My roller coaster ride has put my brain into another search for more answers. Sometimes I wonder if I should search. Sometimes the searching leads to more questions. Sometimes the answers that I find are wrong and sometimes their right and I really don't know what to make of them.
For instance, is RO4588161 the same drug as R1626? I didn't think that it was, but then up pops someone who gave me this link:
http://www.maxygen.com/pdf/EASL_Roche_2006.pdf
"R1626/RO4588161".
So is RO4588161 the prodrug of R1626? I suppose it is.
So then the search went to figuring out what a "prodrug" actually is.
"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.
There seems to be many reasons for making "prodrugs". Better obsorption in the body, less sides or less intensive sides to name just a couple. Sometimes a drug is just too much of a whamy to take all at once, so they slow down the
intake by making the drug one thing and having it slowly turn into something else once inside the body. It seems that if a drug like R1626 is not excepted in the body they had to find a way for it to be excepted. So they kind of "trick" the body like you would trying to get a child to take medicine by saying "no no honey it's not nasty tasting....it tastes good" or the way you'd get your pet to take a pill "Here ya go Fido, a nice piece of hamburger! You'll never know that the pill is wrapped up inside"
Your body excepts the Prodrug and once inside, it converts or changes into the regular drug (R1626?).
Ok, so why is this a Phase 2 drug and not at the same phase as R1626? Why do my consent forms say only 130 people have taken it?
My thought is that there's been change in the Prodrug part of it. It still becomes R1626 but how its delivered must have changed. (Holding the kids nose to pour the spoon full down didn't work so well, so how about we try putting it into a piece of candy?)
Oh who knows....not me. Most of this is just my guess or my compiling all the info from different corners of the world.
One concern, which in reality is something of a concern for even Standard Care treatment, is viral mutation or 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 bitch isn't it?
So far R1626 doesn't seem to have increased that risk yet. As far as I can see anyway. The risk is there....but weighing the risk against the gain? I'm not convinced to pull out of the trial.
Another risk that I have personally witnessed and I can't find much on is the idea that treatment could cause a type of immune system confussion. I traveled to Vermont to spend some time with my Sister-in-Law who underwent tx for Hep B years ago. (and by saying "years ago" I am praying that the medical advancement has progressed greatly since her treatment) While on treatment her immune system became confused as to what cells it should and should not be fighting. It turned against all cells with no descrimination, attacking her good cells right along with her Hep cells.
While she lives her life taking medication to control her immune system...her life is forever changed and painful at times.
Do I worry about this? Well in the back of my mind I do....but as I said, I'm counting on the statement of "years ago".
Look, no matter how we view any of this....I have Hep C and I want it gone. There is a certain and definate danger of living with it. I almost shit when my GI said "Your liver is doing good so far....you might have another 10 years before you're in real trouble." 10 years! I'm 42 f 'n years old! He was trying to make it into a possitive....sometimes I wish people would just shut the hell up.
No matter how you view this, standard tx also has it's dangers. A trial drug always has it's unknown dangers added to that list, I know, but since I'm here and theres a chance that this trial drug could increase my chance of clearing the virus...I'll step into the chance....risks and all.
Now if Sandy would just call.....lol.
Mentally I'm still in line. Anger, frustration and fear take more of my emotions than I'd like them too, but strength holds them back.
I have friends who have or are going through treatment and the path that they have paved gives me incouragement to hold onto my strength.
The love of my Husband forges me forward.
In my search to provide me with the knowledge that I feel I need to make a life altering decision like 48 weeks of chemo, to trial or not to trial, ect., I've come to learn 2 major realities of pre-tx and tx itself.
1. Hep C is a sneaky diabolical little bastard of a dragon that is Not very well understood by the general Medical field. Even "specialist's" have yet to fully understand it. Society is completely ignorant to it and education about it is non-existant in my area. It's a demon hiding in the shadows and the tales that are told about it in my community seem more like folklore than educated statements. (Can I get Hep C by drinking out of someones glass or sitting on the toilet?)
damn it!
2. Everything that I read may or may not pertain to my outcome.
One friend has side effects so hard that getting out of bed in the morning is a chore in itself. Yet another friend only has a rash and loss of hair volume. My sister-in-law has an auto-immune desease. But yet another friend has undergone 72 weeks of the "poison" called tx and she's not only virus free and beginning to find her life again...she's healthy. Still another friend has some bad days and some"groovy" days. One more friend has gone through tx 3 times....and failed all 3.
If you're searching the net looking for what you are faced with by going into tx, you will not find your answer. It truly does depend on you and how your body reacts to it. You won't find your answers here, because here is not where those answers lay.
That knowledge has turned into my frustration, anger and the feeling of being lost while sitting in this limbo waiting for the phone call.
The call will come soon. Or I will call.
The first shot, first pill will come soon enough....all of this will become only a memory in my past.
For right now I continue to wait...
For instance, is RO4588161 the same drug as R1626? I didn't think that it was, but then up pops someone who gave me this link:
http://www.maxygen.com/pdf/EASL_Roche_2006.pdf
"R1626/RO4588161".
So is RO4588161 the prodrug of R1626? I suppose it is.
So then the search went to figuring out what a "prodrug" actually is.
"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.
There seems to be many reasons for making "prodrugs". Better obsorption in the body, less sides or less intensive sides to name just a couple. Sometimes a drug is just too much of a whamy to take all at once, so they slow down the
intake by making the drug one thing and having it slowly turn into something else once inside the body. It seems that if a drug like R1626 is not excepted in the body they had to find a way for it to be excepted. So they kind of "trick" the body like you would trying to get a child to take medicine by saying "no no honey it's not nasty tasting....it tastes good" or the way you'd get your pet to take a pill "Here ya go Fido, a nice piece of hamburger! You'll never know that the pill is wrapped up inside"Your body excepts the Prodrug and once inside, it converts or changes into the regular drug (R1626?).
