Forbes: Who Will Find the Wonder Drug? (HEP -C)

A phenomenal article in this months FORBES mag "Saving your Liver" (pg. 82 - 84)

"Drugs for deadly hepatitis C don't work too well. ...Looking for the drug firms that can fix the problem."

"...cautions that it's still early in the development and stock prices will be volatile for the next two years."

Who Will Find the Wonder Drug (In Order)

1. Human Genone Scienes (Albuferon) Recent $13.15 52 Week High $13.97
2. Idenix Pharma $8.33 / $22.87
3. Intermune $22.09 / $23.45
4. Schering-Plough $21.97 / $23.28
5. Vertex Pharma $39.78 / $ 44. 71
6. Viropharma $12.78 / $24.36

Vertex the leader of protease inhibitors - ViroPharma of polymerease inhibitor (reduced the virus 99% in 1 days in combo with Interferon). Idenix Pharm. polymerase inhibitor NM283 is showing much better results that previously in combo with Peg/Riba

[GrandOak]

As we have seen here, part of the problem with VX950 appears to be the rash sx.  When I talked to my doc about applying for VX950 with FDA waver he indicated that current information was showing that roughly a 10% occurance amoung patients.  He also qualified that this is not simply a riba type rash either, but a rather nasty painful one which covers a large of ones body, which is what we've heard of here by a couple of folks who were in the Phase II trials but dropped out because of it.

[NYgirl]

Thanks GO it's nice to know that we were right about it not being the infamous "riba rash" if for nothing other than...we guessed right.

I thought it was an interesting read because there are so many different avenues of drugs that they are currently working on that it shows me...although it would be nice if Vertex panned out (i personally have serious doubts about it) that they are working towards drugs that might be a more complete "cure" ie: polymerase inhibitors, protease inhibitors etc.

They are at such the beginning of this field that I have to believe someone will finally discover a drug that is much easier tolerated and wipes out the virus for good than ANYTHING INCLUDED with Riba and Peg.

For example, I'd never heard of the Albuferon (I think that was it) or polymerase inhibs.

Always worth learning a bit more about things that potentially lead to a real CURE.

[illo]

Yeah,  I heard Johnson and Johnson went in with Vertex.  They must think it's a winner.

Below is the headline of the story.  Link below that.

Vertex Pharmaceuticals and Janssen Pharmaceutica, a Johnson & Johnson Company, Form Collaboration to Develop and Commercialize VX-950 for Treatment of Hepatitis C
Vertex Retains all North American Rights, Janssen Obtains Exclusive Rights in Europe and Other Regions

http://www.jnj.com/news/jnj_news/20060630_095656.htm;jsessionid=S0FABNVUVYQV4CQPCCFWU2YKB2IIWTT1

[couldn't think of a nickname]

I feel the need to point out, that before a rash problem is declared, it should be published first. I am not saying it isn't causing one in a few patients, but I think it is only fair not to jump to conclusions before data is published, as the prior good news that was actually published, got a chilly reception among some.

[couldn't think of a nickname]

Also, just wondering what your doubts are?

[jmjm530]

I could be wrong on this, but I'm not aware of anyone here "dropping out" of the the VX-950 trials. Yes, I remembered someone stopping the VX-950 a little early, but not dropping out. As to the rash, the "ten per cent" figure you cite somewhat jibes with the very unofficial poll we took here a month or so ago. But as far as it's signifcance in the bigger picture, like CTON suggests, let's take a look at some published data before drawing too many conclusions.

Be well.

-- Jim

[NYgirl]

cton

I don't want to get into a Vertex debate and don't want to post against it at all - but am hoping that the med field keeps on looking into other, more permanent "cure" type avenues.

The forum is now nice and peaceful and so right now I really don't want to 'stir the pot' but I have lots of thoughts on this subject and although I hope to hell it comes to pass...I think it's a TEMPORARY patch at best until they can develop a real cure that isn't like putting gasoline on a fire (and for some people that is how adding on vertex is, they can't handle the peg/riba already).

Having people get to UND quickly is a great thing but...until we know that falsely manipulating the virus into an unmeasurable status doesn't mess with the long term SVR results (coming from the shortened duration of peg/riba) - I'm not too jazzed about it.

I hope that made sense in a PERSONAL way and no one takes offense.

[NYgirl]

I thought two people had to drop out (stop early - same thing) because of the severe side effects from the 950 rash.  Pretty sure about that.

