Aa
Holkira Pak failure?
Hello there
Just wanted to know which meds or treatment the group would consider as best overall effective treatment for hep c genotype 1a, compensated cirrhosis, (previous null responder to interferon and ribaviron)
Just wanted to know which meds or treatment the group would consider as best overall effective treatment for hep c genotype 1a, compensated cirrhosis, (previous null responder to interferon and ribaviron)
Hi cwar1
Just to let you know this isn't a chat room you can post a question and wait for a reply when someone comes by and sees your question they will answer if they can. Posting the same question multiple times won't help get your question answered.
Per the recommendations of the American Association for the Study of Liver Diseases (AASLD)
Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
***So that would be your husband a Viekira Pak failure (which contains dasabuvir)***
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.
***Meaning if he does not have liver disease he should wait for new treatments***
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.
***This is the recommendation if your husband has cirrhosis but it goes on to say****
For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.
*** this means the AASLD would recommend he have resistance testing done to determine what is the best treatment for him***
so to your questions:
A) would he be also resistant to NS5A- inhibitors if he is resistant to THE DASABUViR?
That is why he would be resistant dasabuvir is in that family of inhibitors.
B) if he is resistant to DASABUViR would the HARVONI work to cure him?
Maybe he will need resistance testing to determine his best course of treatment.
If he has no NS5A inhibitor RAV's they recommend 24 weeks of Harvoni with ribavirin.
If he has NS5A inhibitor RAV's but does not have NS3 inhibitor RAV's they recommend simeprevir (Olysio), sofosbuvir (Sovaldi), and RBV for 24 weeks.
If he has both NS5A and NS3 RAV's they recommend retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.
here is a link to the information I quoted:
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
The best person to ask your questions is his doctor he will need resistance testing to know how to proceed at this time.
I hope this helps
Lynn
Just to let you know this isn't a chat room you can post a question and wait for a reply when someone comes by and sees your question they will answer if they can. Posting the same question multiple times won't help get your question answered.
Per the recommendations of the American Association for the Study of Liver Diseases (AASLD)
Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
***So that would be your husband a Viekira Pak failure (which contains dasabuvir)***
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.
***Meaning if he does not have liver disease he should wait for new treatments***
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.
***This is the recommendation if your husband has cirrhosis but it goes on to say****
For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.
*** this means the AASLD would recommend he have resistance testing done to determine what is the best treatment for him***
so to your questions:
A) would he be also resistant to NS5A- inhibitors if he is resistant to THE DASABUViR?
That is why he would be resistant dasabuvir is in that family of inhibitors.
B) if he is resistant to DASABUViR would the HARVONI work to cure him?
Maybe he will need resistance testing to determine his best course of treatment.
If he has no NS5A inhibitor RAV's they recommend 24 weeks of Harvoni with ribavirin.
If he has NS5A inhibitor RAV's but does not have NS3 inhibitor RAV's they recommend simeprevir (Olysio), sofosbuvir (Sovaldi), and RBV for 24 weeks.
If he has both NS5A and NS3 RAV's they recommend retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.
here is a link to the information I quoted:
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
The best person to ask your questions is his doctor he will need resistance testing to know how to proceed at this time.
I hope this helps
Lynn
Can someone answer this question?
If my husband tried the holkira Pak w ribarivon and after /4 wks relapsed and the Sr sain he grew resistant to one of the compliments on the therapy, namely the dasabuvir.
A) would he be also resistant to NS5A- inhibitors if he is resistant to THE DASABUViR?
And
B) if he is resistant to DASABUViR would the HARVONI work to cure him?
If my husband tried the holkira Pak w ribarivon and after /4 wks relapsed and the Sr sain he grew resistant to one of the compliments on the therapy, namely the dasabuvir.
A) would he be also resistant to NS5A- inhibitors if he is resistant to THE DASABUViR?
And
B) if he is resistant to DASABUViR would the HARVONI work to cure him?
