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Avatar universal

GS7977 new study

I was contacted today about possibly participating in a new study of Gilead's GS 7977 that is being fastracked.  I looked up the study, but the information I found says it's been ongoing for a while, so was interested to know what other's experience with this drug has been

What I was told, in this VERY preliminary phone call was GS7977 along with peg/riba for 12 weeks is the plan.  I would be interested to know anything any of you can tell me.

Thank you
27 Responses
Avatar universal
Hi,
Could you  give some info as to how long you have had hep.c, if you have fibrosis and your genotype?
The best fit for you will depend on these answers and probably more. When you post that information you will hear from the Hep. c and peg/riba community.
I am in a study with  7977 and riba. It has been very effective. 7977 is the new and upcoming Hep. C drug. The combinations they will be doing I will leave for more knowledgeable folks to comment on.
Good luck to you.
317787 tn?1473358451
Hi there, I looked up a little of your history and I see that your doc told you back in August that you had no damage.  That is wonderful!
Saying that, is it your doc that told you you did not need to treat... who is now asking you to try a trial?
If I did not know anything I would say, off the top of my head, that 7977 is getting some wonderful results.
I hope you can get it all worked out..if I were you I would question why someone is calling you to try a trial when you have no damage.  It is a quandry.
Avatar universal
Any way we can get into this?  I probably wouldn't qualify though with seatosis and moderate to severe (like almost cirrhosis) fibrosis.

2702..... congratulations, and if you had no damage in August, this would be such a great thing to do.  

GO FOR IT.
Avatar universal
Are you referring to ClinicalTrials.gov identifier: NCT01260350, a Phase II study with 13 Arms?
An Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3?

You need a lot more information (i.e., which study/trial) to make a decision. There are so many ongoing and changing.

I'm in a GS 7977 trial, and yes, they add and change protocols as they go, but it is fully disclosed if you look at the history of the trial. That's kind of how trials work.
766573 tn?1365166466
I read how you had your bx at the beginning of August of 2011 and the following thread about the results ("no damage") but no mention of the stage of fibrosis or your genotype. Is it 1b (is that what that stands for at the end of your user name? Going out on a limb with that one...

If you are uncertain of your genotype and/or have yet to obtain a copy of your bx I strongly encourage you to do so.  :)

I hope this study pans out for you if it is something you truly might be interested in. ♫
Avatar universal
Thank you all for your replies.  I am a genotype 1b and have no fibrosis that I am aware of.  My doctor was heading up a study last year that he was very exited to put me in, but one of the meds I take for high blood pressure knocked me out.  About the time I got knocked out, I had put out some feelers to other research places doing studies.  The study that has contacted me was one of those from well over a year ago - they have kept in contact periodically, just checking in with me.  This study is GS-US-334-0110, but shows as not recruiting. It is open label, Phase 3, 12 weeks.  The scary part, of course, is since I have/had no damage at my last biopsy, I will be volunteering to be sick, or at least flu like symptoms for 12 weeks, when I have no symptoms now.  Of course the huge upside would be to not have to worry about this horrible disease down the road.  Any of you who are in the study, are you having side effects? and if so, which ones?  Am I foolish to volunteer when I am symptom free, or is this prime time to do it? I would so love to be free of this, and 12 weeks seems a small price to pay, not to mention, not the bzillion dollars it will probably cost once the drug makes it thru the trials?  Any input any of you have is most appreciated.
Avatar universal
sorry didn't answer a question that was in one of your replys - I was diagnosed several years ago, but have probably had this for 15-20 years.
Avatar universal
I started treatment on Aug 30th 2011 in a clinical trial called Atomic. I was in Arm C - 12 Weeks of PSI-7977 plus pegylated interferon and ribavirin, then additional 12 Weeks of therapy of just PSI-7977.  I was undetectable by week 2.  I went in for my 3 month followup on May 8th 2012 and was still undetectable, so at this point, according to my nurse,  I have 99+% chance of being cured.  My 6 month followup is in July.

