Hep C Discussion Forum

Jumpy · Member

RE: Sapphire Trial

hrsetrdr · Guru

Marian, glad to hear that life is getting back to 'normal', best wishes for your full recovery and SVR! Merry Christmas.

mallani · Guru

Hi Marian,

Good to here that the drugs are starting to wear off. It takes a while, so don't be impatient. Best of luck for the 12 week VL. Have a great KIWI Christmas. Sorry we beat you in the World Cup. Cheers.

Tig · Admin

I'm sorry to hear you're experiencing a low time in your life and hope that it improves soon. Certainly, if there is something that you'd like to talk about, there are some people here with mighty big shoulders and a willingness to listen. Let us know if we can help, I know I would be happy to talk. It does take a period of time for the negative effects of these medications to free our minds and bodies. I experienced an extended period of depression from Interferon, so I know it happens. If you think there might be a possibility of this drug being responsible, even partly, for your low point right now, please talk to your doctor and at least investigate the possibility. It happened to me and once it was determined to be responsible, things improved quickly. Just think about it okay? "When you feel like you've reached the end of your rope, tie a knot in it and hang on!" Those wise words are from my Grandma, and she always knew what she was talking about!!

Jumpy · Member

Hello everyone, thank you so much for all the positive comments. I am at a somewhat low point in my life right now (nothing to do with the virus) and it means a lot to me to read all of your great responses.

Matt Chris · Guru

Hey Marian (ak) Jumpy

That is really great news because after 4 weeks SVR your odds grow much greater.

I know what you mean about being worried we all go through it in the weeks following EOT, sometime its are own body and mind making adjustments to being off the Meds.

Your in good shape, keep positive and away you go.

matt

Tig · Admin

Sounds like things are really improving Jumpy! I'm glad that you've finally gotten most of that poison out of your system and the healing has begun. Good luck on your week +12 results! Merry Christmas to you and yours! smile

Cinnamon Girl · Guru

Hi Marian, good to hear from you again, and best of luck with your 8 weeks post tx result, hope you get some good news soon!

I`m glad you`re feeling better now. It usually takes a while for the side effects of ribavirin to wear off, that`s quite normal, so try not to worry.

Keep us posted, and a very Merry Christmas to you too! smile

Jumpy · Member

Hello everyone,

EOT +8 weeks tests done two weeks ago today, and no phone call, so I am hopeful that the results were virus undetected and I am beginning to believe that I might actually make it to SVR12! I am surprised at how long it has taken for the effects of the ribavarin to wear off, I feel pretty good now but I was certain I had relapsed at EOT +4 weeks because I really didn't feel so great and the aches and pains had returned.

My EOT +12 weeks test is on the 24th Dec. so I am hoping for a late Xmas present, although with all the public holidays I am guessing that it will take much longer for the results to come in.

On that note, A Merry Christmas to the forum.

Jumpy

suziq · Senior Member

Thanks Matt for the info. Now, I won't complain if my Merck study says I must do the 18 weeks. Many of the newer studies with different companies are only 8 weeks--and today was the end of my 10th week. These new results are fascinating. So glad you post results you find. Can't find them by myself sometimes.

SuziQ

Matt Chris · Guru

Hey all

Abbvie has a new Press Release about the preliminary results data on the Sappfire HCV Trial

It is basically saying that the SVR₁₂ rates of GT1a and GT1b were 95 percent and 98 percent, respectively.

Here is the link http://abbvie.mediaroom.com/2013-11-18-AbbVie-Releases-First-of-Six-Phase-III-Results-from-Investigational-All-Oral-Interferon-Free-12-week-Regimen-Showing-96-Percent-SVR12-in-Genotype-1-Hepatitis-C-Patients-New-to-Therapy

Abbvie is shooting for the 2nd quarter of 2013 to submit to the FDA. Abbvie will also be releasing the other pahase III results in the coming weeks so stay tuned.

matt

Jumpy · Member

Hi Matt,

Thanks very much for the info. Its interesting that they are posting SVR12 stats when there must be a few people (including myself) who havent yet reached EOT +12 weeks. I wonder if these people are included in the 'intent to treat'.

