Another Relapse

[GP7852]

Some had questions about Harvoni relapses and I can tell you I did.After clearing a year ago on sovaldi-olysio I relapsed immediately.This time I did 6 months of Harvoni and finished July 3rd.Just got bloodwork back today that was done on August 18.Just 6 weeks after finishing and it says quantitation 455,000. HCV log10  5.658   They will never give me coverage for another treatment,They know I cant be healed and its just throwing money away.I was starting to believe I beat this and now I'm headed straight back to the nose bleeds,the paralyzing cramps in my legs and the unbearable itching.I don't know what to do.Too tired of being defeated by this disease.
                                                                                
                                                             Glen

[GP7852]

Thank you Kim
I am getting a lot of help on here to go towards the next step.As crushed as I am I still have hope.Just have to stay as healthy as I can until the right meds come my way.Thanks for writing.
                                                         Glen

[Livelife777]

Oh Wow Glen I'm so sorry.  I'm sure you were shocked as Harvoni seemed to be the one.  It's good that your aligning yourself with upcoming treatment or a clinical trial.
Please see how much we all care with all the responses you've been given.
You will not have to wait long to treat again as you see many good options everyone has shared.  We are all rooting for you and know that your day WILL arrive.
......Kim

[GP7852]

What your saying is true.I didn't need any bloodwork to let me know it was back.My body let me know before the results came.
                          Good Luck  Glen

[susan400]

Glen,

It really depends on the trial and the trial site investigator.  See, the protocol is set up between the drug company and FDA and then, it gets sent to the approved trial sites that want it(that trial).  Each trial site has it's own investigator that reports back up the chain of command.  The investigator says yes or no on whether or not your accepted into that trial at that site.  They normally look at each case.., see if you meet the protocol, as far as what was decided upon like inclusions/exclusions (whether that's 6 mon. clear out or a year, for example),  then, you get set up for a screening appt.  At the screening appt. they take a huge amount of bloodwork, do a physical, EKG, perhaps an ultrasound, fibroscan(if they have one), weight, etc. and they go over all your records and medications, etc. Sign the informed consents, too. After that, than you wait for the results to get back and for them to give you the go ahead. If you're approved for the trial, then, you get scheduled for your day 1.  Each trial has their own regimen. As I think I said above, earlier, I've been in 4 or 5 trials.  I think this one I'm waiting on, now, that I mentioned to you, is still trying to get the protocol and final specifics all ironed out with powers that be, as they told me when they first mentioned it to me that they didn't have 100% of the paperwork and protocol in hand. It should be available soon, and then, I'll know, one way or another if it's something that will be a possibility for us non-responders.  When I was looking around on the web., the only thing I would find was for people that were either naive patients, or had the exlusion listed as not having used a DAA inhibitor.  So, I know that wasn't this trial that they'd mentioned because the person at the trial site who told me about it, specifically said that they were including DAA failure patients.  Susan400

[keepingOnkeepingOn]

I hear you. The sexual function was the first thing to come back after being cured.
It's a creepy virus. You can almost feel when it's gone and feel if it's come back.

I'd ask my specialist how long after being on treatment can you try again?
Give them a call.

[GP7852]

Thanks Sue
I will keep you informed of my progress
               Glen

[GP7852]

Thank you Susan
I got a call back from gilead today.They said I did need my doctors input as far as what I should be taking,if there is anything available for someone in my situation.I also talked with a man at the university of penn,he said there might be a trial available to me at the end of the year.What I don't know is how long of a clean out period is needed before you can start something new.I am ready to go right now but I am afraid they are going to say its too soon.I finished the 24 weeks on July 3rd.December would be 6 months.Is that too soon for them?
                                          Glen

[sue4hula]

Glenn,
I'm so glad to hear of some possible trials in the future.  Sending prayers, good thoughts and energies your way.  I have my 12 week post to labs 11/20.  After 3 tx failures, I'm am hopeful, but scared.  

Take care.

