Aa
Sovaldi and Olysio My Update
I was approved for both S&O...however my test came back that I was resistant to Olysio becaue the Q80K was detected. The Q8OK polymorphism has been found to have a significant impact on SVR in patients with HCV genotype 1A (me). I don't know why they didn't mention Solvaldi...but will ask on a follow-up with Dr. He said, since I was resistant (80% chance) I should wait for a better treatment or trial and mentioned one that will come out in May - called Jenssen. (better over 90% cure..rate)
He did a Fibrosure which the good new was that I was not a candidate for some other trial called Abbvie.....(sorry don't have exact names. He said, you don't have the C word which I took as good news. My 2011 biopsy said was 2/3...
Now: The Fibrosure Score. 0.16 Fibrosis Stage F0 - No Fibrosis, Necroinflammat Activity Grade: A-2 moderate activity..something called Apolipoprotein - A-1 at 211 which is High... (don't know what that means).
I am treatment naive...(been waiting for the orals)...so was excited that finally I got the orals and APPROVED by insurance only to find I am resistant to at least Olysio. :-(
Anyone familiar Jassen trial? Do my numbers above still look good?
As always, thanks for your continuous help...
Millie
He did a Fibrosure which the good new was that I was not a candidate for some other trial called Abbvie.....(sorry don't have exact names. He said, you don't have the C word which I took as good news. My 2011 biopsy said was 2/3...
Now: The Fibrosure Score. 0.16 Fibrosis Stage F0 - No Fibrosis, Necroinflammat Activity Grade: A-2 moderate activity..something called Apolipoprotein - A-1 at 211 which is High... (don't know what that means).
I am treatment naive...(been waiting for the orals)...so was excited that finally I got the orals and APPROVED by insurance only to find I am resistant to at least Olysio. :-(
Anyone familiar Jassen trial? Do my numbers above still look good?
As always, thanks for your continuous help...
Millie
Yes...my test's comments indicated: Q80K. The Q80K polymorphism has been found to have a significant impact on Sustained virologic response in patients with HCV genotype 1a treat with simeprevir...(Olysio...
I like to wait just a bit to see if I have an opportunity for something that has a 90 and above cure rate as opposed to the 80% (though some may consider better than nothing). But, at a price of $2,000 a day...(I will have to pay some out of pocket...but very lucky to have insurance)...I like to wait just a couple of months..to see what my dr. advices since he did say to wait until May.
Pooh...I can always decide or insist to take S&O....I can ask my dr. again...I will bring these findings to him...I am sure he knows them being the director of heptalogy at NYU Medical Center in NY...
Pamelajean...thanks for the additional information...
I am conflicted given the information from all...but no worries...May is around the corner and hopefully my dr. has the alternative plan..we want 100% cure...lol
I like to wait just a bit to see if I have an opportunity for something that has a 90 and above cure rate as opposed to the 80% (though some may consider better than nothing). But, at a price of $2,000 a day...(I will have to pay some out of pocket...but very lucky to have insurance)...I like to wait just a couple of months..to see what my dr. advices since he did say to wait until May.
Pooh...I can always decide or insist to take S&O....I can ask my dr. again...I will bring these findings to him...I am sure he knows them being the director of heptalogy at NYU Medical Center in NY...
Pamelajean...thanks for the additional information...
I am conflicted given the information from all...but no worries...May is around the corner and hopefully my dr. has the alternative plan..we want 100% cure...lol
More experts that support pooh's research. Note the last sentence...
HCVguidelines.org.....updated 2/13/2014
"The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA) this week announced the first new hepatitis C treatment guidelines that include next-generation direct-acting antiviral agents recently approved by the FDA. The guidance is available on a new website, HCVguidelines.org, that will enable frequent updates to reflect emerging data.
"It is important to keep in mind that FDA only will approve drugs that have gone through rigorous testing," said IAS-USA panel co-chair Michael Saag from the University of Alabama at Birmingham. "We cannot run a Phase 3 trial on every possible [drug] combination or every possible patient population. The website allows experts in the field to look at the emerging data and craft what we feel the evidence supports, [which] may fall short of what is specifically in an FDA-approved package insert."
"For genotype 1 patients who cannot take interferon, the panel recommends sofosbuvir plus the HCV protease inhibitor simeprevir (Olysio), with or without ribavirin, again for 12 weeks. This off-label regimen has not been through full Phase 3 testing, but performed very well in the Phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for patients with liver cirrhosis."
