vx-950

[suzieq2]

Hi everyone, I saw a great hep Dr. yesterday, He just completed clinical trial with peg, riba, & vx-950 12 pts, all cleared. 12 week program. I am first on the list for non responder trial. he said late fall, but they have been running a little behind. So most likely I will start in january after the holidays.YEH! He has several trials going on, but in his words ,you want to wait and go right to big one! I do not want to mess around . This is my last time around. The responce of this medication is having such great results. If I do not clear on this. I will put my disease totally in the Lords hands, and what will be will be. I hope to find all as well as can be.Great hope for nonresponders. Will keep you "all" posted

[willows]

There are so many of us here that are "non-responders" and are waiting patiently or impatiently, in my case, that your post was great to read this morning.  My hep doc was considering putting me on maintenance, but then changed his mind and wants me to wait for VX.  So your news was great to read.  

Yes, yes, please let us know how it goes.  I will keep checking back with crossed fingers and a lot of prayers for you.  

Willows

[fivecities]

Thanks for posting this.  I am so undecided about treating again. My blood work shows normal counts and normal alts, etc in all respects except the VL, which is 6.8 million.  Im leaning toward waiting to see what comes next.  Im 1b and have only treated on interferon alone back in 1996.

[cuteus]

any ideas when they will do a post tx follow up PCR on those 12 subjects? I understand that there is still no data as to whether anyone has remained clear on any of the new meds on trial. It is such a waiting game! Is he also on the NM283 trials?
good luck in the next step you take.

[jmjm530]

Preliminary SVR data supposedly will be available early 2007 with a lot more flowing in all throughout that year. While the drug still won't be ready for prime tim --  by early 2008 I would think the medical community would have pretty much decided whether Vertex is a go or blow.

-- Jim

[jmjm530]

Just to add to that, based on solo trials already completed, if I was a betting man I do believe that Vertex will become part of future treatment protocols. The question remains however, will it be part of a 12 week, 24 week or 48 week protocol; what drugs will it initially be combined with; and how much better the results of adding Vertex to the mix will be vis a vie the lovely combo treatment we now endure.

-- Jim

[Kalio1]

May peoplle clear the virus on the current meds, IFN and Riba by week 12. That does not mean they will acheive durable SVR. There is NO SVR data showing VX950  participants will remain SVR after they stop the IFN/Riba they are on along with the VX950. Everything is speculation, there isn't any SVR data at all yet.

[NYgirl]

it will be interesting to see what does happen in the long term.  You are right most people DO clear by week 12 - I hadn't thought of it in that respect.

I may be quitting my job and if I do it will make me ineligible to use insurance for the next go round...not sure what I will do but this place - it will kill me faster than my liver will.

Just trying to figure out if I should waste $600 to go to Dr. J next week or not at this point.

Hopefully I'll have regressed a stage and won't have to worry about this for many years - I can live as a stage 2 and not treat so it should be ok if I can just go back one stage.

[Kalio1]

Yikes, 600 bucks. I hope you get a LOT of questions answered for that much! I would want to hear what he has to say but I wonder if it will change anything, maybe he will recommend something specific to your case? I'd have my questions ready so I don't get the bums rush. Sometimes the "big wig" doctors are short and not very communicative.
I would be nervous about changing insurance companies too but maybe you will qualify for the state high risk insurance pool? Maybe your next job will have better insurance, you never know.
Hope you are able to stay cool, looks like the whole ounntry is heating up.

[jmjm530]

See Dr. J. or you will be kicking and second guessing yourself forever. Sh*t I just paid $300 to speak to a stink*ing SKIN doctor, can you believe. But this is your LIVER. From what I heard, he is very personable and I'm sure will take the time to answer your questions. As to the insurance, Kalio has a good suggestion. Call the major carriers in your state directly and find out what self-insured options are available to you BEFORE you leave your job. Hep C aside, you don't want to be without ANY lapse medical insurance, especially with all you have going on your plate including the thyroid issue. You may be surprised to find out that your state offers pretty decent and reasonable plans. Sorry things aren't working at work but maybe things will look better soon.

-- Jim

[jmjm530]

BTW it's not unheard of for patients to make payment arrangements with their doctor. I'm sure the office would like to hear about it *before* the visit but I don't think anyone is going to throw you in hep c jail if you discuss that post visit.

-- Jim

[bobbyullc]

jim,

mind sharing what your skin dr said? i am still having some sun sense, psoriasis and rosacrea. bothers the heck out of me and am worried how long it will last. i still have some short term memory problems. scary.

thanks. bobby

on vx950. i am still waiting for 6 mo pcr but me and my hepatologist feel vx 950 will be the magic bullet if no svr. if the virus is deprived of the food it needs to live and cannot replicate it follows it must go away. with no sides if it takes 6 months or a year as a mono tx it is still 100% better than peg/riba and i hope this will be the final result. i hope that is in the stars.
apparantly major drug companies and investors are willing to put hundreds of millions up conforts me.

[Upbeat]

VX-950

      Don't you think those in the know have the updated info from the 12 people and the people from the earlier trial?  J and J had to be given some info we are not pevey to.  You don't just give 500 million for the rights of over seas sales unless your certain.