I would have to say my side effects weren't that bad.  I was emailing two other people that were in the same trial and they were having a harder time than me.  One was having trouble with her red blood count getting way too low and the other was having thyroid issues.  All of us had fatigue (from reduced red blood cell count), moodiness and irritability, insomnia. I believe most of the bad side effects were from the peg.  

I feel very fortunate that I got tested and found out I had hep c (I had no symptoms) and even more fortunate that I was able to get in this trial that is having such high cure rates.
Avatar universal
Congrats on your success so far! I believe the 7977 is making a huge difference especially if you happen to be genotype 1, but you did not say. If you are g2 I doubt you would have gone und by week 2 either without the 7977?

I am curious as to the dosing they used in this combo? Was the inf at 180 and ribavirin at 800 for everyone or was it weight dosed?

You wrote, "I believe most of the bad side effects were from the peg."  Did the symptoms all resolve for the others the last 12 weeks on just 7977...they stopped both the riba and inf?

Thanks and continued good luck. Yes, I think you were fortunate to get into this trial, too.
1747881 tn?1546175878
PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)

Arm C
Experimental: PSI-7977 with PEG/RBV
12 Weeks of PSI-7977 in combination with PEG/RBV; subjects are re-randomized at Week 12 to either PSI-7977 monotherapy or PSI-7977 with RBV

http://clinicaltrials.gov/ct2/show/NCT01329978
Avatar universal
Thanks. I see it can be "PSI-7977 monotherapy or PSI-7977 with RBV".

Just curious how they structured (or experimented) with the dosing. I don't think they outline that, or maybe I'm not following the links within your link to see that info? (Anemia brain-challenged right now....)

1747881 tn?1546175878
Pharmasset Initiates Phase 2b ATOMIC Trial of PSI-7977 for Multiple HCV Genotypes


PRINCETON, N.J., March 30, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that screening has begun in a Phase 2b study of PSI-7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (HCV).

"The trial will evaluate PSI-7977 400mg QD with pegylated interferon and ribavirin in patients with HCV genotype 1, 4, 5 or 6 who have not been treated previously."

"We are encouraged by the early efficacy and safety data being generated with our nucleotide analogs, PSI-7977 and PSI-938," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "The ATOMIC trial is designed to explore 12 and 24 week durations of PSI-7977. The potency, high barrier to resistance, and consistent antiviral activity across genotypes provided the data to support an interferon free dosing period in this trial, as well as enabling us to enroll multiple genotypes in this trial."

About the Phase 2b ATOMIC Trial

This Phase 2b trial is planned to enroll approximately 300 patients with chronic HCV genotype 1 who have not been treated previously. The primary endpoint of the trial will be the safety and tolerability of PSI-7977 in combination with peginterferon and ribavirin over 12 or 24 weeks. The trial will be conducted in the U.S. Patients will be randomized (1:2:3) into the following arms:

PSI-7977 400mg QD with peginterferon and ribavirin for 12 weeks;

PSI-7977 400mg QD with peginterferon and ribavirin for 24 weeks;

PSI-7977 400mg QD with peginterferon and ribavirin for 12 weeks, followed by either PSI-7977 400mg
QD monotherapy for 12 weeks or PSI-7977 400mg QD plus ribavirin for 12 weeks.

HCV GT1 patients will be stratified by IL28B status and baseline HCV RNA to ensure balance across cohorts. An additional 25 treatment-naïve patients with HCV genotype 4, 5, 6 or indeterminate genotype, will receive PSI-7977 400mg QD with peginterferon and ribavirin for 24 weeks.
Additional details on this and all Pharmasset trials can be found at http://www.clinicaltrials.gov

http://hepatitiscnewdrugs.blogspot.com/2011/04/hepatitis-c-update-phase-2b-atomic.html
Avatar universal
I was genotype 1a

I don't remember the dosage.  I do remember that is was the same for me as the two other folks I was emailing which surprised me.  They were both women and  lot smaller.  One of them had their peg dosage reduced because of side effects.

The other folks I was emailing were not in arm C so they continued on the riba the last 12 weeks.  For me, once I stopped the peg and riba my sides started disappearing.  Rash, irritability, etc was gone in about 3 weeks.  One thing that did linger was short term memory problems.  It was bad before the trial but I think a little worse now.

