Hep C Discussion Forum

Tig · Admin

RE: New Third Gen Drugs Abbvie Trial- The journey so far...

freesoul · Member

Hey hey hey everybody...always meant to come back, but life got in the way, as we had a death in the family and some job changes recently...since I can work again, nearly full time now.

Anyways. Passed my 12 weeks undetected point a few weeks back- yaaaay!!! And I feel mostly awesome. Except some litre aches and such which might or might not be related and are nonetheless minor. Abbvie wants one more test done, around xmastime at the six month post treatment point, to check for anything. I still have anemia; otherwise my numbers are great, all within range :)

I'm thinking about taking up hiking.

Canuck · Guru

Pablo,

The IL28b data Gilead collected on you and I, is just that, "data".

Who knows what significance it will hold for them.

The IL28b topic is an old one, more so the topic was more active during the interferon days.

The link I posted was just part of a bigger older conversation. That link (the study) itself is "old" now (relatively speaking) - 2014 - and, note is was in regard to GT3's and the "old drugs" G3's were being treated with - and the only reason I stumbled on this single "semi-recent" study was because I had been researching and trying to learn more about why G3's were supposedly "tough nuts".

In just a couple years the whole DAA world has now changed from interferon days, this is why (in part) Mallani (I think) was vaguely interested in why Gilead was determining IL28b in their newest daa trails.

This continuing data collection may help to show that the new daa's are effective (not only regardless of GT) but regardless of IL28b categories. G3's may no longer be tough nuts, with the likes of sov/vel/vox.

You may note the date of my original post (to that link/study) - I had just finished running a desperate, panicked marathon to arrive breathlessly to the relieving but scary 8 week pioneering door of my treatment? I felt some better, and lucky, just being at the right door, but I was still frightened, and researching, and would hang on to ANY tidbit of info that might further the kind of assurance I so wished for. I am not surprised I held some hope that being a CC was a good thing, even if it is meaningless, in the end! Unfortunately, I think it is a normal thing for me to "worry everything" until I am a sustained und. With the new daas, it is appearing hopeful, right now, that people can approach treatment in a much more fearless manner.

Being CC, CT, or TT may be a non-issue (N/A) period, when it comes to sof/vel/vox, and new daas. smile C.

Pablito · Senior Member

Hi Rob

That's really well and simply explained for a complicated topic.

Thanks

Pablo

-- Edited by Pablito on Wednesday 1st of June 2016 02:54:57 PM

robertsamx · Guru

Hi Pablito, The IL28b gene has 3 sub types. CC has the best response to HCV , with CT in the middle meaning it's just a little bit better response than TT

It's about your own immuneur system response, if you have CC it helps your immune system kill the virus, the treatment drugs stop the virus from replication , and your immune system kills the virus.Its more complicated than this but it's you killing the virus, not the treatment drugs. RC

CC--- Stop talking treatment failure!! RC

Pablito · Senior Member

Thanks Canuck

Oh these scientific papers are so hard to interpret sometimes. So am I righting in saying that CC IL28 is a good thing, but CC/TT IL28 is bad?

P

Canuck · Guru

Hey pablo,

Re: IL28 ... http://www.ncbi.nlm.nih.gov/pubmed/24415442

This link is from within is from one the first posts on that "GT 3's and Sof/Velpa trials". Mallani made a commrnt on it as well.

I only found out my CC status by "accident".

With trials is seems a lot of the data is well harboured by the company.

We had another fellow here, who, after a failure, pursued his resistance data, and arduously (eventually) got some data released to him, but it did not sound easy. If I can find that person's thread again i will send it.

Haven't heard from chinacat for a while now about how her ABT 530/493 trial went.

Your trial handout language and info appears much like mine, BTW.

I still have not been able to secure a clear answer from my doc about what meds I might go to next in case of failure. I am not anticipating relapse tho!! smile C.

Pablito · Senior Member

Well done Freesoul. Great news!

China Cat - I read your profile and on it you mention that you had done prior to treatment to determine what you will respond to. I'm also on a trial (Polaris, sof/vel/GS-9857 x 8 weeks) and in the trial protocol they mention testing for viral resistance...is this the same thing? And, if so, what should I ask them for in terms of results; just in case - God forbid - the trial doesn't work and I need another round of treatment. which would be through the NHS so it would be good to be armed with info as to what DAA combo would work.