I am coming up for my EOT +8 weeks tests next week, was undetected at EOT +4 weeks. So its a pretty anxious time for me.

Jumpy

NB: I have read it again now and its not very clear but I assume the results for SVR12 are for the non-placebo arm of the trial.

-- Edited by Jumpy on Monday 18th of November 2013 09:37:51 PM

Jumpy · Member

Hi Matt, Yes I agree its really interesting. I am particularly interested in how the stats for relapse are calculated, I did find a different set of stats which touched on this issue on another webpage and could kick myself for not bookmarking it. Now I cant find it again. Dohhh! And yes this year's trial data will be very interesting.

I really feel for you re your relapse, and I do hope that Abbvie or someone comes up with a rescue package for you. Dont lose hope!

M

Matt Chris · Guru

Thanks Jumpy

I read through that report, its very interesting to see that 11 of 13 the relapsed trial participants did not develop (Rav's) resistance associated variants.

Also the study showed the longer the treatment the better the odds were of achieving SVR, something I personally believed was a determining factor in my relapse.

Can't wait until this years trial data is published

Matt

Jumpy · Member

Thanks everyone for your comments. Here is a link to some updated stats about relapse in Genotype 1 from the Abbvie Aviator study, the interesting part for those on Sapphire and Turquoise trials is the 12 week arm with ribavarin.

http://www.natap.org/2013/CROI/croi_06.htm

mallani · Guru

Hi Marian,

Congrats on finishing. Just a couple of Undetected's to come and it's all over. Just in time for a great Kiwi summer! Cheers.

Matt Chris · Guru

Hey Marian

Congrats on making it to the EOT, you might get a rush of energy then followed by being more tired than before for a couple of weeks. If this happens don't be alarmed it has happen to others after treatment ends. Also like you said the Ribavirin takes months to lose its effects.

Everything should go well as you had good early results (UND at week 4) so take a deep breath and enjoy the spring/summer weather with a walk in nature.

Matt

-- Edited by Matt Chris on Tuesday 1st of October 2013 03:28:25 PM

Jumpy · Member

Took my last 5 pills this morning, no more jumping for the pill folder when my phone alarm goes off! Saw trial nurse and hepatologist today, still UND, all other tests good, and I'm told my chances of SVR are good and not to worry too much - easier said than done for me, anxiety is my hobby. Having said that, I do expect to be able to start exercising more as the effects of the ribavarin wear off, and this should improve headspace etc.

garfield · Veteran Member

ios9 wrote:
No relapse in Germany, even in the 12 weeks group ? great ! but this is for for Saphir only or Turquoise and Saphir ?

-- Edited by ios9 on Thursday 19th of September 2013 05:38:22 PM

Hi Do,

for both. But I got the information from my study doc to my EOT8 date. In Germany study begin was from mid march to end of april.

This means on 2. september participants were between SVR12 and EOT6.

cheers

garfield · Veteran Member

Hi Do,

you are right, it looks implausible. But look; in the 12-week group one relapsed, in the 24-week group two.

The attendance was to small, statistic isn't an exactly science, this was in my opinion by pure chance.

I think nobody outside abbvie has official data, but so far as I know up to now no relaps in Germany. In Hamburg all received SVR12,

in other cities the study has started later. Your EOT12 date must be soon?

cheers

ios9 · Senior Member

Hi Garfield,

Yes you'r right : my EOT 12 weeks is the 21th September ...

No relapse in Germany, even in the 12 weeks group ? great ! but this is for for Saphir only or Turquoise and Saphir ?

You'r right, 2 have relapse in the 24 weeks group, and this must have happen before 16 weeks treatment (12 + 4) I guess, not sure of course.

See Jumpy, you'r on a reither good trial it seems smile

-- Edited by ios9 on Thursday 19th of September 2013 05:38:22 PM

ios9 · Senior Member

Hi Garfield,

Thanks for the information.

