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Starting Sovaldi - Prior relapser
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Starting Sovaldi - Prior relapser

Just got a call from my hepatologist's office to start the process of getting me started on Sovaldi.  I am a gt 1a, twice non-responder to Int+Rib and I relapsed after 48 weeks of triple therapy with Incivek. Anyone know what the cure rate for this treatment is for a relapser?
37 Comments Post a Comment
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142526_tn?1288055161
Hi, I can try and help to find an answer.

What will your protocol be, which meds and for how long will you do this tx?
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Avatar_m_tn
That would be great. I just can't find anything specific. When I went on Incivek I did so thinking the cure rate was 80+ percent, but found out all along my chances were really only 30 percent. I am a genotype 1a, I relapsed from triple therapy with Incivek after 48 weeks. Not sure what my liver status is right now, getting a biopsy in January. Thanks for anything you can find.
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Avatar_m_tn
I meant to add that in the 90's I was a non-responder to two Int+Rib treatments
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142526_tn?1288055161
I think we will need more info on your exact protocol your hep doc is planning to use before finding such results from previous trials, etc..
I asked a couple questions up above :)
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Avatar_m_tn
The meds are the new Sovaldi which is Sofusbufir+Interferon+Ribivirin supposedly for 12 weeks.
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142526_tn?1288055161
Thank you!  That will help facilitate some answers for you :)
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142526_tn?1288055161
It is estimated that the response rate in patients who previously failed pegylated interferon and ribavirin therapy will approximate the observed response rate in NEUTRINO subjects with multiple baseline factors traditionally associated with a lower response to interferon-based treatment (Table 9). The SVR rate in the NEUTRINO trial.

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf
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Avatar_m_tn
Not sure your doctors reason as it seems clear interferon does not work for you. Though I do wish you the best.

HCV Genotype 1

The ELECTRON team then proceeded to test sofosbuvir in people with more difficult-to-treat HCV genotype 1, both treatment-naive and null responders to previous interferon-based therapy. They looked first at the same combination of 400 mg sofosbuvir once-daily plus 1000-1200 mg ribavirin for 12 weeks.

As Gane reported at this year's Retrovirus conference, although all participants saw a rapid decline in HCV RNA and had undetectable viral load at the end of the 12-week course of treatment, almost all genotype 1 prior null responders relapsed soon thereafter, resulting in a very low cure rate.

Given that sofosbuvir plus ribavirin as a dual regimen is not adequate for this more difficult-to-treat patient population, researchers then asked whether adding a second direct-acting agent could increase cure rates.

http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3860-aasld-2012-sofosbuvirgs-5885ribavirin-shows-high-early-response-rates-for-genotype-1-hcv
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Avatar_m_tn
Having the same result with an INF based therapy 3 times and once with a protease added(Incivek)  I also wonder what your physician's logic is.

Have you discussed with him/her possibly waiting until the virus can be attacked  from multiple fronts (ie two or more of the all oral drugs) and leave the failed INf out of the mix?

best of luck..
Will
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142526_tn?1288055161
I agree can-do.  Seems the 3 DAA's are working the best for the geno 1's null responders and for those who previously relapsed.
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Avatar_m_tn
Also Has the physician had any discussion with you about possible resistance issues developing .....meaning if you failed the NS3 /4 drug ( Incivek)  because  partially of the insensitivity to INF. and you happen to fail the NS5B  drug (sovaldi) for the same reason then your options may be very limited beyond that  as resistance issues are still greatly unknown.

