Aa
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)
Funny that you should notice this older post when just minutes ago I noticed my trial center is still enrolling for this study (a month and a half later) when they told me it was going to close that week.
I have continued to read here and at other sites that wbc's are the problem for this drug, My problem is low platelets not wbc, so if I can't get into Phase 3 of the Teleprevir trial, now that I know they are still recruiting... ya never know.
I have been watching Clinical Trials like a hawk to see if my clinic pops up for Vertex Phase 3, and left messages but haven't heard a thing. Vertex returned a call to me on Friday and said to just keep watching (she said that she noticed Texas just began recruiting). By the end of the day they had added AL and Puerto Rico, but that was it.
I swear someone posted that they had already done their enrollment testing for this phase, but couldn't find the post. I also know that the trials site is sometimes slow, but was surprised that Vertex was mum on the subject. Apparently it is up to our trial sites to get their info posted? And maybe they actually begin screening sometimes before they get their center added to the Clinical Trials site?
I have continued to read here and at other sites that wbc's are the problem for this drug, My problem is low platelets not wbc, so if I can't get into Phase 3 of the Teleprevir trial, now that I know they are still recruiting... ya never know.
I have been watching Clinical Trials like a hawk to see if my clinic pops up for Vertex Phase 3, and left messages but haven't heard a thing. Vertex returned a call to me on Friday and said to just keep watching (she said that she noticed Texas just began recruiting). By the end of the day they had added AL and Puerto Rico, but that was it.
I swear someone posted that they had already done their enrollment testing for this phase, but couldn't find the post. I also know that the trials site is sometimes slow, but was surprised that Vertex was mum on the subject. Apparently it is up to our trial sites to get their info posted? And maybe they actually begin screening sometimes before they get their center added to the Clinical Trials site?
Hi foofighter,
perhaps this info is still interesting, sorry for the delay.
http://www.mediwiss.de/R1626.htm
PS: There ist a typing error in the heading, R1626 is a polymerase inhibitor, no protease inhibitor.
Good luck, drofi
perhaps this info is still interesting, sorry for the delay.
http://www.mediwiss.de/R1626.htm
PS: There ist a typing error in the heading, R1626 is a polymerase inhibitor, no protease inhibitor.
Good luck, drofi
StainedGlass and I are posting our results on this on the "Social" side ... care to join us in posting your Week 1 results there? :)
I am on this trial in Australia, shot 3 down last night and I have minimal to no sides. I note that I think there is a typo with the 7 treatment arms above Group B I suspect is 1500 mg daily of trial drug. I know of a couple on this site who are on the trial and 2 others from elsewhere. Baseline to Week 1 VL drops that I know of are 4,000,000+ to 350, 350,000 to 18, 3,020,000 to 277,000. I will get my results at week 3 clinic on Friday this week. No rescue drugs in this trial so it's a bit like free falling. I travel 4 hours each way to clinic and have clocked up 40 hours so far to Week 2 clinic, but I feel it's worth the money and effort. If anyone has any questions please ask. Oh definately R1626 as it is written on each of the trial drug bottles. Regards Emi
foofighter, Hell of a situation isn't it? Talk about uneducated choices.
You're on your way though....you're fighting....you'll win.
My prayers are with you.
Dointime, thank you for the link.
I had a pretty good idea of what "viral Breakthrough" was What I had been looking for is not how they know it's happened, but the why it happens.
"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."
Equals
"and then the virus bounces back and your viral load goes up again."
Regardless of the why's or the whats, i found that it's pretty much up to the virus and the tx. I won't have any input. All I can do is try to eat as well as possible, drink massive amounts of water, exercise, rest and muddle through it.
Oh yeah....and keep my fingers crossed.
You're on your way though....you're fighting....you'll win.
My prayers are with you.
Dointime, thank you for the link.
I had a pretty good idea of what "viral Breakthrough" was What I had been looking for is not how they know it's happened, but the why it happens.
"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."
Equals
"and then the virus bounces back and your viral load goes up again."
Regardless of the why's or the whats, i found that it's pretty much up to the virus and the tx. I won't have any input. All I can do is try to eat as well as possible, drink massive amounts of water, exercise, rest and muddle through it.
Oh yeah....and keep my fingers crossed.
