I will wait for solvaldi/GS5816,  I know I would not tolerate RIBA... so happy for you!!!  YIPEE

TazKat wrote:

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Solvadi with interferon & riba kicked my hep's butt.. been free for6 months.. yayayayya..

TAz

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Solvadi with interferon & riba kicked my hep's butt.. been free for6 months.. yayayayya..

TAz

Good luck Ro, I am sure it will work for you!!!

Connie, 

I have now completed 16 of my 24 weeks on Harvoni..... I pray this is the last treatment I will need ;)

Ro

Gator Man wrote:

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Yep, thank you, I was a little disappointed but feeling better on a daily basis.. I will be waiting for probably solvaldi and GS5816,  no problem... just gotta keep my body pure... and I will feel great...  Thank you for your concern!!!!!

connie

 

I know you are disappointed, Connie, and simply want rid of this virus.

I don't think there is any tarnish on Harvoni as an effective medication, but as your response demonstrates, it may not work for everyone. A combination of Sovaldi with GS5816 instead of Ledipasvir might do the trick as previously mentioned.

We are not at the point, and may never be, that one drug with a specific tx duration will be the SVR bullet for everyone with Hep C. One shot or a single pill for a few days would be great if it ever happens, but the more important goal is to have treatments that work, even if they take more time. 

I am confident that there will be effective therapies for everyone with Hep C when we get beyond the one size or drug for x weeks fits all approach.

You keep the great attitude going forward, and your time of slaying the dragon will be in the near future!

---

I know you are disappointed, Connie, and simply want rid of this virus.

I don't think there is any tarnish on Harvoni as an effective medication, but as your response demonstrates, it may not work for everyone. A combination of Sovaldi with GS5816 instead of Ledipasvir might do the trick as previously mentioned.

We are not at the point, and may never be, that one drug with a specific tx duration will be the SVR bullet for everyone with Hep C. One shot or a single pill for a few days would be great if it ever happens, but the more important goal is to have treatments that work, even if they take more time. 

I am confident that there will be effective therapies for everyone with Hep C when we get beyond the one size or drug for x weeks fits all approach.

You keep the great attitude going forward, and your time of slaying the dragon will be in the near future!

Thanks, wow 3 times... arghhh, what is next for you??

Ro wrote:

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So sorry to hear your news.  But you seem to be taking a positive approach, which is wonderful.  

This virus and all its mutations is tricky.. having never achieved SVR before, but failing treatment 3 times I truly understand all the emotions and questions running through you.  

Remain positive and believe that the future holds good things for you.

Sending postive thoughts

---

Thanks for you comments... I am just pondering doing this deep DNA testing... I will print up everything I can find and see what my PA has to say about it.. it gets complicated with mutations and such

Peace,  connie

Cinnamon Girl wrote:

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I`m really sorry you relapsed, Connie, and I`m sure you must be feeling so disappointed and also puzzled about the causes too. 

You gave it your very best shot and nothing you did or didn`t do could have changed it so please don`t feel that you are in any way at fault

Remember that it`s still early days for Harvoni in the real world of treatment and although none of us expected this outcome it seems that 8 weeks won`t be long enough for certain people.  I would try to put it behind you now, give yourself a break from worrying about it and move forward with your life.  There are other treatment combos in the pipeline, for example Solvadi with GS5816 as Mark mentioned, and I`m sure the next time around will be your time to be cured. 

In the meantime take good care of yourself and try to stay optimistic...better times are ahead! 

 

---

So sorry to hear your news.  But you seem to be taking a positive approach, which is wonderful.  

This virus and all its mutations is tricky.. having never achieved SVR before, but failing treatment 3 times I truly understand all the emotions and questions running through you.  

Remain positive and believe that the future holds good things for you.

Sending postive thoughts

I`m really sorry you relapsed, Connie, and I`m sure you must be feeling so disappointed and also puzzled about the causes too. 

