Where are the New Wonder Drugs?

[geterdone]

Where are the New Wonder Drugs?

I read posts of waiting for the “new” drugs coming out in the near future? When are these drugs coming to market? and are the side effects the same or less than the SOC? I read here about prove 3, what about the sx of this durg is there any difference? Lots of questions here but the reason I’m asking is that I had a biopsy back in 2004 and had read an article that new drugs were on the horizon and here it is 3 years later and NO new drugs on the market and I have wasted 3 years before starting tx and could have been done with this mess back then. Why is it so compelling by some to wait.

jasper  

[jmjm530]

Depends what you mean by a "wonder drug". I think a case can be made that a drug 'WONDERful' if it cuts treatment time in half with double the SVR rates.

We 'may' have a drug like that currently in trial called Telaprevir with other similar drugs on its heel.  Anecdotally, our small group of 24-weekers on Telaprevir plus SOC (12 weeks triple and 12 weeks SOC) have done quite well and by the end of the year we should have a lot more SVR data on the 24-week treatment group comprised of  genotype 1's.  More WONDEfull would be even shorter treatments, without interferon, and with even fewer side effects. Hopefully that will start happening in the near future (5-10 years)?

-- Jim

[jmjm530]

The reason why it's "so compelling by some to wait" is because treatment with the current SOC (48 weeks for Geno 1's) does not come without risks. Therefore waiting for newer treatments -- such as 24-week treatments discussed previously -- can make a lot of sense. And for those that can wait even longer (little or no liver damage) newer drugs/regimens may be even less toxic. So where does one jump in and treat? While some -- including a slew of liver specialists -- say everyone with HCV should treat, others are more selective and take many factors into account, with liver damage being one of the primary ones. Probably no surprise that I agree with the latter group.

-- Jim

[VXman]

I completely understand your frustration. If there is a silver bullet out there, it certainly will not be around for at least another 5-years or more. Telaprevir (VX-950) is likely to be FDA approved as a new drug used in triple combination therapy with Peg/Rib. The good news is that we are looking at the potential for 80%+ SVR and for treatment time to be considerably less than the SOC. I review a "Pipeline Summary" report from HCV Advocate on a monthly basis. Their updates are a little behind the press releases: however, it gives you a good snapshot of what's coming down the pipe.

I'm in Prove 3 Week 11 and UND!

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

[FullOfHope77]

How do you know that you're UND? I'm also in the study for Prove 3 Phase II and very grateful that I'm in but understand that all aspects of that are double blinded so I'm naturally curious how do you know if you're UND or not or do you have a different protocol that you follow? My protocol will not disclose anything until 24 weeks but I would love to find out what I really am looking at in terms of my treatment and counts. Is there a legal way to do that?

Geterdone
I would say if you're having any scarring at all then I would go for tx NOW without hesitation. If you have no scarrng at all then that would be the only reason to wait for 3 years+ before Telaprevir (which is on 'fast track') will be FDA approved and generally available. It could be up to 5 years I understand as well. The interferon is soooo good for your liver that it will literally buy you time even if you don't clear if you do have a little fibrosis. If you smoke pot then studies show a 7X speed up in fibrosis activity according to the UK study that I read which is just another reason to not do that if you're tempted in that area. But the key to all of it is time. If you have no scarring you have time if you have scarring that has started then the time has speeded up for you and IMHO then you should consider stopping the advance of the virus. Talk to several doctors and get several opinions. Have you ever tx'ed before?

[VXman]

Follow the subject "Prove 3 - Week 4 Criteria" that I originally posted 7/13. I also responded to a similar question today 7/16 that is at the end of the same thread. I'm beginning to wonder whether Vertex is arbitrarily establishing different criteria at each of the 50+ centers that make up the 440 patients. I have no reason to doubt any of the claims that individuals have made regarding the criteria that they have been told. The protocol was left ambiguous and subject to modification at any given time.  Some individuals have posted the criteria as being explained to them as remaining 1-log, while others have been told 2-log or even more stringent: UND after Week 4. Please read the comments and let me know what your take on it is. I have tried googling info about specifics and I have not found anything with a solid lead.

[APKhaos]

So, when I was diagnosed with HCV in 2005, the best they could offer was a 50% chance of SVR after 48 weeks of SOC. With Stage 3 liver damage, spending a rough year on a 50% chance didn't seem like a good deal but that was all that was offering.

I lucked into the Prove 1 trial. With a starting VL of 26,460,000 and elevated ALT/AST, I did 12 weeks of Telaprevir + SOC followed by 12 weeks of SOC. Six months post TX I'm a solid SVR, and so are others who were in Prove 1.