Ok, so why is this a Phase 2 drug and not at the same phase as R1626? Why do my consent forms say only 130 people have taken it?
My thought is that there's been change in the Prodrug part of it. It still becomes R1626 but how its delivered must have changed. (Holding the kids nose to pour the spoon full down didn't work so well, so how about we try putting it into a piece of candy?)
Oh who knows....not me. Most of this is just my guess or my compiling all the info from different corners of the world.
One concern, which in reality is something of a concern for even Standard Care treatment, is viral mutation or 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 bitch isn't it?
So far R1626 doesn't seem to have increased that risk yet. As far as I can see anyway. The risk is there....but weighing the risk against the gain? I'm not convinced to pull out of the trial.
Another risk that I have personally witnessed and I can't find much on is the idea that treatment could cause a type of immune system confussion. I traveled to Vermont to spend some time with my Sister-in-Law who underwent tx for Hep B years ago. (and by saying "years ago" I am praying that the medical advancement has progressed greatly since her treatment) While on treatment her immune system became confused as to what cells it should and should not be fighting. It turned against all cells with no descrimination, attacking her good cells right along with her Hep cells.
While she lives her life taking medication to control her immune system...her life is forever changed and painful at times.
Do I worry about this? Well in the back of my mind I do....but as I said, I'm counting on the statement of "years ago".
Look, no matter how we view any of this....I have Hep C and I want it gone. There is a certain and definate danger of living with it. I almost shit when my GI said "Your liver is doing good so far....you might have another 10 years before you're in real trouble." 10 years! I'm 42 f 'n years old! He was trying to make it into a possitive....sometimes I wish people would just shut the hell up.
No matter how you view this, standard tx also has it's dangers. A trial drug always has it's unknown dangers added to that list, I know, but since I'm here and theres a chance that this trial drug could increase my chance of clearing the virus...I'll step into the chance....risks and all.
Now if Sandy would just call.....lol.
Mentally I'm still in line. Anger, frustration and fear take more of my emotions than I'd like them too, but strength holds them back.
I have friends who have or are going through treatment and the path that they have paved gives me incouragement to hold onto my strength.
The love of my Husband forges me forward.
In my search to provide me with the knowledge that I feel I need to make a life altering decision like 48 weeks of chemo, to trial or not to trial, ect., I've come to learn 2 major realities of pre-tx and tx itself.
1. Hep C is a sneaky diabolical little bastard of a dragon that is Not very well understood by the general Medical field. Even "specialist's" have yet to fully understand it. Society is completely ignorant to it and education about it is non-existant in my area. It's a demon hiding in the shadows and the tales that are told about it in my community seem more like folklore than educated statements. (Can I get Hep C by drinking out of someones glass or sitting on the toilet?)
damn it!
2. Everything that I read may or may not pertain to my outcome.
One friend has side effects so hard that getting out of bed in the morning is a chore in itself. Yet another friend only has a rash and loss of hair volume. My sister-in-law has an auto-immune desease. But yet another friend has undergone 72 weeks of the "poison" called tx and she's not only virus free and beginning to find her life again...she's healthy. Still another friend has some bad days and some"groovy" days. One more friend has gone through tx 3 times....and failed all 3.
If you're searching the net looking for what you are faced with by going into tx, you will not find your answer. It truly does depend on you and how your body reacts to it. You won't find your answers here, because here is not where those answers lay.
That knowledge has turned into my frustration, anger and the feeling of being lost while sitting in this limbo waiting for the phone call.
The call will come soon. Or I will call.
The first shot, first pill will come soon enough....all of this will become only a memory in my past.
For right now I continue to wait...
Oh and by the way - GO N.E.!!!!!!!!!
8 comments:
All I can say is "This too shall pass". When you're txing, you'll wonder why you put yourself through so much stress leading up to the main event. Take a deep breath and realize that you don't control this process, it controls you, no contest. Surrender like a leaf in the wind and let it happen when it's supposed too.
If I could count how many times "this too shall pass" has been told to me.
And everytime it was true.
Deep breath taken (again)
Que será, será
Well, 2morrow will be 2 weeks since your biopsy - if Sandy hasn't called today - call her 2morrow. Or, post her phone # here and I'LL CALL HER!!
lol....Iris to my rescue! :)
No, I'll call her tomorrow.
Once again I can't stand waiting any longer! Even if she can't tell me anything (which I can't believe that by now she wouldn't have some info for me) she still has a way of making me feel better about waiting.
I'll give it until lunch time and then I'll call.
Hi Laurie,
Try not to stress out! Ifyou have made the decision to do the treatment the just go for a walk or the movies, whatever takes your mind off of it. My drug research is RO4588161 also. My consent forms say that there are 490 people the specialist told me 169 in the U.S. so I guess we are 2 of them. I too am scared but now that I have made my decision I am just going to go with it for as long as I can handle it and then I can always change my mind if I think I can't do it anymore. I will tell you one thing...your story has helped me alot and I think you should feel proud of yourself for fight this best way you know how. So give yourself a treat and a pat on the back. My your journey is going just the way it is suppose to. Be easy on yourself and feel proud!
Rosie
Wow my spelling was terrible...Sorry my mind is already fogged! Dear Lord what will it be like later! LOL
Rosie
Hi Rosie! :)
Wow! I'm excited that we are able to go through this together!
Amazing! What are the odds :)
Do you have a start yet?
Thank you for the compliment, but it's not really earned. This blog is just my thoughts and feelings poured out on a page where I have found beautiful friends and countless support.
I'll be thinking about you Rosie :) Take care of yourself and stay in touch...we've got a long road ahead of us.
((hugs))
Laurie
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