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TOPAZ I - Viekira Pak long Term outcomes clinical trial

Posting this info for anyone considering treating with Viekira Pak.

I started in an open-label clinical to measure the long-term effectiveness of this treatment 9-days ago. It's a wonderful opportunity for me as there is no prescription medication insurance where I live. Harvoni is not even approved here yet, and even if it was, it's the most expensive in a suite of treatments that are already completely unaffordable. Our government run Pharmaceutical Benefits Scheme is unlikely to list it any of the treatments soon. Like most other countries it is highly unlikely that the scheme can justify the cost of treatment subsidy until someone is on a proven path toward requiring a liver transplant.

I have seen quite a few people posting about wanting Harvoni instead of Viekira Pak. I would want it too, if it was an option. So for people in the same boat, I am happy to say that is not too bad at all! A walk in the park on a sunny day compared to IFN treatments.

For those that like lots of detail this is the study. Might still be recruiting.
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
https://clinicaltrials.gov/ct2/show/NCT02219490?term=TOPAZ+I&rank=1

Viekira Pak - FDA prescribing information, side effects and uses
http://www.drugs.com/pro/viekira-pak.html

I will post my progress and numbers as time goes on.
GT1a C/T. Failed IFN/Riba combo treatment in b2008.

37 Responses
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Avatar universal
What caused the palpitations? Riba?
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Avatar universal
I don't know what to think about this hip c stuff. I have it and I'm so lost hurt and very emotional but I don't have friends and I don't have anyone around me in my shoes so to speak. Someone close to me has it but I don't feel right to talk to her all that much. I'm so emotional its crazy
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Avatar universal
This post is long overdue. I meant this thread to be helpful to people wondering about treatment with Viekira Pak. To document recovery as well as the treatment experience. I needed a break from medical topics and life was a bit demanding. Now I have something really good to report.

24-WEEKS POST TREATMENT VIRAL LOAD =  UNDETECTED!!!!!!

I am feeling much better overall. My liver enzymes are in normal range and the fibroscan results are great. It took much longer than I expected to regain physical strength and energy but 6-months post treatment I think I am nearly there. I just need to do more physical exercise now. I feel happier and calmer than I have felt for as long as I can remember.

While I had HCV I tended to gravitate toward negative outlooks. I fluctuated between feeling either mildly or very depressed. I was often a little anxious about the future.  Was definitely "liverish" - easily annoyed by lots of little things in life. There are reasons other than HCV why people have negative emotions but I can genuinely say that now the virus is gone that an invisible veil has lifted. The burden of a negative outlook has dissolved and life is not at all bad.

My advice to others considering this treatment:
There are other treatments that may offer cures with shorter duration and fewer side effects. I could not hide the treatment from colleagues at work. Failure is quite unlikely but this treatment carries the risk of developing resistance to several classes of DAA concurrently which might complicate re-treatment options for a lengthy period. There are a number of significant contraindications, especially if you have to take Ribavirin as I did. Do your research thoroughly before deciding. Know what the treatment is going to be like.

However, if you can safely treat with Viekira Pak and other options are not available to you, go for it. You will recover from the side effects. The treatment is very effective and it is great to be rid of Hepatitis C.
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Avatar universal
Hi Dee,
Yes. I am feeling much better now. My strength started returning about 3-months after EOT. Now 5-months after and I would say that it's close to normal but I need to do some training to get the last bit of power back. The post treatment depression cleared up quickly and a little psoriasis on my scalp has also gone. All cleared up without any medications.

My EOT12 results were HCV not detected but there was a slight liver enzyme elevation. Probably alright, but inevitably one can't help worrying a little bit. I go in for EOT24 labs in a couple of weeks. Cure is considered to be HCV UND at 6-months post here. I will post more detail here when I get those results.

The recent FDA warning notice doesn't surprise me. It was very clear that I would have been excluded from the trial if over F3 or with heart irregularities. Nevertheless I do hope that it doesn't mean bad outcomes for people. Viekira Pak has quite a few exclusions, especially with Ribavirin added. Not the best from a resistance profile perspective if it fails. That said, it is effective and so so so much more tolerable than anything with Interferon in the mix. Fingers crossed this is just the FDA making AbbieVie emphasise the contraindications rather than a harbinger of something worse.

How are you doing?
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Avatar universal
Hi there. I have replied to you in the FDA warning thread as well. Yes, we were all carefully screened for heart conditions before starting treatment. Also having cirrhosis would have prevented me participating in the trial. I do seem to remember slight heart palpitations but no chest pain. It didn't happen a lot. Maybe once or twice. Get your mom checked anyway. Better safe than sorry. Act decisively with the ticker :-)
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317787 tn?1473358451
I know it has been a long time but wanted to say great to see you.  I have experienced same and am now doing much better

Odin I hope you are feeling better, changing my diet, taking supplements, drinking water and time all seemed to help

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Avatar universal
Do you faced a palpitation with viekirax and ribavirin? Do you checked heart function?
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Avatar universal
Hey Mr W :-) Yes it has been years in fact. Congrats to you too on your cure.

