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This forum is for questions about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis. If you would like to communicate with other people who have been touched by Hepatitis, please visit our new Hepatitis Social/Living with Hepatitis forum

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heart_in_the_keyes

Dec 08, 2012

To: orphanedhawk

thank you...20 years in to this is I am playing catch up learning...you, Hector and some of the others are so knowledgable and it is very much appreciated. at my last appt.w/doc he was leaving room and turned and put a firm hand on my shoulder and told me to do what I do best which is research and read...information...and reaching out is what I need to do so this is one of the reasons I started on this site...to learn. Thank you to you all.

HectorSF

Dec 09, 2012

To: acaba

"Does anyone have any advise? The only treatment that has been offerred to me is Interferon, Ribavirin+nucleotide for a full treatment year. I am not very excited about this option, particularly now being immune suppressed, and finally recovered from the surgery and illness. "

Which nucleotide? The only nucleotides are in trials. Current commercially available treatments are peg-INF + ribavirin with Incivek or Victrelis which are Protease Inhibitors.

You should to talk to your transplant center regarding or ALL changes in your drugs. And about any medical treatments. Common drugs can cause drug to drug interactions with immunosuppressants that can effectively increase or decrease blood levels dramatically making the combination of drugs very dangerous. Only your transplant center knows your health situation. They are the only ones who should advice you on the best treatment options for you personally.

The only trial for post transplant patients is the Gilead trial which is already full. My doctor will be leading it at our transplant center. It will only have 50 patients world-wide. Being stage 2 you should treat now. Your hepatitis has gone through 2 stages of liver disease in only two years. Time is of the essence. There are only two choices in the end. Treat and hopefully cure the hepatitis or don't treat and you will soon develop cirrhosis, then decompensated cirrhosis within a year and finally End-Stage Liver Disease.

No one post transplant is excited about being ill from the side effects from peg-INF treatments. But there are no other trials and no one can guarantee the Gilead trial will be successful. We are all hoping the trial will be successful as the options for post transplant patients are very limited with poor results.

Once we are transplant patients I'm afraid our only choices are not between good and bad but between the lesser of two evils mostly. You have been given a second chance at life by someone donating their liver to you. Unfortunately once a person has a transplant it is a life long commitment to immunosuppressants and lab tests. Otherwise we will have acute or chronic rejection. If you don't treat our hep C either before or after transplant I'm afraid the outcome is usually the same. Which is why transplant patients with hepatitis C post transplant have the shortest life spans of all liver transplant patients.

We all have a choice. We either fight what is trying to kill us or we give up let nature take is course.

Talk to you transplant center if you want to fight. I hope you do.

Cheers!
hector

heart_in_the_keyes

Dec 10, 2012

To: hectorsf

Hi, as you know I have a severly decomposed liver and end stage liver disease...so it always seemed so silly to do the liver transplant when my Hep C levels were still so high...but my doctor who is in the forefront of this fight being the medical director of liver transplants in our area said that it is his profound belief that there will be a simple cure within the next couple of years for the Hep C and it would would better with a new liver...but then I read things like what was in the Wall Street journal where the drug companies are fighting each other and do not necessarily want to go further because it would cost them incoming revenue in other areas and I have to wonder. He believes me to be a strong fighter who will has always been positive even in my illest of times...blind trust has gotten me this far...knowledge will take me farther down the path. What do you think..is optimissum all we have in the end?

UKgirl55

Dec 10, 2012

To: heart_in_the_keyes

Your doctor is 100% correct. I'm on the ONE PILL trial (Gilead). I started at 15 million VL. I'm a genotype 1a and have had the virus since 1976. After TWO WEEKS of being on ONE PILL I became Undetected. Do not give up the fight!

Doofus_jones

Dec 11, 2012

To: heart_in_the_keyes

I read this medical obstruction story and I find it confusing. My understanding is that Gilead does not want to share any information with Bristol Myers.

Gilead's 7977 appears almost good to go - why would they not go to FDA with their drug?

I think it is more a case of Gilead, which is estimated to be 1 year ahead of Bristol, not wanting to share any credit ( or revenue). But I do not see why this would delay the Gilead drug which to my understanding is being tested with ribavirin now anyway.

