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5080348 tn?1416844854

Viekira Pak (in trial / during it went FDA approved)

Just giving back to the forum where it all started for me.

Geno 1b, non-cirrhotic, treatment naive

October 30, 2014  I went on 12 wk clinical trial study of AbbVie Topaz II without Ribavirin
It was 2 pills to be taken twice daily, 12 hours apart with food.
1 pill combo was  > ABT450 (Paritaprevir ) / Ritonavir / ABT267 (ombitasvir) for a total of 150mg/100mg/25mg daily
1 pill was ABT-333 (dasabuvir) for a daily total of 250mg

At 2 wks undetected (11/11/2014)
At 4 wks undetected (11/25/2014)
On December 19, 2014 this trial became FDA approved. Name issued is Viekira Pak
At 12 wks undetected (01/21/2015)
On February 17, 2015 I went for my 4 week lab after last pills taken.
The results are not available to me yet as of this writing.

Because of my participation in this trial study prior to FDA approval, I am still obligated to the guidelines at start.

1) Everyone views my labs before my Hepatolgist or his Study Coach. Which means AbbVie looks first. Which did mean my own anxiety level increased while waiting. But, at most 10 days.
2) During my trial I was called once a week from AbbVie by their own study coach.
3) EOT AbbVie will now call be every 2 weeks for 6 months. Then will decrease to 1 call for per month and then 1 call every 3 months and so on.
It is good that I will be monitored for 5 years post and will be able to report with my SVR success.

SIDE EFFECTS:
Fatigue:
None for the first 3 wks. towards the 10th week it was noticeable that I was tired.
I do not work outside the home. I did although, keep up with chores like laundry, dusting, vacuuming, cooking meals, (including 2-bake sales), washing dishes, pet responsibilities and grocery shopping. I also read some books, crocheted, built jigsaw puzzles, played computer games and rode my recumbent twice a week.
I paced myself as I chose to, I did notice that the busier I was for the day, the more relaxed I slept at night.
During the first 5 wks of eating food with the pills, I had some weight gain. It took some adjustment to organize meals within the 12 hour intervals. At about week 10 I did feel "full" and experience a slight lack of appetite.

Pill Burden:
Well it may be the case, that some would rather take 1 pill daily. Some also juggle more pills daily because of other health issues. To me, To achieve SVR ? I did not feel burdened. Also, being treatment naive, I do not know what other treatments are like. Taking 2 pills, twice daily... was not a burden.

Well, that's it.
I wish all success at achieving SVR and like myself maintaining!  

5 Responses
Sort by: Helpful Oldest Newest
Avatar universal
Congrats on finishing treatment. Now on to SVR.

My very best to you.
Helpful - 0
10175413 tn?1427170251

Well that is terrific news!  Good to hear the positive posts. Wishing you the best on your new HepC life!

Debb
Helpful - 0
Avatar universal
Obviously so worth a few pills a day.
Wishing you much success attaining SVR.
Thanks for sharing
......Kim
Helpful - 0
Avatar universal
Sounds like a great treatment!  Thanks,for,sharing!
Helpful - 0
4670047 tn?1375730401
Really happy for you!!! :)   Bring on the SVR!!

Kitty
Helpful - 0
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