You gave it your very best shot and nothing you did or didn`t do could have changed it so please don`t feel that you are in any way at fault

Remember that it`s still early days for Harvoni in the real world of treatment and although none of us expected this outcome it seems that 8 weeks won`t be long enough for certain people.  I would try to put it behind you now, give yourself a break from worrying about it and move forward with your life.  There are other treatment combos in the pipeline, for example Solvadi with GS5816 as Mark mentioned, and I`m sure the next time around will be your time to be cured. 

In the meantime take good care of yourself and try to stay optimistic...better times are ahead! 

I havn't spoken to any women on the trial 

your best bet would be to ring a center that is or has conducted a trial and ask if someone will talk to you I am being seen at Lind research center plymouth hospital in the uk 

If you rang plymouth hospital and asked to be put through to the Lind research center I am sure someone would be willing to answer your questions

Good luck 

Hi Angel girl, truly sorry to hear of your relapse.  When I relapsed on the S/O tx it was difficult.  Hoping and praying  Harvoni does it.  You have a fantastic attitude, outlook, and perspective, in dealing with this.  Thanks for sharing.  Hold fast to the faith.  :)

Matt Chris wrote:

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Thanks Matt, trying to wrap my little head around that article, may take a few readings.. I am so grateful for your input!!!

 

Hey Angel Connie

RAV's = resistance-associated variants (RAVs)

Also more recent up to date expression that clinicians are using now is Polymorphism of the HCV  (sometimes referred as a quasi-species)

The last sentence meant you will still likely wait some time for your next treatment attempt, regardless of knowing your reason for relapse.

Checkout this link on more about Ravs entitled  Antiviral therapy of hepatitis C in 2014: do we need resistance testing?

   http://www.ncbi.nlm.nih.gov/pubmed/24583028

matt

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Hey Angel Connie

RAV's = resistance-associated variants (RAVs)

Also more recent up to date expression that clinicians are using now is Polymorphism of the HCV  (sometimes referred as a quasi-species)

The last sentence meant you will still likely wait some time for your next treatment attempt, regardless of knowing your reason for relapse.

Checkout this link on more about Ravs entitled  Antiviral therapy of hepatitis C in 2014: do we need resistance testing?

   http://www.ncbi.nlm.nih.gov/pubmed/24583028

matt

Thanks so much for this information... I guess it is kind of a "crap shot" with treatment in a way....  there will be something else down the road for sure... good luck with Harvoni!!!!

Connie

Miss B wrote:

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Connie,

Before I started Harvoni, I thought about asking my doctor if it would be a good idea to run tests to see if I have a resistant strain of the virus.  But, I decided that I didn't want to give my insurer another reason to delay my treatment.  

Today, I went to the NIH for labs, & exam.  I am not on a drug trial there, they have been "following" me for 20 + years. I have never qualified for a trial that was a good fit for me.  So, I asked the dr. what he thought about me going from UND to detected but <15.  He said that is not a breakthrough. I asked what # would be considered a failure after EOT.  He said by EOT week 12, my #'s would need to be up where they were before treatment (in the millions, not thousands).  He said that even if I am not UND at the end of treatment, the immune system can kick in and finish the job.

I asked him if he thought the 8 week protocol was enough.  He said yes, they have seen good results in their trials with 8 weeks. He also said he is working on a trial now that is a 4 drug combo for 4 weeks & it has shown good results. And, there are many more drugs coming along.

I asked him if he thought I should be tested for NS5A & NS5B variants.  He said it has not been a reliable predictor of treatment success.

I hope that puts your mind at ease a bit. 

---

Matt Chris wrote:

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Matt, now that makes perfect sense... ok, I did not quite follow your last sentence.... glad to get this information so I can show it to my hepatologist office... tell me exactly what Rav stands for??  Thanks so much

 

angel connie (I hope one day)

 

Hey Angel / Connie

If I was in your shoes and wanted to focus my pent up energy on something, it would be finding out if RAV's caused your relapse. Its an expensive test but done all the time in HCV clinical trials studies. The blood test is referred to as (deep genetic sequencing & or population-based sequencing). When I relapsed they did the population based sequencing and found no RAV's which opened up the possibility that duration of treatment was a factor.  If you do nothing and just wait, that's what you will do anyway regardless of the sequencing test result.