[susan400]

Glenn,

I wish I could give you a definite answer on the trial question, but unfortunately, since I'm waiting to hear back from them, I don't know how to answer it.  It is supposed to be a Merck study, no interferon...with next generation inhibitors with the possibility of a Riba arm.  It's supposed to be with or without Riba. But, I have no study number to give you since it hasn't been confirmed yet as far as what I've been told. So many of the studies that I've been interested in, would turn me down because of my Telaprevir exposure and null response to it. And now, with the exposure to the the Sovaldi within the past year time frame.., another reason for the drug companies to say 'no', as far as with a trial.  But, it will be 1 year since I had any meds in my system, as of 9/18/15.., , so I'll have had ample opportunity for a clear out.  As far as your situation, I wish I could say, definitely, yes, this trial would be a 'go' for you, too. But, since I don't know yet with 100% certainty that this trial will be a definite, it's just a 'hopeful expectation' right now.  If I hear anything one way or another, I'll definite be contacting you with a trial number.., like for example :  NCT###   , etc., etc.  Personally, I wish the treatment drugs weren't so ridiculously high in cost, because doing them outside of a trial is so much easier. But, it is what it is.  I would think that with you being a later stage that the drug companies would be giving you compassionate usage though.  In my case, that won't happen because of the earlier staging. One plus though, if I do get into the trial, at least I'll get a fibroscan.  Susan400

[jules2551]

Great news Glen!!!!!!!!!!!!!

[GP7852]

and thank you for your efforting with that phone #

[GP7852]

Hi Jules
Just got off the phone with the U of Penn by coincidence.I talked with a gentleman who is going to have someone get in touch with me to attain my records.He said there will be a trial for me at the end of the year.When I get all the details I will relay them on here in case somebody else needs this.
                                   Thank you Glen

[jules2551]

dot                   com

[jules2551]

three six seven dash one one six eight one one six nine alerts at gilead *******

ridiculous!

[jules2551]

Hi Glen I found a trial that they are currently recruiting at the Univ of PA in Philly.  It is GS-9857+SOL/VEL for 12 weeks.  For people who failed prior tx and have compensated cirrhosis.  Clinical Trial Identifier # NCT02378935 which you can find this at www.clinicaltrials.gov.  Or you can contact the Gilead Study Team @ 367-***@****

Hope this helps!

Jules

[GP7852]

Jimmy
I just got the bloodwork back in the mail right before the start of the labor day weekend.I did have an appointment before that to see my doctor but that is not until the end of September.After reading your information I do wish the ribavirin was added.I am definitely going to say that to DR Santoro when I see him.This is such a mess.I don't know anything about trials and my insurance company is gonna fight me tooth and nail if there is another treatment that I can do being I am already a 2 time relapse.They will say that they are just throwing money away with me.
                                     Thanks Glen

[GP7852]

Thank you so much Susan
I really do take care of myself.I eat right and am at the gym daily.I have beautiful kids and I really want to stick around to help them.I have contacted u of penn medicine and temple u medicine about trials.I left my name and # at gillead.If you do know of a specific trial or anything else coming up pleeez shoot me a text-609 470 9975  
                         Thanks again and God bless    Glen

[GP7852]

Thank you so much Surfer
I would appreciate you doing that.I still believe that I can keep my liver if I act in time,but I also know time is not on my side.I don't know how to give you a way to contact me cause this site will not let me post my email.I will put my information on here now but I don't know if they will let it through. email is ***@**** and to text or call its 609 470 9975
                             Thank you  Glen

[susan400]

Glenn, once again, I am SO SORRY.  I have treated out the A*S as you know and I am totally understanding how you are feeling..,

