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Hep C Trials of VX-950
Are there any trials of VX-950 now enrolling volunteers either in the US or abroad?
CDM: Don't quite understand your point.
Wasn't trying to make a point per se or contradict anything you said. Simply wanted to add more information/references regarding the Vertex trials.
CDM... In my post i has said i did not think vertex was one using a placebo.
Again, not contradicting anything you said, just wanted to expand/clarify that they are using a placebo in the sense that early trials will placebo the Vertex component, while still using peg and riba. Later they might drop the placebo component if things pan out. This is different from using a 100% placebo arm where someone gets only placebo and no drugs.
CDM: Are you saying someone with little or no damage that has time to wait jump right in the early trials, shouldn't they wait for vertex to prove them selfs more?
I did not make that point in my post. But personally, if I had little or no liver damage, yes, I'd wait until Vertex proves itself in the trials. That way, I'd have both more data to consider as well as be able to have my treatment personalized regarding dosing, length, real-time blood test results, rescue drugs, etc.
CDM: Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?
Yes, "projected" but so far they seem to be moving along on schedule. I believe they are using ribavirin in all the intial American trials. Only one European arm will be without ribavirin. I have no idea what their policy will be regarding rescue drugs such as ribavirin, nuprogen, etc. That's another advantage of waiting until a drug comes to market.
CDM: you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right?
According to what I read, those that do not RVR will not be dropped. Instead their treatment will be extended longer. I don't know what their policy is regarding conventional benchmarks such as two-log drop, etc. However, based on data from the initial small trials, most people should get at least a two-log drop -- actually be non-detectible by 12 weeks. In any event, it's a good question, and anyone who's thinking about a trial should try and get hold of the exact trial protocol, or at least call/email Vertex for clarification.
CDM: ...and when they add the ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?
Don't think that was covered in release. Again, a good question for Vertex.
CDM:
Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive.
Again, I agree. And personally I don't think a person with little or no liver damage should treat with any drug. But others have a different view.
CDM: While this drug looks good now as you know lots can happen.
Yup. And I guess that's why they are called "trials". Still, looks promising so far. Certainly hope so for everyone's sake.
-------
What you didn't ask, but possibly alluded to, is who should do the Vertex trials?
We both agree that those with little or no liver damage should wait. That said, some folks might not agree with you and I :) --
and therefore want to treat with little or no liver damage. I think entering the Vertex trial might be reasonable for this category, since treatment/exposure could end up being less, plus it it doesn't work out, they have time to watch and wait. Also, those with more liver damage might also want to take a chance with the trials after considering the risks versus awards of the Vertex trials against conventional treatment. And, then of course, there are the projected trials for relapsers in early 2007. Should I relsapse, depending on my biopsy result and how the preliminary data flows in, I might be interested in entering one of those trials. Frankly, don't think I have another year of treating with peg and riba in me.
Hope this finds you relatively well.
-- Jim
-- Ji
Wasn't trying to make a point per se or contradict anything you said. Simply wanted to add more information/references regarding the Vertex trials.
CDM... In my post i has said i did not think vertex was one using a placebo.
Again, not contradicting anything you said, just wanted to expand/clarify that they are using a placebo in the sense that early trials will placebo the Vertex component, while still using peg and riba. Later they might drop the placebo component if things pan out. This is different from using a 100% placebo arm where someone gets only placebo and no drugs.
CDM: Are you saying someone with little or no damage that has time to wait jump right in the early trials, shouldn't they wait for vertex to prove them selfs more?
I did not make that point in my post. But personally, if I had little or no liver damage, yes, I'd wait until Vertex proves itself in the trials. That way, I'd have both more data to consider as well as be able to have my treatment personalized regarding dosing, length, real-time blood test results, rescue drugs, etc.
CDM: Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?
Yes, "projected" but so far they seem to be moving along on schedule. I believe they are using ribavirin in all the intial American trials. Only one European arm will be without ribavirin. I have no idea what their policy will be regarding rescue drugs such as ribavirin, nuprogen, etc. That's another advantage of waiting until a drug comes to market.
