viral breakthrough

I have been doing some researching on this topic, As I understand it is that the virus changes DNA, and is resistant to interferons. I had a question asked that got me thinking,this virus is so elusive could it change it's DNA in a way  that is undetectable by current PCR testing in some cases.Cringe at the thought, but it was A question that really got me to thinking.

[couldn't think of a nickname]

HIV is a retrovirus that makes changes in DNA. HCV is an RNA virus, and does not incorporate into the DNA.
What you described is the problem with HIV. That is why interferon is not used with HIV.

[cuteus]

Hi there! long time no see! I must have made an invocation! check the thread by bronxrican, veterans' woes...

hope you are staying healthy and out of trouble!

[cougareyes]

I don't want to sound so gloom and doom, but I hope people aren't holding their breath over these new drugs. They aren't even being tested to provide SVR yet, and that's the true test. As stated about about the HIV PI's, this same thing can happen with the HCV PI's; when you stop taking them you relapse. That means they will be using these new drugs in a cocktail, so watch out here comes riba. If I'm not mistaken that's their plan already.
Even with fast track FDA approval, these new drugs won't have any legimate track record for at least 7 to 8 years; and that is being very generous. If you've got 7 to 10 years to wait to take a shot with these new drugs then good for you.      Peace

[couldn't think of a nickname]

A track record is not a requirement for FDA approval. Undetectable status with a 6 month follow up is the endpoint they will look for-safety and efficacy.

While Riba is being done in some arms in phase 2 for both SGP and VRTX, early data did not use riba, and they still crushed the efficacy of interferon and riba (much fewer sides in early reports too). Clearly, this is moving towards a combo of interferon and a PI, at least initially, with a potential for monotherapy for the most potent of PI's.
VRTX does have SVR as an endpoint for phase 2, which is scheduled to finish in 2006.

As far as relapse, HIV is a retrovirus, HCV isn't.
HIV doesn't relapse because of the PI, it relapses because of the hidden reservoirs in the body and that it incorporates into the DNA. HCV does not do that.
Relapse is the same issue with these drugs as it is with current therapy. Also, resistance is a greater issue with current therapy because it is not as potent.

[GoofyDad]

When does the VRTX timeline project vx-950 availability via prescription to the general public?

[cuteus]

I agree with you cougar, is just too soon to judge, and for some too long to wait for the final results, either because of liver damage or aging. it is ok for those with wiggle room.
CTON
it worries me that so many are waiting without the full knowledge of their liver damage status. Without a fibroscan+fibrotest(combo test that most accurately reflects bx results) available for most, biopsy is the best diagnostic tool still. I would be scared to wait without that knowledge, especially after reading lvdbygod and painintheside experiences.
Adverse events are so rare now that they use ultrasound guidance that it makes me wonder why drs are so reluctant.
Best to you

[couldn't think of a nickname]

They won't say, but if they file in early 2008, they would have the drug approved in less than 6 months. From there, it does take some time to get to market. I don't see how it could be any time before late 2008, and that of course, assumes everything goes according to plan. So far, the time line they have been giving from the start of the clinical trials is holding up, but the tough studies are ahead.
In order to cut down on time to market, they have stated they will be manufacturing to 1 ton scale up by 2006. They are preparing as if there will be high demand once approved. It is a large task, that is why they are starting it soon.

I guess with any drug, there is a window in between approval and time to launch, and I don't think they know what that would be right now.

[couldn't think of a nickname]

My doc isn't necessarily reluctant, if I wanted one tomorrow, he would whole-heartedly endorse it. I made the decision based on other diagnostic tests, etc., and other monitoring. The thing that most in here don't realize is, that I am NOT a good candidate at all for current treatment. Riba is not a good option for me, and interferon will exacerbate other problems, probably severely. Yes, it is good to know, and both docs agree with that.

[couldn't think of a nickname]

I should add, that adverse events were not a factor in my decision.

[cuteus]

it sounds as if you would not be able to do anything, even if you were close to stage 4, even scarier...
how do you deal with the mental part of those thoughts? is it mostly HOPE?

[couldn't think of a nickname]

If I were there, then yes, I could try treatment. My other numbers as of last test were not indicative of that.

"how do you deal with the mental part of those thoughts? is it mostly HOPE?"

Those are not my thoughts. It is not good to make assumptions. This focus on me the last couple of days (where no one knows me or my situation) quite frankly, is making me uncomfortable. I don't like being a focus for attention, I never have. I usually don't post on most message boards because I like to leave ME out of things. I much prefer to pass along information.

[beamishboy]

no focus just appreciation for all your knowledge&info-thank you v much&please continue helping.....

[couldn't think of a nickname]

Thank you, I will. It is probably my own fault really, for bringing it up.