As Jim said, a significantly increased rate of SVR after 24 weeks of treatment makes it over my personal wonder drug threshold. If the further Phase 2 trials support results like this, then maybe you should be checking on the Phase 3 trials that will happen next year or waiting till 2009 or so for full FDA approval.

[nygirl7]

It'd be awful nice if they came out with the one shot wonder drug wouldn't it?

Anyone with severe liver damage really has to take into effect that there is absolutely no guarantee in this entire world that ANY drug will ever be developed that will be more effective than current SOC.  We all hope and we pray and continue to do so but - how could anyone ever guarantee something like that?

Instead I decided to do 72 weeks of the current SOC to try and up my lower my odds of relapse.  the information that is released by ANY drug company on a drug in DEVELOPMENT is always going to be a bit better than the ACTUAL results...so whatever you read take it a bit lightly and realize...money makes the world go around and you know someone WANTS to be able to come out with the "cure" but it might not be so practical.  Then treat based on all of that.

[stacyb321]

have you started tx yet?  what stage are you?  were you treating in your pic cause you look great?  Im worried about looking old and losing hair - but that wont stop me from treating.  Just curious.

[nygirl7]

I treated for 72 weeks and am post treatment now 5 1/2 months (UND at 4 months post still praying for SVR)

That picture was before treatment...believe me when I say my hair FELL out it did gobs and gobs.  But you know, it's worth it - beating this disease and getting rid of it is worth every second of the whole experience.  It's just odd to find out how really vain you can be about something like HAIR...when it was gone I cried and cried but then discovered that wigs on ebay were really affordable and bought a whole bunch of them and what a difference in my psyche it made!  

It's worth it Stacy.  Just do it, stay the course and say "this too shall pass" it's a temporary thing that leads to a permanent solution - a CURE!  I hope I am SVR but if I'm not - I'll never regret having done it.

My BEST luck to you.

[geterdone]

My thought is that “if” you have the virus why not get it taken care of at that point of knowing or in short order rather than waiting (1-5) years for a newer drug with a “promise” of SVR in 24 weeks, which by the way I do not see happening. Lets say this triple combo does come to market by the end of the year and people start the taking it, and at the end of 24, 12/12 weeks they reach SVR, WOW! Great! then three months later lab work shows it’s back what are the back up drugs going to be? Interferon and Ribavirin that takes a 48 week course to kill the virus. A slow process that is proven to work in 85% of the peoples.

In addition to the standard SX associated with the Interferon and Ribavirin which is bad enough is there going to be additional sx associated with the Telaprevir such as a bad rash and other unknown sx’s that is not being published at this point?

I guess the point I was trying to make is,

When you find out that you have the virus and depending on a number of variables of ones personal situation why not start to TX asap and get it over with. Sure the Telaprevir may be the latest and greatest and takes 24 weeks to work and does do its job, then at the 3 month PCR the virus shows up again. So, now it has been 36 weeks of TX and zero to show but heart ach and grief. Then another month at least to come to terms with the fact THAT if I had started the TX with the present SOC some 40 weeks ago I would be coming down the home stretch and will be done with it and get on with life.

The trials are GREAT! and are needed to move the cure forward but for people just finding out that they have the virus and with or without viral loads should consider starting tx ASAP. Yes, the trials are very good for people who have relapsed or did not respond to the present soc. But, Isn’t Interferon and the Riba the basic building blocks in frame work in the many newer drugs coming to market in the years to come?

Fast is not always better and waiting too long can compound problems
Again just my thoughts.

jasper

[FlGuy]

'Interferon and Ribavirin that takes a 48 week course to kill the virus. A slow process that is proven to work in 85% of the peoples.'

The problem is that current combo treatment is not proven at 85%.  It might be for geno 2 and somewhat less for geno 3 but keep in mind that the most common is geno 1 and that rate is closer to 50%.  So, when you weight all the genos together, proportionally, the success rate is much lower than 85%.  And, 'depending on a number of variables' is a whole deck's worth of wild cards.

[jmjm530]

Geter: Sure the Telaprevir may be the latest and greatest and takes 24 weeks to work and does do its job, then at the 3 month PCR the virus shows up again.
-------------------------------------------------------------------------------------------------------
But that is not what is happening to the majority of those in the Telaprevir trials here. Many are reporting back still non-detectible at the 3 and 6 month (SVR) POST TREATMENT mark. Just check out "PLN's" recent post here: http://www.medhelp.org/posts/show/203808

If this trend continues and is backed by the more complete 24-week trial results (avail later this year) then Telaprevir will offer twice the odds of SVR in half the time of SOC.