Best...
Will
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Avatar_m_tn
Thanks Magtx, I wonder if my Hepatologist knows what he's doing. He's Mr. Big at Einstein in Philly. Everything everyone is saying makes sense, wonder what he's thinking.
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142526_tn?1288055161
You're welcome.
I think I would get a second opinion on re treating again with the inf and RIBA. You may very well have a good hep doc, but going thru tx again after a few failed attempts can cause resistance issues like the other posters have said, and you want the best chance at beating this as possible with solid knowledgable advise given before hand.
I'm a geno 1a relapser ( did 48 weeks of SOC) and approaching my next chance at beating this virus very cautiously!
Good luck and please let us know what you decide.
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Avatar_m_tn
Have you read through this thread? This is something I would bring up to my doctor if treatment is needed ASAP.

http://www.medhelp.org/posts/Hepatitis-C/Anyone-know-if-Insurance-will-pay-for-these-new-drugs/show/2058000
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Avatar_m_tn
Looks like I have my answer according to p.21 of the Sovaldi package insert. I would be looking at a cure rate of probably 71% which is significantly better than the 30% I was looking at for Incivek, but much lower than the COSMOS study with Simeprevir+Sofusbuvir+Ribivirun. which is over 90%. I wonder if I would be able to talk my Hepatologist into going off label. I wonder what the approach would be. Do they have a criteria that must be met to go off label. Would the Dr. be liable for anything with that process? Here is the info from p.21

It is estimated that the response rate in patients who previously failed pegylated
interferon and ribavirin therapy will approximate the observed response rate in
NEUTRINO subjects with multiple baseline factors traditionally associated with a lower
response to interferon-based treatment (Table 9). The SVR rate in the NEUTRINO trialin genotype 1 subjects with IL28B non-C/C alleles, HCV RNA >800,000 IU/mL and
Metavir F3/F4 fibrosis was 71% (37/52).



I don't know what my Metavir score is or my IL28B is but it looks like if I don't have Cirrhosis my worse case scenario is a 71% cure rate.
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180992_tn?1383377657
I agree with can-do-man. Are you advanced stage fibrosis, is this why treatment might be needed ASAP?  Non-responder and interferon?  what is your IL28B?.  Have you  had this tested?  Is the IL28B a factor since interferon is part of the treatment? It's not a factor with Sovaldi when used with the GS5885, but what about Interferon?  I would want all these answers from my Hepatologist.  The second half to the Sovaldi(sofosbuvir) will be out next year.  Can you wait?
Do all your homework and approach this 4th try with caution.  Best Wishes.
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Avatar_m_tn
I see you are also a gen 1a relapser. I stumbled across the 135 posts associated with OC and 3xlucky's experience with Sovaldi, and they seem to be having some serious success and they are also both treatment experienced. While I have asked my Hepatologist to look into going off label with Simeprevir+Sofosbrevir, after rereading their experiences, I may be excited again about Sovaldi.  Thoughts?
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142526_tn?1288055161
Hi 48,  there's not that much data out there that I can easily find on relapsers that have previously TX'd with a protease inhibitor ( Incivek or Boceprevir),  did triple therapy, and then treated with Sovaldi, a polymerase inhibitor along with the other DAA's. I think there have been some trails with others in your exact situation that got into Gilead's trials with Sovaldi, but I'm not as well informed on this scenario since I haven't ever TX'd with a protease inhibitor. Perhaps there will be new info coming around soon as the population who failed triple therapy may soon be treating with Sovaldi and semeprivir, off label, if that is even a choice for this group...it would be a good idea to discuss what options you have with a sharp hep doc, and ask about the possible mutations if any the protease inhibitor may have caused with the virus during and after your relapse. Remember semeprivir is also a protease inhibitor, so these are some of the questions I would ask someone who's "very" experienced, about taking your next step.
My advise is that if you don't have to rush in to this, and your hep doc says you can wait a while, then I would. Or, look at trial data, discuss with your doc and go from there. ;)
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Avatar_m_tn
If you are using insurance to pay for the drugs you need to find out what they will cover. Also what the  U.S. Patient Assistance Program might cover  Off label might be a big problem.
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Avatar_m_tn
Talked to my doctor today and was told its going to be awhile before the ins and pricing is worked out.
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Avatar_m_tn
One thing I am curious about is when approval was sought it stated quite clearly for genotype 1 that was treatment naïve and as far as I know that has not changed so wouldn't that be considered going off label if one has treated prior?