"I think I have made my mind up"
-----------------------------------------------------
That happens to me a few times a day too....
Seriously though, when you (I use that as in the universal "you" as this is the type of thing I've been struggling with lately too, but I'm sure that many, like yourself, have have had to deal with these questions far longer than I have) have complex treatment issues with multiple options, none of which are perfect nor clear, and many of which are ALSO complex in and of themselves (like combining this option with that option, or part of this other option), it seems, to me anyway, that the case planning gets really murky.
I mean, to me it just feels so much like we're out here winging it with a computer, a message board, the published studies we're able to dig up, and whatever experts we're able to find as consults...
I think that I never thought, nor realized, and probably couldn't have even fathomed prior to now, that I ever could be in this type of medical situation, where the direction of treatment wasn't clear. I thought if something "bad" happened, in terms of an accident or an illness, then I'd go to the doctor and THEY would tell ME my treatment options, offer me best-case scenarios for each option, and then help me choose the best one for me. That's just like so fairy-tale fantasy land now, looking back.
Instead, I've found that this is a very patient driven treatment process, like nothing I've ever seen before. Frequently there are comorbidities and other complex health issues that need to be managed, but this doesn't really happen very well because treatment isn't handled in a "case management" type style by the treating physician (I'm sure this is not always the case, but it seems to occur this way frequently), this is left to the patient.
Anyway, trying to get my stuff together here and I wish you the best of luck with yours! You'll be in my thoughts and prayers!
-----------------------------------------------------
That happens to me a few times a day too....
Seriously though, when you (I use that as in the universal "you" as this is the type of thing I've been struggling with lately too, but I'm sure that many, like yourself, have have had to deal with these questions far longer than I have) have complex treatment issues with multiple options, none of which are perfect nor clear, and many of which are ALSO complex in and of themselves (like combining this option with that option, or part of this other option), it seems, to me anyway, that the case planning gets really murky.
I mean, to me it just feels so much like we're out here winging it with a computer, a message board, the published studies we're able to dig up, and whatever experts we're able to find as consults...
I think that I never thought, nor realized, and probably couldn't have even fathomed prior to now, that I ever could be in this type of medical situation, where the direction of treatment wasn't clear. I thought if something "bad" happened, in terms of an accident or an illness, then I'd go to the doctor and THEY would tell ME my treatment options, offer me best-case scenarios for each option, and then help me choose the best one for me. That's just like so fairy-tale fantasy land now, looking back.
Instead, I've found that this is a very patient driven treatment process, like nothing I've ever seen before. Frequently there are comorbidities and other complex health issues that need to be managed, but this doesn't really happen very well because treatment isn't handled in a "case management" type style by the treating physician (I'm sure this is not always the case, but it seems to occur this way frequently), this is left to the patient.
Anyway, trying to get my stuff together here and I wish you the best of luck with yours! You'll be in my thoughts and prayers!
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
Thanks for the pdf., no one has been able to show me anything that actually linked R1626 together with RO4588161 before. It's nice to know for sure!
"Did you ask if they would give you neupogen?" - I did ask about rescue drugs like neupogen. Doc said that no rescue drugs can be given. If my counts fall they'll have to lower my dosages until my counts climb back up on their own. Risks are around every corner I guess...it's a risk that I except nerviously.
"what would they do if you have viral breakthrough early on in tx? Would they just keep dosing you anyway to no benefit to you (and how would you feel about that) or would they terminate the meds?" - If I'm in arm C of the trial if the virus is cleared from week 4 to week 22 they'll stop all treatment at week 25. Other than that they plan to tx for the full 48 weeks. How do I feel about that? Well I'm in for the long haul of 48 weeks. I almost don't want to be in arm C. I don't want to stop tx and then find out later down the road that I relapse. It's in my mind that the longer I can withstand treatment the better my chances are at killing every last Hep C cell. Too many Type 1b patients are being put through 72 weeks of tx to increase their chances of clearing the virus. 48 weeks worries me already....24 weeks? I'd rather do the time and pain and have a better chance to clear that one last lone Hep C cell. No pain, No gain?!. My fingers are crossed that I don't land in the Arm C. But if I do....so be it.
If I fail tx....if I can't withstand the trial, they'll put me into a standard tx and treat me for 48 weeks with rescue drugs.