Cheers

matt 

 

 

---

Hey Angel / Connie

If I was in your shoes and wanted to focus my pent up energy on something, it would be finding out if RAV's caused your relapse. Its an expensive test but done all the time in HCV clinical trials studies. The blood test is referred to as (deep genetic sequencing & or population-based sequencing). When I relapsed they did the population based sequencing and found no RAV's which opened up the possibility that duration of treatment was a factor.  If you do nothing and just wait, that's what you will do anyway regardless of the sequencing test result.

Cheers

matt 

Connie,

Before I started Harvoni, I thought about asking my doctor if it would be a good idea to run tests to see if I have a resistant strain of the virus.  But, I decided that I didn't want to give my insurer another reason to delay my treatment.  

Today, I went to the NIH for labs, & exam.  I am not on a drug trial there, they have been "following" me for 20 + years. I have never qualified for a trial that was a good fit for me.  So, I asked the dr. what he thought about me going from UND to detected but <15.  He said that is not a breakthrough. I asked what # would be considered a failure after EOT.  He said by EOT week 12, my #'s would need to be up where they were before treatment (in the millions, not thousands).  He said that even if I am not UND at the end of treatment, the immune system can kick in and finish the job.

I asked him if he thought the 8 week protocol was enough.  He said yes, they have seen good results in their trials with 8 weeks. He also said he is working on a trial now that is a 4 drug combo for 4 weeks & it has shown good results. And, there are many more drugs coming along.

I asked him if he thought I should be tested for NS5A & NS5B variants.  He said it has not been a reliable predictor of treatment success.

I hope that puts your mind at ease a bit. 

Thanks Matt, I am probably overreacting,  I am just upset the doctors office told me they checked for all variants and mutations which is not the case... I just need to let this go

Matt Chris wrote:

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Hello Angelseven

I was sad to read of your relapse, the whole 8 weeks concept is a worthy goal but in the real world (Non-Clinical study) it yet has to be proven. Things will get better for you but some time will have to pass. I appreciate your positive attitude about your future and your good eating habits as these will serve you well in the future as they have in the past.

In quite a few of the clinical studies on HCV it shows that even with baseline RAV's detected it does not determind the outcome for every patient. Their is a lot more to be understood about why and how patients respond to DAA's  

matt 

---

So maybe I should not be upset about this:

Now the thing I am wondering about is why the doctor's office did not run the NS5a drug resistance test for ledipasvir or the NS 5B test for sofosbuvir... I mean shouldn't that be standard for everyone to see if they are going to be resistant to Harvoni??
They told me they checked for all mutations with the RNA ns3 test but his only checks for Boceprevir, telaprevir, and simeprevir... at which time I was noted to have the q80K mutation but this test does not check for all mutations/variants

It seems to me that if you were resistant to one of the meds that it would make sense to wait on another treatment.. especially considering the cost of the treatment... again, the doctor's office flat out lied to me, or maybe the girl doesn't even know what she is talking about...they told me they check for all mutatations and variants with the Ns3 test and this is just not so....

Am I way off base thinking that everyone prescribed harvoni should have the NS5b and NS5a testing done???

I am not a doctor and I have called a pharmacist and a lab to get the above information

I am thinking about other people here....

thanks,  connie

Hello Angelseven

I was sad to read of your relapse, the whole 8 weeks concept is a worthy goal but in the real world (Non-Clinical study) it yet has to be proven. Things will get better for you but some time will have to pass. I appreciate your positive attitude about your future and your good eating habits as these will serve you well in the future as they have in the past.

In quite a few of the clinical studies on HCV it shows that even with baseline RAV's detected it does not determind the outcome for every patient. Their is a lot more to be understood about why and how patients respond  to DAA's  

matt 

It seems all doctors offices should be checking in advance of treatment for these variants:  K24R, M28T/V,Q30R/J/K/L, L31M and Y93H/N... I should have been more on top of this I guess before treatment... I blame myself for not checking this out, it is mentioned in the literature, it is complicated..