UKgirl55

Dec 11, 2012

To: Doofus_jones

There isn't any delay with 7977 (Sofosbuvir). Gilead are filing for FDA approval next year. At first it will only be all orals for geno 2's and 3's (7977+riba) and then hopefully in 2014 they'll be able to file for their one pill (7977/5885) combo, which will be for geno 1's (not sure what other geno's this combo will work for).

countrygirlcansurvive

Dec 20, 2012

To: UKgirl55

One Pill and Undetected!
That's Wonderful!!!
So happy for you!
I am 9 weeks out of tx of course my Trial is Blinded.They told me NO NEWS IS GOOD NEWS!

It's beginning to look a lot like CHRISTMAS for us all!!

Merry Christmas Everyone!
~ Country~

mythoughts

Dec 28, 2012

How awful is the Riba with 7977? My situation is unique, as I am co-infected with HBV and HCv but my doctor (Bzowej at CPMC San Francisco) said that she'd like me to tak 7977 WITHOUT Ribo but with INF - the INF iswith the hopes that it will rid me of the HCB. Will it even be possible to get 7977 without Riba?

270217-1b

Dec 29, 2012

So good to hear about all the amazing results from those doing the trials. I have what I think is my last post study appt this next week (might not be the last but close to it since I finished meds in October). Don't think I will hear any numbers but will be seeing my gp the week after that on something totally unrelated and am gonna ask him to run my vl. Good luck to all of you still in the middle of the trials!

countrygirlcansurvive

Dec 31, 2012

To: mythoughts

Hello!
Riba is Riba no matter what you take with it...GS7977 (Sofosbuvir) is the Best out there right now.I went with the Sofosbuvir,Riba and Inf for 12 weeks.Side effects was really mild ,hardly any other than brain fog from Riba..
I am 11 weeks @ EOT.I am doing better than I was b4 tx.I cant wait till I find out if I have reached SVR..March or April they say..

Good Luck to You!

HAPPY NEW YEAR TO EVERYONE!!!

~Country~

jerialice

Jan 08, 2013

wow!!! great news y'all, i am waiting for those FDA approvals. i got so sick from tx (soc) both times that i have to wait until i know that tx is milder and effective (finally) i am geno 1-b with low VL and minimum fibrosis and inflammation. possible a result of the times i did tx with soc.

after my bx last fall, i have the luxury of waiting a bit. but i am so pleased that you all are having GREAT results!!! yay!!!
happy new year
jerialice

Renee543

Jan 11, 2013

To: Hector

I went for my blood work yesterday and it will be a couple of weeks before I know the results. Something that was brought up on the other forum was that to be in this study you either had to be txt naive or cirrhotic. The nurse told me yes, that is true that you could automatically be in the trial if you were either but if you fell in between (which I may) I had to have a biopsy. She did not tell me what the biopsy had to indicate in order to be in the trial. I just sent her an email asking that very question. She made it sound like if I were in between the two that the biopsy would tell for sure. That i needed to be one or the other. Well I know I am not at the low end and not sure if I am at the high end (Cirrhotic). So I guess this will depend if I can be in the trial or not. Which is now disheartening to know. I did not fully understand this yesterday. I will let you know what the nurse says.

Eki1

Jan 30, 2013

I'm so glad to be able to finally post on this epic thread.

Last spring I failed triple therapy.  That qualified me for a clinical trial that just opened for Sofosbuvir/5885/Riba.  I'm on the pills now for 12 weeks.

There are four arms to the trial:
12-week, Sofosbuvir/5885
24-week, Sofosbuvir/5885
12-week, Sofosbuvir/5885/Riba
24-week, Sofosbuvir/5885/Riba

I can answer any questions about my trial.  They didn't put me under an NDA or anything like that.

I wanted to add that this forum was fantastic to me last year while I was treating, particularly when I failed.  I'm grateful to all the people who donate so much of their time and energy to help those in need.

Cheesegrater

Jan 31, 2013

To: Eki1

I am sure we all wish to know about your experience, Eki1.
Were you ever treated with only interferon and riba and if so, did you respond or were null?

