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Sofosbuvir -Tx naive Hepatitis C Genotypes 1, 2, and 3
http://hepatitiscresearchandnewsupdates.blogspot.com/2013/07/sofosbuvirbased-antiviral-therapy-for.html#.Ue89Lqysphs
In the treatment-naïve HCV genotype 1 group, 21 (84%) had SVR at 24 weeks after treatment with 12 weeks sofosbuvir and weight-based RBV therapy. Of the 4 patients who had a relapse during follow-up, 3 had within 4 weeks and 1 between 12 and 24 weeks after the end of treatment. The S282T mutation was not detected in any of these 3 patients on population sequencing or on deep sequencing. No other mutations at conserved sites were consistently observed among the patients who had a relapse during this study. In the nonresponder HCV genotype 1 group (n = 10), only 1 (10%) had a SVR at 24 weeks after treatment. None of the 9 patients without SVR had any S282T-containing mutations on population sequencing and deep sequencing.
In the treatment-naïve HCV genotype 1 group, 21 (84%) had SVR at 24 weeks after treatment with 12 weeks sofosbuvir and weight-based RBV therapy. Of the 4 patients who had a relapse during follow-up, 3 had within 4 weeks and 1 between 12 and 24 weeks after the end of treatment. The S282T mutation was not detected in any of these 3 patients on population sequencing or on deep sequencing. No other mutations at conserved sites were consistently observed among the patients who had a relapse during this study. In the nonresponder HCV genotype 1 group (n = 10), only 1 (10%) had a SVR at 24 weeks after treatment. None of the 9 patients without SVR had any S282T-containing mutations on population sequencing and deep sequencing.
Well Hector without us "lab rats" new treatments would never come about. It has to be a good thing in your case that you have maintained a UND status for so many weeks without a breakthrough. I see nothing but good coming from that.
Gerald, I am sure you already know that it has always been a lot (not all) relapses have happened in the first 4 weeks post treatment. Since the PI's having a 4 week post PCR has become common and has showed great results when one is still UND at the time. And it is really encouraging when someone that is as hard to treat as you are still UND. That has to be exciting for people reading this.......Best to you and Hector, you guys have earned it.
Gerald, I am sure you already know that it has always been a lot (not all) relapses have happened in the first 4 weeks post treatment. Since the PI's having a 4 week post PCR has become common and has showed great results when one is still UND at the time. And it is really encouraging when someone that is as hard to treat as you are still UND. That has to be exciting for people reading this.......Best to you and Hector, you guys have earned it.
Congratulations!!!
Yes the data that is availble from Gilead shows that most relapse within the first month. So you have a good chance of being SVR. Keep getting tested just in case. I wish you SVR!
Here is an example of Gilead treatment and relapse...
"This phase 2a, open-label trial (sofosbuvir plus ribavirin) randomized treatment naïve HCV genotype 2 and 3 patients (n = 40; 10 patients per group) stratified by HCV genotype (2 vs 3) and interleukin (IL)-28B (CC vs CT or TT) in 1:1:1:1 ratio to receive weight-based ribavirin (RBV) and sofosbuvir (400 mg once daily) for 12 weeks with and without pegylated interferon (PEGIFN)-α 2a. Groups 1–3 received PEGIFN for 4, 8, and 12 weeks, respectively, in addition to 12 weeks of weight-based RBV and sofosbuvir. Group 4 received 12 weeks of weight-based RBV and sofosbuvir only. After completion of dosing in groups 1–4, the protocol was amended to include 2 additional groups of treatment naive HCV genotype 2 or 3 patients (group 5: PEGIFN, weight-based RBV and sofosbuvir for 8 weeks; group 6: Sofosbuvir monotherapy for 12 weeks). An additional 35 HCV genotype 1 patients (10 nonresponder and 25 treatment naïve) received 12 weeks of weight-based RBV and sofosbuvir.
In the treatment-naïve HCV genotype 1 group, 21 (84%) had SVR at 24 weeks after treatment with 12 weeks sofosbuvir and weight-based RBV therapy. Of the 4 patients who had a relapse during follow-up, 3 had within 4 weeks and 1 between 12 and 24 weeks after the end of treatment."
SVR ALL THE WAY!!!
Hector
Yes the data that is availble from Gilead shows that most relapse within the first month. So you have a good chance of being SVR. Keep getting tested just in case. I wish you SVR!
Here is an example of Gilead treatment and relapse...
"This phase 2a, open-label trial (sofosbuvir plus ribavirin) randomized treatment naïve HCV genotype 2 and 3 patients (n = 40; 10 patients per group) stratified by HCV genotype (2 vs 3) and interleukin (IL)-28B (CC vs CT or TT) in 1:1:1:1 ratio to receive weight-based ribavirin (RBV) and sofosbuvir (400 mg once daily) for 12 weeks with and without pegylated interferon (PEGIFN)-α 2a. Groups 1–3 received PEGIFN for 4, 8, and 12 weeks, respectively, in addition to 12 weeks of weight-based RBV and sofosbuvir. Group 4 received 12 weeks of weight-based RBV and sofosbuvir only. After completion of dosing in groups 1–4, the protocol was amended to include 2 additional groups of treatment naive HCV genotype 2 or 3 patients (group 5: PEGIFN, weight-based RBV and sofosbuvir for 8 weeks; group 6: Sofosbuvir monotherapy for 12 weeks). An additional 35 HCV genotype 1 patients (10 nonresponder and 25 treatment naïve) received 12 weeks of weight-based RBV and sofosbuvir.
