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New Drugs. New Treatment Decisions.
Recently, someone at another discussion group asked me how I thought the newer protease inhibitors like Vertex should affect our current treatment decisions. Here’s an edited version of my answer.
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That's an excellent topic for discussion!
"To treat or not to treat" has always been a controversial issue.
Nowhere is it more controversial than genotype 1's with no or minimal liver damage, i.e. stage 0 or 1.
In this group, doctors are split. Some advocate treatment, the idea being you have a better chance for SVR if you hit the virus early in the cycle, when you're younger, healthier, and when the liver has little or no scarring.
Others advocate a "watchful waiting" approach with regular lipid monitoring and follow-up biopsy in 3-5 years. The idea here being why expose yourself to the side effects of these powerful drugs when your liver is still in decent shape.
In this debate, I tend to favor watchful waiting, although I respect anyone who decides to treat as long as they're making an informed decsion, weighing the pro's and con's. The only right answer is the one that's right for you.
That said, the new protease inhibitors in trials -- like Vertex -- seem to be shifting the "treat or not to treat" paradigm in this select population toward "not to treat". Because even if we're off with the project 3-5 year release date, this group still has time to wait.
PART II WILL SHORTLY FOLLOW...
-----------------------------
That's an excellent topic for discussion!
"To treat or not to treat" has always been a controversial issue.
Nowhere is it more controversial than genotype 1's with no or minimal liver damage, i.e. stage 0 or 1.
In this group, doctors are split. Some advocate treatment, the idea being you have a better chance for SVR if you hit the virus early in the cycle, when you're younger, healthier, and when the liver has little or no scarring.
Others advocate a "watchful waiting" approach with regular lipid monitoring and follow-up biopsy in 3-5 years. The idea here being why expose yourself to the side effects of these powerful drugs when your liver is still in decent shape.
In this debate, I tend to favor watchful waiting, although I respect anyone who decides to treat as long as they're making an informed decsion, weighing the pro's and con's. The only right answer is the one that's right for you.
That said, the new protease inhibitors in trials -- like Vertex -- seem to be shifting the "treat or not to treat" paradigm in this select population toward "not to treat". Because even if we're off with the project 3-5 year release date, this group still has time to wait.
PART II WILL SHORTLY FOLLOW...
Ah my doctor DID say I had to have a blood test ONCE A WEEK EVERY WEEK during treatment to watch my red blood cells.
Now I know why. I had no idea how important this could be.
I am going to "attempt" to work through this (need the insurance) and if I get fatigued and the Procrit will help (have seen the tv commercials for chemo patients) I am on it.
I am so glad I asked. It's so important to know what we are coming up against.
Is the main reason you get fatigued due to the anemia you think?
Thanks Jim and Cuteus (ps not too much champagne C...you aren't used to it anymore) LOL hahahah! YAY!
Now I know why. I had no idea how important this could be.
I am going to "attempt" to work through this (need the insurance) and if I get fatigued and the Procrit will help (have seen the tv commercials for chemo patients) I am on it.
I am so glad I asked. It's so important to know what we are coming up against.
Is the main reason you get fatigued due to the anemia you think?
Thanks Jim and Cuteus (ps not too much champagne C...you aren't used to it anymore) LOL hahahah! YAY!
Yes, yes, yes, I know there is a difference between HIV and HCV and I did state "general" model as an acknowledgement of the differences. Investigations for HIV treatment have resulted in investigations applicable to HCV treatment.
Currently we do not have much to base a belief that any of the various inhibitors will be a cure. We have hopes. I have no crystal ball, but I envision, if not a continuous combo of inhibitor/interferon/riba, an initial assualt with that combo with follow up treatment with just inf/riba. Anyway you slice it and dice it, a shorter, more effective treatment, with less treatment induced damage is the goal.
Currently we do not have much to base a belief that any of the various inhibitors will be a cure. We have hopes. I have no crystal ball, but I envision, if not a continuous combo of inhibitor/interferon/riba, an initial assualt with that combo with follow up treatment with just inf/riba. Anyway you slice it and dice it, a shorter, more effective treatment, with less treatment induced damage is the goal.
Hey C
What do you mean treat against oxygen deprevation and anemia?
This sounds like something I need to know (we) for the future if it will help us stay in tx and help with the sx!
:)
What do you mean treat against oxygen deprevation and anemia?
This sounds like something I need to know (we) for the future if it will help us stay in tx and help with the sx!
:)
Wow....you're the first one to mention that you're investing in the stock market based on this insider knowledge! LOL.
Obviously I want the biggest return on investment - my life.
With that said, what's your opinion about all of the protease inhibitor companies' stocks??? I've had it on my to do list for three months to by stock in Vertex, Idenix, Schering or all three. Any tips?
Obviously I want the biggest return on investment - my life.
With that said, what's your opinion about all of the protease inhibitor companies' stocks??? I've had it on my to do list for three months to by stock in Vertex, Idenix, Schering or all three. Any tips?