I've attached the trial protocol. If you scroll to pages 3 and 4 you'll see the itinerary...they test for RAVs at multiple time points and also test for IL28B. Is having IL28B a good thing or bad thing?

Thanks

Pablo

Canuck · Guru

Hi China Cat,

So glad to see you on your way with the ABT530/493. The new drugs are proving good. It is amazing how humane the newer treatments have become. So glad you got an opportunity at these ABT's.

I know what you mean about not being able to freely discuss matters with peers. This site IS a god-send.

Onward, to good and even better days ahead!

Canuck

Tig · Admin

That's excellent news Saundra! WOOT! I hope you were able to get some relief from that itching. That can be miserable, but I'm not telling anyone here what they don't already know, lol! We're all looking forward to hearing your lab results next week. So cool to see how effective these new treatments are. You're getting treatment at the best time I've ever seen. We used to be really limited in the rates of success. The first time I went through Interferon back in 96, the rates of success were 20-30%, maybe. I failed miserably. Then when I did it again in 2103, the rates had rose to about 75-80% and it did work. Now we're seeing 95-100% rates, incredible stuff! Good luck with the tests, the itching and the fatigue. Keep drinking that water, stay active, but don't overdue. You'll be finished in no time and living the Hep C free life!

ChinaCat · Member

That was good advice..exactly what my trial nurse told me today. One trip for blood draws next week and then every 2 weeks. I did find good info today... They anticipate no Virus will be detected from this draw today. Hopefully the reports are back when I go next week,

that really blows my mind that these meds can act so quickly and effectivel. Oh but I am a bit tired. Nite all

Tig · Admin

Hi Saundra,

I haven't seen too many comments about itching specific to your protocol, but looked at some of the posts here and our member "Freesoul" said that while the mention of it is limited, she experienced it too. You might send her a PM. I would attempt to minimize it with the same techniques we use with the Riba itching. Antihistamines, calamine, hydrocortisone and mild bathing soaps using cooler water on a less frequent basis. Be sure to talk to your trial team first. They need to be aware of it.

Let me know what you hear after your appointment. Keep the water flowing and don't scratch!

ChinaCat · Member

Just curious Tig...

did your ears and eyes itch? I'm heading to doc tomorrow or wed and may see if there's anything I'm cleared to take. Got to drink more water. Leaps and bounds better than the effects of interferon/ribs combo.

Im happy to have this forum. I don't talk about my Hep often. usually folks don't understand the disease and frankly I educate my GP and FNP.

I'm in healthcare and have had a number of patients with end stage liver disease. Yep..these side effects are well worth a positive outcome!

nite all

Tig · Admin

Good news Saundra! These are effective treatments and you're already a week into the game. You can expect to feel some changes during the first few weeks and then hopefully your body will have adjusted in part to the medication and the side effects will be less. Just continue to drink that 3-4 liters of water per day. That's so important to maintain.

As for the itching, it's common too. If you're not seeing a skin rash, it's worth asking your doctor if taking an antihistamine is okay. I had to and it helped greatly. Avoid taking hot showers, keep it cooler and use a milder soap. If you notice a rash developing, some topical lotions like Caladryl and Calamine will help.

Hang in there! You're on your way.... smile

ChinaCat · Member

im so happy to hear this as I am in Week 1 of Abbvie trial. Got some side effects but not intolerable. I'm so itchy and kinda burning under the skin but it's intermittent. Kinda bitchy though..hmmm not sure about that. Anyway I can do anything for 12/16 weeks to slay this dragon. It's starting to mess with me so time to take it down.

Bills · Guru

Great News Alex

And now you are a fee soul Free of HepC Good luck

BillS

Jaded · Senior Member

Congrats...I'm happy to hear the great news!

Tig · Admin

Hi Alex,

HOORAY!!! You did it and are over with everything but the shouting. I also remember your initial anxiety, but you handled that so well, realizing the importance of achieving the goal you have finally reached. Please let us know what you hear from Abbvie. Your willingness to do this study is beyond valuable for everyone coming after you on this road to wellness. We all thank you for your courage and congratulate you on your successful treatment. Now on to SVR!!!

Cinnamon Girl · Guru

Hi Alex, what brilliant news.. congratulations on your EOT undetected, what a great result!!!