I agree with you that there is so much else going on in addition to the effects of medications. I have been thinking a lot about all the thought patterns and life decisions that have resulted from having HCV. The effects of being tired for so long. Those things have been on my path for at least two thirds of my life. A very good thing to be able to discard them at last, but it can be like removing a stubborn stain. Having HCV isn't just about the physical effects of an infection (although I wish it was). It's been about keeping secrets, being unable to completely let go of the hurt around the circumstances of contracting it in the first place because the disease is still there.

When I see all these people getting cured I think what an amazing thing it's going to be for so many lives. Need to get the price of treatment down though.

Thanks Willy. Go well :-)
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Avatar universal
Thanks for the heads up about platelets. It's really helpful to know about other people's experiences. I can relate to what you say about the combined mood + fatigue and feeling like you have snapped out of it briefly, only to crash back down again later. Although I am not getting whole good days yet.

I generally feel like I am going forward more than backward. Will hang on to that thought!
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Avatar universal
Hiya, it;s been a while.

First off, CONGRATS!!

I have been on line in HCV sites for over a decade. Here is what I notice;

1) No one gets better after ending TX as fast as they
want/wish/expect

2) Disclaimer to #1; everyone reacts differently to their TX (those different drugs we all take). People also respond and recuperate on their own schedules as well,

3) and the long term prognosis..... people respond over years and improve or stay the same based on a variety of reasons; (that could be) genetics, sex, staging, post TX lifestyle, the drugs they did for TX and those other drugs they may continue to take post TX, other extra-hepatic issues/co-morbidities. Your mileage WILL vary

4) I think there is an almost PTSD element to doing chemo, being infected, not knowing the outcome, having an expectation of what it will be like when we are done, when we are cured, when we are recovered.
         Even when you are done, you really can only see the light at the end of the tunnel. It's just the very beginning
..........of the beginning.

***********************

I was in a trial, I had been getting worse the few years before the TX, very incrementally. And then I essentially triple dosed and did more drugs than were needed. I suffered some sides, and now not quite two years from ending TX, I am starting to feel more and more normal (I did Harvoni and RBV for 21 weeks).

I was scared about my neuropathy for about a year. It has taken me some time to realize that I am going to be OK, that the possibly "permanent" damage is reversing.

I continued to try to do diet and lifestyle improvements, and while I was improving s l o w l y I really improved much faster when I cut out sugar and dairy. It's not per se that I was allergic to these..... but they really may be just one more negative, at least they seem to have been for me.

Regarding feeling weird after ending TX; all of a sudden you liver starts working differently. I think it takes time to find an equalibrium.
Same is true for gut bacteria. I did prebiotics post TX, and I think that eliminating some types of foods may have helped. It takes time to rebuild.

Grant yourself some time without excessive worry.
Know that you will see improvements; just not as fast as you want.
Continue to pay attention to health issues and see if you can find those "new" things that you can obsess about.
HCV may no longer be one, but recovery can be a new thing to work on.

Hello, cheers, blessings, congrats and
happy trails.

~W
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Avatar universal
Bravo Odin.   Glad you heard me loud and clear.  I go to Mayo Clinic ( head honchos in the states) for my liver care and they couldn't/wouldn't explain the phenomenon to me.  It was only thru hours and hours of research did I understand the connection.  Was kinda getting somewhat worried as I thought I may be losing my mind.  Have done other therapies thru the years and not once did I encounter such perplexing state of mind.  Might add its not only mood that's affected, but continued fatigue and just feeling kinda "Off".
Some days you may feel as tho you've "Snapped" out of it, only to return a day or 2 later.  
As always, once you know what's going on its easy to deal with.  Your on the path now and given time you will be feeling great.
.....Kim
BTW. Another thought.  Certain people find that while on Riba their Platelets go up.  This causes them to celebrate that their liver is getting better.  Then they finish treatment and a few months later their Platelets come crashing down and they think their liver is failing.  If this does happen to you "No worries".   It was the Riba again.  For some they go back down to where they were pre-treatment.  Only telling you this because it's happened to several of us on this forum, including me!    Totally Normal!
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Avatar universal
Thanks Kim. That is very helpful. The current cranky blah moods make perfect sense. I can manage with that explanation! It's good to have a timeframe too. Maybe time for a holiday so that I can ooze negativity in a safe space and not get myself fired. I am biting heads off at work. No one is guaranteed safe at the moment no matter how lofty their station!

It's interesting. I was wondering why I felt so positive, eek, almost invincible despite anaemia, a blood curdling cough, and all the other rubbish Ribavirin sides. I was asking myself is this the effect of losing the liver munchers? Is this the happy-liver version of me, or is this stuff artificially boosting my feel-good chemistry? Definitely felt a bit too good to be true.

The trial people at the hospital have been commendable, but they don't seem to mention these things.