No, you should not blame yourself for not knowing which variants you should be tested for prior to treatment! There was always the chance that treatment would work and that was a chance worth taking. And yes, it is complicated!

Yes, I have contacted my insurance company and support path... talked to the pharmacist etc.  They have my relapse documented.. Thanks so much for this link, I will get right on it!!!!  No support path had no advice....they figure I have some mutant variant mentioned in the harvoni literature although my doctor's office says they checked for all variants,  there is some conflicting info on this.. I will be working on it...appears you might need some deep dna testing to get to the bottom of that... It seems all doctors offices should be checking in advance of treatment for these variants:  K24R, M28T/V,Q30R/J/K/L, L31M and Y93H/N... I should have been more on top of this I guess before treatment... I blame myself for not checking this out, it is mentioned in the literature, it is complicated....  BUT my liver got a 3 month break, the treatment was not hard on other parts of my body... my viral load is only 6000 right now (will be interesting to see what happens here)  and my liver enzymes continue to be perfect... My diet will be completely pure with absolutely NO SUGAR which feeds virus... so I will wait and continue to my routine I have had for 40 years.... such is life... we accept it and be happy for all the good things............................xoxo

Miss B wrote:

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Connie,

Looks like Gilead has a registry to follow patients for whom Harvoni didn't work.  This link is to a new study but it is recruiting by invitation only & you would have to have failed on a previous Gilead trial to qualify. But, it might be useful to follow its progress.

https://clinicaltrials.gov/ct2/show/NCT01457768?term=SOF%2FGS-5816&rank=13

Also, have you contacted Support Path & asked if they have any advice for you?

I have been in an HCV study at the National Institutes of Health for 20 years. I have an appointment tomorrow. If you have a question that I can ask for you, let me know.

 

---

Connie,

Looks like Gilead has a registry to follow patients for whom Harvoni didn't work.  This link is to a new study but it is recruiting by invitation only & you would have to have failed on a previous Gilead trial to qualify. But, it might be useful to follow its progress.

https://clinicaltrials.gov/ct2/show/NCT01457768?term=SOF%2FGS-5816&rank=13

Also, have you contacted Support Path & asked if they have any advice for you?

I have been in an HCV study at the National Institutes of Health for 20 years. I have an appointment tomorrow. If you have a question that I can ask for you, let me know.

Thank you Mark for telling me this, as solvali/5816 will probably be my next course of treatment although it seems men have less problems with side effects!!!  Do you know any woman that have done that treatment??

Thanks,  Connie

Marktq1 wrote:

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I guess it's different for everyone I did 12 weeks solvadi with GS5816 and pretty much no side effects whatsoever nurse tells me that is what most peeople find and that side effects are usually minimal if at all but of coarse some people are not so lucky 

but in general she said this treatment definitely has less side effects than any other tratment so far

---

I guess it's different for everyone I did 12 weeks solvadi with GS5816 and pretty much no side effects whatsoever nurse tells me that is what most peeople find and that side effects are usually minimal if at all but of coarse some people are not so lucky 

but in general she said this treatment definitely has less side effects than any other tratment so far

Thank you Mallani, that was very informative!

thank you, this is complicated and hopefully helpful down the road...........connie

Hi Roey,

This is off-topic, but this is what the letters and numbers mean. The virus is divided into several segments. We are interested in some of the NS (non structural) proteins. These are called NS-3, NS-5A and NS-5B.

The antiproteases (like Olysio) block NS-3, Daclatasvir and Ledipasvir block NS-5A and Sovaldi blocks NS-5B.

If a treatment fails, it is usually because resistant variants of the virus have developed. So, if you're taking Ledipasvir (part of Harvoni) and relapse, you should test for variants at the NS-5A site. Harvoni doesn't contain an antiprotease, so it's a waste of time checking the NS-3 site. Patients who relapse on Sovaldi (the other component of Harvoni) may have variants at the NS-5B site but these have proved difficult to measure, and are probably transient (short-lived).

Hope this helps.