I am told that resistance goes away. Is 2 years the magic number? I doubt anyone knows that for sure and it is likely different for each patient. It is just good to know that it will go away and patients will be able to treat again with the PI's and by adding a 2nd or third drug, have a much better chance at SVR.
I was just relating you had reported that information.
I am still trying to understand the significance of the statement hrsepwrguy posted by Mark S. Sulkowski, MD as to whether it means the resistance decreases after 2 years or just all they know at this point is that "are likely to be stable and detectable for as long as 2 years after treatment" does that means the resistance declines after 2 years?
I am still trying to understand the significance of the statement hrsepwrguy posted by Mark S. Sulkowski, MD as to whether it means the resistance decreases after 2 years or just all they know at this point is that "are likely to be stable and detectable for as long as 2 years after treatment" does that means the resistance declines after 2 years?
It's not really what I said. It is what the researchers have said in seminars and workshops. They say the virus that is resistant is weak. The wild type takes over and resistance goes away. I have never heard anyone put a time on that but have heard the two year mark mentioned.
Great aticle thanks!
As I read the comment
"More importantly, we know that variants that are associated with resistance to NS5A inhibitors, including ledipasvir, ombitasvir, and daclatasvir, are likely to be stable and detectable for as long as 2 years after treatment."
I take that to mean they don't have data for more than 2 years out to see if the resistance continues beyond 2 years. Or could that mean as Surfside Gal said that resistance begins to decrease after 2 years time?
Wish I knew what they intended with that statement
As I read the comment
"More importantly, we know that variants that are associated with resistance to NS5A inhibitors, including ledipasvir, ombitasvir, and daclatasvir, are likely to be stable and detectable for as long as 2 years after treatment."
I take that to mean they don't have data for more than 2 years out to see if the resistance continues beyond 2 years. Or could that mean as Surfside Gal said that resistance begins to decrease after 2 years time?
Wish I knew what they intended with that statement
Here is one more, it won't copy and paste so follow the link and scroll down to the article titled "What the heck are RAV's", it is about half way down the page.
http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2015/advocate1015.pdf#WhatAreRAVs
http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2015/advocate1015.pdf#WhatAreRAVs
forgot the link
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Resistance%20Alert/Clinical%20Thoughts/CT1.aspx
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Resistance%20Alert/Clinical%20Thoughts/CT1.aspx
How I Use Resistance Testing to Guide Management of Patients With Chronic Hepatitis
Mark S. Sulkowski, MD - 9/15/2015
Recently, I have begun to hear many questions from colleagues and trainees regarding the use of resistance testing in the management of HCV-infected patients. To be honest, my answers to their questions are not always straightforward, as this is a rapidly evolving area of discussion in the field and I am confident that my opinion will evolve along with the data.
When Resistance Testing Is Recommended
That said, the AASLD/IDSA guidance has now highlighted at least one patient population for whom resistance testing with commercially available assays can be used to guide treatment decisions: Persons for whom treatment is urgent and previous treatment with NS5A inhibitors has failed to achieve cure. This would include previous exposure to such regimens as ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, and daclatasvir plus sofosbuvir. We know from follow-up data of patients treated in clinical trials that resistance associated variants (RAVs) against any of the available DAAs are likely to be detected upon on-treatment virologic breakthrough or posttreatment relapse with the exception of the nucleotide analogue NS5B inhibitor sofosbuvir. More importantly, we know that variants that are associated with resistance to NS5A inhibitors, including ledipasvir, ombitasvir, and daclatasvir, are likely to be stable and detectable for as long as 2 years after treatment.
Based on these data, updated AASLD/IDSA guidance recommends that, if treatment is urgent, patients who are not cured after receiving an NS5A inhibitor should undergo testing for the presence of resistance associated variants in the NS5A region and NS3 region (selected by protease inhibitors which target NS3, such as paritaprevir and simeprevir). Per the guidance, such patients who have no NS5A RAVs can be treated with 24 weeks of ledipasvir/sofosbuvir and ribavirin, those with NS5A RAVs but no NS3 RAVs can be treated with 24 weeks of simeprevir plus sofosbuvir and ribavirin, and those with both RAVs should be treated in clinical trial settings only.
