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GS-7977 and Ribavirin Clinical Trial
I found out today I AM UNDETECTABLE after 2 weeks of treatment with GS-7977 and Ribavirin.
Not bad for a previous null-responder to peg-INF and Ribavirin where after 12 weeks of treatment my viral load never went below 360,000.
"An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant" ClinicalTrials.gov Identifier: NCT01559844
During screening my viral load was 1,200,000
On day 1 692,000
1 week 581
2 week <25
COBAS TaqMan HCV Test
week 1 dropped 3.06 logs
week 2 dropped 4.44 logs
Cheers!
Happy
Hector
Not bad for a previous null-responder to peg-INF and Ribavirin where after 12 weeks of treatment my viral load never went below 360,000.
"An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant" ClinicalTrials.gov Identifier: NCT01559844
During screening my viral load was 1,200,000
On day 1 692,000
1 week 581
2 week <25
COBAS TaqMan HCV Test
week 1 dropped 3.06 logs
week 2 dropped 4.44 logs
Cheers!
Happy
Hector
Hooo-raaay !!!
This is absolutely wonderful~ the very best news.
Two weeks and UND~wow.
Now for that transplant and a healthy, happy, hep C free wonderful life!
This is absolutely wonderful~ the very best news.
Two weeks and UND~wow.
Now for that transplant and a healthy, happy, hep C free wonderful life!
I told my hepatologist to start thawing out my donor liver form the hospital's freezers. (I heard that at least one recipient thought they had livers stored for transplant and they were wondering what "the wait" was about).
One young, shiny, nutmeg-brown liver coming up.
I am ready for my transplant. Let's do this thing! Before my cancer comes back with an attitude. (AFP still rising since beginning of April). :-O
;-)
Hector
One young, shiny, nutmeg-brown liver coming up.
I am ready for my transplant. Let's do this thing! Before my cancer comes back with an attitude. (AFP still rising since beginning of April). :-O
;-)
Hector
awesome news hector!!!!! i'm so happy for you. you really deserve it. best wishes. belle
Hector I am so happy for you. I can imagine what incredible releif you must feel. I could not believe my eyes when I saw the first lab report (ever) the words "Not Detected." Part of me thought I never would. You are well on your way to getting healing!
Awesome news Hector, Congratulations!!! You've given so many people hope here and are still doing so with this fabulous result - kudos plus to you, and a celebration for us all. Words don't do this justice!
So the first part of the trial is done. YES!
The true test will be if I/we remain virus free 12 weeks after transplant. I may not know this until 9 months from now depending on when I get my transplant.
There are also many other things they hope to learn from this study.
* For those that don't get a transplant by week 24, will they be cured of hep C after 24 weeks of treatment?
* To assess safety and tolerability of treatment (levels of side effects if any)
* To evaluate the HCV RNA viral kinetics during the treatment phase and following liver transplant and correlate results with the duration of study treatment prior to liver transplant. Will how long you are undetectable effect if the virus comes back post transplant?
* To explore the presence or absence of HCV RNA in the liver explants (in the old cancerous recipient's liver) and correlate with plasma HCV RNA viral kinetics during therapy, plasma GS-7977 and metabolite exposure (if possible), duration of therapy, duration of plasma HCV RNA negativity. They will take a piece of my liver for study along with all of my blood tests throughout the study.
* To explore the dynamics of non-tumor MELD score during the study. My blood level MELD score has already gone down (MELD score 11) indicating my liver is more healthy than before which will help me to bounce back from transplant better.
* To determine concentrations of GS-7977 and metabolites (if suitable analytical methods can be developed) in the liver explants in a subset of subjects who cease GS-7977 therapy within 24 hours of liver transplantation. We will take our treatment drugs on the day of our transplant. And a viral load will be taken before transplant to show if any has virus present and how that might effect recurrence in the donor liver.
This is a phase II study, which is why there are only 50 people world-wide in it. If successful, there will be a Phase III study including a much larger group of patients.
Cheers!
Hector
The true test will be if I/we remain virus free 12 weeks after transplant. I may not know this until 9 months from now depending on when I get my transplant.
There are also many other things they hope to learn from this study.
* For those that don't get a transplant by week 24, will they be cured of hep C after 24 weeks of treatment?
* To assess safety and tolerability of treatment (levels of side effects if any)
* To evaluate the HCV RNA viral kinetics during the treatment phase and following liver transplant and correlate results with the duration of study treatment prior to liver transplant. Will how long you are undetectable effect if the virus comes back post transplant?