[vegas777]

Hi there :)

I found this really neat site that has a chart that shows the "The New Drug Timelines" from research all the way through to market, but it's a jpeg file...I would like to post that here but I don't know how to post images in here...Anywhoo, it says the timeline from soup to nuts is 7-12 years...How long did it take Vertex for Phase I do you know?

*diipers*

[mistybean]

My doctor said we have at least 10 years before better drugs.  This is as good as it gets.  I also heard that Hep C does not become resistant to the interferons.  Meaning you can treat once and fail and do it again.

[couldn't think of a nickname]

I believe this first started to be developed in 1995 or so, so it is already 10 years in. When things get into the clinic, then assumptions can start to be made. For example, lets take HGSI with Albuferon. Assuming it works and is safe, which available data supports, we know that trials will be up to 48 weeks with 6 month follow up. Depending on when P2 started and finishes, you can start to make an estimate. There is some time in between for data analaysis, etc.

There were 2 delays that I know of when it comes to VX-950. First, there was a legal battle with Chiron, who discovered the virus. They have patents on it, and no one can research it without settling with them first. I will bite my tongue here. Hard.
I think I might have a PR saved on that somewhere, otherwise I know I have read this in non-Vertex articles.

Second, they were originally partnered with Ely Lilly with this drug. A few years ago, Lilly decided to go in a different direction. At the time, phase 1 was planned to be started in 2003. The settlement took a while, and delayed phase 1 by a year.

I also get the feeling that it doesn't matter if the FDA fast tracks or not (different than priority review). Due to the large amount of work it will take to get the drug to market as quickly as possible, they don't feel they could get it out any sooner anyway.

I will mess this up, but fast tracking has to do with how the FDA speeds up the analysis of and submission of data (someone please correct me here, I don't think I am explaining this right).
Priority review happens AFTER clinical trials, where an NDA is submitted, and a ruling is made in under 6 months (might be 5 months or less, whereas normal timeframe is around 11 months).

[couldn't think of a nickname]

I accidentally hit post.

So, with VX-950, it looks like it will be 13-14 years soup to nuts (1995-late 2008). 1 year of that was not due anything with the drug, and I would consider to be an anomaly.

Let's take another example. BIIB (Biogen Idec) announced right after VRTX's news that they discovered the gene responsible for causing MS, and actually shut it off and REVERSED the process in vitro. BTW, I think this was important news that got overshadowed by other things, including their problems with Tysabri at the time.
I don't know when they started working on this, but we can watch and see how long it takes for this to progress. It is my opinion that this is still many, many years away, as I am not sure if it has even been tested in animals yet. But, they were able to re-generate the myelin sheathing around the nerves with the lesions. Since I follow biotech stocks, I actually did call the company and ask them about this, but they couldn't say much.

[vegas777]

let's all keep our fingers crossed that 950 progresses smoothly without hitch..It seems to be the front line runner..Maybe ny 2010 we can have that puppy available to all...

[couldn't think of a nickname]

My wife has always wanted a puppy. Since I am allergic, let's call it a hypoallergenic dog.....

[cougareyes]

I think you missed my point, it all looks like the new drugs(at least 2) will be available by 2010, by FDA standards. They are still adjusting tx protocol to improve svr stats and control sx with the current meds, how many years pass lauching. Svr rates for type 1's started in the 20 something % range, with alot more drop outs and people being pulled.
I believe for them to get a true handle on protocol, sx management, risk vs SVR stats; it will be heading toward 10 years.   Peace.

[couldn't think of a nickname]

I understood your post. I do think that the next generation drugs, whether they be PI's Polymerase Inhibitors, or Helicase Inhibitors have major advantages over current SOC. There have been many lessons learned in the last 10 years that can be applied. For example, in the beginning, tx time. It was long for everyone. Then, they found that those who cleared early (4 weeks, mostly 2's and 3's) had the same odds of SVR if they treated only 12 weeks, etc.
Also, the next generation of drugs (at least 950 anyway) has identified the trough concentration level necessary to produce a continued decline, which is what got those 4 in TID to undetectable in 2 weeks.

For those who don't know what trough concentration levels are, that is the MINIMUM amount of drug in the liver due to dosing times, etc. I belive it is 1050 nanograms in TID, whereas the rebound groups only had about 700 nanograms. Again, that was without interferon, which will help that.

It is kind of like being the 3rd of 3 kids in a family. The oldest goes through all of the garbage-early curfews, less freedom, etc. By the time you get to the baby of the family, they're thankful for those who came before them. For example, my parents taught my older sister to drive. After that, thank God I had a driving school.