The utility of testing for RAVs in the NS5B polymerase region is much less clear. Resistance to nucleotide analogues that target the NS5B active site (ie, sofosbuvir) is rare, and data indicate that retreatment with sofosbuvir-containing regimens is feasible in patients for whom a previous sofosbuvir-containing treatment has failed. Given the rarity of resistance to the NS5B active site, resistance testing is not routinely recommended. Currently, dasabuvir is the only other NS5B inhibitor available; however, it is a nonnucleoside inhibitor that targets domains of the NS5B polymerase distinct from sofosbuvir. Dasabuvir is used only with the NS5A inhibitor ombitasvir and the protease inhibitor paritaprevir, against which RAVs are more common. Thus, the results of NS5B inhibitor resistance testing would be unlikely to change the treatment decision.
Utilizing Resistance Testing in Practice: A Case Example
Of course, recommendations are only helpful if they can be applied to the care of real patients in clinical practice. A recent patient from my clinic is one such example. The case patient was a 54-year-old man with genotype 1a HCV infection and compensated cirrhosis who had a null response to treatment with peginterferon/ribavirin years before the availability of DAAs. He was subsequently treated with ledipasvir/sofosbuvir and ribavirin for 12 weeks and had an outstanding initial drop in HCV RNA. However, he unfortunately experienced relapse after stopping therapy. HCV drug resistance testing revealed a mutation in the NS5A region at position 93 (Y93H) that confers decreased susceptibility to ledipasvir (and ombitasvir and daclatasvir). However, testing of the NS3 protease domain revealed no Q80K mutation, suggesting that simeprevir would be active in this patient.
Case Treatment Decision
Based on the presence of an NS5A RAV but absence of NS3 RAVs, we elected to retreat this patient with sofosbuvir and simeprevir plus ribavirin for 24 weeks.
Why 24 weeks? Because longer therapy appears to decrease the risk of HCV relapse in patients with cirrhosis.
Why add ribavirin? Because ribavirin appears to decrease the emergence of HCV variants resistant to the DAAs in this regimen.
Can we anticipate insurance challenges? Based on this being the recommended approach in national guidelines, I expect insurance would cover this regimen for our patient.
Mark S. Sulkowski, MD - 9/15/2015
Recently, I have begun to hear many questions from colleagues and trainees regarding the use of resistance testing in the management of HCV-infected patients. To be honest, my answers to their questions are not always straightforward, as this is a rapidly evolving area of discussion in the field and I am confident that my opinion will evolve along with the data.
When Resistance Testing Is Recommended
That said, the AASLD/IDSA guidance has now highlighted at least one patient population for whom resistance testing with commercially available assays can be used to guide treatment decisions: Persons for whom treatment is urgent and previous treatment with NS5A inhibitors has failed to achieve cure. This would include previous exposure to such regimens as ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, and daclatasvir plus sofosbuvir. We know from follow-up data of patients treated in clinical trials that resistance associated variants (RAVs) against any of the available DAAs are likely to be detected upon on-treatment virologic breakthrough or posttreatment relapse with the exception of the nucleotide analogue NS5B inhibitor sofosbuvir. More importantly, we know that variants that are associated with resistance to NS5A inhibitors, including ledipasvir, ombitasvir, and daclatasvir, are likely to be stable and detectable for as long as 2 years after treatment.