Pre-trial tests show's my good blood counts to be higher than normal (except for proteins which are low due to nausea from fatigue - Hep C induced). So at least I'm starting off on the right foot.
Thanks again for the info Dointime! You found a piece of the puzzle that I've been looking for!
I'll stay in touch. Hopefully with good news!
Laurie
"Did you ask if they would give you neupogen?" - I did ask about rescue drugs like neupogen. Doc said that no rescue drugs can be given. If my counts fall they'll have to lower my dosages until my counts climb back up on their own. Risks are around every corner I guess...it's a risk that I except nerviously.
"what would they do if you have viral breakthrough early on in tx? Would they just keep dosing you anyway to no benefit to you (and how would you feel about that) or would they terminate the meds?" - If I'm in arm C of the trial if the virus is cleared from week 4 to week 22 they'll stop all treatment at week 25. Other than that they plan to tx for the full 48 weeks. How do I feel about that? Well I'm in for the long haul of 48 weeks. I almost don't want to be in arm C. I don't want to stop tx and then find out later down the road that I relapse. It's in my mind that the longer I can withstand treatment the better my chances are at killing every last Hep C cell. Too many Type 1b patients are being put through 72 weeks of tx to increase their chances of clearing the virus. 48 weeks worries me already....24 weeks? I'd rather do the time and pain and have a better chance to clear that one last lone Hep C cell. No pain, No gain?!. My fingers are crossed that I don't land in the Arm C. But if I do....so be it.
If I fail tx....if I can't withstand the trial, they'll put me into a standard tx and treat me for 48 weeks with rescue drugs.
Pre-trial tests show's my good blood counts to be higher than normal (except for proteins which are low due to nausea from fatigue - Hep C induced). So at least I'm starting off on the right foot.
Thanks again for the info Dointime! You found a piece of the puzzle that I've been looking for!
I'll stay in touch. Hopefully with good news!
Laurie
I can see why you don't want a stage 4 bx to get into the trials. I have had a scan from HR and was a 6, pretty dam good. I then a year later got a fibrosure, because I thought it may be good to get. It turned out to be F3. I freaked out. So I am not sure why anyone is sure of this test. From what my Hep Dr. says and HR, along with others the fibrosure is not as reliable as a fibroscan or bx. I am going next week for another fibroscan as I am worried since I relapsed and wonder if I have progressed in fibrosis. The Fibroscan is really amazing. looking at the liver in up to 20 places puts in perspective how limited the bx can be. Yes, there are things the bx can show, but in my mind the fibroscan is much more specific in where in the liver the problems lie.
RO4588161 is the same drug as R1626. See
http://www.maxygen.com/pdf/EASL_Roche_2006.pdf
Thanks for letting us know that they are using new names. I would never have recognised the drug by this name. .
"In general the side effects were considered mild to moderate. However, there is concern because of the incidence of grade 4 neutropenia which was the major reason for dose reductions and treatment discontinuations."
Did you ask if they would give you neupogen? Better make sure that you steer well clear of bacterial infection, get your teeth fixed etc. before starting tx. Any minor bacterial infection can run out of control if your neutrophils get really low.
One question that I would personally want to ask when starting a double blind trial is what would they do if you have viral breakthrough early on in tx? Would they just keep dosing you anyway to no benefit to you (and how would you feel about that) or would they terminate the meds?
Well hope this helps. Good luck and would be great if you let us know from time to time how you are getting on.
dointime
http://www.maxygen.com/pdf/EASL_Roche_2006.pdf
Thanks for letting us know that they are using new names. I would never have recognised the drug by this name. .
"In general the side effects were considered mild to moderate. However, there is concern because of the incidence of grade 4 neutropenia which was the major reason for dose reductions and treatment discontinuations."
Did you ask if they would give you neupogen? Better make sure that you steer well clear of bacterial infection, get your teeth fixed etc. before starting tx. Any minor bacterial infection can run out of control if your neutrophils get really low.
One question that I would personally want to ask when starting a double blind trial is what would they do if you have viral breakthrough early on in tx? Would they just keep dosing you anyway to no benefit to you (and how would you feel about that) or would they terminate the meds?
Well hope this helps. Good luck and would be great if you let us know from time to time how you are getting on.
dointime
Oh...and hey....the protocol for the RO4588161 is that the Biopsy can be no older than 12 months old. If it is, Roche requires a new biopsy to be done.