LOL but I would be careful-none of this is insider knowledge-everything I know is public knowledge. I found out about it by looking for news on HCV. I actually don't follow the other companies that much, because my orginal path made me believe this might be best in class....and it does look that way. I did not know much about Schering's at all until very recently. Vertex actually mentions it in their presentations. It, too, is a small molecule PI that has been highly active in replicon assays, but there is no other data yet, nor in humans. It will have a high barrier to reach in order to surpass 950. I am not that excited about Idenix's drug, simply for the fact that even though it is better than current therapies, (or with current therapies) it's data is not as impressive. I think that in this area, any company that comes out with good data or approval will see their stock react well.
As an aside, I think the way I found out about VRTX and 950 was that during the bubble days, it was a high flyer, and my news feed might have had a press release about 950. I remember that in replicon assays, it eliminated the virus in 14 days with no rebound. I have followed it, and every press release and web cast since. After the stock crashed from the bubble, it spent 18 months basing. I bought it at the low end of that basing pattern. It has since done very well, with the 950 news and data being the catalyst. My personal rule of thumb is, that when a stock doubles, sell half, manage the other half. I have sold nothing because I feel that this can be a blockbuster. The risk is, if something negative happens, or there are delays, the stock will suffer. It is the chance you take.
With all of that said, Schering's drug could turn out to be better than NM283, but there is no data yet. Being better than 950 might be tough. They are also significantly behind VRTX, by at least 1 phase, and at least 1 year. First to market is big. Anything that comes after would probably need to be either more efficacious, or safer, or both in order to dominate. If docs get comfortable with something, they may be reluctant to change. The advantage for Schering is, that they are a big name, already known by hepatologists. Phase I is a big step for drugs like these-BILN never made it out of there.
As an aside, I think the way I found out about VRTX and 950 was that during the bubble days, it was a high flyer, and my news feed might have had a press release about 950. I remember that in replicon assays, it eliminated the virus in 14 days with no rebound. I have followed it, and every press release and web cast since. After the stock crashed from the bubble, it spent 18 months basing. I bought it at the low end of that basing pattern. It has since done very well, with the 950 news and data being the catalyst. My personal rule of thumb is, that when a stock doubles, sell half, manage the other half. I have sold nothing because I feel that this can be a blockbuster. The risk is, if something negative happens, or there are delays, the stock will suffer. It is the chance you take.
With all of that said, Schering's drug could turn out to be better than NM283, but there is no data yet. Being better than 950 might be tough. They are also significantly behind VRTX, by at least 1 phase, and at least 1 year. First to market is big. Anything that comes after would probably need to be either more efficacious, or safer, or both in order to dominate. If docs get comfortable with something, they may be reluctant to change. The advantage for Schering is, that they are a big name, already known by hepatologists. Phase I is a big step for drugs like these-BILN never made it out of there.
Mike, I should add that I believe there are 9 compounds in various clinical stages, and 950 has been considered best in class.
One company that neither of us mentioned is Human Genome Sciences (HGSI). I believe that they have a replacement for pegylated interferon in late phase II right now. It is called Albuferon and uses their albumin-fusion technolgy (they are also using that tech. for an anthrax vaccine funded by the gov't). Albuferon has a much longer half life than Peg. Int. and only needs to be taken once every 2-4 weeks. It is possible that if a form of interferon is needed/desired in the future, it could be one or 2 shots of that with a drug like 950. Talk about transforming the treatment paradigm-it would be possible to use a single agent, but if not, 1 or 2 shots instead of 48.
And, you are right, the best return on investment is always the health aspect.
I think many are focusing on possible monotherapies, which is great, but if interferon is needed, HGSI could be a future player.
And no, I don't know all of the other players in this market. I do think the 3 you named are the ones getting/will get much of the future attention. I hope that word of these developments does get out there so that people will be less afraid of a diagnosis and more likely to treat. Only 5% of those infected treat, and maybe 25% know they have it. Those numbers need to change.
One company that neither of us mentioned is Human Genome Sciences (HGSI). I believe that they have a replacement for pegylated interferon in late phase II right now. It is called Albuferon and uses their albumin-fusion technolgy (they are also using that tech. for an anthrax vaccine funded by the gov't). Albuferon has a much longer half life than Peg. Int. and only needs to be taken once every 2-4 weeks. It is possible that if a form of interferon is needed/desired in the future, it could be one or 2 shots of that with a drug like 950. Talk about transforming the treatment paradigm-it would be possible to use a single agent, but if not, 1 or 2 shots instead of 48.
And, you are right, the best return on investment is always the health aspect.
I think many are focusing on possible monotherapies, which is great, but if interferon is needed, HGSI could be a future player.
And no, I don't know all of the other players in this market. I do think the 3 you named are the ones getting/will get much of the future attention. I hope that word of these developments does get out there so that people will be less afraid of a diagnosis and more likely to treat. Only 5% of those infected treat, and maybe 25% know they have it. Those numbers need to change.
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