0.36 = Grade A1 -minimal activity
<strong>0.36 - 0.52 = Grade A1 to A2</strong>
0.52 - 0.60 = Grade A2 -A3
0.60 - 0.62 = Grade A2 - A3
>0.62 = Grade A3 - severe activity

So I fax these results to Doc with NOTE, lol, that said "I got a fibrosure and a CBC".  Next thing I know I'm getting a call in about a week.  He was very nice.  Told me he got the results, that a biopsy would probably show the same, he apologized about VX, and then he told me about a HCV 796 trial coming up that I can get in.

In Nov, he told me it would be sometime in March it would probably start up.  

Now I'm paranoid.  I'm just paranoid over everything now, I think.  I'm just scared to death I'm sitting here worse off than biopsy (regardless of what labs say or what that fibrosure says)  and that no one knows what my liver is really doing, and no one is doing anything but routine LABS on me.  I need to treat, and now I CAN treat,  and so -- it's a matter of WHEN do I treat.  I have told myself to stop questioning what my doc is doing.  But now (especially after reading Foo's note on progressing so fast), I'm just scared to death.  And so.. I'm going to drink another cup of coffee and gather myself and place a call to them.  For over a year I've only called them once,  and so - it's not like I have bothered them with endless questions.  I'm afraid that sitting here being a yes ma'am patient is putting me at risk.  I want a da** biopsy.  Thanks for letting me say "da** " !  Maybe now I won't say "da** biopsy" to the doc ! (or worse :)

You have a good one!  Thanks for being here.

[ChrisDDD]

Hi.  I'm new here.  I'm 52, 1b, infected 1976, diagnosed '93, Grade 2/Stage 3 by biopsy 7/05, failed monotherapy '99, failed Peg and Riba '00, failed Infergen and Riba 3/5/06.  Current ALT and AST 82 and 96, viral load 6,550,000.  First two failures were due to nonresponse.  I was pulled off Infergen and Riba after just 9 weeks of treatment due to retinal hemorrhaging and cotton wool spots, though eye symptoms were mild.  I was very angry and upset at being taken off the drug.  Viral load dropped from 2,950,000 in January of '06 to 780,000 at week 9, March '06, when pulled from treatment because of eye problems.  Saw a specialist for a second opinion, and he wants to put me in VX 950 trial for non-responders, but I'm a little upset that nick m, mremeet and chcnme are apparently already on it or soon to start?

I was told by this doc the trial would begin right after the first of the year.  Latest info is prescreening would begin mid-January '07 with treatment to begin March 2007?  The reason I was so angry and upset at being taken off the Infergen is I had my disability all lined up and have been getting checks through my employer, with the same health insurance still in place.  I don't know if since it's the end of the year my disability and health insurance will be pulled.

I'm frustrated because I want to get on with my life and am climbing the walls not working this whole year, first time in 30 years I haven't worked full-time.  I'm all ready for treatment and have no place to go!  I'm concerned not only about losing my disability and having to go back to work, but about my liver and that I don't feel so good anymore, lots of fatigue.

Does anyone on VX-950 or any other person on interferon know if eye problems disqualify me from candidacy for a VX 950 trial?  My eyes are fine now and I read about lots of patients on interferon with eye problems, but my local doc doesn't even want to put me on maintenance interferon now due to my retinal problems.  How did you guys get into the trial?  This second opinion doctor is a fabulous doctor at a leading research hospital that's currently running a VX 950 trial for treatment-naive patients, but this board is the first time I've been aware that the VX 950 trial for non-responders is apparently already underway?!

I've talked to Vertex and they told me the same thing my second opinion fabulous doc told me.  This fabulous doc told me he thinks I'm the perfect candidate for this upcoming trial, but he has no control over whether Vertex will disqualify or refuse to enroll me due to my retinal problems with interferon.  Since interferon is the primary drug used to treat HepC, am I just screwed?  I don't want to go blind to cure the HepC, but I don't want the HepC to progress either.  Help!

Thanks.