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R1626 News - Anyone else have feedback?
Got a call today from trial coordinator saying Doc and PA are super excited about results coming in on their Roche R1626 trial. I guess viral loads are unblinded and they are seeing great responses. She mentioned a 9 million+ starter below 100 at 4 weeks. Also said side effects have been minimal. They originally called me about this drug in Oct. and for some reason I thought it was closed to recruiting.
I read drofi's "Roche's Pol Inhib R1626" thread which has some good observations and I will bring along to appointment to discuss. As before, I can't find much. There's the Nov. info from Boston, but I thought there was someone else here that was thinking about participating.
I just went in a few weeks ago for a bunch of tests and I told them I was trying to get it together to go out to California for a scan with HR. NP didn't discourage me from doing so, but that I should be prepared to hear that I am a stage 4. Wouldn't order a Fibrosure test for me : (
They know that I am not interested in SOC (unless I absolutely have to) but did let them know that I am very interested in the Phase III 950 trial just around the corner.
I almost wish they wouldn't have called with this info. I had convinced myself, that if the 950 trial happens at their location and I can get in, I would do it, no matter what stage I am. But this Roche trial is a 6 out of 7 shot with unblinded results and Vertex would be 3 out of 4. Arrrrgggh.
WWJD? (I mean jim)
I read drofi's "Roche's Pol Inhib R1626" thread which has some good observations and I will bring along to appointment to discuss. As before, I can't find much. There's the Nov. info from Boston, but I thought there was someone else here that was thinking about participating.
I just went in a few weeks ago for a bunch of tests and I told them I was trying to get it together to go out to California for a scan with HR. NP didn't discourage me from doing so, but that I should be prepared to hear that I am a stage 4. Wouldn't order a Fibrosure test for me : (
They know that I am not interested in SOC (unless I absolutely have to) but did let them know that I am very interested in the Phase III 950 trial just around the corner.
I almost wish they wouldn't have called with this info. I had convinced myself, that if the 950 trial happens at their location and I can get in, I would do it, no matter what stage I am. But this Roche trial is a 6 out of 7 shot with unblinded results and Vertex would be 3 out of 4. Arrrrgggh.
WWJD? (I mean jim)
Thanks for the info on the prodrug thing. I have to read up about that.
A viral breakthrough is when your viral load goes down to undetectable while you are on the meds and then the virus bounces back and your viral load goes up again. This means that the meds have not been able to keep your virus down, therefore there is no point in continuing taking them.
When your viral load is measured frequently, as Susan describes, by taking blood and doing PCR's, this is how you find out how you are responding to the meds. A fast response is good. Or you can be a slow responder (viral load goes down slowly) or not respond at all (viral load does not go down) . Or you can have viral breakthrough, or you can relapse, or you can clear the virus and get what we all want which is SVR.
If you want to get educated on all this try this link. The site is excellent. You will need to register first time in but it's free.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Management%20Tools/Virtual%20Presentations/Corbett.aspx
There is a lot to be anxious about, that's true. There's no getting away from the fact that hepC is a serious disease. I was diagnosed in August 2006, so recently, just like you. Some people cope better by ignoring what is going on and taking it as it comes, some find it better to understand, it's really up to you. There's usually somebody here who's been through it and can help, whatever it is that comes up.
dointime
A viral breakthrough is when your viral load goes down to undetectable while you are on the meds and then the virus bounces back and your viral load goes up again. This means that the meds have not been able to keep your virus down, therefore there is no point in continuing taking them.
When your viral load is measured frequently, as Susan describes, by taking blood and doing PCR's, this is how you find out how you are responding to the meds. A fast response is good. Or you can be a slow responder (viral load goes down slowly) or not respond at all (viral load does not go down) . Or you can have viral breakthrough, or you can relapse, or you can clear the virus and get what we all want which is SVR.
If you want to get educated on all this try this link. The site is excellent. You will need to register first time in but it's free.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Management%20Tools/Virtual%20Presentations/Corbett.aspx
There is a lot to be anxious about, that's true. There's no getting away from the fact that hepC is a serious disease. I was diagnosed in August 2006, so recently, just like you. Some people cope better by ignoring what is going on and taking it as it comes, some find it better to understand, it's really up to you. There's usually somebody here who's been through it and can help, whatever it is that comes up.
dointime
Dointime, "I don't think it's 2 drugs. I think it's one drug with 2 names"
I think you're right....but wrong at the same time. I think it's a Prodrug.