[vegas777]

I am allergic to dogs too so let's call it a bunny *smile*

*dip*

[couldn't think of a nickname]

To anyone interested, Naomi Judd is getting a talk show.

http://www.post-gazette.com/pg/05325/609926.stm

[dammitjanet]

No-Nick:  Thanks for the response.  I definitely will try to find the #1 book you recommended.  I don't know how Reiki works, but I believe that it does.  I have felt it.  And you're right about the spirituality of the practitioners - My MT is currently in India working with a Mahareeshi helping to find homes for orphaned children.  She is a very kind hearted soul.

Veg:  How are things in the northland?  Are you snowed in yet?  I've just been busy getting ready for Thanksgiving; thus my late respose to everyone - just got sidetracked for awhile.  This seems to be happening more & more these days.  Can't seem to remember what I'm doing from one minute to the next!  

Tater:  Like your attitude girl.  
PS - My mother has a cute, fluffy white dog named Tater Tot!  I'm sure you're cute, but I hope you're not fluffy, with 4 legs!

[couldn't think of a nickname]

Something in there was intriguing to me. She mentioned looking at HEALING as well. To me, being cured is different than being healed. In fact, many in here might be cured of the virus, but might need healing also.

I wonder if Reiki had a place in that healing mix. I am thinking of getting Reiki done, and we are considering taking a class.
I have had some Reiki done already, and it was quite interesting.

[vegas777]

I remember when she announced she was retiring from her singing career, she said she was seeking alternate approches to treat her disease and her healing would be begin immediately...I know she is a very spiritual person, mostly with her religeous beliefs, maybe thats part of her healing...If you go on her site she offers a list of books to read and many are regarding healing...I don't think I ever saw anything on her using conventional drugs so not sure if she ever went that route...

I agree with you about people that have attained SVR through conventional drugs could use healing as well...Just the thought of going a year or maybe longer with the drugs they use for HCV has got to do a number on ones mind as well as body...

I never thought to look into Raiki (sp)..I have been some research into Zen and actually have found a couple good exercises to do...Let me know what you think if you take the Raiki class...

I just fired up my karoke machine, think I will sing "Mama He's Crazy"  here's to you Naomi!!!

[couldn't think of a nickname]

Here is what got me interested in Reiki. While on vacation over the summer during a massage, the therapist told me a story about one of her customers who was terminal with cancer. 3 docs gave her 6 months to live. The 3rd doc said he couldn't help her anymore, but he suggested she find a good Reiki master.

She found one, and got treatments for about a year. At the end of the year, the master told her that her body had healed, there was nothing more he could do for her. She goes back to the doc, they do tests, and there are no traces of cancer.

Our massage therapist is Reiki level II (III is a master). She knew I had bought some books and was starting to read about it, and we had talked casually about it. At the end of a session, she had her hand placed on the back of neck, while she worked on the front of my neck. I felt a strong sensation of heat. In reading a couple of days later, I learned that was a Reiki hand position.

She did more of it on me another time, but this time she placed her hand on the back of my hip. I had a knee injury years ago playing basketball, and my chiro kept telling me L5 was irritated, and that sometimes knee problems were felt in the hips (as a side note, he asked me if I had a knee problem, he diagnosed that before I told him).

As she kept her hand on the back of my hip, I felt a strange sensation of pins and needles, which quickly shot down my right leg and stopped right at the knee that had the old injury. My calf then started to twitch, quite a bit.
When she got to the last position which was my feet, again I felt the same sensation on my right lower leg that went to my right knee. This time, my hips violently twitched.
It was quite interesting.

As a side note, she also told me I had an excess of energy in my crown (top of head) and a deficit of energy in my mid section, which is the Chakra for the digestive track, and it isn't really surprising considering the HCV.

That's how Reiki got my attention. I have a few books on it too, which are all interesting.

[dammitjanet]

I'd be interested to hear your interpretation and understanding of Reiki.  Mine is very limited.  My massage therapist is trained in Reiki, and I know that I feel a sense of healing when she lays her hands on me.  Had to use a different MT today as mine is out of the country, and it just wasn't the same.  Thanks.  DJ

[cuteus]

well it is probably because you did not dip in the sacred waters of lake quinetacka.

[couldn't think of a nickname]

Reiki is an ancient form of healing by the laying of the hands. Everything in the universe has energy, some call it universal life force energy. Some of it can be measured, such as EEG, or ECG, and one of the books I have shows other ways.

When illness occurs (dis-ease), there are energy blockages in the body, and energy deficits. Energy isn't flowing properly, throwing your body out of balance. Energy flows similar to meridians in accupuncture. I have read that modern science can measure energy in the meridians.
The cause of dis-ease could be anything, and Reiki helps bring it out. It could be physical, emotional, spiritual, etc.