Good luck Patrick!!!! 

Connie,

I felt the sting when the VL comes back....it was a tough one especially after the incivek...

the thing that kept me positive is the incredible advances that are still going on.  And it looks like you are in good shape for the next wave. 

I am on my 2 wks eot of harvoni with my first eot SVR in 2 wks so it will be a very nervous 12 wks. 

Than you for your strength and mindset as we all go through our journey. everyone is pulling for you!

Patrick

Roey, call Gilead support path.... they will tell you what to do to get the meds paid for, don't give up, you have gone this far!!!!!  Here is the link:

http://www.mysupportpath.com/

Hey, I am not doctor myself, believe me, I can try to help to the best of my ability,  Mallani is the best expert on this list... you will see a note he made below.. I haven't heard of anyone having a rash... are you only on Harvoni...is the rash bothering you??  It doesn't sound to serious...you can check with your doctor... Have you done labs yet to see if virus in undetectable...??  Hang in there and continue treatment... you can find a way to get the meds, don't give up, you have gone this far!!!!

 Hi Angel,  I 'm getting so discouraged with Harvoni.  I've been on it for almost 4 weeks, having an incredibly hardtime to find the first grantors pay for my second bottle soooo there is a good chance I will have to stop my treatment.  I also broke out in a little rash right where my liver is no place else.  Anyone else have this problem?  Angel I don't want to sound stupid but I am uneducated when it comes to the initials and numbers you have used.  Could you please explain to me what all of them mean?  THANKYOU and G d bless!

Roey

Connie,

I'm really sorry about your 4 week EOT numbers. What is your doctor saying about re-treatment?  

I am starting my 12th & final week tomorrow. Before treatment started, my VL was >4million, at 2 weeks, <500, at 4 weeks, UND, at 8 weeks - detected but <15.  So, Harvoni is not quite the miracle we hoped for.

They should reconsider the 8-week option.  It really doesn't save the insurance companies money if they have to re-treat you.  

I hope that Gilead's new drug will do the trick for you.

Hang in there, you are doing all the right things.

-- Edited by Miss B on Sunday 22nd of February 2015 02:44:45 PM

Angel , words cant describe how I feel for you . I started my 12th week yesterday , weeks ago I thought getting Harvoni was like winning the lottery.  but I never prayed to win the lottery. So for me its not,  ""you have to play to win" , Im praying to win/ SVR. Hang in there , after all you are an Angel ....... MIchaele

Well, my doctor's office said the name of the test to check for variants was

HCV N53

Mutations detected:  80K    (this is directedly taken from my lab reports... they said this checks for all mutations including the ones you mentioned... I sure would like to know this for sure because if they aren't checking others for these mutations it is just wrong!!

Although I did give my liver a 3 month rest and the treatment has had no bad effects on my body I can tell... I have heard there are muscle problems with the 5816??!!

Thanks so much for your response,

Connie

Angel, that other person was on 12 weeks.

Hi Connie,

Thanks for the PM. I'll answer it here.

Sorry to hear the news, but the shorter treatments are going to cause relapses. It's a shame that cost is going to determine treatment length.

I'm not sure about your RAV test. I think you mean a test for the NS 5A variants (not N53). Q80 is an NS 3 variant which is not relevant in your case.

The common variants that arise in treatment failure at NS 5A are Y93H and Q30E in genotype 1a. These are common in both Daclatasvir and Ledipasvir. Gileads new NS 5A blocker, GS-5816, is effective against these RAVs.   I would wait until this has been approved, and you'll be fine next time. It appears 12 weeks of Sovaldi/ GS-5816 is best for previous treatment failures, and 100mg of GS-5816 appears to be the better dose. Here's a link to the latest data:

http://www.aidsmap.com/Sofosbuvir-GS-5816-for-12-weeks-shows-high-HCV-cure-rates-but-8-weeks-is-less-effective-for-some-patients/page/2923542/