Based on these data, updated AASLD/IDSA guidance recommends that, if treatment is urgent, patients who are not cured after receiving an NS5A inhibitor should undergo testing for the presence of resistance associated variants in the NS5A region and NS3 region (selected by protease inhibitors which target NS3, such as paritaprevir and simeprevir). Per the guidance, such patients who have no NS5A RAVs can be treated with 24 weeks of ledipasvir/sofosbuvir and ribavirin, those with NS5A RAVs but no NS3 RAVs can be treated with 24 weeks of simeprevir plus sofosbuvir and ribavirin, and those with both RAVs should be treated in clinical trial settings only.
The utility of testing for RAVs in the NS5B polymerase region is much less clear. Resistance to nucleotide analogues that target the NS5B active site (ie, sofosbuvir) is rare, and data indicate that retreatment with sofosbuvir-containing regimens is feasible in patients for whom a previous sofosbuvir-containing treatment has failed. Given the rarity of resistance to the NS5B active site, resistance testing is not routinely recommended. Currently, dasabuvir is the only other NS5B inhibitor available; however, it is a nonnucleoside inhibitor that targets domains of the NS5B polymerase distinct from sofosbuvir. Dasabuvir is used only with the NS5A inhibitor ombitasvir and the protease inhibitor paritaprevir, against which RAVs are more common. Thus, the results of NS5B inhibitor resistance testing would be unlikely to change the treatment decision.
Utilizing Resistance Testing in Practice: A Case Example
Of course, recommendations are only helpful if they can be applied to the care of real patients in clinical practice. A recent patient from my clinic is one such example. The case patient was a 54-year-old man with genotype 1a HCV infection and compensated cirrhosis who had a null response to treatment with peginterferon/ribavirin years before the availability of DAAs. He was subsequently treated with ledipasvir/sofosbuvir and ribavirin for 12 weeks and had an outstanding initial drop in HCV RNA. However, he unfortunately experienced relapse after stopping therapy. HCV drug resistance testing revealed a mutation in the NS5A region at position 93 (Y93H) that confers decreased susceptibility to ledipasvir (and ombitasvir and daclatasvir). However, testing of the NS3 protease domain revealed no Q80K mutation, suggesting that simeprevir would be active in this patient.
Case Treatment Decision
Based on the presence of an NS5A RAV but absence of NS3 RAVs, we elected to retreat this patient with sofosbuvir and simeprevir plus ribavirin for 24 weeks.
Why 24 weeks? Because longer therapy appears to decrease the risk of HCV relapse in patients with cirrhosis.
Why add ribavirin? Because ribavirin appears to decrease the emergence of HCV variants resistant to the DAAs in this regimen.
Can we anticipate insurance challenges? Based on this being the recommended approach in national guidelines, I expect insurance would cover this regimen for our patient.
http://www.hepatitiscnewdrugresearch.com/hcv-resistance-to-new-and-experimental-drugs.html
Ok, so my understanding is that you aren't resistant from the beginning. You develop resistance as you go along in the treatment. Sometimes resistance is caused by patients who miss doses. Sometimes it is caused by using the drug as monotherapy when two or more drugs are needed to protect against resistance. Sometimes it is because you have certain mutations that "fight" against a particular drug.
I wish I could do a better job explaining. I am not a scientist, far from it. So I often do not understand the actual explanations and just have to go with the bottom line(conclusion) when I hear it from someone I respect in the field. I have heard a few virologists talk about the weakness of the resistance problems with the DAA's....something about the wild type virus taking over and getting rid of the resistant virus and they believe it takes about two years.
I am hoping someone a lot smarter than I will come along and explain this in layman's terms to all of us.
I wish I could do a better job explaining. I am not a scientist, far from it. So I often do not understand the actual explanations and just have to go with the bottom line(conclusion) when I hear it from someone I respect in the field. I have heard a few virologists talk about the weakness of the resistance problems with the DAA's....something about the wild type virus taking over and getting rid of the resistant virus and they believe it takes about two years.
I am hoping someone a lot smarter than I will come along and explain this in layman's terms to all of us.
No I did not have this testing because I did not take and fail Hokira Pak yes that is the name in Canada in the US it is called Viekira Pak but same stuff.