The person performing Reiki will tell you that they are not doing the healing themselves, it is the body. They are only channeling the energy.

There are 4 books I have read (some not completely or thoroughly enough) that you might want to look into.

Reiki For Life by Penelope Quest was very good, and would be no. 1 on my list.

The Reiki Sourcebook by Bronwen and Frans Stiene is more technical in nature.

Reiki Energy Medicine by Libby Barnett and Maggie Chambers is pretty good.

The one I currently am reading doesn't call it Reiki, per se, but it is very similar. It is called Hands Of Light by Barbara Ann Brennan. Funny thing, when I first looked at the book, it was late at night, and I went to end of the book to see any conclusions, etc. In chapter 25 they described someone who was very similar to us, with how he felt, and that he had been diagnosed at one time with hepatitis.
This book has been a tough read at times, very interesting at others. My MT has studied some of her work.

The sensation you felt is a common one. Reiki is to be performed with "loving intent"-an intent to heal. I have noticed that many who practice Reiki are deeply spiritual people.

Talk to her more about it, I would be interested in your experiences, thoughts, etc.

I tried to explain it to the best of my ability to understand it, but I could be off on some points.

Oh, also, when it addresses blockages of energy, and energy flows better, I think it enhances our immune systems and helps in repair.

[couldn't think of a nickname]

How convenient that you only wanted the Teddy Bear. Couldn't you subconsciously have asked for something of value? LOL

[couldn't think of a nickname]

I should clarify. I wouldn't expect Reiki to cure HCV. I do think it can help our bodies though. Hence, the difference between healing and curing.

[vegas777]

CTON - Where I live there is very big Native North American population and they believe in the healing of the hand as well, not sure what they call it, some Ojibway name...I am going to  look into getting a MT, it was suggeted by my ND and when I do I will try to get one that is familiar with it...

Shugah! - Hi there!!  where ya been, haven't heard from you in awhile..I was planning on sitting down and sending you a nice long message and then you pop in here!!...I will do it tomorrow...Hope all is well in VA....

*dippers*

[couldn't think of a nickname]

I am beginning to like your ND quite a bit. Sounds like you have a good one.

[vegas777]

Yes, she seems quite at peace with herself and her surroundings, and very knowledgable, just wish she wasn't so dang expensive  lol...She's native too, not that means she's beter than anyone else at what she does, but I find natives to be more "earthy" if you know what I mean...

*dip*

[couldn't think of a nickname]

Well put, I agree. Even if you weren't cured, maybe in some levels you were healed.

My wife and I consider ourselves quite religious. I am the first to say, that things happen for a reason, even if we don't understand at the time. My wife hurts her foot badly, has to stop her dancing career, which was just getting started. Because of her injury, she moves back in the area. If that doesn't happen, we don't meet, and fall in love. I find out I have HCV right after we get engaged. If I found out before, I might not have wanted to get involved in a relationship. I truly believe that is how it was meant to play out.


We have the poem Footprints in one of our bathrooms. I can't help but read it from time to time.

[vegas777]

YIPPE!!!

Thank you so much for letting us know that about Miss Naomi...I love her!! And have from time to time "attempted" to sing her songs :)

*dancing dip*

[cougareyes]

Sorry to hear you have not responded well to tx. By all measures there are 2 new drugs, vx-950 and another; estimated to be out in 2009; at least by 2010. The down side is they are still looking into mixing cocktails with these drugs. VX-950 has already mentioned using interferon.
That complicates matters when alot of people that are in need of new drugs, have to also get away from the current meds. It's not as simple as adding something to become more effective. Some people can't take the interferon, or can't take the riba.
My sceptical side still sees them using one or both, and because of the way the new drugs are acting; I think they will probably still use the riba. Just one man's thoughts.   Peace

[dammitjanet]

Sorry bout the hair!  But, I hear it grows back.  Let's just hope it doesn't grow back WHITE & fluffy!

[NYgirl]

Wow you have a lot of lifetime similarities with ME (my daughter too).

I know how much you've got on your plate but doesn't it seem like all things lined up perfectly for you to find out that you had HCV?

I think those of us who had NO idea - who have some strange way of finding out that we even HAVE it - we are the very blessed ones.  

When I get depressed about tx I just stop and think WOW if not for the set of circumstances I could have gone on for another ten years not knowing.......and been completely out of liver cells by then and it could have been too late.

I think in the scheme of things....we are the lucky ones. I truly believe that the millions of people running around with these cooties in them that have NO idea - that will find out many years from now when it's too late.....they are the ones who have it hard.

Not us!  :) :)

Debby

[vegas777]

howdeee....no bowling today?

have you heard from cquest?  I sent her a couple emails and they came back as email no longer valid....

*dip*