Reset. Under control :-)
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Avatar universal
Hi Odin.  Chalk it up to Ribavirin.  I was on Sovoldi/Ribavirin for 12 weeks and for me the after effects were the worst.  The Riba messes with your neurotransmitters which are responsible for mood regulations.  These would include Dopamine, Serotonin, and not least Endorphins.  The Riba can last in your system for up to 6 months post Tx but the depression may linger for up to 3 months as it did in my case.  It has a lot to do with each individual as some bounce right back while others need more time.
The other medical symptoms you shared hit my experience to a tee. Now on the other hand if you are worried and things head south then talk to your Dr.
I'm not trying to give you medical advice but when treatment ended for many of us including myself, we felt blah!   Wanted you to know that you are not alone on this one, and give it time to clear out of your system.  The best way it seemed was to drink as much water as possible.  These symptoms are temporary and gradually you will feel virus free and amazing.
Keep the faith
......Kim
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Avatar universal
Hey Brian, how are you feeling now? I definitely experienced the same thing as you.
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Avatar universal
I finished treatment just over a week ago. Went off for the EOT tests. I was stir crazy with the limitations on life and really ready to move on. Part of the trial was to do an EOT Fibroscan. The results were really positive. The Fibroscan results show a significant drop already down to 4.8 KPa. Amazing, since last year it was around the 5.8 KPa mark, three years ago 6.3 KPa. (The slight slow drop over 2-years was due to lifestyle, diet and herbs). So, I was mentally primed for a quick improvement...

Within a half a day of stopping treatment I felt the heaviness lifting from my chest. I could breathe more easily. I was less dizzy when walking. For the first few days I woke in up in the morning feeling like I was getting better and better. Then about 3-days into the recovery process I stupidly went for a gentle walk and bang! I realised the anaemia is still there, the battery power disappeared suddenly at the bottom of a small hill. By the time I got back to the top I was trembling, nauseous and pale. Had to lie down for a few hours. Too much too soon.

Since then I have been feeling pretty low. Borderline depressed and worried about when, or if, I will get better. I was quite clear-headed during treatment except for a short period when affected by insomnia. Now I am definitely fuzzy, demotivated, and irritable. While I was taking Ribavirin I wasn't irritable most of the time! My digestive system is whacky too. Things were flowing quite nicely from about the second month. Now I feel bloated and like my guts are going on strike. All this has been getting worse over the past week not better!

I know that I have to give recovery more time. I just didn't expect to start feeling like I am going backwards. I wonder what is actually going on? It is easier to cope with things that make sense.
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Avatar universal
Hi Brian,
I can't speak from personal experience yet. I still have 4-days left until EOT. Will find out soon. I have heard people saying it took varying amounts of time before they felt better.

Unlike the last time when I treated, I have been able to work the whole time - with a little understanding from colleagues. I would have liked to take a few weeks off but it wasn't a good time. No brain fog at all. Maybe felt a bit less mentally alert due to fatigue some of the time.

How did you feel before treatment? Is the fogginess worse? Two weeks isn't very long. There's so much going on mentally and physically when getting rid of HCV. More than just nuking critters in your liver!
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Avatar universal
well, after having an artery blockage and having it fixed in Nov 2014. . I was given the news 1 hour before being released from the hospital. Everything looks good, you do not have any heart muscle damage, but....."you have tested positive for Hepatitis C". I am/was 1B. My side effects were fatique and loss of motivation. Guess I"m more sensitive than others and I did not have to take RIBO with my V-Pak. My load was 5 million and I believe in 3 weeks it was undetectable. I still have to wait a few months to see if i have achieved SVR. My problem is I do have some post fatique and fogginess. AM i the only one, it has been two weeks off the V-Pak.
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Avatar universal
I was pretty scared too after the Interferon and Riba experience. So good that you could achieve SVR. I remember when that when things were bad enough just trying to get rid of HCV with little liver damage. The choices were far  tougher once cirrhosis set in. How's your recovery going?
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Avatar universal
I did have ribavirin and was scared to death as my hemoglobin dropped horrifically on Peg and riba. This time it dropped a little bit...not enough to make me feel it. I was a cirrhotic 1a and did 24 weeks in Turquoise II.
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Avatar universal
Did you have Ribavirin? I have been able to work the whole time during TX which was good. Certainly a breeze compared to Interferon. The trial nurse said the 1b's have no side effects.
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Avatar universal
Woo Hoo. I had no trouble with Viekira Pak and have been clear for over two years now.
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Avatar universal
Got my undy!

Baseline: 6,000,000
Week 2: 42
Week 4: 20
Week 8: ZERO ZERO ZERO!!!

I am starting week 10 tomorrow. Coping a bit better with the haemoglobin drop but can't wait until this is over now. Sides are mostly more of the same but manageable. Slightly sore joints, and muscles, weakness. From week 9 the dizziness (normal without swordfish trombones) has eased up enough to walk a short distance without feeling like I am going to roll into the gutter. To celebrate I took myself and my undy out for a banquet with friends.
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Avatar universal
Thanks Dee. Have seen it, but good to be reminded and good to share :-)
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317787 tn?1473358451
Hey there, thanks for updating!  I am so happy to see!  I found this article I hope might help you.  The new tx's aren't like the old ones where they wanted to you be UND by 4 or 8 weeks.  I don't know if you have seen this, I hope it helps you.

http://www.medhelp.org/posts/Hepatitis-C/HCV-UND---SVR-NEW-INFO/show/2527772
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