I was asking Surfside gal where she heard about resistance going away Ihad not heard that.
As I understand it because he too those meds and failed he may now have resistance to some similar family of meds.
Th eresistance testing is looking for genetic variations called polymorphisims. The Q80K is a name for one it is a NS3 protease inhibitor catagory I am sorry I dont know how to explain any simpler but they are just names of things that make treatment more difficult to succede with the current meds. The other is called NS5A.
Yes the recommendation of the American Association for the Study of Liver Disease is that he be tested for these resistance factors because of his treatment failure.
If he tests negative for the NS5A he should be treated for 24 week of Harvoni with Ribavirin per the current AASLD guidelines. As you asked yes the recommendation is he neds to test negative for the NS5A to get Harvoni and Ribavirin for 24 weeks unless his doctor wants to try anyway and his insurance agrees.
If he tests positive for NS5A but not the NS3 (Q80K) he could be treated with Simeprevir (Olysio) and Sofosbuvir (Sovaldi) with Ribavirin for 24 weeks again per the guidelines.
If he tests positive for both NS3 and NS5A we would need to look for a clinical trial or wait for new medicines to be approved the AASLD guidelines current have no specific recommendations for someone in this situation
But there are other even newer meds coming soon that will work differently than the current meds so hopefully if he doesnt have any other options right now he may have options later with the new medicines.
Here is a wikipedia link about the NS5A (nonstructural protein 5A) but it is farily technical if you want to read more about it. I can try to find some less technical links but it is still a complicated subject
https://en.wikipedia.org/wiki/NS5A
I treated last year with Sovaldi and olysio for 12 weeks with out ribavirin. I was not detected on treatment but I also relapsed 12 weeks after treatment. A few months after I relapsed the recommendation was revised for people with cirrhosis from 12 weeks to 24 weeks I will never know but I tend to think had I treated for 24 weeks I would have been cured last year.
The thing about testing is the medicine can drive th evirus down to such low levels it is below the test ability to detect but unfortunately if any virus survive after the medicine is stopped the virus comes charging back.
As I said I believe the resistance maybe induced by taking the medicine and failing treatment so he would not have tested positive for NS5A prior to treating but he may now.
Sorry this is probably a lot of information right now hopefully his doctor can explain somewhat more than I and also and where he thinks he should go from here.
The Sovaldi I took does not create resistance but olysio does but not to the medicine contained in Harvoni. But at least one of the meds in Hokira does create cross resistance to an ingrediant in Harvoni which is actually 2 medicines Sovaldi and Ledipasvir the effectiveness of ledipasvir is potentally compromised due to cross resistance from Hokira Pak.
I have had cirrhosis for almost 8 years now and an still hanging in there.
How long has you husband had cirrhosis and is his cirrhosis still compensated? Meaning does he have any symptoms of cirrhosis?
Best of luck to you both looking to see how it is going
Lynn
I was asking Surfside gal where she heard about resistance going away Ihad not heard that.
As I understand it because he too those meds and failed he may now have resistance to some similar family of meds.
Th eresistance testing is looking for genetic variations called polymorphisims. The Q80K is a name for one it is a NS3 protease inhibitor catagory I am sorry I dont know how to explain any simpler but they are just names of things that make treatment more difficult to succede with the current meds. The other is called NS5A.
Yes the recommendation of the American Association for the Study of Liver Disease is that he be tested for these resistance factors because of his treatment failure.
If he tests negative for the NS5A he should be treated for 24 week of Harvoni with Ribavirin per the current AASLD guidelines. As you asked yes the recommendation is he neds to test negative for the NS5A to get Harvoni and Ribavirin for 24 weeks unless his doctor wants to try anyway and his insurance agrees.
If he tests positive for NS5A but not the NS3 (Q80K) he could be treated with Simeprevir (Olysio) and Sofosbuvir (Sovaldi) with Ribavirin for 24 weeks again per the guidelines.