Good luck... geeze, i hated to write this info cause i didn't want people to freak out with worry.... what ever happens just happens....with a 95%  or so success rate i am sure people will be few and far behind that don't stay clear.... i was really shocked cause i have taken such good care of my body... my diet, alternative healings, exercise... but obviously it made no difference with the drugs... so whatever... i will continue to live and eat carefully!!!  maybe i  will wait for the injection that kills te virus in one shot... that would be nice!!  i am lucky because my fibrosis is low... and i never felt to bad with the virus, no brain fog... etc.. i mean as long as i ate the right things i was ok

So sorry for your news!  I had read about you before because I completed 8 weeks on Feb 2nd.  I won't have anymore tests till April 28th and I am anxious about knowing my outcome.  I dread another treatment but I won't have a choice.  I hope the next one is the one for you.  Fingers crossed for all of us.

gracie, thanks for  you kind words.... yes new treatments are coming, but i am not rushing in again... of course i could change my mind in a few minutes about that.. hehehe

Gracie wrote:

---

Yes, I've failed twice, and it sucks! Plus the way they do things up here in Canada, I probably won't even get to try harvoni until I get really sick. So I just enjoy life and have as much fun as I can. I'm confident someday I'll be Und. Rather it be sooner, but have been waiting so long now, what's a while longer going to do. Great attitude Btw. Treatments are coming through fast and furious and everybody will someday get a magic bullet that works for them, you and I included. 

---

well, good luck to you.. believe me i said some choice words during the day after i found out.... how many weeks was that person on of Harvoni that failed??  peace, connie

Angel,  So sorry to hear the news.  I'm on another forum and another person has failed on Harvoni.  I suppose this is the reality we all must face, although it's not easy.  I failed triple hell therapy in 2012 and all through my treatment my doctor was telling me I was not detected, I was doing great but he was reading my labs incorrectly.  Anyway, I know the disappointment you are feeling, but you have more grace about it than I had.  I'm on week 16 of 24 weeks and if I fail, I will try again just like we all will.

Yes, I've failed twice, and it sucks! Plus the way they do things up here in Canada, I probably won't even get to try harvoni until I get really sick. So I just enjoy life and have as much fun as I can. I'm confident someday I'll be Und. Rather it be sooner, but have been waiting so long now, what's a while longer going to do. Great attitude Btw. Treatments are coming through fast and furious and everybody will someday get a magic bullet that works for them, you and I included. 

thanks for your concern!!  peace,  connie

Connie,

I am sorry to hear of your latest results.  Failing treatment is always hard and it is tough to keep a positive attitude, but you are showing us how to "lose with grace".   It sounds like there are some new treatments in the works, so you may lost this particular battle but you will get another chance.

my doctor tried for 12 weeks... insurance would only approve 8 weeks,  considering there was only a 2% difference in success rate between 8 and 12 weeks in clinical trials I did not feel it was worth the hassle of appeals and such to try to get 12 weeks... since I was barely detectable at 2 weeks and not detected at 4 weeks I was not worried.. considering my excellent physical condition .. my work out routine, diet and such I really absolutely figured I would not relapse... so strange!!!

Well, I have a friend that was on the 5816 trial with solvaldi... she had a horrible time with muscle problems and such and is still suffering following treatment... I won't take anything that has side effects like that... but I need to see how others did because she had some potassium problems before she started treatment so maybe it related to that.. plus she had gall bladder issues...

Thanks for your info,  connie

Hi Connie,

I'm very sorry to hear this kind of news. But your attitude is strong and you're right, the liver had a good break in between episodes. Take a break and the next round should be the last one.

The next Gilead drug is currently in the Phase 3 trials and is currently named GS 5816 with Sovaldi. It is supposed to be pan genotypic and very effective across the board. So we have yet another arrow in our treatment quiver on the way soon! Your doctors should understand that next time a longer course of Tx may be the wisest course of action. Sometimes I have to question all of the variants they find now. Let's hope the next magic bullet has no issue with all of them!

Please let us know more about this and never give up! We will all celebrate SVR in the near future! Good luck...

Tig

They did the variant check... all I had was the Q80... I think that is the correct name... the one that affects treatment with Solvaldi/olysio