I wasn't sure what that meant until I found this:
"A prodrug is a pharmacological substance (drug) which is administered in an inactive (or significantly less active) form. Once administered, the prodrug is metabolised in vivo into an active metabolite."
Translated to me means: It's a drug that changes into R1626 once inside the body.
So yes I guess in a way RO4588161 is R1626 ( "one drug with 2 names")
But at the same time you're wrong because before being introduced into the body,RO4588161 is (by itself) a different drug. It's just that it metamorphasizes into R1626.
Susan, I don't know what I was thinking they would do at all of those appt.'s! Blood work!....yes I'm an idiot...lol.
I know about the schedule, mine will be wks 1,2,3,4,8,12,16 etc. Sounds like of blood to me! :-)
But "Viral Breakthrough"........I didn't really understand what that was until I came across this article - http://www.medicinenet.com/hepatitis_c/page2.htm
"In addition, within a single host, there are minor genetic differences in the hepatitis C virus. These minor differences give rise to what are called quasispecies (quasi means resembling each other). Where do the quasispecies come from? Well, one of the non-structural hepatitis C virus proteins mentioned above is the enzyme polymerase. This enzyme is the machine that allows the virus to reproduce its genetic material (RNA) in order to multiply. Now, this RNA polymerase is very prone to making mistakes, resulting in changes (mutations) in the genetic material. The majority of these mutations result in a non-viable (not living) new quasispecies of hepatitis C virus, but sometimes the mutation results in viable quasispecies. With time, the accumulation of these viable mutations results in multiple quasispecies of the virus within the same host.
Why are there so many different varieties of hepatitis C virus anyway? Perhaps the different varieties confer an advantage to the survival of this virus over the years. For example, some of the new species may become more efficient in reproducing themselves (replication). By the same token, however, the genetic variability of hepatitis C virus has made the development of a protective vaccine against all of these genotypes and quasispecies a near impossible task with our present technology. Moreover, this variability probably also explains how this virus results in such a high rate of chronic infection. Thus, the genetic variability may enable the hepatitis C virus to avoid destruction by the host's cellular immune cells or antibodies, and so maintain (perpetuate) the chronic infection"
It seems that there are a number of factors that can cause this virus to mutate into a different genetic makeup. A fear with Polymerase Inhibitors (which RO4588161 is) is that the drug itself can irritate this Enzyme into producing a genetically changed "Super" Hep C cell that can avoid treatment and that will replicate itself throughout the body.
Smart little son of a ***** isn't it?
Thank you all for making my brain work. It tends to get bogged down with emotions and getting it working is sometimes hard.
Of course I could be wrong with any or all of what I've said here. Please if anyone knows better...I would truly like to hear what you have to say or think.
Always nice to focus on something other than the waiting......
I think you're right....but wrong at the same time. I think it's a Prodrug.
I wasn't sure what that meant until I found this:
"A prodrug is a pharmacological substance (drug) which is administered in an inactive (or significantly less active) form. Once administered, the prodrug is metabolised in vivo into an active metabolite."
Translated to me means: It's a drug that changes into R1626 once inside the body.
So yes I guess in a way RO4588161 is R1626 ( "one drug with 2 names")
But at the same time you're wrong because before being introduced into the body,RO4588161 is (by itself) a different drug. It's just that it metamorphasizes into R1626.
Susan, I don't know what I was thinking they would do at all of those appt.'s! Blood work!....yes I'm an idiot...lol.
I know about the schedule, mine will be wks 1,2,3,4,8,12,16 etc. Sounds like of blood to me! :-)
But "Viral Breakthrough"........I didn't really understand what that was until I came across this article - http://www.medicinenet.com/hepatitis_c/page2.htm
"In addition, within a single host, there are minor genetic differences in the hepatitis C virus. These minor differences give rise to what are called quasispecies (quasi means resembling each other). Where do the quasispecies come from? Well, one of the non-structural hepatitis C virus proteins mentioned above is the enzyme polymerase. This enzyme is the machine that allows the virus to reproduce its genetic material (RNA) in order to multiply. Now, this RNA polymerase is very prone to making mistakes, resulting in changes (mutations) in the genetic material. The majority of these mutations result in a non-viable (not living) new quasispecies of hepatitis C virus, but sometimes the mutation results in viable quasispecies. With time, the accumulation of these viable mutations results in multiple quasispecies of the virus within the same host.