If he tests positive for both NS3 and NS5A we would need to look for a clinical trial or wait for new medicines to be approved the AASLD guidelines current have no specific recommendations for someone in this situation
But there are other even newer meds coming soon that will work differently than the current meds so hopefully if he doesnt have any other options right now he may have options later with the new medicines.
Here is a wikipedia link about the NS5A (nonstructural protein 5A) but it is farily technical if you want to read more about it. I can try to find some less technical links but it is still a complicated subject
https://en.wikipedia.org/wiki/NS5A
I treated last year with Sovaldi and olysio for 12 weeks with out ribavirin. I was not detected on treatment but I also relapsed 12 weeks after treatment. A few months after I relapsed the recommendation was revised for people with cirrhosis from 12 weeks to 24 weeks I will never know but I tend to think had I treated for 24 weeks I would have been cured last year.
The thing about testing is the medicine can drive th evirus down to such low levels it is below the test ability to detect but unfortunately if any virus survive after the medicine is stopped the virus comes charging back.
As I said I believe the resistance maybe induced by taking the medicine and failing treatment so he would not have tested positive for NS5A prior to treating but he may now.
Sorry this is probably a lot of information right now hopefully his doctor can explain somewhat more than I and also and where he thinks he should go from here.
The Sovaldi I took does not create resistance but olysio does but not to the medicine contained in Harvoni. But at least one of the meds in Hokira does create cross resistance to an ingrediant in Harvoni which is actually 2 medicines Sovaldi and Ledipasvir the effectiveness of ledipasvir is potentally compromised due to cross resistance from Hokira Pak.
I have had cirrhosis for almost 8 years now and an still hanging in there.
How long has you husband had cirrhosis and is his cirrhosis still compensated? Meaning does he have any symptoms of cirrhosis?
Best of luck to you both looking to see how it is going
Lynn
That was the first I had seen about resistance "going away" to you have a link for that information?
Lynn, above you say the resistance going away? What do you mean. I guess in order to take the Harvoni he has to test negative to the NS5A correct?
Lynn, above you say the resistance going away? What do you mean. I guess in order to take the Harvoni he has to test negative to the NS5A correct?
What I do not get or understand is this. When we talk about RESISTANCE, shouldnt that mean while taking the drug also? How could one test negative for Hep C Virus while taking the drugs and once stopped, 12 weeks later we realize that one had a resistance to the treatment? Where was the resistance when we were taking the drugs? To me it would make sense to NOT test negative for the virus all along if you were going to have a resistance to the entire treatment?????
Hi Flyin-
Yes he started with a v/l of over 2.5million and after 24 weeks of treatment, 12 weeks later his v/l was 176,000.
My husband was the opposite within the first week of treatment his viral load went undetected and so on for the duration of the 24 weeks of treatment. However 12 weeks later after he ceased the treatment the V/L came back!
Yes he started with a v/l of over 2.5million and after 24 weeks of treatment, 12 weeks later his v/l was 176,000.
My husband was the opposite within the first week of treatment his viral load went undetected and so on for the duration of the 24 weeks of treatment. However 12 weeks later after he ceased the treatment the V/L came back!
Wow, do I feel like I have my oars out of the water! Resistance testing Lynn? Not sure what you mean and no I don't have a link that would be great if you could send it my way! We are leaving early in the morning and heading up to see the Dr. but if you are saying that his resistance testing would somehow help point us in the right direction of next steps/treatment then I would like to know all about it so I can recommend it tomorrow. We are from Canada perhaps this is why Abbvie Calls it the Holkira pak?
From what I was seeing in the current AASLD guidelines the resistance testing is recommended in order to determine the best treatment after Viekira Pak failure and if he does not have the NS5A the AASLD recommendation is he should be treated for 24 week of Harvoni with Ribavirin.
However as you said of course that will be up to his doctor how to go from here but he really should have the resistance testing.