I know you were a bit anxious at the start about being on the 8 week arm rather than the 12 week, but it`s been clear right from the start how well you`ve responded, and I`m very happy for you!

When do you have your next viral load tested, at 12 weeks post?

Thanks so much for sharing your trial journey with us, you`ve given us so much valuable information and feedback.

Now it`s time to celebrate!

freesoul · Member

Lab results back-

NO HCV DETECTED- NO REFERENCE RANGE....

I'm undetected!!!! Yay!!!!

One More Dragon Down!

freesoul · Member

Sooo...my experimental treatment is now done. Side effects were a little more for the second half of it, but not too bad, and now, I have taken my last pill. I went back to the clinic for all the testing and exams and check up yesterday...now waiting for results (some of the material will be going all the way to California for consults). Last thing I knew, I was super close to cured...hope for the best!!!

Greg D · Senior Member

I also have no idea what you are experiencing but anxiety has been documented in 3% of trial participants so perhaps you are one of those lucky few.

I feel for you and need you to know that each and every one of us are in your corner. Most of those who have already treated have seen the darkness, in one form or another....remember we are all in this together and that it's okay to share your good moments and your no so great ones too...deep breaths, you got this!

freesoul · Member

Jaded- I don't know why I'm panicky like that...maybe it's anxiety or depression? I know it makes no sense, I was tested 4 weeks ago, I might be clear by now...its paranoia, I guess? It will be all over soon, anyways. Yay! I will know in about ten days or so :)

Jaded · Senior Member

Try to relax...easy for me to say but right now it's the only thing you can do. There are no definite answers to your questions...but honestly from what I've seen so far...everyone who's viral load is as low as yours goes on to clear it ether by the end of tx or by 12 weeks EOT (yes even after they stop taking the drugs). If I had to bet...I'd say you will eventually be clear because statistically this is what I have been seeing. Worrying will only rob you of energy...try to believe you will be well. Really...you ARE doing very well and have come a long way. Almost there now...have a Happy New Year.

freesoul · Member

Found it!

Reported common side effects from Phase 2 trials:

-Fatigue 12%
-Headache 9%
-Nausea 8%
-Diarrhea 6%

Less common:

-Anxiety 3%
-Dizziness 3%
-Back pain 3%
-Upper respiratory track infection/inflammation 3-6%

My experience...I had nausea if I didn't take the pills with food- not recommended. No problems as long as I ate.
I had a sore throat and a lot of thirst- you have to drink! if you don't, I can see how you can end up with inflammation.
I had headaches basically daily for the first week- none after, except normal/occasional (i.e. PMS, hunger, etc)
I did get back pain, for a week or two...right in the middle of treatment (I am doing 8 weeks, for at the one month point, more or less). It was bothersome, and disconcerting. They are gone now.

One side effect not mentioned here, but that both me and the one other trial participant got, was itchiness and mild rashes.

None of these was anywhere near a deal breaker...very mild, and this is from someone with known sensitivities- I usually get every side effect in the book, and suffer horribly even on simple stuff like antibiotics.

I have only 3 days left now. I go back on Tuesday for my last in-treatment blood test. As of the previous one, I had not yet cleared. I am hoping I will this time. I am losing my optimism no matter how much I try to maintain it...I have spent a part of the holidays kinda isolating myself (I can't drink, anyways, and everybody is getting drunk!) and feeling like crap. I feel like I have not cleared...I know this is not okay, I am probably depressed or something...I am mad that because it is a trial I cannot have more drugs or a dose increase or anything...I was feeling SO MUCH BETTER that I just cannot go back to how I was before!

Is that what happens? Do you immediately go back to same as before, if treatment is unsuccessful?

-- Edited by freesoul on Sunday 3rd of January 2016 02:01:03 AM

Tig · Admin

Sounds like you have discovered why you're feeling stressed. You have put an awful lot on your plate and I think you'd feel a lot better, with much less anxiety, if you took time to relax and finish up the last 3 weeks of treatment. Remember, the actual test for confirmation of SVR isn't until the 12th week following the end of treatment. Disregard the viral load until then and you'll sleep a lot better. Do your best to relax, enjoy the season, and finish treatment. These are powerful medications that can affect every facet of your life. You're also on a new protocol, one we know little about. You're discovering aspects (including side effects) of these new drugs that few have experienced. Don't try to burn the candle at both ends right now.

