Here is my history:
I was a Null Responder to Standard of Care back in 2002.
I was in this Clinical Trial (NCT01435226) and was considered a relapser, finished 10-17-12. I didn’t clear the virus at 2 weeks (baseline 11,100,000 to 65), so I went on the Rescue Study with 2 DAA’s, Ribavirin, & SOC. I cleared the virus at week 16, but went back and forth between undetected and <25 for most of the time. I was undetected at 48, but after 1 month the virus was back.
Here is a link to the thread that I posted, http://www.medhelp.org/posts/Hepatitis-C/Gilead-study-GS-US-248-0131---phase-2-all-oral/show/1610899?personal_page_id=2264261
I just got a call from the study coordinator saying that Gilead has a rollover study, that consists of GS-7977, Peg, Riba for 12 weeks that I can participate in.
I think I'm going to go for it, it’s my understanding that Gilead will only use the 7977 with Peg/Riba for Genotype 1’s.
I have heard of this study too and yes, I believe it is for gen.1 only.
I will look for the link but from what I read, it has shown to be a very effective treatment combination.
I would say, go for it.
What drugs did you take in your studies?
There were multiple arms and various placebos.
So you have never take Sofosbuvir (GS-7977)?
Sofosbuvir is highly effective with just Ribavirin so I would imagine it would be at least as effective if not more so with Peg-interferon.
I would go for it, as if you aren't undetectable by week 4 you know it won't work. Most of us on Sofosbuvir clear by week 2 or 3. It is only 12 weeks which even on peg-INF makes it much more tolerable than 24 or 48 weeks.
On week 30 of Sofosbuvir + Ribavirin. Hep C 1b, cirrhosis and liver cancer awaiting liver transplant. Undetectable since week 2.
I looked up the trial you were in, NS5A, non-nuc polymerase and protease inhibitors and ribavirin, in one combo or another (with or without Riba or Togobuvir, the protease inhibitor).
You then went on rescue with 2 DAA's (the same or different?) and Peg-interferon and riba. And failed.
You have potentially been on a number of different classes of DAA and failed. Have you been checked for resistant mutations against any of the classes of DAA (protease, NS5A, non-nuc etc( that you were exposed to?
At this point it looks like the only promising class you were NOT expoded to was GS-7977 a nuc - polymerase inhibitor, but in the trial you mention, pairing it with Peg-IFN and riba, this is not the ideal combination, and the Peg-INF / Riba failed to work in you before with 2 DAA's.....
I think you are best to wait this one out until you can show you have no resistance against a protease or NS5A, then treat with GS-7977 + GS-5885 and riba (maybe throw in another DAA in there if trials go that route).
Using sub-optimal treatments breeds resistant strains of the virus.
I am sorry to here of your bad fortune. My advice...Wait for a better trial.
OOOPS, I meant to say test to see if your are resistant to NS5A and protease then treat with GS-7977 and an NS5A or GS-7977 and a protease inhibitor, (Or throw in another DAA AND riba for good measure).
Hector how long is your trial? I noticed you said you are on week 30. I was just curious if they keep you on Gilead trial meds until you get your tranx, or if there is a predetermined week that they stop treatment ? You are also undectable now. H, I think about you all the time. There are so many people in Phx who have heard my story of my online friend Hector that has possibly saved my life ( depending on how my Gilead study goes!). Hang in there!!!
My trial, the first use of all oral treatment in cirrhotics, was supposed to be up to 24 weeks. Us candidates in the trial (with HCV and liver cancer awaiting transplant in the next 6 months) were expected to have transplants before we reached 24 weeks of treatment. So we would treat until the day of our transplant hoping to not have HCV recurrence in our new donor livers.
For me, my liver cancer has gotten unmanageable, so I am not eligible for a transplant and missed the 24 week window. Luckily, Gilead had a sub-study for us to continue treatment for up to another 24 weeks or until we get our transplants. I don't know how many of us of the original 50 people in the trial are in the sub-study, but I am sure it is a very small number.
I was a previous null responder to peg-INF and Ribavirin in 2008. With Sofosbuvir + Ribavirin I have been undetectable since week 2 of treatment. So for 28 weeks as of now.
For us awaiting transplant, we are in a different situation than the vast majority of folks treating their hep C. For us the goal is to suppress the virus for at least 4 weeks before transplant, as it has been shown that suppressing the virus for 4 weeks of more prevents recurrence of hepatitis C post transplant in most patients. So if you think about it, we don't have to worry about relapse which is why almost all people fail Sofosbuvir treatment.
So I should be hep C free if I can survive my cancer. So my and my doctor's challenge right now is to get a handle on my cancer so I can get a life saving transplant very soon.
Thanks for your well wishes and support I appreciate it.