* To explore the presence or absence of HCV RNA in the liver explants (in the old cancerous recipient's liver) and correlate with plasma HCV RNA viral kinetics during therapy, plasma GS-7977 and metabolite exposure (if possible), duration of therapy, duration of plasma HCV RNA negativity. They will take a piece of my liver for study along with all of my blood tests throughout the study.
* To explore the dynamics of non-tumor MELD score during the study. My blood level MELD score has already gone down (MELD score 11) indicating my liver is more healthy than before which will help me to bounce back from transplant better.
* To determine concentrations of GS-7977 and metabolites (if suitable analytical methods can be developed) in the liver explants in a subset of subjects who cease GS-7977 therapy within 24 hours of liver transplantation. We will take our treatment drugs on the day of our transplant. And a viral load will be taken before transplant to show if any has virus present and how that might effect recurrence in the donor liver.
This is a phase II study, which is why there are only 50 people world-wide in it. If successful, there will be a Phase III study including a much larger group of patients.
Cheers!
Hector
Wooot!!! Doesn't that Undetected feel great?? I have read vitamin B12 shots may help, in sustaining SVR, have you looked into this?
Wooot!!! Doesn't that Undetected feel great?? I have read vitamin B12 shots may help, in sustaining SVR, have you looked into this?
Hector you go my friend wahoooooooooo! Und at 2 weeks that is freaking fabulous wonderful spectacular marvelous incredible news!!!!!!!!!!!!!!
YAY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ♥
YAY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ♥
Congratulations Hector!!!!!!!!!!!!!!!!
That is really wonderful news!
Good luck,
Mike
That is really wonderful news!
Good luck,
Mike
I know, OH, I was thinking of the future. He wants to be 12 wk SVR before the Transplant (he mentioned in his above comment).
I wasn't sure if vitamins were allowed, once
cirrhotic, etc. My Doctor ordered me off all my vitamins and supplements during my Tx, so I was wondering what other Txing people were doing, in terms of that~
I wasn't sure if vitamins were allowed, once
cirrhotic, etc. My Doctor ordered me off all my vitamins and supplements during my Tx, so I was wondering what other Txing people were doing, in terms of that~
If you reread my reply, I congrat him on his "Undetectable" status, in my first sentence. Why would you assume I thought him to be SVR, and not know he is waiting for a Liver transplant??
I am so happy for you, Hector. Now you see why I am so amazed at 7977 and riba? I was never told my viral load, that's why I just recently ran my own Heptimax but I did see my ALT drop like a rock and by week 2 it was normal! So, you have a ways to go. How many weeks are they planning on giving you the medication? It says under the study up to 24 weeks. I forget what genotype you are but if you are type 1 I'd want all 24 weeks. Otherwise, well, as you know I am type 2 and so far so good. I can't wait to hear that your new liver is safe and sound for the monster virus.
You are the man!! I am so happy for you. If anybody deserves good news its you......and all of us that you have helped for so long. You must be on top of the world!! Good luck my friend and I will be praying for more good news from you!!
It is truly amazing to know that GS-7977 has the ability to bring someone with a ravaged liver down to an undetectable level in 2 weeks. It's incredible stuff when compared to SOC and even the PI's, which can be long a brutal treatments.
Congrats HectorSF, wish you the best.
Congrats HectorSF, wish you the best.
"How many weeks are they planning on giving you the medication?"
24 weeks or until I get a liver transplant whichever is first.
SVR for this treatment is 12 weeks after end of treatment. Or 12 weeks after transplant.
I forget what genotype you are but if you are type 1 I'd want all 24 weeks.
Good question! I am genotype 1b. I am also IL28B C/C. Even though I was a previous null-responder to peg-INF and Riba treatment. So much for C/C predicting response to interferon in all people.
Hector (Nice to be undetectable after 43 years of infection)
24 weeks or until I get a liver transplant whichever is first.
SVR for this treatment is 12 weeks after end of treatment. Or 12 weeks after transplant.
I forget what genotype you are but if you are type 1 I'd want all 24 weeks.
Good question! I am genotype 1b. I am also IL28B C/C. Even though I was a previous null-responder to peg-INF and Riba treatment. So much for C/C predicting response to interferon in all people.
Hector (Nice to be undetectable after 43 years of infection)
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