"For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism. Thus Q80K testing can be considered but is not strongly recommended."
HCVguidelines.org.....updated 2/13/2014
"The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA) this week announced the first new hepatitis C treatment guidelines that include next-generation direct-acting antiviral agents recently approved by the FDA. The guidance is available on a new website, HCVguidelines.org, that will enable frequent updates to reflect emerging data.
"It is important to keep in mind that FDA only will approve drugs that have gone through rigorous testing," said IAS-USA panel co-chair Michael Saag from the University of Alabama at Birmingham. "We cannot run a Phase 3 trial on every possible [drug] combination or every possible patient population. The website allows experts in the field to look at the emerging data and craft what we feel the evidence supports, [which] may fall short of what is specifically in an FDA-approved package insert."
"For genotype 1 patients who cannot take interferon, the panel recommends sofosbuvir plus the HCV protease inhibitor simeprevir (Olysio), with or without ribavirin, again for 12 weeks. This off-label regimen has not been through full Phase 3 testing, but performed very well in the Phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for patients with liver cirrhosis."
"For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism. Thus Q80K testing can be considered but is not strongly recommended."
Pooh said, "Ask your doctor about treating off label with Sovaldi and Olysio because the SVR rates are very high. The Sovaldi mitigates the Q80K polymorphism's effect on Olysio. Your chance of SVR (cure) with this all oral combo is excellent, even if you do have the Q80K polymorphims."
She can't take Olysio because it's resistant to Q80K polymorphisms, which she has... she needs to take Sovaldi with an NS5A inhibitor, which also has a high barrier to resistance. Her doc advises against taking Olysio with Sovaldi (and I agree 100%), so why push for it? She should opt for the TX that's NOT resistant, which is Sovaldi + NS5A inhibitor.
Millihepc, find out if the new trial from Jassen has Sovaldi and Jassen's NS5A inhibitor (or another NS5A inhibitor). Don't take something to which you know you have resistance. You'll be wasting your time and money.
Good luck,
HC
milliehepc said, "...however my test came back that I was resistant to Olysio becaue the Q80K was detected. The Q8OK polymorphism has been found to have a significant impact on SVR in patients with HCV genotype 1A (me). I don't know why they didn't mention Solvaldi...but will ask on a follow-up with Dr. He said, since I was resistant (80% chance) I should wait for a better treatment or trial and mentioned one that will come out in May - called Jenssen. (better over 90% cure..rate)"
She can't take Olysio because it's resistant to Q80K polymorphisms, which she has... she needs to take Sovaldi with an NS5A inhibitor, which also has a high barrier to resistance. Her doc advises against taking Olysio with Sovaldi (and I agree 100%), so why push for it? She should opt for the TX that's NOT resistant, which is Sovaldi + NS5A inhibitor.
Millihepc, find out if the new trial from Jassen has Sovaldi and Jassen's NS5A inhibitor (or another NS5A inhibitor). Don't take something to which you know you have resistance. You'll be wasting your time and money.
Good luck,
HC
milliehepc said, "...however my test came back that I was resistant to Olysio becaue the Q80K was detected. The Q8OK polymorphism has been found to have a significant impact on SVR in patients with HCV genotype 1A (me). I don't know why they didn't mention Solvaldi...but will ask on a follow-up with Dr. He said, since I was resistant (80% chance) I should wait for a better treatment or trial and mentioned one that will come out in May - called Jenssen. (better over 90% cure..rate)"
Thank you...hepcat, wow...so happy you been cure...every minute cure is precious.
pooh and can-do man...very thorough advice. I am going to print it and have it when I go see my dr. He said to come back in May...for a better trial or I guess one that he thinks its better than the combo O&S. I am going to question him about the combo - and the study you mention that had a better cure rate....so given that I have the dreaded Q80K...I have to wait for something that works with it...or against as it may be.
Oh, boy...so much stuff...
I thank you all..as I said I will print information/advice you sent me and study it....
You are all the best EVER...THANK YOU!
pooh and can-do man...very thorough advice. I am going to print it and have it when I go see my dr. He said to come back in May...for a better trial or I guess one that he thinks its better than the combo O&S. I am going to question him about the combo - and the study you mention that had a better cure rate....so given that I have the dreaded Q80K...I have to wait for something that works with it...or against as it may be.
Oh, boy...so much stuff...
I thank you all..as I said I will print information/advice you sent me and study it....
You are all the best EVER...THANK YOU!