Why are there so many different varieties of hepatitis C virus anyway? Perhaps the different varieties confer an advantage to the survival of this virus over the years. For example, some of the new species may become more efficient in reproducing themselves (replication). By the same token, however, the genetic variability of hepatitis C virus has made the development of a protective vaccine against all of these genotypes and quasispecies a near impossible task with our present technology. Moreover, this variability probably also explains how this virus results in such a high rate of chronic infection. Thus, the genetic variability may enable the hepatitis C virus to avoid destruction by the host's cellular immune cells or antibodies, and so maintain (perpetuate) the chronic infection"
It seems that there are a number of factors that can cause this virus to mutate into a different genetic makeup. A fear with Polymerase Inhibitors (which RO4588161 is) is that the drug itself can irritate this Enzyme into producing a genetically changed "Super" Hep C cell that can avoid treatment and that will replicate itself throughout the body.
Smart little son of a ***** isn't it?
Thank you all for making my brain work. It tends to get bogged down with emotions and getting it working is sometimes hard.
Of course I could be wrong with any or all of what I've said here. Please if anyone knows better...I would truly like to hear what you have to say or think.
Always nice to focus on something other than the waiting......
Laurie,
In most trials, they draw your blood so often it feels like they are vampires! Like in Prove 3, I had the pre-dose blood draw, then, week 1,2,3,4, etc., and so on and so forth. I was told at week 5 that I'd had viral load rebound, from the results of my week 4 blood draw, and that I had to stop treatment and I was pulled from the trial. I did have two more post treatment follow-up blood draws. Anyhow, that's how they know if you've had viral breakthrough. Susan
In most trials, they draw your blood so often it feels like they are vampires! Like in Prove 3, I had the pre-dose blood draw, then, week 1,2,3,4, etc., and so on and so forth. I was told at week 5 that I'd had viral load rebound, from the results of my week 4 blood draw, and that I had to stop treatment and I was pulled from the trial. I did have two more post treatment follow-up blood draws. Anyhow, that's how they know if you've had viral breakthrough. Susan
" the more you know before you start the less anxious you will be" - Boy I just don't know that that's true. Seems to me that the more I learn, the more I'm finding out how much more there is to be anxious about!
Ok....so viral breakthrough. How is it that they know when there's been a viral breakthrough?
What exactly is a viral breakthrough?
Ok....so viral breakthrough. How is it that they know when there's been a viral breakthrough?
What exactly is a viral breakthrough?
I don't think it's 2 drugs. I think it's one drug with 2 names.
The trial protocol seems fine, except there's still no mention of what happens if there's early viral breakthrough. You understand, right, that viral breakthrough means it's all over, the end, the virus won that round.
I mention this because I did the Prove2 trial and had viral breakthrough by week 4. But because it was double blind I was not told and I had to endure another 8 weeks of meds which they knew could not clear the virus. In later trials they changed the protocol so that people with breakthrough were told by week 4 and their meds were terminated. It's a disappointment when that happens but imagine how you'd feel if you were given 24 weeks of meds and 20 of those weeks were known to be useless. I hope the lesson was learned by the drug companies after the Prove2 trials but who knows.
Well this probably won't happen to you anyway but trust me, when the meds kick in you will start to worry about all kinds of scenarios that you can't imagine now, and the more you know before you start the less anxious you will be.
dointime
The trial protocol seems fine, except there's still no mention of what happens if there's early viral breakthrough. You understand, right, that viral breakthrough means it's all over, the end, the virus won that round.
I mention this because I did the Prove2 trial and had viral breakthrough by week 4. But because it was double blind I was not told and I had to endure another 8 weeks of meds which they knew could not clear the virus. In later trials they changed the protocol so that people with breakthrough were told by week 4 and their meds were terminated. It's a disappointment when that happens but imagine how you'd feel if you were given 24 weeks of meds and 20 of those weeks were known to be useless. I hope the lesson was learned by the drug companies after the Prove2 trials but who knows.
Well this probably won't happen to you anyway but trust me, when the meds kick in you will start to worry about all kinds of scenarios that you can't imagine now, and the more you know before you start the less anxious you will be.
dointime
By the way.
My consent forms say that RO4588161 has been given to 130 people previously, worldwide.
It also say's that this is a phase 2 study that will involve 490 people worldwide.
If this is R1626, why does the consent form say the above?
I'm not clear on the connection between these 2 drugs.
Laurie
My consent forms say that RO4588161 has been given to 130 people previously, worldwide.
It also say's that this is a phase 2 study that will involve 490 people worldwide.
If this is R1626, why does the consent form say the above?
I'm not clear on the connection between these 2 drugs.
Laurie
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