Don't you think someone who doesn't have significant liver damage owes it to themselves (and family) to wait at least until Vertex reports the 24-week trial results which should be by end of year?

-- Jim

[geterdone]

Any Liver Damage is Significant. But what would that safety zone be, 10k, 100k, what is the age group finding out that they have HVC and when is the fastest replication of the virus?

jasper

[jmjm530]

I'm using the word "significant" in regards to liver damage as it's often used by liver specialists which would be stage 3 or 4. Not sure what you mean by "safety zone" but all I'm saying is that we already have anecdotal evidence (right here at MH) that Telaprevir is working (working as in SVR) but more important, we should have more complete official trial data by the end of the year. And yes, there is a school of thought that everyone should treat regardless of liver damage, but you asked the question, "why wait" and I'm trying to give the logic of that school of thought. One waits because one feels that the potential risks and hardships of treating with current SOC drugs outweigh the potential (50-50) rewards of SVR.

-- Jim

[geterdone]

Yes, I understand what your saying jim and that it is up to the individual and there own situation of when and how to treat and there are two sides to everything. To me (50-50) is better than ?- 50%. We'll just have to wait until the end of year for the trial data.

jasper    

[Mr Liver]

HCV is the only virus we can eradicate on a somewhat successful basis. Man has developed a cure for a viral infection for the first time ever,through good R&D' ...I'd say between the ever-changing drugs and tests and the modified tx algorithms closley tailored for the individual, has all combined to reduce tx discontinuance.

[willows]

I have a fantastic doc in Seattle, one of the best here on the west coast and his hospital is involved in a couple of different trials and he is absolutely excited, off the wall happy with what is going on in the Teleprevir trials.  I advanced a stage since my last biopsy, but considering my profile, viral breakthru at 30 weeks, he gave me odds of about 10% to reach SVR on current SOC if I tried again.  Now he says, up those odds to about 70% with teleprevir and reduce exposure to IFN by 12 weeks and it made a compelling arguement for me to wait for teleprevir.  He believes that it will be the winter of 2009 when we will truly know and perhaps have teleprevir available to folks with my profile.  

I watch the posts here, and the stock for Vertex and all the companies releases of info etc. and the company believes it will be about 2009 also.  A big tell will be what comes out of Vertex meeting with the FDA at the end of this summer, I wait patiently for that information.

Whether I am experiencing scarring or not, all I read and hear and am counseled on says to wait.  Two years is not a long time in Hep C land, I had this virus for 30 years, a few more WILL NOT hurt me and is a good investment in upping my chances.  "Expose the virus to IFN the least amount of time possible, to minimize the chance of virus mutation."  That is what Doc Scott said, the man rocks and I listened.

[glucklich]

FullOfHope77

I am in the trial.
I was told:
4 week: 1 log drop
12 week: 2 log drop
20 week undetectable

I started with >21,000,000 and a non responder.

[merryBe]

thank you for the list of trials, and to all for such bountiful, intelligent discourse. I am new to the site and disease, and slightly overwhelmed.

I recommend tx with all the old and funny movies!! At least for my first week with the news, it proved most helpful.

would someone with time on their hands mind directing me to the list of Jargons?
without a medical degree, I've figured out SVR, survivor? IFN interferon perhaps...but there are dozens in here.

also, to Full of Hope...
.I did find out, through a GH(growth hormone) trial I went through, that by law they must give you your bloodwork results if your doctors needs them, or if you just say, have another condition that makes it needful to know. I was told, by law, even though it's supposed to be a "big secret" that they have to hand them over if you ask. I already knew, by the effect on my body that I was not on placebo, but wanted my doctor to see that I really was sick. If that helps you.
Merrybe

[meki]

OK - check this...

There is ALWAYS going to be something better ---- later on... There is ALWAYS going to be something you shouldn't have done - or should have waited for.

The point is (to me at least) - Right here - Right NOW --- what is/was available?

Because --------- yanno..... Tomorrow might not come for me... I might be walking and Godzilla might step on me... Then phhhhlllllbbbbbbt... I'm just a pile of poo then...

LOL!

Meki

[CockSparrow]

I am with Meki on this one guys.
Anyone remember BILN2061 or NM283? Both gave us hope but where are they now.

No matter how promising they look, no matter how many SVR on them during trials, until these new drugs are released all they are is VaporWare.

Take whats available today. Why? cause tomorrow never comes.
If they are released you can always have another go.
CS