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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
Remember GS-7977 (sofosbuvir) is in trials for data is hard to come by as many of the studies are ongoing right now.
What we do know is that GS-7977 + RBV in the ELECTRON trials with 35 genotype 1 patients...
* Had No discontinuations
* No grade 3 or 4 adverse events
* No grade 2 adverse events in more than 1 patient
- 1 null-responder had (anxiety, depression)
- treatment naive patients 1 experienced headache. 1 experienced nerve pain. 1 experienced chest pain and 1 had vomiting.
* Low rates of laboratory abnormalities
- In null-responder arm. 1 patient had hemoglobin 7.0-8.9 g/dl
- In the treatment-naive arm. 1 patients had WBC<1000/mm3
This is similar to our group's experience. None has had anemia which is commonly linked to Ribavirin. And no serious side effects.
So 8snicker8 experience seems typical at least as far as I know at this point. Although we all know ribavirin when taken with peg-interferon treatment can wreak havoc with anemia, rashes, and other nasties. But I don't think anyone has taken ribavirin by itself, without some form of interferon. So what side effects come strictly from ribavirin? Who knows.
As orphanedhawk said "The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers."
I am undetectable down to <25.
From what I know, no virologic Breakthrough has been seen during treatment. Also all patients are undetectable by week 4.
We may have more information on this issue of HCV in blood vs HCV in the liver from the trial I am in. I have chosen to give my blood samples while on treatment and after treatment and a sample of my liver after transplant so Gilead can study the correlation between viral load and the GS-7977 in my liver. I hope this will ultimately help scientists better understand HCV and liver disease and help others in the future with this additional knowledge.
As far as I know this is the first study to take samples of the liver and blood for study post treatment.
"To explore the presence or absence of HCV RNA in the liver explants 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."
This study will also study any improvements in liver function caused by the treatment. "To explore the dynamics of non-tumor MELD score during the study."
Okay, enough work for today. I had 3 hours of school tonight and an essay on Medicare. I am beat...
Hector
What we do know is that GS-7977 + RBV in the ELECTRON trials with 35 genotype 1 patients...
* Had No discontinuations
* No grade 3 or 4 adverse events
* No grade 2 adverse events in more than 1 patient
- 1 null-responder had (anxiety, depression)
- treatment naive patients 1 experienced headache. 1 experienced nerve pain. 1 experienced chest pain and 1 had vomiting.
* Low rates of laboratory abnormalities
- In null-responder arm. 1 patient had hemoglobin 7.0-8.9 g/dl
- In the treatment-naive arm. 1 patients had WBC<1000/mm3
This is similar to our group's experience. None has had anemia which is commonly linked to Ribavirin. And no serious side effects.
So 8snicker8 experience seems typical at least as far as I know at this point. Although we all know ribavirin when taken with peg-interferon treatment can wreak havoc with anemia, rashes, and other nasties. But I don't think anyone has taken ribavirin by itself, without some form of interferon. So what side effects come strictly from ribavirin? Who knows.
As orphanedhawk said "The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers."
I am undetectable down to <25.
From what I know, no virologic Breakthrough has been seen during treatment. Also all patients are undetectable by week 4.
We may have more information on this issue of HCV in blood vs HCV in the liver from the trial I am in. I have chosen to give my blood samples while on treatment and after treatment and a sample of my liver after transplant so Gilead can study the correlation between viral load and the GS-7977 in my liver. I hope this will ultimately help scientists better understand HCV and liver disease and help others in the future with this additional knowledge.
As far as I know this is the first study to take samples of the liver and blood for study post treatment.
"To explore the presence or absence of HCV RNA in the liver explants 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."
This study will also study any improvements in liver function caused by the treatment. "To explore the dynamics of non-tumor MELD score during the study."
Okay, enough work for today. I had 3 hours of school tonight and an essay on Medicare. I am beat...
Hector
Hector is not on Incivek. He is doing a trial with the new oral med GS-7977 and ribavirin.
Read the first line of his post.
8snicker8~
Hector is in a unique situation as he is doing this trial pre-transplant. Once he is undetected he can get his new liver.
The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers.
I agree with Rivil. If you had no side effects from ribavirin, you were fortunate.
Read the first line of his post.
8snicker8~
Hector is in a unique situation as he is doing this trial pre-transplant. Once he is undetected he can get his new liver.
The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers.
I agree with Rivil. If you had no side effects from ribavirin, you were fortunate.
Hector, you are on Incivek, and NO complaining?? It just goes to show me how much education(and the necessity to get well) can ease our side-effects...you Dah Man!
Amazing news!!!! Congrats!!!! Finally, after all these years. Wishing you all the best!!!!!
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