Until published data is read it's all speculation - and that is 99.999% of what we do in here on this forum.

Considering a good portion of people can't handle the pegriba on it's own - it's really no surprise that adding another drug on top wouldn't cause worse side effects or exacerabe already existing ones becuase of the peg/riba.  which is pretty much why I'm not holding my breath on this drug.

[jmjm530]

NY: I thought two people had to drop out (stop early - same thing)
------------------
I should have clarified better. What I meant was that they had to stop the VX-950 early but continued on with SOC.

NY: Considering a good portion of people can't handle the pegriba on it's own - it's really no surprise that adding another drug on top wouldn't cause worse side effects or exacerabe already existing ones becuase of the peg/riba. which is pretty much why I'm not holding my breath on this drug.
---------------------------------
As being tested now -- with Peg and Riba -- the whole hope with VX-950, is not only will SVR rates increase, but that total treatment time will significantly decrease. From 48 weeks to perhaps 24 weeks to maybe less. With VX-950 only being used for the initial 12 weeks -- with SOC thereafter -- there's good reason to believe that toxicity and side effects will be dramatically reduced. Time will tell. It also should be mentioned that VX-950 is currently being trialed in Europe without ribavirin. So more toxicity removed from the equation if the trials are successful. And lastly, the down the road hope is that some sort of HCV "cocktail" will be developed with VX-950 in the glass that will finally eliminate Interferon from the mix. And in my lay opinion, that is the worst drug of all because it plays monkey bars with our immune system.

Be well.

-- Jim

[couldn't think of a nickname]

I have posted on albuferon a lot, it is a shame you have missed those. It is second on my list of important HCV drugs.

Just to clear something up, 950 is not a temporary solution or band aid at all. In fact, they have gotten some prelim svr data in the last couple of weeks.
How these patients were treated, was a decision between them and their doctors-they were given options on continuing, or not.

There were 6 patients that tx'd with 950 and IFN ONLY for 2 weeks, then SOC for an additional 22 weeks, where the decision was made to stop based on EVR.
5 of those 6 are now SVR12, meaning they have just had 12 week pcr's and are still negative. SVR24 is of course, the standard, but 24 weeks have not passed yet.
Basically, that's twice the rate in half the time, and they only took the drug for 2 weeks, and there was no riba during those 2 weeks either.

There was a patient who tx'd 28 days with triple combo, and decided to only treat for 14 more weeks after that. After a total of 16 weeks of tx, this one patient is also SVR12.

As you can see, that is transformational data (as defined by analysts). As you also know, most people if they are to relapse, do it within the first few weeks. They test to a <10 sensitivity, so this isn't like other trials where the assays aren't as low.

I am not telling you this to change your mind, or start a problem, but for your own information, and since you have missed (apparently) my prior posts on this and especially Albuferon before (which I have very high expectations for).

And yes, this data is published, and was just presented at the recent liver conference.

[willows]

I missed the Albuferon posts also, but have been spending a little of my spare time, watching some of the stocks mentioned in the article nyg posted.  I'm a little freaked about Albuferon, it is, as I understand, natural interferon and an artificial type bonded, as to last for two weeks in the system instead of just one week.  But the sx are proportional to the strength and that makes it one nasty drug in my book.  Also, anyone who has mutated against IFN will probably have the same reaction to Albuferon, sort of the one time I am really glad I have mutated virus.  Whew!

There are a couple of companies working on a better INF, a pill, less side effects, but it is 5 years out.  Works the same way, sort of, by using immune system to create T cells to seek and destroy the Hep C virus.  

There is a difference between polymerease and protease inhibitors and from all I can read, protease takes the cake, so to speak.  My doc threw out a wildly speculative mix of drugs for me to think about....protease inhibitors, a better riba, a kinder IFN and perhaps the puzzle of Alinia.  Many pills to take in a day.  But there is so much hope they will all work together.  Yes, there will be rashes.  I will take the rash.  

As for the vaccine, we are about a billion dollars away and five generations of drugs away from a vaccine.  The AIDs virus will probably benefit from a vaccine before we will, the HCV virus is the sneakiest, trickiest virus around today.

As you can tell, I have no life, so I spend much time watching stocks, all of them dealing in HCV.  I learn much about the research and the prospective drugs while I am doing it.  "Focused research" is what my husband calls it.  I am a Hep C nerd.  And anything I have posted, I will gladly accept any challenging differing opinions, I learn new stuff every day.