However, when looking at the document you gave, there is some numbers I do not understand :

- they say no relaps after EOT week 4 in the naive groupe with AbbVie 's med plus Riba , that's great !

but if we want to go farther and SVR :

We read that for patients on 12 weeks, rate is 99% success, and those on 24 weeks have less success as they are only 93% to have succeed ? Am I wrong ?

Should we understand that on this trial, there was no cirrhotic ?

Do you have any result for the Turquoise II (cirrhotic patients on 12 or 24 weeks) ?

Thanks a lot, Garfield for all the informations you bring here smile

Have a nice day,

Dominique

garfield · Veteran Member

Hi Do,

no breakthrough in the treatment-naive group and no relaps in this group after week 4.

I hope the attach image works.

cheers

Jumpy · Member

Hi Do and Garfield, Thanks very much for your posts. I did ask the research nurse if anyone on my trial (10 participants) had relapsed and the answer was 'no', I am trying not to think that this then increases my chances of relapse. The statistics I have seen for Abbvie are 89-96% cure rate for treatment naive, although I have seen other stats which are different, don't remember where.

garfield · Veteran Member

Hi Jumpy,

scientists have detected the relationship between a high Ribavarin level in blood and SVR in therapy with Ribavarin/Interferon +.....

People, who get anaemia have ratiocinative a high Ribarvarin level. Vice versa the fact isn't valid, because personal gene have a huge influence, if one is developing an anaemia.

It is a bit shrewed affair. Docs are divided over this influence in coming therapies. So abbvie is proving in their Pearl studies, if Ribavarin is generally necessary.

Only a very few individuals got a breakthrough with abbvie drugs so you can relax for the next 4 weeks.

Afterwards...., I had a rough trot until SVR8, now I am little bit more relaxed.

cheers

ios9 · Senior Member

Hi Garfield !

So you are UND EOT week 8 ? biggrin

WONDERFUL ! I was worried about you ! Do you know how many people had break through with Abbvie drugs during their treatment ?

@ Marian congratulations for your 8th week too ! AbbVie is to give you a silver medal, you will get a gold one on the 12th week :)

Take care,

Do

-- Edited by ios9 on Tuesday 17th of September 2013 01:17:32 PM

Jumpy · Member

Thank you everyone for your supportive comments. Week 8 results today, still UND but anaemia down to 10.8. Is the general thought still that there is a positive relationship between anaemia and SVR? I hope so, as EOT draws closer my anxiety levels increase....I do so wish for SVR, as of course does everyone who is on treatment.

Matt Chris · Guru

Jumpy

Congrats on your week 6 lab results, you are well on your way and will be through the treatment phase before you know it. Keep up your good habits they are working well with the Meds.

Matt

Jumpy · Member

Thanks Do, I hope so, I am very anxious about SVR.....so I try to keep busy and put the worries aside.

ios9 · Senior Member

Hi Marian,

Congratulations ! also for what members says here, anemia is a good news, means Riba is working smile

Jumpy · Member

Week 6 results this week. All good - still UND, still slight anaemia but not bad enough to reduce ribavarin. Side effects still exhaustion, BUT general aches and pains that were my everyday life have still not returned and no insomnia, also a feature of my life in the past.

Jumpy · Member

I am thinking now that perhaps I got the number wrong - I thought she said 15 but its entirely possible with the brain fog and the general old lady brain issues that I remembered it wrong.....

However today there is good news in New Zealand for Hep C sufferers - the government has approved funding for victrelis (boceprevir) treatment, so those who were not as lucky as I was in getting onto a drug trial now have some hope!

Thanks Garfield, I have read your post. It was a little technical but I think I got the drift.

Do, I am impressed, with your oriental boy but not surprised. Compared to the siamese I had in the 1980's the orientals I have now are astoundingly intelligent and also highly manipulative, very good at getting what they want.

garfield · Veteran Member

Hi Jumpy,

I assume you mean with 15 the Hb-level. In Germany the following levels are classified as normal:

for men: 14 - 17,5 g/dl, equal 8,7 - 10,9 mmol/l for women: 12,0 - 15,5 g/dl, equal 7,5 - 9,6 mmol/l

But I think the Hb-Level for women averages more likely 13 than 15. Gilead, Abbvie, .... refuse female participants with a Hb-level smaller than 12 at baseline.