What genotype, 1a, 1b, 2, 3...?

How long were you on gilead treatment?

Have you SVR 4, SVR 12 or SVR 24?

I think this info will help others decide what type of treatment they want in the future.
Thanks

Cheese

Eki1

Jan 31, 2013

To: Cheesegrater

'm 1a.

I started yesterday, and I'll treat for 12 weeks.

Yes, I falied Incevik/Interferon/riba. I'm still unclear on what it means to be a non-responder. I can tell you this. I got a 4 log drop after two weeks, but then had a viral breakthrough past 1,000 at week 4. They pulled me off the drugs immediately and told me that I was non responsive to the peg-interferon.

I'm not UND yet. I don't expect to be und until my week 4 tests, but I don't know for sure. I'll keep you posted with my test results.

UKgirl55

Jan 31, 2013

To: Eki1

What arm did you get. With riba, or without?

Eki1

Jan 31, 2013

To: UKgirl55

with riba...12 weeks.

But everyone else that registered at the San Diego site got without riba (arm 3). I'm in arm 4.

BunnyFoot

Feb 07, 2013

Just got a call to screen for NCT01687257. Gilead trial for cirrhotics. Two arms 7977 and riba for 24 weeks. One arm Active Comparator: 24wk observation then 7977 and Ribavirin.

Have to quick get an endoscopy (needed to be within 6 months of screening and I am a year out) and then head in for labs, EKG, etc. to hopefully end up with a Child Pugh score <10. Last step is a venogram which I have never done.

I thought the venogram might actually help to decide whether to participate or not. Maybe give me another piece of the puzzle (beyond gleaning portal vein pressure) to add to all the other diagnostics. Anyone done one and walked away with some good info?

With chatter being the drug could be approved next year, being able to treat without the constraints of a trial is enticing (failed triple therapy in 2008 trial that was nightmarish). That being said, when cirrhotic, you just never know when you will hit that tipping point.

I know how lucky I am, diagnosed with varices in 2006 that remain exactly the same 7 years later and liver is functioning as well as a normal person in spite of its gnarly state. One look at Hector's journey has made me count my blessings more than once.

Anyway, I will start making appointments in the morning and let you know what is up.

countrygirlcansurvive

Feb 12, 2013

No Word yet on this Clinical Trial? I haven't heard anything.Has anyone else got any News or have read about it.Is results coming in yet?

(¯`v´¯)
`*.¸.*´ COUNTRY❤
¸.•´¸.•*¨) ¸.•*¨)
(¸.•´ (¸.•´ .•´ ¸¸.•¨¯`

UKgirl55

Feb 12, 2013

To: Eki1

when you say that everyone else at the site got the arm without riba. Did they get the 12 week arm or the 24? Also, were they tx experienced or tx naïve?

Eki1

Feb 12, 2013

To: UKgirl55

They were a mix of both. There were seven others. They all got the 12 weeks without riba...but then that arm got delayed and converted. I believe (I'm not sure) that they were all switched to 24 weeks without riba.

UKgirl55

Feb 12, 2013

To: Eki1

I believe you are right. That's what I heard too. Awesome news for you!

Eki1

Feb 12, 2013

To: UKgirl55

Just looked at my notes. They were all tx experienced. It was a mix of cirrhotics and non-cirrhotics.

UKgirl55

Feb 12, 2013

To: Eki1

Interesting. I've been wondering how the 12 week without riba, treatment naïve are doing. I haven't come across anyone on that arm...Only with riba.

katla

Feb 18, 2013

To: all

interested in hearing from anyone who did 7977/BMS (no riba)...
thanks.

UKgirl55

Feb 18, 2013

To: katla

Hey Katla,
I was on the 24 week arm of 7977/5885, no riba. I stopped tx @ 14 weeks, last week. I felt like I was going backwards. Felt really ill and decided my body had had enough. I go in tomorrow for my end of tx exam. I'm praying 14 weeks did the trick! I'm a la, CC...same as you I think.

katla

Feb 18, 2013

To: UKgirl55

I was just reading through your posts to see where you were. Good luck, hoping it's all good. Please keep me posted.