Um, I thought Gilead was working on Sofosbuvir (GS7977) Ledispavir (GS5885) with Ribavirin for Geno 1a??? I think on the ION trials? Perhaps they are not offering you that because nobody knows if treatment with an NS5A inhibitor like Ledispavir (GS5885) leads to resistance?
There are so many new INF-free treatments in the pipeline, but it seems not yet for HCV 1-a :-(( See the video at http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/4052-croi-2013-advances-in-hepatitis-c-treatment-2013-video
If your liver is okay and you can live with being HCV+ a bit longer, I would wait, which is what I am doing after relapsing from GS5885, GS9541 (placebo) and INF/Rib. But I had a rotten time with INF, and the further out of the tx I get, the more I see how bad it was. Also, I'm reluctant to risk taking things on trials that create viral resistance and lock me out of tx options in the future when my liver might be much sicker than it is now.
I got offered the same trial as I had to quit the 9451/5885/INF/RBV due to resistance to either the 9451 or 5885. I participate in the Registry study for monitoring and research. I am thinking about this trial but want to get input from my hepatologist as she told me at my January appt that I need to get the most optimal tx the next time due to my being a non responder to INF/RBV in 2010 and then having the trial not work. Being at Stage 3 fibrosis, I want to get cured as quickly as possible and want to make sure that the next tx is the one! Will let you know what my hepatologist says when she gets back from vacation next week.It does sound like this is the tx that Gilead is going to push for Geno 1.
I am another one that was on the Gilead trial with two drugs and inf/rib. I went from 34 million to 100 but could not clear and at six months stopped. I was a non responder to two int/rib treatments.
I have been in a follow up resistence testing with Gilead and was told that 10 months later the resistence should have cleared. My doctor is getting this new trial but does not have the particulars yet so I have not been offered it but if I I will do. I have been told that 9777
Does not have any resistence and since I developed resistence to 5885 it is unlikely that I should go on that again and I know that is what Gilead will pair 9777 with if they do not use int/rib
Good luck to all and am so happy to hear Hector's good news.
For those reading I was also on this trail Gilead 9451/5885/interf/riba and failed. 1a, CT. Also treated previously with soc and failed. I am passing on this trail. I don't feel it is the optimal tx for me. I don't want to test the resistance thing on this one. Best of luck to all.
There are many new DAA being tested. Which one is for me?
Why would Gilead not offer 7977/5885 interf./riba to us? Gilead is offering non-responders this combo for folks that failed Incivek and Victrelis. ION-2.
There are massive relapse on 7977/riba with 12 weeks of tx. Will 24 weeks be the cure?
Do we still have resistant mutations lingering? I am in the registry study and they have been taking my blood for the past year.
Is Gilead just trying to get more data at our expense?
Will failure on this rollover exclude me from future 7977 trials with other DAA's?
I'm holding out for more data showing the most optimal tx before I treat again. There will be other trails.
Gilead can't offer you the trial with 7977+5885 because your previous trial had 5885 and you've probably developed resistance to 5885. That's why they're only offering the 7977+riba.
Here's data on the Tx:
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. Of the 35 patients with genotypes 4, 5 or 6, 97 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12. All patients in this study became HCV RNA negative on treatment and relapse accounted for all virologic failures.
In FISSION, treatment-naïve HCV genotype 2 and 3 patients were randomized (1:1) to receive either 12 weeks of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day) (n=256) or 24 weeks of peg-IFN (180 μg/week) plus RBV (800 mg/day) (n=243). Overall, 20 percent of patients had compensated cirrhosis (advanced liver disease) and 72 percent had genotype 3 infection.
The SVR12 rates in patients receiving sofosbuvir plus RBV were
97 percent for genotype 2 patients and
56 percent for genotype 3 patients.
You can read these under Hector's post in this thread:
From an earlier post: >
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. <
OK so here we see 89% of 327 (291 patients) had geno 1. Of those how many were genotype 1a or 1b? 1b is usually easier to cure. 1b generally do better than 1a's.
ALL of them were treatment niave. Treatment niaves tend to do MUCH better than relapsers and non-responders. Several studies have shown when it comes down to 1 or 2 DAA's with or without peg-riba, non-responders tend to do way worse than niaves! And 1b's do better than 1a's, in general.
You ( OC ) have been on treatment with Peg/riba in the past at least TWICE and it failed to work for you. Peg-Riba failures do not do so well when retreated with peg-riba.
If you treat with 7977 and peg-riba and it fails because the 7977 needs the help of the peg-riba, (well, you do not seem to respond that great to peg-riba) then you put yourself at risk of relapse. If you relapse you will have been exposed to so many classes of DAA that you probably will not qualify for treatment (trials) for a long time.
I would bring these facts up with the 2 hepatologists you are seeing and ask some serious questions. It is your future on the line, not theirs.
This Feb/March 2013 Gilead started a trial in which genotype 1 peg-riba non-responders AND genotype 1 who failed a protease inhibitor are now being given 7977 with 5885 with-without riba.