Perhaps my posting about reduction of Hb-level is interesting you: http://hepcfriends.activeboard.com/t54548888/responce-to-my-inquire-on-any-trial-issues/

ios9 · Senior Member

Thanks Jumpy for the so sweet photo ! Orientals love to be together :)

We had an Oriental boy before and my son found funny to teach him to say "Maman", would you beleive it, he did success lol Aldor always screamed "MA MAAAAN" when he wanted his dinner, but only for this reason, otherwise, he was just a good talker. smile

Well, 15 Hb must give Kewees nice red cheeks lol

-- Edited by ios9 on Wednesday 21st of August 2013 08:52:59 AM

Jumpy · Member

Hi Do,

Thanks for the info, the study nurse said that 15 is considered normal for iron levels, its interesting how these levels differ by country.

I love your Peterbald. I attach a photo of my two boys, they look so sweet like that, nobody would ever guess how naughty they are. Manny (the Havana) is quite talkative but only when he has something to say, then he can be very strident if you don't get the message straight away. For instance 'I WANT TO GO OUTSIDE!!!!'.

Jumpy · Member

Thanks Garfield, that's helpful.

garfield · Veteran Member

Hi Jumpy,

don't worry - in abbvie studies 1. if I remember correctly, all participants , who had to reduce Ribavarin reached SVR.

2. the influence of Ribavarin for SVR isn't so huge

Jumpy · Member

Hi Malcolm.

Welcome home, its always nice to get back to the comfort zone, espec after the trials and tribulations you have had! Thank you for the info re the ribavarin, I am hoping that if I do end up on a reduced dose that it wont affect the likelihood of SVR. I have been reading the posts about the link between the optimum levels of ribavarin and achieving SVR, so its a bit worrying.

M

mallani · Guru

Hi Marian,

The anaemia is due to a direct effect of the Ribavirin so eating red meat won't help as it's not due to Iron deficiency. You shouldn't really have any symptoms with a Hb of 12. Congrats on the 4 week Indet. As far as any Riba. dose reduction is concerned, your Trial probably has a strict protocol for that. You're on your way. Cheers, I'm finally back in Brisbane.

Jumpy · Member

Well it was good news today - 6 week check up, and was <25 at week two and undetected at week four!!! Must say I feel strangely emotionless at this point, its been such a roller coaster to get this far. All test results good, although a level of anaemia (12) and if this gets worse (10) then the ribavarin dosage will be reduced. Will up the red meat in my diet and hope that this will help, don't want to reduce the ribavarin unless I absolutely have to. Perhaps the anaemia explains the exhaustion.

ios9 · Senior Member

Hi Jumpy Jump :)

Congratulations for being UND ! sorry to be late in my answer : yes the kitten is my little Gerswhin, a velvet Peterbald (nude oriantal). Do your Oriental cats speak a lot ? Peterbald love to speak and have the last word lol Here Under his face :)

In France, as far as for women, 12 is not anemia, it becomes anemia only under 12. I ended with 11.something, but that was ok. Like Malcom said, this anemia does not come from lake of iron (one of my doc told me that too lately) so it's useless to take too much meat as your liver does not like it that much. Being at 11 did not affect me and I was far as tired as I had been before the treatment,when I was around 13, but with a high VL.

Keep giving us news smile

Do

-- Edited by ios9 on Tuesday 20th of August 2013 01:56:32 PM

Jumpy · Member

Hi Malcolm, Thanks for your encouragement. Yesterday was pretty dire, today not so bad. Have had my coffees now and am gently entering the real world. Yes as I said my fibroscan score came as a total surprise, I was prepared for a far worse result so I have been very lucky.

Jumpy · Member

Hi Do, Thank you for your encouragement and congratulations on making it to EOT and UND!!! Good for you. Pleased you like Australia, I am actually a Kiwi but there isn't much difference between the two espec with the number of Kiwis moving to Australia, its pretty much a case of the last one out turn off the lights. Life in NZ has been pretty hard for a number of years, a small economy, so those who move to Oz do so in the hope of a better life.