Good luck to you..
Avatar universal
Thanks for the info. I'm on SOC and just had my inf cut in half due to platelets, and my hgb is getting lower. I sometimes wish I'd have to roll over to the 7977, but then again, IDK. I get those two counts checked on Tuesday so we shall see what they decide. No question inf and riba are rough stuff. And the brain fog? IDK, I had it before and it almost seems better on tx, lol. Who knows? There are so many issues can that affect brain fog, stress being one, depression another. I hope that gets better quickly for you.
Thanks again, and continuing good luck to you, too.

Avatar universal
Here is some information that another forum member, specda, provided awhile back:
http://www.medhelp.org/user_journals/show/332520/Clinical-Trials-and-Medical-Research-in-Hep-C
It's important to find out as much as you can about the trial, what their goal is, whether the results are open or not, how side effects (if any) will be managed, and very importantly how will the trial affect future tx for you.
Advocate1955
Avatar universal
Wow, what a great article, I wish I had seen it before! This is the most concise and complete description of how trials work in one article I have ever seen.

Thanks for reposting it. I bookmarked it and I hope others will, too. When someone new comes on asking about trials, or even txing privately, this is the link they should get for starters. I have heard about people who treat privately, pay big money and get big surprises half way through treatment that were never disclosed while sitting and talking to the doctor before tx started. Uniformed newbies (which we all are at some point) don't have enough knowledge to even know what to ask, this tells them exactly what to ask the doctor.

It also clears up a lot of rumors about getting a placebo or having your meds switched w/o one's knowledge, the difference between a Phase 2 and Phase 3, etc. Trials have full disclosure and outside independent monitors watch over them. Drug companies can't just say, "hey, let's do a trial and try this" (i.e., some hair-brained drug combo) or decide it's time for a Phase 3 without providing extensive documentation to back up it's merits and then get outside approval. One only takes a risk if one is informed of the risk, in writing, and chooses to participate.

A person can then make an informed decision to take the "risk" which in a Phase 3 can be no greater than the risk one takes when treated privately. If one's current health status is not critical, one can choose to wait; likewise, one in critical status and no other options may choose to go ahead.

Thanks again for taking the time to post this. I for one, find it invaluable.
Avatar universal
I got the call to schedule the start of tx, GS-US-334-0110, phase three, open label,12 weeks peg inf/riba and GS7977.  Nervous and excited at the chance for all this to be gone.  I start on 07.19 - wish me luck
317787 tn?1473358451
Really happy to hear you got the good news
Best of luck to you
317787 tn?1473358451
Your info  was really good.  I wish I had known all of that before my trial back in 2008.
I hope that others will read, I did not know anything about a trial, just trusted the doctor knew what was best.  He was supposedly one of the best in the county I live in.  If I ever had to do again, I would wait for the phase 3 or 4.  
Thank you for sharing this
Dee
3097131 tn?1357084881
Congradulations to you!

   You will not be disappointed..I want to start another thread for just the ones that are in this Study,so I know who's who sort of speak.So we all can keep up with each others progress.This is DAY 13 for me and I feel Great! Going to try and get us all together here,look for New Thread under HepC...So Happy for you!

Kathy
Avatar universal
I too am signed up for GS-US-334-0110 would like to know if a forum is started.
Avatar universal
I was selected to do the gs-us-334-0110 trial. I had a fibrosure test done and have almost no scarring on the liver. the score was .09. I am a 26 year old male and in great shape. Im having a hard time to decide if i want to wait for an interferon free trial. Genotype 1b and my doctor says GS7977 +RV and peg for 12 weeks will almost guarantee a cure. They also said peg side effects usually get bad after 6+ weeks and ill already be halfway thru. Any advice would be appreciated. My real fear is the interferon alfa 2.
Avatar universal
Let me know if you are successful in starting a thread for this trial - would be fun to keep up with everyone else on this particular trial.  I am not particularly tech-savvy when it comes to navigating this forum lol, so if you could send a link, I would be very appreciative!
Avatar universal
Thank you - keeping everything crossed that can be!
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