That was the first I had seen about resistance "going away" to you have a link for that information?
However as you said of course that will be up to his doctor how to go from here but he really should have the resistance testing.
That was the first I had seen about resistance "going away" to you have a link for that information?
Please ask your doctor about this. But I believe that if a patient does not respond, or relapses, on ViekiraPak (Holkira) he will have resistance to harvoni. However, there may be other drugs that can be used. You can ask your doc to do resistance testing. By the way, resistance to these drugs will likely go away within two years
Do you know what is post treatment viral load result was? How many weeks post treatment was he when tested?
There have been some who tested weakly positive at end of treatment testing but still went on to acheive long term cure being not detected at 12 weeks post treatment.
They had results like less than 15 detected or I think one had 36 detected but when tested again weeks later they were not detected.
Wish I had better news
There have been some who tested weakly positive at end of treatment testing but still went on to acheive long term cure being not detected at 12 weeks post treatment.
They had results like less than 15 detected or I think one had 36 detected but when tested again weeks later they were not detected.
Wish I had better news
OK that must be the Canadian name sorry for my ignorance on that score.
I am in the US my insurance throught my employer paid for the meds and then I had a copay coupon from Gilead the maker of Harvoni so all I paid for the 6 bottles of Harvoni was 5 dollars each or 30 total.
The prescribing information sheet for Holkira Pak has clinical trial results and other valuable information here is a link to a copy:
http://www.rxabbvie.com/pdf/viekirapak_pi.pdf
If you look at table 11 paragraph 14.2 they list the results I will copy partly here:
Table 11. TURQUOISE-II: SVR12 for Chronic HCV Genotype 1-Infected Subjects with Cirrhosis Who Were Treatment-Naïve or Previously Treated with pegIFN/RBV
SVR12 by Prior pegIFN Experience
Null Responder
93% (39/42)
Meaning ot the 42 patients in that clinical trial 39 of them who had treated before with Ribavirin Genotype 1a and were null responders like your husband were cured of hep C or 93% success
I hope that helps you beleive you have hope he can be cured the odds are in his favor
I am in the US my insurance throught my employer paid for the meds and then I had a copay coupon from Gilead the maker of Harvoni so all I paid for the 6 bottles of Harvoni was 5 dollars each or 30 total.
The prescribing information sheet for Holkira Pak has clinical trial results and other valuable information here is a link to a copy:
http://www.rxabbvie.com/pdf/viekirapak_pi.pdf
If you look at table 11 paragraph 14.2 they list the results I will copy partly here:
Table 11. TURQUOISE-II: SVR12 for Chronic HCV Genotype 1-Infected Subjects with Cirrhosis Who Were Treatment-Naïve or Previously Treated with pegIFN/RBV
SVR12 by Prior pegIFN Experience
Null Responder
93% (39/42)
Meaning ot the 42 patients in that clinical trial 39 of them who had treated before with Ribavirin Genotype 1a and were null responders like your husband were cured of hep C or 93% success
I hope that helps you beleive you have hope he can be cured the odds are in his favor
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Per the American Association for the Study of Liver Diesase (AASLD)
HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C
RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
here is the recommendation for his situation
Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.
For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.
Hi me again
Basically if he has failed 24 weeks of Holkira pak (paritaprevir/ritonavir/ombitasvir plus dasabuvir) he will need to be tested for his resistance factors to treatment to best determine where to go from here
The tests would be to see if he tests positive for (technical stuff) the Q80K polymorphism a NS3 protease inhibitor and for NS5A protease inhibitors.
If he tests negative for the NS5A he should be treated for 24 week of Harvoni with Ribavirin.
If he tests positive for NS5A but not the NS3 Q80K he could be treated with Simeprevir (Olysio) and Sofosbuvir (Sovaldi) with Ribavirin for 24 weeks
If he tests positive for both NS3 and NS5A we would need to look for a clinical trial or wait for new medicines to be approved