Second time I'm trying to post this!...lol...and it's long! :-(
I'll be starting a trial for a drug called RO4588161 within the next few days. There have been people saying that this is the same drug as 1626 but the research team refers this drug as a "new" drug. What do I know.
It's a Phase 2 double blinded study with 7 arms:
A- RO4588161 1000 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
B- RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
C- RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
Participants with no HCV RNA at week 4 through week 22 - no treatment wks 25 through 48
all other participants in "C" - wks 25-48 = RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
D- RO4588161 1500 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
E- RO4588161 1000 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
F- RO4588161 500 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
G- Placebo
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
The sides for RO4588161 are supposed to be pretty much the same as with reg. tx. Does that mean they are more common....or more intence....or the same as taking reg. treatment? I don't know and neither do they. Maybe it depends on my body.
Am I worried about the lower dosages of pegasys? Kind of but not really too much....maybe the RO4588161 will replace the lack of pegasys.
Protocol calls for me to begin within 35 days of my first screening visit - no later than Feb 12th.. I'm waiting for the phone call that brings me to my first shot.
I'm scared and ready to start all at the same time.
I'm tired of waiting and I'm sick of having Hep C and it fatigue.
All in all...I'm normal. I'm ok and I'm strong!.
lol....nothin' like a roller coaster ride.
I'll be starting a trial for a drug called RO4588161 within the next few days. There have been people saying that this is the same drug as 1626 but the research team refers this drug as a "new" drug. What do I know.
It's a Phase 2 double blinded study with 7 arms:
A- RO4588161 1000 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
B- RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
C- RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
Participants with no HCV RNA at week 4 through week 22 - no treatment wks 25 through 48
all other participants in "C" - wks 25-48 = RO4588161 500 mg twice daily
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
D- RO4588161 1500 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
E- RO4588161 1000 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
F- RO4588161 500 mg twice daily
Pegasys 90 micrograms wkly
Copegus 1000 mg daily
G- Placebo
Pegasys 180 micrograms wkly
Copegus 1000 mg daily
The sides for RO4588161 are supposed to be pretty much the same as with reg. tx. Does that mean they are more common....or more intence....or the same as taking reg. treatment? I don't know and neither do they. Maybe it depends on my body.
Am I worried about the lower dosages of pegasys? Kind of but not really too much....maybe the RO4588161 will replace the lack of pegasys.
Protocol calls for me to begin within 35 days of my first screening visit - no later than Feb 12th.. I'm waiting for the phone call that brings me to my first shot.
I'm scared and ready to start all at the same time.
I'm tired of waiting and I'm sick of having Hep C and it fatigue.
All in all...I'm normal. I'm ok and I'm strong!.
lol....nothin' like a roller coaster ride.
No mention of what the reduction would be and you never know, maybe it was a gentle nudge to keep me interested in the Roche product (per dointime's comment). But I guess it makes sense for all of them to test reductions in these nasty drugs.
Also after trying to decipher my notes, the response they were excited about with the Roche product may have been in a week, which they should be excited about.
I would like to slow down and make sure I am clear on things, but they are so, so busy.
Also after trying to decipher my notes, the response they were excited about with the Roche product may have been in a week, which they should be excited about.
I would like to slow down and make sure I am clear on things, but they are so, so busy.
Wow! I wonder if it's true that Vertex will be having 90 mg Peg arms. That's a big step.
I told them I am waiting on the Vertex trial. Glad I did after reading dointime's post.
I mentioned what Aquila posted and NP said he heard that the Vertex trial will have reduced Peg as well.
I think I have made my mind up to do the Vertex trial, if I can get in, whether I know if I am a 2 or a 4. I will do it even if I haven't figured out the trip to see HR.
NY girl, I know this is confusing, but I want to keep that stage 2 biopsy working for me, as it will allow me to participate in trials (even though, I haven't--turned down two now).
If I don't get into the Vertex thing next month, then I will see how long it is before insurance will pay for another. (Biopsy done 7-24-06). Docs, of course want me to treat but I don't want to if I really am a stage 2. And the Fibroscan may at least give me an idea until I get another biopsy.