In the treatment-naïve HCV genotype 1 group, 21 (84%) had SVR at 24 weeks after treatment with 12 weeks sofosbuvir and weight-based RBV therapy. Of the 4 patients who had a relapse during follow-up, 3 had within 4 weeks and 1 between 12 and 24 weeks after the end of treatment."
SVR ALL THE WAY!!!
Hector
Hector you were the one that told me 8months ago about the Gilead trial for pst transplants, cirrhotic, non responders. I was in touch with your Doc and she was kind enough to call me and let me know her arm was full. I was able to find a spot elsewhere. For this I am forever grateful to you. I started in December of 2012. Finished my 6months ( 24week) trial of Sofo/RIBA 30 days ago. I too cleared within 2weeks. I just received the news that I am still undectable after 1 month off the Sofo/RIBA.
My concerns are the relapse possibilities. My trial Doc felt the 30 day undectable point was a huge turning point in clearing. He clearly told me this was just his experience and he had no data to back this up. He had not seen a relapse from any Sofo/RIBA trial who was undectable at 30 days. Obliviously not a lot of data to draw from and he was clear about that.
Now that I have been clear for thirty days I feel my chances are greatly improved on SVR. After reading the 1 non responder in the beginning of the thread I wonder if any others have heard any data on non responders and time tables of relapsing?
My concerns are the relapse possibilities. My trial Doc felt the 30 day undectable point was a huge turning point in clearing. He clearly told me this was just his experience and he had no data to back this up. He had not seen a relapse from any Sofo/RIBA trial who was undectable at 30 days. Obliviously not a lot of data to draw from and he was clear about that.
Now that I have been clear for thirty days I feel my chances are greatly improved on SVR. After reading the 1 non responder in the beginning of the thread I wonder if any others have heard any data on non responders and time tables of relapsing?
Can-do, good point. Indeed I will be a guinea pig to see if sofosbuvir + ribavirin can cure a genotype 1b previous null-responder and cirrhotic with 48 weeks of treatment.
ClinicalTrials.gov Identifier:
NCT01559844
"The primary objective is to determine if the administration of a combination of GS 7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks (extended to 48 weeks for those of us not getting transplants) can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant."
I found out last week that Gilead is cutting off treatment at 48 weeks for us first cirrhotics to ever treat with sofosbuvir + ribavirin. I will have been undetectable for 47 weeks. Unfortunately because of the timing I could have hep C return in my liver before getting a transplant and then will have to treat post transplant all over again. If I relapse it will probably be with a month after stopping. Oh well here goes nothing starting August 15th. Needless to say I will try to get a transplant ASAP so my hep C doesn't have a chance to come back as soon as I am back on the transplant waiting list. Anyone got a spare liver? haha
Not until 2014 will we see the data from studies of hard to treat cirrhotics and post transplant folks.
I am keeping my fingers crossed.
Hector
ClinicalTrials.gov Identifier:
NCT01559844
"The primary objective is to determine if the administration of a combination of GS 7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks (extended to 48 weeks for those of us not getting transplants) can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant."
I found out last week that Gilead is cutting off treatment at 48 weeks for us first cirrhotics to ever treat with sofosbuvir + ribavirin. I will have been undetectable for 47 weeks. Unfortunately because of the timing I could have hep C return in my liver before getting a transplant and then will have to treat post transplant all over again. If I relapse it will probably be with a month after stopping. Oh well here goes nothing starting August 15th. Needless to say I will try to get a transplant ASAP so my hep C doesn't have a chance to come back as soon as I am back on the transplant waiting list. Anyone got a spare liver? haha
Not until 2014 will we see the data from studies of hard to treat cirrhotics and post transplant folks.
I am keeping my fingers crossed.
Hector
Thanks Rivll, here is my concern. The hard to treat people, non responders did not fare well at all in this study. So what happens when the cherry picking ends? We already know certain types do better with current treatment. It is the hard to treat folks that concern me.
" However, the safety and efficacy of sofosbuvir-based therapy among prior nonresponders, patients with advance fibrosis and cirrhosis, posttransplant recipients with recurrent hepatitis C, and non-liver solid organ transplant recipients with hepatitis C needs to be established."
" However, the safety and efficacy of sofosbuvir-based therapy among prior nonresponders, patients with advance fibrosis and cirrhosis, posttransplant recipients with recurrent hepatitis C, and non-liver solid organ transplant recipients with hepatitis C needs to be established."
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