Did you post anywhere about the sx?

katla

Feb 18, 2013

To: UKgirl55

I'm ct actually.

UKgirl55

Feb 18, 2013

To: katla

no, I'm on HepCentral most of the time. Had tremendous support there.

UKgirl55

Feb 18, 2013

To: katla

Are you SVR 12 or 24 Katla?

katla

Feb 19, 2013

To: UKgirl55

SVR36

linda880

Feb 20, 2013

To: neutrino trial GS-334-0110

Has anyone heard about their viral load results?  I am 6 months post
treatment and have not received any results on my svr status. I go
for my 6 mo. visit on March 5th and really hoping that gilead releases
the results from this study.  I am confident that i am svr, but would like to
see it on paper!!!  Has anyone else heardabout their status??

countrygirlcansurvive

Feb 20, 2013

To: linda880

Hi Linda !!! Thats funny how I just come back for a visit the same day as you and was thinking of the same as you are.My appointment is March 6th and is my 6 month post tx..LOL..I had some blood work done in Nov. before a Upper Endoscopy.My test results turned out pretty darn good,so I and hoping for some GOOD NEWS! good to hear from you.
Component Your Value Standard Range Units
Albumin 4.2 3.5 - 5.0 g/dL
Total Bilirubin 0.3 0.0 - 1.0 mg/dL
Alkaline Phosphatase 72 35 - 129 U/L
AST 21 0 - 37 U/L
ALT 22 0 - 41 U/L
Total Protein 7.4 6.4 - 8.3 g/dL
Bilirubin, Direct <0.1 0.0 - 0.2

UKgirl55

Feb 20, 2013

To: katla

Woooooo Hoooooo Katla!!!!!!

Do you know anything about the people who didn't make it? Like why?

I'd send you a PM, but can't do it for some reason. Hope life is treating you well Katla! SO, SO happy for you :-)

linda880

Feb 21, 2013

To: countrygirlcansurvive

Hi country,

My labs in December were all normal also. I have pain and stiffness in my
lower back, groin area, and neck. I am relating it to treatment, because that's when it all started with my lower back area and then spread to other areas. I go see chiropracter monday. Rheumotologist says its fibromyalgia, but i am not convinced. I am going to have them test me for lupus and other connective tissue disorders. All i know is it ***** being in pain constantly.
Linda

Michigan57

Apr 06, 2013

I am hoping to get in this trial. I had to retest because my bili was out of range for the study. I should have the results back by Monday or Tuesday of next week. It sounds like an awesome opportunity!

grateful_to_be_here

Apr 13, 2013

I am delighted to join you guys. Finished liver biopsy on Monday and have been accepted into the Gilead four arm 12-26 week study. Wednesday I find out the luck of the draw and learn which arm I am in - and get begin with treatment.

I was diagnosed as type 1a in 2000. Went to Dr and they happened to notice elevated enzymes. I was very fortunate have a personal entre to Dr Schiff in Miami. I had a biopsy & laparoscopy performed and lucky me - stage one!

after much research I determined not to agree to treatment with interferon & ribavirin. for the past 13 years I have waited for this day. I have been bumped from several earlier studies - disappointing at the time but ultimately seemingly the best for me. After all I dodged Vertex and the previous trials that all included interferon.

I look forward to sharing my experience with you guys and learning as I go.

cgap1

Apr 13, 2013

I was contacted last Monday to see if I wanted to participate in the phase 3 Gilead trial. Passed physical exam on Thursday and waiting for my lab work to make sure I qualify. I'm a little apprehensive as my Hep C has been very manageable to this point.
Not sure which testing arm I'm rooting for.

grateful_to_be_here

Apr 13, 2013

To: cgap

find myself wondering the same thing cgap

have come to the conclusion that best would be the longest arm with the most drugs but I will be content with my luck of the draw.

what city are you in?

cgap1

Apr 13, 2013

To: grateful_to_be_here

I'm in down river Detroit area.
I agree. Just want to get rid of something that I have no idea how I got.
Can't wait to get moving on it!