Willow

[NYgirl]

I don't know how I missed the Albuferon posts - but since I have put all of my energy into doing the 72 weeks of SOC I probably didn't pay too much attention.

Just getting through each day (and typing now with one hannd) is too hard to remember.

I hope to God something does work out.  If I relapse for any reason I'd like to know I can do something besides THIS all over again.

Never. Again.

I just want them to develop one shot that is all we ever have to do and we are cure and innoculated from then on.  Now isn't that they way to go?

(In my dreams....in my dreams)

[couldn't think of a nickname]

They are still testing Albuferon in 4 week doses also, but it seems likely at this point that 2 weeks has the best chance of how it gets approved, and I do expect it to be approved. As I mentioned, this has other uses, also cancer. I know someone who took IFN for 2 years for cancer (he is ok now).

The hope is that 6 shots and 12 weeks of pills will work, as that will be a tremendous advance (still a couple of years away of course), but this might reduce symptoms and increase compliance.
After that, much farther down the road, treatment should/will hopefully evolve even better.

One thing that has been discussed is either a possible cocktail of protease and polymerase inhibitors, then there are the other players not really factored in yet, like what role ritonavir (boosts protease inhibitors, used in HIV) or even Alinia might play.

[GrandOak]

Albuferon is one of the few in the pipe which seems to hold some real promise for G1 nonresponders such as myself.

As for the rash issue, I wasn't attempting to draw any conclusions, simply passing along the information my doctor provided me.

As for dropping out of the trial, I do know of one individual in our local support group who did, but didn't mremeet or prettydamnscared also have some serious rash issues from the trial which seemed to also be narrowed down to VX950 and not riba?  I can't recall or find posts on whether they were continuing or had dropped out though.

Bottomline is that no silver bullets appear to be emerging at this time and although VX950 is looking quite promising as another drug for the HCV cocktail which improves SVR odds that it too is being observed to carry it's own sx's, some of which can be nasty.

[jmjm530]

Not sure if you've been following the recent dialogue with a newer member here, "hepatitisresearcher" (HR). Latest thread is from 11/12 by Double Dose, titled "Conversations with Hepatitis Researcher. In post "C42" of that thread, I've listed previous threads re HR. You might want to take the time and back read. HR is as his name suggests a professional hepatitis researcher and in was involved in the invention of some of the blood tests we use today to detect HCV. He also has his own Fiborscan machine and is very interested in Alinia, which you just referenced. Just thought you might be interested.

Be well.

-- Jim

[couldn't think of a nickname]

Thanks, I did originally miss those, but did read some of them. It was hard because I hadn't been in here much, and I missed the genesis of that discussion, so I felt like I was started to watch a movie about an hour into it.
Unless it is Airplane! I need that first hour lol

I purposely did not mention the cholesterol drugs that are currently on the market as possible replacements for riba (based on some small studies) because most of those can cause liver damage, so they may not be a good idea. At least my present family doc who does tx many hcv patients himself wouldn't want to do that, as we have discussed it.

I also did not mention viramadine, which has had mixed results so far. But I believe it is still being tested.

[jmjm530]

FWIW I was given the green light on statis by my hep doc even before tx when I was a stage 3. Of course my liver enzymes would be followed carefully. Still haven't taken them, but it's not a liver damage issue.

-- Jim

[couldn't think of a nickname]

That's interesting, I think there will be more done in research on that issue, as there are still probably a lot of questions out there.
Anything to replace riba.......

[jmjm530]

To be clear, Statins were only discussed in terms of helping my cardiac profile, not to treat my Hep C. As an SVR with approx stage 2 liver damage, one doc told me that it's a misconception that I have to treat my liver any different than if I had a "normal" liver. His point was that certain drugs, etc, are toxic to the liver -- and in combination even more toxic -- but that holds true for everyone not just an SVR with stage 2. This gets very close to some of more "controversial" topics around here :) so I'll leave it at that. But the gist was it's not any one particular thing we ingest, but the whole ball of wax which might include statins other otc and rx drugs, and even ******* (The "*" are mine). LOL.

-- Jim

[couldn't think of a nickname]

gotcha.

[couldn't think of a nickname]

edit to above, my math lost it there. The patient who treated for 28 days SOC, then treated for 14 weeks with SOC for a total of 18, not 16. Also, I think that person was SVR6, which is still early.

sorry for the confusion, I got mixed up when spitting out the numbers.