P.S. As far as your numbers, you should talk to your doctor about those. I can't keep track of all those. If your biopsy has been done and you're eligible for the trial (and it's the one you want), I say go for it.
Again, good luck!
HC
Again, good luck!
HC
Olysio (Simiprevir), by Jassen, is an oral protease inhibitor and has a low to medium barrier to resistance. Sovaldi (sofosbuvir), by Gilead, is a nucleotide analog NS5B polymerase inhibitor and has a high barrier to resistance.
It looks like your doc wants you to wait for a companion drug for Sovaldi that also has a high barrier to resistance, which is a good idea IMO. What's producing excellent results is Sovaldi is coupled with an NS5A inhibitor, which also has a high barrier to resistance.
There are several NS5A inhibitors on the market. As I mentioned, Ledipasvir is Gilead's NS5A inhibitor. Bristol Myers' NS5A inhibitor is known as Daclatasvir. (When Bristol Myers and Gilead fell out 2 years ago, people made big stink because at that time, it was the only combination of drugs (sofosbuvir & daclatasvir) with a high cure rate and a high barrier to resistance.) In October 2013, Jassen "acquired" (purchased?) it's own NS5A inhibitor, GSK2336805, for folks with the Q80K and resistance to Olysio.
Since NS5A inhibitors have a high barrier to resistance, Jassen has wisely acquired their own. The "Jassen" trial they're talking about must be comprised of Sovaldi coupled with GSK2336805 (or whatever name they eventually give it) NS5A inhibitor.
Take note that ALL NS5A inhibitors (and the new oral protease inhibitors like Olysio) have to be taken with the KING of HCV drugs - Sovaldi. If you don't have the dreaded Q80K polymorphism, you can take Sovaldi with Olysio, which a lot of folks are doing. However, if you have Q80K, then you have to couple Sovaldi with an NS5A inhibitor. I think all the NS5A inhibitors are comparable.
Here's a link about Jassen's acquisition of its new NS5A inhibitor.
http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=795554
Verify that the Jassen trial you're considering will consist of Sovaldi and GSK2336805 or another NS5A inhibitor. If so, find out how close the trial is to opening up and RUN, don't walk, to get in line.
Good luck to you,
HC
P.S. [I too had high resistant polymorphisms (to Invicek) and had to stop triple treatment after 12 weeks. About a year after stopping, I started a Gilead trial with Sovaldi (sofosbuvir) and Ledipasvir (formerly GS-5885). I've been cured for 10 months after taking those 2 drugs for 12 weeks.]
It looks like your doc wants you to wait for a companion drug for Sovaldi that also has a high barrier to resistance, which is a good idea IMO. What's producing excellent results is Sovaldi is coupled with an NS5A inhibitor, which also has a high barrier to resistance.
There are several NS5A inhibitors on the market. As I mentioned, Ledipasvir is Gilead's NS5A inhibitor. Bristol Myers' NS5A inhibitor is known as Daclatasvir. (When Bristol Myers and Gilead fell out 2 years ago, people made big stink because at that time, it was the only combination of drugs (sofosbuvir & daclatasvir) with a high cure rate and a high barrier to resistance.) In October 2013, Jassen "acquired" (purchased?) it's own NS5A inhibitor, GSK2336805, for folks with the Q80K and resistance to Olysio.
Since NS5A inhibitors have a high barrier to resistance, Jassen has wisely acquired their own. The "Jassen" trial they're talking about must be comprised of Sovaldi coupled with GSK2336805 (or whatever name they eventually give it) NS5A inhibitor.
Take note that ALL NS5A inhibitors (and the new oral protease inhibitors like Olysio) have to be taken with the KING of HCV drugs - Sovaldi. If you don't have the dreaded Q80K polymorphism, you can take Sovaldi with Olysio, which a lot of folks are doing. However, if you have Q80K, then you have to couple Sovaldi with an NS5A inhibitor. I think all the NS5A inhibitors are comparable.
Here's a link about Jassen's acquisition of its new NS5A inhibitor.
http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=795554
Verify that the Jassen trial you're considering will consist of Sovaldi and GSK2336805 or another NS5A inhibitor. If so, find out how close the trial is to opening up and RUN, don't walk, to get in line.
Good luck to you,
HC
P.S. [I too had high resistant polymorphisms (to Invicek) and had to stop triple treatment after 12 weeks. About a year after stopping, I started a Gilead trial with Sovaldi (sofosbuvir) and Ledipasvir (formerly GS-5885). I've been cured for 10 months after taking those 2 drugs for 12 weeks.]
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