The trials that I'm hoping for are supposed to be starting screening in Nov sometime. I was contacted about this potential trial that would accept somebody like me a Telaprevir and Sovaldi failure patient.  But, the trial site is waiting for the final on the protocol package. The early stuff they've received says that I'm okay for it.  But, it sounds promising in that a trial site hasn't completed written me off.  I checked an it's not up yet on Clinicaltrials.gov, but there's another trial site with the CDC I think.., I think it's called Centerwatch. I haven't checked there yet.  If it does appear, it will probably show as 'not yet recruiting'...  I don't want to give you false hope that it will definitely be a go, as I haven't officially been told that yet.  However, with that being said, DON'T give up.  We will BOTH beat this thing, WE HAVE to!  If I can try at it over 12 times and be still considering going forward..., SO can you.  They are constantly working on more powerful agents to crush Hep C and trust me these drug companies are falling all over each other trying to outdo each other.  I had waiting on the Harvoni specifically because of the A. Cost factor and rejection by the insurance company and B. Because I was worried about this happening with someone (like you've had happen), and I didn't want to jump into it too soon.  Fortunately, for me, with all the treatments, even though I haven't gotten to SVR, it's helped to delay alot of the progression.  Working out physically, it very hard sometimes. I don't often feel like it. But, I push myself to work out and it's paid off in helping my numbers and helping me to not progresss as fast as I may have.  Don't give up.  Keep your eyes on the trials and wait a bit for the TX drugs to 'clear out of your system'.  Right not, you're realing from this disappointment.., I know, I know, because I was in that same mindset, nine months ago when I got the news about my Sovaldi+SOC relapse.    In the meantime.  Take good care of yourself.  Take care of it all, spiritual, emotional, physical and as the meds clear out, you will regain your focus. Keep the faith.  I recommend, avoiding alcohol, avoiding giving in to dispair (at least after the first couple of weeks-you deserve time to grieve), if you're having nosebleeds-avoid NSAIDS/aspirin, do any amount of exercise you can tolerate and enjoy.  If you pray-pray.  If you meditate-meditate. These are recommendations, as you know, I am not a doctor and I have to say that so that I don't get into trouble.  I believe in a 'whole body-integrative' way of thinking as opposed to 'just my liver'.  Our minds and the rest of our body physically, all play a role in how well we can stay on in the fight. I know for me, I am extremely prone to depression and if I give in to it and stay home from the gym and allow my brain to start rolling into the worry and 'down-cycle' it gets out of hand. I have to push myself to keep moving. But, I know it's not the same for everyone.  Anyway, I know you don't need a lecture. I just want you to know, that I really know, really understand wanting to lay down and say, 'that's it, I'm done with this treatment thing'..., because I was there.  But, now, here it is 9 mon. later and I'm thinking about a trial. And if it doesn't work out, then, I'll wait for a later date and retreat again with something new.  Start in touch, Glen.  You can PM me if you need to.  Susan400

[fretboard]

Sorry to hear about your unfortunate failure to Harvoni.  Normally the site to go to get information on all health issues is pubmed.gov.  The only thing they have related to failures on Harvoni is from the clinical trials that were done by Gilead last year.  With that said, I only entered one search and that was:  treatment failure harvoni   good luck to you!!


http://www.ncbi.nlm.nih.gov/pubmed/25773757

[scottie24]

Roche and Gilead - Creating customers, not cures.

[scottie24]

One's body cant go through this crap over and over.

[JimmyMose]

Thanks for the link but it has no relativity to Glen's situation.

12 Weeks of Harvoni and Ribavirin Cures 96% of Cirrhotics With HCV
"Twelve weeks of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) plus ribavirin boasted a nearly perfect cure rate among highly treatment-experienced cirrhotic people with genotype 1 of hepatitis C virus, MedPage Today reports. The cure rate was almost identical to that achieved through treating the same demographic with 24 weeks of just Harvoni. "

"The participants were randomly assigned to receive either Harvoni plus a placebo for ribavirin for 24 weeks, or 12 weeks of a placebo for all three drugs (including the ledipasvir and sofosbuvir that make up Harvoni) followed by 12 weeks of Harvoni plus ribavirin."

"Seventy-four of 77 participants (96 percent) in the 12-week ribavirin group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Seventy-five of the 77 participants (97 percent) in the 24-week Harvoni arm were cured. Thus, adding ribavirin to Harvoni allowed the treatment length to be cut in half with essentially the same results."

yes comparing 24 weeks vs 12 weeks

At the time of Glen's treatment start, his doctor proscribed a hcvguidelines.org recommended treatment that was in effect at that time early January 2015 in my non medical opinion.  

This is my final comment on whether Glen got the right treatment at that time and whether his doctor is at fault. It's history now.

I think the focus in my opinion should be to support Glen from this point on and suggest possible information that may be helpful and pray for the best outcome.

[ASmile4U]

According to the following, Harvoni and RBV cure rates were known before Glen started treatment in January.  If I were Glen, regardless of this doctor having treated him for many years, I would look for a team of Hepatologists.  I started treatment on Thanksgiving day and within 5 weeks I was taking RBV as well.  

http://www.hepmag.com/articles/Harvoni_ribavirin_cirrhosis_2501_26459.shtml