                                                           Ron

[jmjm530]

Sure. Just like the three derms before him, he changed my topical regimen around. This is not unusual for derms as no two ever seem to agree on ANYTHING including diagnosis. Let me know if you want to know skin regimen and I'll post.  He did suggest going on doxycycline or the newer low dose version called Oracea? I'm holding off antibiotics for now and waiting to see how the skin reacts to topicals and time. His major suggestion was for IPL (intense pulsed light) which is a sort of laser. He says I need six treatments which would cost me around $3,000 with touch ups a couple of times a year costing around $500 each. That includes face but not my neck which would be extra. Yikes. At this point it's not even the money but I really have to research this more and make sure that's the right direction for now. Hope you feel better soon.

-- Jim

[bobbyullc]

DO get the bx. you will die of worry if you do not.
are you stage 3 now?
i am sorry i missed the post but did you not svr on the first try?

on vx950, what i read is 95% cleared at 1 or 2 weeks and all cleared at 12. much better than peg. there are also many other breakthrough drugs in trials. hope is out there.
bobby

[jmjm530]

You are correct. The viral clearance in the Vertex trial was SIGNIFICANTLY better and fast than with the current combo drugs. How this will translate into SVR data is what we are all waiting for.

-- Jim

[NYgirl]

GOD you are right what about my thyroid meds, eeeek. You know what hell I've gone through with this job...my GOD I want to leave and get something else.....

I hate them here with such a passion these disgusting perverted pigs I just can't tell you.

$600 to Dr. J is to get him to approve the 72 weeks....my doctor can't (won't) take responsibility as he said he is a GI and he can't ( I guess I could sue him if something seriously goes wrong) without a second opinion.  That's all. So basically it IS going for me to just ask a few questions and then leave and never see him again.

If I do quit on 8/18 like I was supposed to originally...maybe it will be long enough. But I'll have to do something about the thyroid and my KIDS insurance oh man.

WHY is this happening? All of the Paxill in the world can't help me now.

[NYgirl]

Said:  When it comes out, yrs from now, it will be accompanied by the same drugs people are trying to avoid.


Bingo...that is why I don't let any of this drive me nuts.  Yes it appears to give better odds to clear quicker but...there already is a 50% chance for a geno 1 to clear with the current meds.

I worry that people who could treat now and clear think...wow I'll just wait for these new easier and quicker drugs when in reality they could be risking more liver damage and a much harder chance at SVR years from now when / IF it does come out for general use in tx.

I personally consider a 50/50 chance of beating this now with the current drugs and duration a pretty good chance (even if in some cases we have to extend).

[jmjm530]

I agree that most side effects occur within the first six months but at least with me -- and many others I see posting -- it is the accumulation of these sides *over time* that is the killer. Vertex combined with riba and peg potentially could shorten treatment to 12 weeks with better SVR rates. To me, there is a SIGNIFICANT difference between treating 12 versus 48 or more weeks, even with the same drugs. Significant maybe not in terms of the number of sides but the severity of the sides and what I would imagine to be the probablity of those sides becoming chronic or even permanent. It should also be noted that Vertex is either currently -- or very shortly -- being trialed WITHOUT ribavirin in Europe. Should those results come in positive, look for riba to be dropped faster than a hot potatoe in follow-up American trials.

-- Jim

[GrandOak]

Although many do UND by wk 12, not all do.  It would be interesting to see if there is any correlation between base PCR and UND by wk 12.  At 72 mil base PCR, I figured the expected 2 log drop by wk 12 might be optimistic and was please to see a 1.6 log drop despite reduced riba for 8 of the 12 wks.

The real disappointment came when I learned that PCR actually increased by 0.5 log between wks 12 and 24.

As for trusting in the Lord, I've come to believe that sometimes I must but my faith that He will guide the docs to help where my faith may not be strong enough to receive His healing totally upon belief.

[jmjm530]

I'd like to add that my major autoimmune skin issues didn't emerge until around week 14 of treatment. Had I only treated 12 weeks instead of my 54, I'm convinced I wouldn't have the problems I'm still having 19 weeks post treatment.

-- Jim

[cuteus]

but you don't know that for sure, of course. The ball could have been set in motion already and even if you stop at wk 12, it still would have happen.  Like said, a lot of guessing, for many yrs to come.

I stopped the meds at 74 wks and continued shedding hair for months afterwards, what was already started, could not come to a screeching halt.

[Upbeat]

Count me as one a little more optomistic then most of you. There is a better chance that vx-950 will work as monothearpy than with current drugs. I have spent sometime talking to people involved with the FDA approval process and vertex is doing what they need to do to get that approval as soon as possible. They understand the huge loss the company reported and what they need to do to keep their investors happy. As someone at the company said to me, A person could always use vx-950 as mono if they wanted to.

                                                           Ron

[Kalio1]

What information is the idea VX950 will work as monotherapy based on? Just wanting it to be true or saying it is so isn't enough, there is no data showing this might be true that I can find, they are testing VX950 WITH IFN/Riba at this point and trials using it alone haven't even begun yet, so who is saying it could work alone? The only time you hear this claim is from those interested in the stock prices and is based on rumors and speculation not on fact. I have looked high and low and can't find any evidence that VX950 would work as a monotherapy or even that it will work WITH IfN/Riba. Where are you getting this information? Please share it because the only people I find saying this are those who are hoping to cash in on their stocks or eouraging people to buy those stocks. My doctor told me there isn't any information available yet to back up these claims. I want it to be true too but I need evidence.

[Upbeat]

VX-950 was first tested as a mono treatment. As I recall they had up to a 4 log drop using vx-950 alone. They did not try for SVR. All that early info is out there.  

                                                         Ron