Aa
Sofosbuvir Question
Like most people I thought Sofosbuvir & Ribavirin did not work well with Genotype 1 . I understand this is a small study but after reading below , what do you think ? I mean around a 70 % cure rate with harder to treat genotype 1 , do you think it is possible maybe that they will allow people to give it a go when it comes around December
or do you think this is just a limited study which will not go further ?
Evidence continues to mount suggesting Gilead's experimental drug for hepatitis C virus could flip the current HCV treatment paradigm on its head.
Results of the Phase II trial, sponsored and led by the National Institutes of Health, suggest that a regimen of sofosbuvir and ribavirin was highly effective in clearing the virus and well tolerated in two difficult-to-treat groups—patients with severe liver damage and African Americans. Both groups were comprised of those with genotype-1 HCV, which accounts for 70% of all HCV infections.
The findings among patients with genotype 1, which appear in the current issue of JAMA, come on top of data showing strong efficacy for sofosbuvir in cohorts with genotypes 2 and 3. As such, analysts say the drug is poised to take the lion's share of the HCV market. A recent forecast from FactSet Research Systems put annual sales of sofosbuvir at $6.4 billion by 2017.
In the current study, of the 60 enrolled volunteers, 50 were African American (88% of whom suffer from genotype 1 and are known to be harder to treat with interferon-based therapies).
The bifurcated study broke out one group of 10 people with liver fibrosis. Fibrosis is part of the scarring process and represents the liver's response to injury.They received sofosbuvir and ribavirin. After 12 weeks of therapy, HCV was no longer present in all volunteers who completed therapy (nine out of 10).
The other group consisted of 50 volunteers, including 13 with serious liver damage. They received sofousbuvir and either a dose of ribavirin based on weight or a low-dose ribavirin. From that group, 17 patients had no detectable levels of the virus 24 weeks after treatment stopped. Of the 22 volunteers who received the low-dose ribavirin, 12 were considered cured after the end of treatment.
In an NIH press release, researcher Dr. Shyam Kottilil summed up the findings, saying, “We saw an overall cure rate of about 70% using regimens that did not include interferon. This is an encouraging result, especially considering the proportion of volunteers who had characteristics…that are recognized as predictors of poor response to treatment.”
The findings could make it harder for other prospective all-oral treatment regimens. Boehringer Ingelheim unveiled Phase II data earlier this month of its HCV combo of faldaprevir and deleobuvir, reporting high efficacy rates—85% in genotype 1b—but the sample did not include African Americans.
Gilead's new drug application for sofosbuvir was filed in April. This initial application, under priority review, is for use in genotypes 2 and 3, and in the treatment-naïve for types 1, 4, 5 and 6.
FDA expects to review the application by December 8, the agency said. The European Medicines Association, too, has given sofosbuvir an “accelerated assessment,”and if approved the drug could become available by the first half of next year.
or do you think this is just a limited study which will not go further ?
Evidence continues to mount suggesting Gilead's experimental drug for hepatitis C virus could flip the current HCV treatment paradigm on its head.
Results of the Phase II trial, sponsored and led by the National Institutes of Health, suggest that a regimen of sofosbuvir and ribavirin was highly effective in clearing the virus and well tolerated in two difficult-to-treat groups—patients with severe liver damage and African Americans. Both groups were comprised of those with genotype-1 HCV, which accounts for 70% of all HCV infections.
The findings among patients with genotype 1, which appear in the current issue of JAMA, come on top of data showing strong efficacy for sofosbuvir in cohorts with genotypes 2 and 3. As such, analysts say the drug is poised to take the lion's share of the HCV market. A recent forecast from FactSet Research Systems put annual sales of sofosbuvir at $6.4 billion by 2017.
In the current study, of the 60 enrolled volunteers, 50 were African American (88% of whom suffer from genotype 1 and are known to be harder to treat with interferon-based therapies).
The bifurcated study broke out one group of 10 people with liver fibrosis. Fibrosis is part of the scarring process and represents the liver's response to injury.They received sofosbuvir and ribavirin. After 12 weeks of therapy, HCV was no longer present in all volunteers who completed therapy (nine out of 10).