I know a genotype 1a peg-riba null responder who failed telapervir, who is now in this study. They are on 7977 with 5885 and riba. UND at week 4.
So you see, Gilead IS treating genotype 1 with 7977 and 5885. There will soon be Vertex and BMS in phase 2 trials with their polymerase and BMS-790052 (Daclastavir?) and there will be other DAA combos coming out as well.
Sounds like you may be starting this trial tomorrow - good luck and God speed to getting a cure.
I am going to pass on this trial - I spoke with my hepatologist and she said that since I have such a limited/non response to INF, that she is concerned that I may relapse after 12 weeks. She wants to wait for the data to see if the 12 week timeframe will work for me as I am in the "hard to treat" group. She also said that with all of the upcoming trials, there may be a combination of that would include 2 DAAs that may work better for me given my history. Keeping faith for all of us!
I am going in next week to be screened for this trial. I was on the 5885 and 9541 plus SOC for six months but could not clear. I went from 34 million to 80 by 12 weeks. No breakthroughs but built a resistence. I finished June last year. In the registry for resistence. I am 1a CT. So far I have been told very little chance of resistence on 7977. The worst that can happen is I do not clear. I tolerated the trial pretty well last time. As far as I have been told I would be available to treat in a year with 7977 and 5885 if this fails.
Maybe when they release the results in a couple of weeks of previous non responders I will change my mind. The doctor said that with only RIBA and 7997 non responders had a 60% chance.
If I am missing something please let me know so I can ask the right questions next week
Hi Hector. I read your post and you really inspire me. I stated this before (somewhere in this forum) but I have severe cirrhosis. Will that lead to liver cancer. Are there any symtons to watch for. I have several people tell me I might need a transplant, and others say they don't think I do need one and not to worry. Gee how lucky they are to be psychic. I may not understand all the numbers and such, but I do understand another human helping another. Keep on trucking bluebird305
Awesome so happy for you. Glad to know it takes as long for you two. My mind was saying delayed results meant bad news but turned out not to be true. Trying to live in the present enjoy the good news and let go of any expectations.
How are you doing must be nearing the end. I will finish on August 17 and then the three month wait to find out if it has worked. So far still undetected at 8 week blood draw. Exhausted and but hopeful.
Awesome news. I just got my 4 week post treatments results and am
Undetected!!! Hard to not rejoice at the news but know I still have 5 months to go before reaching SVR. The treatments are getting there. 4 treatments and first time Undected at all. Good luck to you for the next tests
In 2 months.
Congrats on the great news! Will look for the SVR post. Hoping that warriors like you and OC will open the door for all of us who have not responded with the triple and even quadruple combos like I had in a trial to get this tx
Hope you are doing well. Any update? Went for my three month post treatment draw today. Will get results next week. The doctor told me they are seeing good results. Hope I am one of those that stays undetected but it is jot in my hands. Have faith. But it seems as though there will be a drug combination that works for us all in sight. Exciting times unlike a few years ago.
Congrats on the 12 week. I just went for my annual registry labs today and the nurse at the site told me they are having good results with their patients in this trial. I am hoping that it works for you. It sounds like if they get good results from prior non responders, then this may become the treatment for folks like me.
Will keep thoughts and prayers for an undetected 12 week post. I went for my annual registry labs today and the nurse at the trial site said that they are getting good results with this trial. It sounds like if they get good results then it may become the next treatment for folks like me.
Music to the ears. Congratulations. A long time in coming. Hoping the same for me. I too go back at the end of January for the six month if next week is undetected. I can only imagine the joy you must have felt when getting the news
Can't believe it Undetected 12 weeks after
Treatment. For the moment fourth treatment seems the one. Go in for 6 month test end of January when, if I am undetected they will call it SVR.
Even though all treatments
Included interferon it was worth it. Since sofosubir
Will be approved in December worth in my opinion worth doing if you are a null responder. It really seems they are near to getting rid
Of hep C. Good luck to all.
Thanks for the good wishes. As eduardian said. I am taking a bow and singing a song!!!! Of course after so many years hard to let it sink in and not think it will return but working on the positive energy flow. But if I can get to undetected after so many bad responses it shows that almost everyone can get there. Peace, love and SVR to all.
Am so happy for you. Just today I wondered if you had been in as I know you are ahead of me. I go in on the 27th for my 24 weeks. Hoping to follow you and stay undetected. What a journey we have been on over the last year and a half. I think they say you are now cured if undetected at 24 weeks. Have an awesome day, night and life.
Just got results from a biopsy last week and I am grade 2 stage 2-3, and I am GT 1a, Phenotype TT otherwise I failed and relapsed just like you did. I will probably try to wait for a year, but if my Hepatologist insists I do Sovaldi, it's great see you made it