At my appointment two weeks ago it was the main topic again. I talked with my NP about a breast cancer scare in November that had imaging studies totally contradict pathology. He thoughtfully said, "Let's check for focal nodular hyperplasia, that can affect your liver's appearance." So that was cool. Alas, no FNH and the CT results came back with the same "nodular, bumpy surface typical of a cirrhotic liver."
Can't wait for the Phase 3 info to go up. Thanks all.
Shout out to 4C. I am a million miles from where I was when I found this board because of her and all the others that take the time to help one another.
I mentioned what Aquila posted and NP said he heard that the Vertex trial will have reduced Peg as well.
I think I have made my mind up to do the Vertex trial, if I can get in, whether I know if I am a 2 or a 4. I will do it even if I haven't figured out the trip to see HR.
NY girl, I know this is confusing, but I want to keep that stage 2 biopsy working for me, as it will allow me to participate in trials (even though, I haven't--turned down two now).
If I don't get into the Vertex thing next month, then I will see how long it is before insurance will pay for another. (Biopsy done 7-24-06). Docs, of course want me to treat but I don't want to if I really am a stage 2. And the Fibroscan may at least give me an idea until I get another biopsy.
At my appointment two weeks ago it was the main topic again. I talked with my NP about a breast cancer scare in November that had imaging studies totally contradict pathology. He thoughtfully said, "Let's check for focal nodular hyperplasia, that can affect your liver's appearance." So that was cool. Alas, no FNH and the CT results came back with the same "nodular, bumpy surface typical of a cirrhotic liver."
Can't wait for the Phase 3 info to go up. Thanks all.
Shout out to 4C. I am a million miles from where I was when I found this board because of her and all the others that take the time to help one another.
"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.
If you are talking about comparing vx950 to R1626 then a response of below 100 at 4 weeks is not a great response. The VX950 trials are getting mostly RVR's which is defined as clear by 4 weeks. I would also want to know what the 'minimal' side effects are. I heard that neutropenia was a problem with R1626. But then you might get the rash with VX950. Take your pick.
The point is that trial docs get paid to find good candidates and it is in their interest to make their offer sound as attractive as possible. They might not lie to you but they might omit certain details and use non'specific adjectives. It is up to you to do your research very thoroughly, then make an informed choice.
Good luck,
dointime
If you are talking about comparing vx950 to R1626 then a response of below 100 at 4 weeks is not a great response. The VX950 trials are getting mostly RVR's which is defined as clear by 4 weeks. I would also want to know what the 'minimal' side effects are. I heard that neutropenia was a problem with R1626. But then you might get the rash with VX950. Take your pick.
The point is that trial docs get paid to find good candidates and it is in their interest to make their offer sound as attractive as possible. They might not lie to you but they might omit certain details and use non'specific adjectives. It is up to you to do your research very thoroughly, then make an informed choice.
Good luck,
dointime
Dear Foo - get the biopsy if you can do it, too much information isn't a bad thing and it might give you some clarity rather than go out all the way to Cali for the test that isn't as accurate.
thanks for posting on the r1626.
I had a fibroscan performed last year. the score came back 47, the highest HR had ever seen. HR wanted me to have the fibrosure test, but i have not been able to get any of the docs to order it. in 1981 i fractured my liver, so i thought that the fibroscan might give a more representative reading than the biospy. I am glad i had the fibroscan performed. it was certainly a wake up call for me. Now if i can just get a doc to order alinia with soc.
I had a fibroscan performed last year. the score came back 47, the highest HR had ever seen. HR wanted me to have the fibrosure test, but i have not been able to get any of the docs to order it. in 1981 i fractured my liver, so i thought that the fibroscan might give a more representative reading than the biospy. I am glad i had the fibroscan performed. it was certainly a wake up call for me. Now if i can just get a doc to order alinia with soc.
Thanks so much for pointing this out. There have been many threads about riba dosing (weight-based discussions), but I didn't give the Peg much thought. Half of what everyone else does in SOC? Yikes.
Late for work right now, but I am going to try and hop on at the office to look at the Vertex arms again before my appointment. Trial nurse says there is a 30-day window to qualify for this Roche thing and the Vertex announce is next week.
Late for work right now, but I am going to try and hop on at the office to look at the Vertex arms again before my appointment. Trial nurse says there is a 30-day window to qualify for this Roche thing and the Vertex announce is next week.
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