CDM: you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right?
According to what I read, those that do not RVR will not be dropped. Instead their treatment will be extended longer. I don't know what their policy is regarding conventional benchmarks such as two-log drop, etc. However, based on data from the initial small trials, most people should get at least a two-log drop -- actually be non-detectible by 12 weeks. In any event, it's a good question, and anyone who's thinking about a trial should try and get hold of the exact trial protocol, or at least call/email Vertex for clarification.
CDM: ...and when they add the ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?
Don't think that was covered in release. Again, a good question for Vertex.
CDM:
Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive.
Again, I agree. And personally I don't think a person with little or no liver damage should treat with any drug. But others have a different view.
CDM: While this drug looks good now as you know lots can happen.
Yup. And I guess that's why they are called "trials". Still, looks promising so far. Certainly hope so for everyone's sake.
-------
What you didn't ask, but possibly alluded to, is who should do the Vertex trials?
We both agree that those with little or no liver damage should wait. That said, some folks might not agree with you and I :) --
and therefore want to treat with little or no liver damage. I think entering the Vertex trial might be reasonable for this category, since treatment/exposure could end up being less, plus it it doesn't work out, they have time to watch and wait. Also, those with more liver damage might also want to take a chance with the trials after considering the risks versus awards of the Vertex trials against conventional treatment. And, then of course, there are the projected trials for relapsers in early 2007. Should I relsapse, depending on my biopsy result and how the preliminary data flows in, I might be interested in entering one of those trials. Frankly, don't think I have another year of treating with peg and riba in me.
Hope this finds you relatively well.
-- Jim
-- Ji
Thanks. I am desperate for what looks like the best new drug on the horizon. Age and cirrhosis probably will keep me out of the trials but I keep hoping.
My doctor told me to stop caring about one particular pharm company and their drug. He compared pharm companies to any other corporation like Exxon, McDonalds, Phillip Morris even.. They will do everything possible to not let the shareholders get concerned about their product up to the point of practically lying.
He knows from experience. He pointed to a piece of paper on his wall that had a Phase 3 HIV drug he had about 20 or so of his patients on that just collapsed when it got to the FDA. Whole thing scrapped, millions down the drain.
He did say that in 5 years better drugs will come down the pipe...It is almost a certainty. but for me and my situation I needed to focus on what is at hand insterad of worrying so much about making it to VX-950. (I had bought 40 shares of VRTX stock hopping it does cure all and my stock will pay for the medication..lol...Im still kind of hoping that will happen, even though I've lost 25 cents a share just today)
52tele: Yea, this looks like the best year for ACL fest in a long time. Antone did die young thats for sure. Definately a bummer. A lot of austin's greatness was originally from Dallas!(Vaughn Brothers) Hopefully everything will be fine next week with bx.
He knows from experience. He pointed to a piece of paper on his wall that had a Phase 3 HIV drug he had about 20 or so of his patients on that just collapsed when it got to the FDA. Whole thing scrapped, millions down the drain.
He did say that in 5 years better drugs will come down the pipe...It is almost a certainty. but for me and my situation I needed to focus on what is at hand insterad of worrying so much about making it to VX-950. (I had bought 40 shares of VRTX stock hopping it does cure all and my stock will pay for the medication..lol...Im still kind of hoping that will happen, even though I've lost 25 cents a share just today)
52tele: Yea, this looks like the best year for ACL fest in a long time. Antone did die young thats for sure. Definately a bummer. A lot of austin's greatness was originally from Dallas!(Vaughn Brothers) Hopefully everything will be fine next week with bx.
Sorry to hear about your loss. As you've already noticed that there are highs and lows asscoiated with hcv. However, and especially in your case, there is always room for hope. It's the anxiety of waiting for the highs and lows that make you kinda nuts.
I gave myself such a letdown. Here I was thinking it might soon be over. So if your getting sick while on a trial the only option is to stop. Then you would have to start traditional treatment from the beginning. Right now a trial does not sound like a wise choice. Sorry for sounding so negative. I lost a family member to cancer this weekend and am at a loss in the hope department.
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