Is the picture of your cat? I have two orientals, a bit hairier but otherwise similar.

I feel a bit better today, yesterday was pretty dire, hence the whining, am hoping that the side affects stay pretty much at this level for the next two months.

M

PS I call myself jumpy because I have high anxiety....not because I am a kangaroo.

ios9 · Senior Member

Hi Marian,

I love your country ! been there for 3 years and my oldest daughter is born in Melbourne (Queen Victoria Hospital), but I mostly lived in a small nice city named Turramurra near Sydney.

The hardest geno 1 is a1 for what I have been told, but with the new drugs, it's much easier to get cured docs say.

I have been on same medicamentations as you for 12 weeks (Turquoise II) and am now off treatment since 1st July. Would you believe it ? I miss it !

About your VL, it's pretty good to have such a low one week 1, congratulations. Mine at week one was 670, and even thought, I am und at 4 weeks EOT.

I had a friend on Saphir who was on placebo like you and had bad headack and nausea from the 1st day of treatment till the last one !

I was on the real one and did not get any of this secondary effects, only intellectual tireless and lost of some immediate memory. But I started the trial being told "no side effect at all with those new drugs" so mental has a lot to say with the way we feel.

Do

mallani · Guru

Hi Marian,

Your Viral Load drop is excellent and I'm impressed with your Fibroscan score. You should do very well. You probably have Geno 1a which is now recognised as the most difficult to treat, but the new antivirals are effective against them all. Keep us posted. I'll be back in Australia in 3 weeks so hope to hear more good news then. Cheers.

Tig · Admin

Yes, the genotype 1 family is the most stubborn but the advent of new treatments and drugs are improving the odds for everyone! We've got several Aussies and a Kiwi or two that you'll enjoy meeting. Plenty of great stories and it sounds like you've got some as well! when you can, please let us know what your plans will be and of course if we can help, let us know!

Jumpy · Member

Thank you Tig56. My viral load was either 1.8 or 2.8 million, my genotype is 1, I forget whether it is a or b, but it is the one that is more difficult to treat. My fibroscan was 6.3 kpa which came as a very big surprise to me, I thought it would be much worse because when I was first diagnosed around 1995, it was made clear to me that I would die. As a result I did some serious drinking for a while until sense prevailed and I reined it in. I do think the saviour of my liver could well be that I have had a serious coffee addiction all my life and never fail to have two double espressos every morning, even when the smell of it makes me shudder.

Tig · Admin

Hey Marian, welcome to the crowd! I don't care who you are, if your viral load drops to 132 after a single week, that's great! What was your starting VL (viral load)? Share as much of your information as possible, it helps us help you. There are so many intelligent people here that want to do nothing but help you through this journey toward better health. People that have been there, done that and can make your trip so much easier and informed. The side effects are well known and I personally have had or am having most of them. Some are tolerable and some are almost unbearable. The doctors and nurses can help you during most normal business hours, sometimes. But we're here to give you the tips you need to ease them and most often at a moments notice. I can't tell you how many times the people here have carried me through the night. These folks are true friends and most of them you'll never meet in person, but they're willing to sit with you and help you with a sad moment or a day when you're so sick to your stomach you just need them to hold your hand and give you an idea of how to make a drink of something you'll be able to keep down. It's the beginning of a relationship that works both ways. Soon those same people may need your help and there is always a new person with these same important questions and something tells me that you're going to be the help that they need at that time. When you feel the grip of that darkness grasping hold, please think of us, share your story and you can count on a friend being here for you. We may not have all the answers, but rarely do we not have an idea or a resource! So hang in there and start by reading the posts here. Use the search function to track down similar situations, it's a great feature and it works well! Again, welcome friend and best of luck! smile

Jumpy · Member

Ha, checked it out and that's me except with a little whining voice. Was tossing up between Ralph Wiggan or Linus (Snoopy)......

Biggyb · Guru

You are funny, remember the Whiners on Saturday Night Live years ago ? Funny stuff.

http://www.youtube.com/watch?v=AkggyqUWDME

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~Bob~

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