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PI trials for F4 Geno1?
Anybody know if there have been any trials for F4 (and above) geno 1s, or if any are being slated?
I'm still toying with the idea of waiting for PI approval, in spite of now being F3/F4. Maybe it's crazy. But since my hospital can't offer me anything but SOC (less than 30% chance for me), and there aren't any PI trials coming up in my area, I don't really know what to do. If there were some data on whether the PIs can clear F4s, at least I'd have some idea of my chances if I wait. Or maybe I could just rule it out and go with what's available with a clearer mind.
Information is the name of the game.
Mike
I'm still toying with the idea of waiting for PI approval, in spite of now being F3/F4. Maybe it's crazy. But since my hospital can't offer me anything but SOC (less than 30% chance for me), and there aren't any PI trials coming up in my area, I don't really know what to do. If there were some data on whether the PIs can clear F4s, at least I'd have some idea of my chances if I wait. Or maybe I could just rule it out and go with what's available with a clearer mind.
Information is the name of the game.
Mike
Furthermore, when looking at clinical trials, don't disregard the Phase II trials either - mine had 7 arms and more risk to it - some are less risk, less arms and decent odds. Come to think of it, there is a Phase II that's been recruiting that a couple people have posted about that looked pretty good and I'll try to remember which one it was and post it to you for consideration.
"I would still very much like to know if there have been any trials of PIs for geno 1, Metavir F4 and above. Does anyone have an idea about this? "
Mike, the trials that are run are usually done on the basis of treatment naive or not and are usually done for Genotype 1's. You've got both things in your favour there when it comes to trials - you're Genotype 1 and you're treatment naive.
As for PI's for 24 weeks, that's not typically done on a trial. Most are PI's or the trial drug for a shorter period of time and then SOC for the greater majority of the time. I wouldn't let the fact that the trial drug is less than 24 weeks put you off at ALL. I would look at it differently, that having an extra drug in there for any portion of time is a bonus on top of SOC. I had a polymerase inhibitor for the first 12 weeks while I was, unknown to me at the time, getting half the usual dosage of interferon.
If you decide to go SOC, Alinia can be prescribed off-label or purchased from an online drug company, you can add Alinia to the mix with SOC. You can also talk to your doc about going with higher doses of ribavirin and/or interferon in the beginning if you want to hit this thing with a hammer. I would also consider doing a lead-in with the ribavirin of 2-3 weeks.
I would start cruising clinicaltrials.gov and look for Phase III trials for treatment naive Geno 1's but also consider how you'd like to do SOC treatment in the absence of a trial and start preparing to do either / or. I was getting myself ready to do SOC and was getting ready to have my son bring Alinia in for me from Mexico - he was in San Diego at the time - and then the trial came along. You may get to the point where you're so ready to treat that you're not waiting any longer for the perfect trial so you might as well plan out your SOC in the event a trial to your liking doesn't come along.
If you truly believe you are F4, then you don't have time to waste. Geterdone, my friend.
Mike, the trials that are run are usually done on the basis of treatment naive or not and are usually done for Genotype 1's. You've got both things in your favour there when it comes to trials - you're Genotype 1 and you're treatment naive.
As for PI's for 24 weeks, that's not typically done on a trial. Most are PI's or the trial drug for a shorter period of time and then SOC for the greater majority of the time. I wouldn't let the fact that the trial drug is less than 24 weeks put you off at ALL. I would look at it differently, that having an extra drug in there for any portion of time is a bonus on top of SOC. I had a polymerase inhibitor for the first 12 weeks while I was, unknown to me at the time, getting half the usual dosage of interferon.
If you decide to go SOC, Alinia can be prescribed off-label or purchased from an online drug company, you can add Alinia to the mix with SOC. You can also talk to your doc about going with higher doses of ribavirin and/or interferon in the beginning if you want to hit this thing with a hammer. I would also consider doing a lead-in with the ribavirin of 2-3 weeks.
I would start cruising clinicaltrials.gov and look for Phase III trials for treatment naive Geno 1's but also consider how you'd like to do SOC treatment in the absence of a trial and start preparing to do either / or. I was getting myself ready to do SOC and was getting ready to have my son bring Alinia in for me from Mexico - he was in San Diego at the time - and then the trial came along. You may get to the point where you're so ready to treat that you're not waiting any longer for the perfect trial so you might as well plan out your SOC in the event a trial to your liking doesn't come along.
If you truly believe you are F4, then you don't have time to waste. Geterdone, my friend.
I even felt my 36 weeks of boceprevir was a bit of an overkill,not by the SX,just that 36 weeks of 18 pills a dy wa s abit much,if this virus is not killed now,it will never die.
In fact 24 weeks of PI's is likely to be overkill. Read the results of the Telaprevir trials: ALL arms get the PI for only 12 weeks, and they have SVR rates of 80 - 85%.
I appreciate that you do not feel enough info is available for you to trust this trial (or likely many others). However, the info for the Phase I and the Phase IIa trial IS in, which I stated in my previous post. It's readily available on the internet.
Lastly, I wish you wouldn't refer to this trial, which my dear husband is on, as "any old thing." We researched it very thoroughly, and, even though I understand that it isn't right for you, it's much more well-designed than you are giving it credit for.
I appreciate that you do not feel enough info is available for you to trust this trial (or likely many others). However, the info for the Phase I and the Phase IIa trial IS in, which I stated in my previous post. It's readily available on the internet.
Lastly, I wish you wouldn't refer to this trial, which my dear husband is on, as "any old thing." We researched it very thoroughly, and, even though I understand that it isn't right for you, it's much more well-designed than you are giving it credit for.
Another thing,RVR with SOC is the same as RVR with the PI ...dont matter what bat you hit the home run with
You might not want to say to your doc you will stop at 30 days if you dont SVR,he may not treat you at all,you can always just stop the TX anytime you want SOC or a trial.But ill garentee if you do RVR in 30 days you will happy.
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