The other group consisted of 50 volunteers, including 13 with serious liver damage. They received sofousbuvir and either a dose of ribavirin based on weight or a low-dose ribavirin. From that group, 17 patients had no detectable levels of the virus 24 weeks after treatment stopped. Of the 22 volunteers who received the low-dose ribavirin, 12 were considered cured after the end of treatment.
In an NIH press release, researcher Dr. Shyam Kottilil summed up the findings, saying, “We saw an overall cure rate of about 70% using regimens that did not include interferon. This is an encouraging result, especially considering the proportion of volunteers who had characteristics…that are recognized as predictors of poor response to treatment.”
The findings could make it harder for other prospective all-oral treatment regimens. Boehringer Ingelheim unveiled Phase II data earlier this month of its HCV combo of faldaprevir and deleobuvir, reporting high efficacy rates—85% in genotype 1b—but the sample did not include African Americans.
Gilead's new drug application for sofosbuvir was filed in April. This initial application, under priority review, is for use in genotypes 2 and 3, and in the treatment-naïve for types 1, 4, 5 and 6.
FDA expects to review the application by December 8, the agency said. The European Medicines Association, too, has given sofosbuvir an “accelerated assessment,”and if approved the drug could become available by the first half of next year.
"Like most people I thought Sofosbuvir & Ribavirin did not work well with Genotype 1 "
It doesn't. Early clinical trial data showed that. That is why Gilead and the other new AA developers will be treating genotype 1s with peg-interferon and ribavirin in 2014. We are not except to have all oral treatment for genotype 1 until 2015.
"do you think it is possible maybe that they will allow people to give it a go when it comes around December or do you think this is just a limited study which will not go further ? "
No. Genotype 1s are not to be treated with Sofosbuvir + Ribavirin. Only genotypes 2 and 3. The treatment that Gilead will bring to market soon for genotype 1 treatment-naive patients is Sofosbuvir +peg-interferon+ribavirin.
I treated for 48 weeks with Sofosbuvir +ribavirin as a genotype 1b and relapsed within a month of EOT. I am just one person but still after 47 weeks of being undetectable everyone assumed I would achieve SRV. Didn't happen.
There are many posts on the details about this that have been posted recently if you want to search for them.
Cheers!
Hector
It doesn't. Early clinical trial data showed that. That is why Gilead and the other new AA developers will be treating genotype 1s with peg-interferon and ribavirin in 2014. We are not except to have all oral treatment for genotype 1 until 2015.
"do you think it is possible maybe that they will allow people to give it a go when it comes around December or do you think this is just a limited study which will not go further ? "
No. Genotype 1s are not to be treated with Sofosbuvir + Ribavirin. Only genotypes 2 and 3. The treatment that Gilead will bring to market soon for genotype 1 treatment-naive patients is Sofosbuvir +peg-interferon+ribavirin.
I treated for 48 weeks with Sofosbuvir +ribavirin as a genotype 1b and relapsed within a month of EOT. I am just one person but still after 47 weeks of being undetectable everyone assumed I would achieve SRV. Didn't happen.
There are many posts on the details about this that have been posted recently if you want to search for them.
Cheers!
Hector
I appreciate your response . I understand something when you see these little studies you can become a bit excited but your right all oral for genotype 1 are still quite a while away .
How are things going for you ? As your HCV cleared for 47 weeks did your liver improve ? and did you notice your blood levels improve , alt ast platelet count ?
How are things going for you ? As your HCV cleared for 47 weeks did your liver improve ? and did you notice your blood levels improve , alt ast platelet count ?
So sorry to hear that the Hep C returned after so long.
What do you think about SOF/LDV + RBV 12 weeks for Gs1? So many people think this could be the magic bullet, but after reading your post, and seeing that after so long, the HCV returned, it's kinda dashed my hopes and I'm sure those of many others. I thought that Gilead added the LDV as a safeguard for Gs1, but from what I understand, the long term data is pretty hit and miss, if there is any long term data.
What do you think about SOF/LDV + RBV 12 weeks for Gs1? So many people think this could be the magic bullet, but after reading your post, and seeing that after so long, the HCV returned, it's kinda dashed my hopes and I'm sure those of many others. I thought that Gilead added the LDV as a safeguard for Gs1, but from what I understand, the long term data is pretty hit and miss, if there is any long term data.
Yes my liver has improved.
My ALT and AST where normal for the first time since 2007.