ChrisDDD

Apr 13, 2013

To: HectorSF

Hector, I am so happy for you! You do so much here for so many other people (me included) and I hope you go on to clear and can enjoy the rest of your life. Keep us posted.

ChrisDDD

Apr 13, 2013

To: orphanedhawk

Very good news. This is what helps me stay interested, which at the moment I'm not. Congratulations!

keith212

Apr 16, 2013

To: All

Hello
I am new to this board.
I am Geno type 1B. Found out I had Hep C in 2001... Contracted it in the mid 80's. today was my first day on Sofosbuvir/Ledipasvir no Ribi and Im on a 24 week arm. I have a few side effects.. racing heart, headache Nausea... so far was just wondering if anyone else had side effects, what they were and if they got better or worse.

Thanks

grateful_to_be_here

Apr 17, 2013

Well I am in as of today. Getting the full Monty 24 weeks with Riba

I am thinking it couldn't be better for me. If I had drawn 12 weeks without Riba and didn't clear then I would always wonder.

Cheesegrater

Apr 17, 2013

To: keith212

Keith212,

I noticed a big increase in the headaches I got soon after starting 7977-5885 and riba. They were almost daily for a few weeks. I am on week 10 now and the headaches have become a thing of the past.

I find it interesting that I have had the same type of headache for a long time, back of the head, thumping if I stood up or sometimes even with movment. Same thing but a hell of a lot more frequent. I guess I also recognize the effects of the ribavirin, I feel like I have consumed mass quantities of coffee much of the time, jittery and a bit irritable, hard to keep my mind on one thing.

That's about it.

I wish you success.

Cheesegrater

Apr 17, 2013

To: Cheesegrater

I should clarify my response...

I have had these headaches in the past, stretching back at least 20-25 years. The headaches were fewer and more days between with no headache, but they could be just as painful. When I started 7977-5885 and riba, a few days in, the headaches became a daily issue. By about week 7 or 8 they had reduced in frequency and intensity.

I can not say if they are due to the treatment or due to another non-related factor. Fact is, people get headaches for all sorts of reasons.

grateful_to_be_here

Apr 18, 2013

so day two - slept great nothing unusual so far

countrygirlcansurvive

Apr 21, 2013

To: All the New People

Welcome!! Glad to see my post has been carried on and helpful to you.I hope for the best for you all and reach SVR..I feel these new Clinical trials that you are going through is the future cure for HCV..

I am 9months out of End of Treatment and still SVR!!! I was on Sofosbuvir/Riba and Interferon for 12 weeks.I feel so much better now than I have in years.

The headaches I got was from the Riba and I cannot express it enough to drink alot of WATER,ALL DAY EVERYDAY...the Riba had me Anemic and thats what caused the headaches,but once they reduce it and my body got use to it the headaches went away.
Looking forward to hearing some more of you getting rid of this virus.

God Bless,
~Country~

ChrisDDD

May 05, 2013

To: countrygirlcansurvive

Keep this good news coming. So happy for you!

ChrisDDD

May 05, 2013

To: Doofus_jones

These drug companies would not do the reasonable thing because they make more money that way. I have no faith in them at all. To me it seems like there's always the positive Guess What? of 100% transitioning down to 50% to, "Well, we thought that ... " Ahem, did we mention that this treatment still needs the interferon? Oh, yeah. That 100% clearance we were talking about? That excluded genotype 1b's and 1a's. Sorry if there was any misunderstanding, but we have something ready to begin clinical trials next year! :) Isn't that great news? Oh, and, sadly enough, that 50% clearance we talked about for 1b's and 1a's? That number should actually be dropped to, oh, say 30 to 37%. Sorry! But look at what we're doing with everyone else? Isn't that just the greatest news? Pardon the acrimonious sarcasm, but I'm just sick of it, really sick of it. I have no hope at all of ever clearing. But, then again, I think of my inspiring moment a year or two ago as I left a hospital and glanced to my right where there's a children's cancer wing, and a little girl or boys of maybe 8 years old was sitting in a wheelchair, IV hooked up, nurse standing ready to wheel her out to I guess to her parents? S/he was bald and looked very ill. THAT is sad, brings me perspesctive, all those good feelings. Poor little child.

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