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Avatar_m_tn
Get a 2nd opinion from Dr Reddy at Univ of Penn.

Problem with new drug Sovaldi is that insurance companies aren't going to pay the $84,000 for 12 week treatment. Gilead will have to lower price or their drug will never take off. There is talk of patent infringement and other things going on behind the scenes. No one knows what is going to happen with court battles, etc.

Insiders must know something because Gilead Sciences stock is sinking fast.

Best of luck
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Avatar_m_tn
Gild is off 5%...?..That's it, Haven't you heard sell the News?
Everyone new it was going to get approved..That was the run up..
Gild is a Buy and Sovaldi with 5816 is a Cure
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4968441_tn?1388673018
1) IL28B is an indicator of how one might respond to Interferon.  There's no known correlation between IL28B and response to Direct Acting Antivirals (DAA's).

2) Sofosbuvir (Sovaldi) is a RNA polymerase inhibitor, not a protease inhibitor, so your resistance to protease inhibitors (which you undoubtedly have) on this drug is a non-issue.

3) Sofosbuvir, with NS5A inhibitors (Daclatasvir or Ledipasvir - both nucleotide analogue inhibitors), has shown SVR rates of up to 100% in people infected with HCV.  

4) If your insurance company does pay for off-label, the fastest, for-sure way to cure your HCV is to take (off-label) Sofosbuvir with either Dataclatasvir or Ledispasvir, whichever gets approved first.

I'm 1a and also failed triple (first tx attempt) in November of 2011 (Incivek/Riba/Interferon) after 12 painful weeks.  However, in 2013 I got on a 12 week Gilead all-oral Sofosbuvir + Ledipasvir study and was UND in 14 days and I achieved SVR24 in July 2013.  Unlike triple, it was quick, effective, so easy and no sides!  In my case I took one pill/day but if you're doing it off-label, you'd be taking 2 pills/day.

Good luck to you!

HC
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Avatar_m_tn
Just found out my IL28B results came back with TT phenotype. Inspite of that, I did seem to respond to triple therapy with Incivek I was undetected right up to a month after my EOT, then at 6 month svr appt I relapsed. So what's to blame the Telaprevir or the Interferon, who knows. Not sure if my Hepatologist is offering the Sovaldi now because it's available and he thinks my insurance will cover itand maybe he's leary of how things will go with Obamacare messing with so many insurance policies.  I will be getting a liver biopsy in the first week of January. I have not had one in over 8 years. I will talk to my hepotologist after that and hopefully I will be in a position to wait things out for a while. Hopefully Obamacare doesn't screw us all, I don't mean to be political.
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4968441_tn?1388673018
48weeks:  "I am a gt 1a, twice non-responder to Int+Rib and I relapsed after 48 weeks of triple therapy with Incivek"

You didn't clear any of the 3 times you tried.  Why you'd consider taking interferon again is baffling.  Why a doctor would give it to you again is equally baffling.  

DAA's are like sniper bullet meds: they specifically target the HCV virus and kill only it.  Riba and interferon are like a shotgun approach: they kill everything and if you respond well to interferon, it will kill the HCV too.  They're considered the "backup" meds in case the sniper DAA's miss some of the HCV virus cells, they're supposed to wipe out the rest.

The 2 DAA's in conjunction eliminate the need for the interferon shotgun.

I took interferon for 12 weeks and NEVER again.  Very nasty stuff.

But to each his own.  Good luck to you.

HC

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Avatar_m_tn
Well like I said, hopefully I get the biopsy and I find that I AM in a position to either wait a while or talk my Hepatologist into going off label for something more surefire, although I could do interferon again if I had to, last time it didn't get to me too bad.
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4968441_tn?1388673018
Even if the side effects on interferon were minimal (which they aren't) YOUR BODY DOES NOT RESPOND WELL TO INTERFERON.