I hope you're feeling better soon! We're always here to talk...

freesoul · Member

Yes, I'm trying not to worry about it...there are still 3 weeks to go, after all. I take all my pills at the same time every day- I haven't even been late by more than half an hour, even once. I don't drink any alcohol, barely smoke at all...wish I could quit altogether but that's not in the books, as it is, its 3 or less a day- sometimes none. I eat ok.

Cant find the new papers...

I feel really depressed and rather tired right now. I took on extra shifts because I was feeling so well, and my co-workers wanted holidays off- but then all the shopping and merry obligations...and also I have been doing a little training for a new role which is quite stressful...so I'm thinking I've been taking on a little too much. Silly me. Oh well- it will get better after Xmas is over.

Wish I could get this stuff out of my mind. I am tired of the "cure- no cure- cure- nope- maybe- yes- no-" roller coaster...

I heard Australia just approved treatment for everyone!!!! yay. Way to go. Wish they were all like that!

Tig · Admin

Hey Alex,

I wouldn't worry about it. I know it's easy for me to say, but the way these new drugs work is entirely different (but the goal is the same!) It's not uncommon for some to wait until the EOT test before they're undetected. We've had people be detected at EOT and achieve SVR12. So you're nearly there! You're so close, I'm going to bet you'll be clear on the next test.

I agree with Gracie. You're not doing anything wrong. We all respond differently to treatment. Do your best to not dwell on everything. You're treating yourself very well, following protocol and it's going to pay off. Hang in there!

Gracie · Guru

Exercise would help and sugar won't hurt your chances. its nothing you've done, it's the nature of the virus. And there are definitely some who done clear at four weeks and go on to SVR. Keep trucking - you still have an awesome chance of clearing so don't give up!

freesoul · Member

So I went for my Week 4 check up last week Tuesday. They had new consent forms to be signed- these reflect the result of the previous study, and it lists side effects reported. I will post them if I can just find that damn paper..

But today I received my results. I almost cried. It's the same thing as week 2- I am still at >15, but detected...no SVR for me yet. I hope this doesn't mean anything. I only get 8 weeks of treatment so...

I won't get another blood test now for a month! Such a loooong time to wait. I am self-doubting, wondering if I did something wrong, too much exercising (I am jogging 1-2 miles maybe 3x a week) or maybe I am eating too much sugar? Is there anything I can do better?

I dunno.

freesoul · Member

I'm not sure how long the process is for approval...they are still getting going for the Phase 3 trials.

Here is the link for anyone interested in participating:

https://www.clinicaltrials.gov/ct2/show/study/NCT02604017?term=hcv+abbvie&rank=16&show_locs=Y#locn

I was very well treated so far- and this stuff is excellent from everything that has been heard from preliminary results. Well worth it for those of us needing treatment and with no other suitable options...

xtra · Veteran Member

This is great news! How long before this drug is approved?

wmlj1960 · Moderator

That's really good news Alex. At that recovery rate I believe it would be safe to say that you are likely UND as I type this. If not, give it a couple of more hours . Carry on! smile

freesoul · Member

Yep I would say this combo is FAST from what I hear...Here are the data from the other person I know who did this drug in trials at same dosage (in Phase 2) which she shared with me online:

Day 1: 2.41 mil
Day 3: 301
Week 1: 25
Week 2: <25
Week 4: UND

She had no side effects and is still SVR at post 12 weeks :)

Edited to add: She was a Genotype 2

-- Edited by freesoul on Monday 30th of November 2015 08:37:27 PM

Greg D · Senior Member

How exciting Alex!! I am so wrapped up in your journey, it's like the Hep-c Olympics lol. Getting ribavirin out of the equation is HUGE! Stay the course.

Tig · Admin

Hey Alex,

Congratulations!!!! Those are rapid results, wow!! Lets take the first three letters of your trial meds ABT, and send a memo to your Dragon with this reminder, you've "Already Been Trashed"!

bubble · Senior Member

" I hear that train a commin, comming around that bend"

freesoul · Member

Blood RNA results are back!!!!

Day 1 (taken before any pills): 8.1 mil

Day 8 (Week 1 check in): 585,000

Day 14 (Week 2 check in): *drum roll please...*

>15...yes!!!!

Sooo close to UND!