Platelets went up to 90,000 during treatment. Now I am back in the 60s as I have been for many years. It was amazing to see normal blood levels as most of mine are abnormal.
I believe that without the treatment I would not now be healthy enough to be having my 7th cancer treatment in early October.
I have absolutely no regards. And feel privileged to be one of 50 people in the world to be the first cirrhotics to use Sofobuvir. The good news is that most others in the trial got transplants and the ones I have met at our center have been cured of hep c after transplant.
What do I think about "SOF/LDV + RBV 12 weeks for Gs1?"
Another option. Awesome. Wish I had it went I treated. No regrets or "what ifs". It is a waste of time and energy.
I joined the trial knowing there was no guarantee. It was my best option and I took. As I have said I have no regrets. I would do it again if it was the only choice I had. And it was my only choice. Interferon has no affect on my virus. It only made me sick as a dog.
My hope is to survive my cancer and treat my hep C post transplant with whatever is the latest and greatest treatment. I don't waste a minute worrying about hep C. If I can survive my untreatable cancer honestly nothing else frightens me and certainly not hep C or TB which I also have and will need to treat. I will beat them one at a time if I have to and anything else that should happen after transplant. I am not saying that hep C or active TB is nothing. I am saying from where I am standing they are pretty much like a fly on the elephant of cancer. I don't spend my time, whatever I might have left, worrying about as Bogart said a hill of beans. I try to live and appreciate the gift of life as fully as I can each day and focuses all of my inner strength on beating my cancer. So my life is very simple in many ways. There is everything I have ever experienced and think and feel and there is an eternity of an empty void. I choose life. Even a life with lots of suffering is okay with me vs the alternative.
I hope this helps.
Hector
My ALT and AST where normal for the first time since 2007.
Platelets went up to 90,000 during treatment. Now I am back in the 60s as I have been for many years. It was amazing to see normal blood levels as most of mine are abnormal.
I believe that without the treatment I would not now be healthy enough to be having my 7th cancer treatment in early October.
I have absolutely no regards. And feel privileged to be one of 50 people in the world to be the first cirrhotics to use Sofobuvir. The good news is that most others in the trial got transplants and the ones I have met at our center have been cured of hep c after transplant.
What do I think about "SOF/LDV + RBV 12 weeks for Gs1?"
Another option. Awesome. Wish I had it went I treated. No regrets or "what ifs". It is a waste of time and energy.
I joined the trial knowing there was no guarantee. It was my best option and I took. As I have said I have no regrets. I would do it again if it was the only choice I had. And it was my only choice. Interferon has no affect on my virus. It only made me sick as a dog.
My hope is to survive my cancer and treat my hep C post transplant with whatever is the latest and greatest treatment. I don't waste a minute worrying about hep C. If I can survive my untreatable cancer honestly nothing else frightens me and certainly not hep C or TB which I also have and will need to treat. I will beat them one at a time if I have to and anything else that should happen after transplant. I am not saying that hep C or active TB is nothing. I am saying from where I am standing they are pretty much like a fly on the elephant of cancer. I don't spend my time, whatever I might have left, worrying about as Bogart said a hill of beans. I try to live and appreciate the gift of life as fully as I can each day and focuses all of my inner strength on beating my cancer. So my life is very simple in many ways. There is everything I have ever experienced and think and feel and there is an eternity of an empty void. I choose life. Even a life with lots of suffering is okay with me vs the alternative.
I hope this helps.
Hector
I am 1a
Have been in Ion 2 for 22 weeks
SOF/lDV with Riba
24 weeks
Undetectable since week 4
Enzymes low end of range
Side effects minimal
Never felt better!
Have been in Ion 2 for 22 weeks
SOF/lDV with Riba
24 weeks
Undetectable since week 4
Enzymes low end of range
Side effects minimal
Never felt better!
You really do have a great attitude to life , many would feel sorry for themselves and beat themselves up , and then play the blame game but you are very positive and also give great advice to many people .
Good Luck I do believe that people die sometimes when they do not want to live anymore almost like it has some effect on your immune system to fight . I have a good feeling that you will beat this . Take Care .
Good Luck I do believe that people die sometimes when they do not want to live anymore almost like it has some effect on your immune system to fight . I have a good feeling that you will beat this . Take Care .
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