3 failures and TT IL28B's.  Q.E.D.


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Avatar_f_tn
I have to agree with hepcat.  in your original question, you wrote:
"I am a gt 1a, twice non-responder to Int+Rib and I relapsed after 48 weeks of triple therapy with Incivek."  You tried and failed to clear the virus 3 times with an interferon based treatment.  Not sure why you would go that route again when there are other options either available or soon to be available with high success rates even for previous null-responders. such as yourself.

This is what hepcat posted:
"I'm 1a and also failed triple (first tx attempt) in November of 2011 (Incivek/Riba/Interferon) after 12 painful weeks.  However, in 2013 I got on a 12 week Gilead all-oral Sofosbuvir + Ledipasvir study and was UND in 14 days and I achieved SVR24 in July 2013.  Unlike triple, it was quick, effective, so easy and no sides!  In my case I took one pill/day but if you're doing it off-label, you'd be taking 2 pills/day."

If my husband, who is post-transplant with recurrent Hep C, had the opportunity to go with this course of treatment, we would jump at it.

I hope you will give this a lot of thought before making a decision.
The advice you are getting here are from people who actually took the meds and are letting you know their experience.  For me, this is priceless information.

Best of luck
Nan
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Avatar_m_tn
Trust me, if my biopsy says I can wait, I am going to wait, and the Gilead all-oral Sofosbuvir + Ledipasvir sounds like what I need. I determined this weeks ago. Abbvie's latest trial sounds encouraging as well, but hopefully the Sofusbuvir + Ledipasvir will be available withing a few months. And hopefully our insurance system isn't so screwed up by the time these new meds come out that none of us gets a chance to go on them.
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Avatar_m_tn
It appears I am in the same boat as you:

IL28 TT
Geno 1A
Twice treated int/rib
Success with clearly via Trelapivr but relapsed shortly after stopping at 48 weeks

Looking forward to knowing success.

Thanks
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Avatar_m_tn
Yes, we have all of that in common except I was still undetected a month after treatment. I am excited about the post that nan535 just made about and hour ago concerning this and you should be too.

http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients
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Avatar_f_tn
Since I am a null responder, treatment experienced it looks like the ION 2, 24 weeks without Riba is good for me.
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4968441_tn?1388673018
From Feb 21 to May 16, I was in the ION-2 Study... 12 weeks, without Riba.  

I was UND in 14 days & achieved SVR24 November 1, 2013.

ABSOLUTELY NO SIDES: it was a cakewalk!

Being cured is a wonderful thing!  Good luck to you penn1023

HC

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Avatar_f_tn
Please forgive me as I didn't read all of the above answers to your post so what I am going to say may already have been said. If you are thinking of going off-label, please ask your doctor about testing you for the polymorphism Q80K as the genotype 1a patients who have a positive result often do not respond well to Olysio (simeprevir). You may be better off waiting for ledipasvir to be approved t be used with Sovaldi, or the abbvie drugs. That should happen sometime in 2014 and would give you a much improved chance of SVR. Wishing you the best.
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Avatar_m_tn
That is the plan, I am having a biopsy next month and hopefully I am in a situation where I can wait for Ledipasvir, thanks.
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Avatar_m_tn
I failed intereron/ribo after three months with a viral breakthrough - this was ten years ago. I've not treated since then,. I'm very interested in the new off label combo Olysio/Sovaldi but I'm concerned that if I fail I will have allowed the virus to mutate and then what are my options? I do not understant how these new meds work on resistence - would I be able to consider Abbievie or another nucleotide combo if I fail this?  I can't find specific data on this  - would love some help. I'm genotype 1b and I do not have Q180 mutation. I'm 54 and in pretty good health..may have developed a low level of cryoglobulemia but not anything so bad it needs to be treated. I am stage 2 fibrosis.
thanks.
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