TazKat · Senior Member

yay. that ribavirin is the pits. but hey I did it 4 times. u do what u gotta do.. many blessings.

Peace out

Taz

bubble · Senior Member

Alexandra: Thanks for being a great influence on us all with this new 1a treatment. Your AST and ALT should be very comforting to see. This new medicine will eliminate Ribavirin for us I think. You look like your on your road. This info is what all of us wish firsthand. I thank you in your concerns. Please keep us informed. I know someone who refused to take riba and is waiting for this new Abbvie medicine. Kinda like the old days when I refused anything to take again with interferon. We are all on your side. Post that Viral count. Good luck.

Matt Chris · Guru

Hey Alex

Way to go! your AST & ALT look fantastic. Keep your good habits and all will turn out SVR.

matt

Tig · Admin

Outstanding Alex! You're well on your way. Looks like this new protocol is a fast performer and is exactly what we like to see! I'm anxious to hear about your viral load too. Keep us informed. smile

wmlj1960 · Moderator

That really good news miss trial participant #1. The future of ABT 493 and ABT- 530, and of your life are looking very promising. Keep doing what you're doing. Drink, drink, drink. Keep the updates coming. Although you are pretty unique as being #1 on a new trial you are not alone here. We're all in this thing together! smile

Jaded · Senior Member

Excellent results...bilirubin fluctuations seem to be part of the tx...at least that was the case for me when I was on Harvoni. Everything looks to be as good as it gets.

freesoul · Member

First lab results are in!!!!

These are from Day 8 after starting treatment. My ALT and AST have both already dropped to normal levels (they are 17 (both same) down from 40 and 29 respectively). My platelet count is also normal- for the first time in about two years.

In fact the only abnormalities seen in any of the blood and the urine work were a very slight elevation in bilirubin and cholesterol (latter a only a couple percents). Even my iron count is better already.

Unfortunately they haven't gotten the virus RNA test back yet :(. Dare I say that I suspect the results speak for themselves?

Still the only side effects are the slight headaches, and having to drink a lot.

And I am beginning to feel better...more energy, no abdominal swelling and better digestion, better color, no nausea and dizziness....well, my system seems to be functioning better. I can walk and even walk/jog a little.

Tig · Admin

Hi Alex,

I noticed that sentence about the first person enrollment in the Phase 3 trial. So that was you? Congratulations, you truly are the first of the Phase 3 pioneers! You'll be in the history books, listed as a number, but hey, you're still a star in our world! I wish you all the best on your journey and will be following your progress.

Penny is right, do your best to put the delay getting your results back. The wait will drive you nuts if you allow it to. Instead, concentrate on the great opportunity and plan on the celebration to come! We'll help you plan the party, we're getting pretty good at that now!

Penelope PePod · Senior Member

That article showed very promising results - so glad you were able to get in the study. I'm in the states, and it still took over a week to get my VL results back. I gotta say, I learned to be patient while I was on treatment!

Good luck with the trial - you'll do fine.
Penny

-- Edited by Penelope PePod on Wednesday 18th of November 2015 06:53:34 PM

freesoul · Member

Today was my second appointment- the Week 1 check-in. I asked for my blood test results when they come back, both viral load, liver panel and the rest; apparently my blood samples have to be sent to the central lab in the states (I'm in Canada) and it takes a week or so to get my results back...that is crazy! I will get an email when they get them back. Next week. Arrrgh!

Also I asked about the little paragraph on top of the article that I linked above that says: "First patient enrolled in Phase 3 trials"...it certainly caught my eye. And yes, it turned out I am the very first one on Phase 3 of this protocol. I mean, what are the odds? I feel very very lucky!

freesoul · Member

Here's the first bit of results from this combo:

www.businesswire.com/news/home/20151116005852/en/Enanta-Pharmaceuticals-Announces-Investigational-Regimen-Enanta%E2%80%99s-Next-Generation

Groupergetter · Guru

Hi Alexandra, these meds can make a person feel "different" The first night I took Sovaldi and Olysio I could literally feel the virus being killed. Midway through that tx I actually got good sleep. Hopefully you'll coast thru tx without many se. As with all these powerful drugs staying hydrated is very important. Good to keep the water handy all the time. Headaches are a common side effect of the Harvoni, not sure about the Abbvie trial. Good luck.

-- Edited by Groupergetter on Friday 13th of November 2015 09:38:55 PM

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