Harvoni Treatment for Cirrhotics Complications

[hepcandme]

Just returned from seeing my medical team about my new treatment with Harvoni. It's rather complicated so I am eager to hear what others have to say about the issues as I understand them.

Those cirrhotics who relapsed on S/O or were null responders are not part of the current approved group of people who can get treatment without going "off label". That is because, even though Gilead offers this to treatment naive and cirrhotic patients who failed under older treatments, those people who did not achieve SVR on S/O are in a new. much smaller class of people and there is currently no data to gauge the efficacy of the Harvoni treatment on them

My team is recommending that I do 24 weeks of Harvoni with Riba - with some additional caveats:

If I failed treatment at the end of next summer, I would be precluded from starting any new treatment for at least 6 months so this decision is really a one year commitment

Though Sovaldi seems to not create resistance issues, Harvoni may, so if treatment fails, I would never be offered Harvoni again (or Olysio for that matter)

There are new drugs on the horizon  - especially the new AbbVie regimen that might be even better than Harvoni. Don't know the exact date that it will be available but I am sure someone here does

http://www.techtimes.com/articles/8523/20140615/fda-approves-abbvies-hepatitis-c-regimen-for-priority-review.htm

There Will be data in February for those in clinical trials who belong to this sub-group - those who relapsed on S/O and tried Harvoni  - with/without Riba

Gilead has a backlog of orders for Harvoni and they can't make it fast enough to get it to patients. This could be a deciding factor, it seems. Kaiser will not begin treatment until one has a full 6 months of pills with your name on it ready and waiting for you to begin treatment

I have never taken Riba but remember reading posts from those who had a Terrible time with it and ended up in the ER with anemia or had Riba Rage and those who thought it was no big deal

Maybe I should just be patient and wait a few months?

I wanted to start Today but that is not possible. Does the fact that the Riba may give me a poorer quality of life during treatment supersede my wish to start right away?

It's easy for those who are not living with this illness to say, so, what's a couple of months? But if one's life is to shortened by the effects of living with Hep C, then 2 months is a big deal

Whew, can't wait to hear your responses. In any case, bottom line for those keeping score. I have been approved for treatment with Harvoni (one pill once a day) and Riba (5 capsules per day), my labs have all been ordered the first week of December, Gilead is trying to get enough Harvoni to fill my script for 6 months and there will be a final recommendation by the "team" in the next 2 weeks

[hepcandme]

And luck to you too Lynn

I certainly wouldn't relish another show down with your insurance company

Let us know how your treatment goes - I don't think I will start for at least a few more weeks

~ Linda

[flyinlynn]

Hi
Ribavirin is not on the prescribing information sheet so that does make it off label just as Sovaldi and Olusio's information sheets did not call out the other med. if you look at Olysio's sheet now it has been changed to include using with Sovaldi the FDA approved that use on 11/5 so Sol/Oly is no longer considered off label.

But if that is what your doctor feels is best and your insurance is ok I would go for it.

I just went 10 rounds with Express Scripts and am not up for another fight and anyway my doctor has not suggested Harvoni with Ribavirin.

But yes I have the bottle of Harvoni in my cabinet and am starting this Thursday for 24 weeks or 168 days should be done in early May.

Good luck on treatment
Lynn

[hepcandme]

Thanks Kim

Yes, I want to start treatment right away and if the Riba gives me an extra edge, then, great!

I am concerned about depression and rage (doesn't anyone ever call it irritability? Rage is such a strong word!)

I had a serious bout with depression but that was 25 years ago and I had a great shrink and took all the usual anti-depressants and then, suddenly, I was fine and I have never experienced depression again

The thing that always worries me is that I won't be able to work because I really enjoy what I do and laying around in bed for days on end feeling miserable sounds just awful.

Still, I am grateful that we're not even discussing Interferon because I would not take that. I just wouldn't. Killed a friend of mine 2 years ago

So, I'm just going to suck it up and take the Riba. It's encouraging that some people didn't seem to have such a hard time with it and I'm sorry that you did

I would say, for the most part, my treatment with S/O was completely bearable.

Funny how, when they review the side effects for Harvoni, it's fatigue, headaches, insomnia, dry mouth. I said, oh, you mean the usual?

Still haven't had my little "talk" about the Riba though

[Livelife777]

Bottom line Linda is do you feel comfortable with the added Riba?  Will tell you what I would do, but I am somewhat of a risk taker and at times it wasn't always the best strategy.
I would take this Harvoni/Riba combo in a flash.  The waiting for me personally would be unbearable.  As I'm supposedly early cirrhotic, becoming decompensated would be a big concern.  Kinda both in the same boat.
As a geno 2, my Tx was Riba/Sovaldi for 12 weeks.  I do believe from what you've said that you would be taking 1,000 mgs of Riba.  I'm 110 lbs and 5'3 and was given 1,200 mgs.  The Riba is weight based, and that was alot for my small frame.   When I questioned my Dr about the high dosage, they commented that the added 200 mgs would knock the virus right out.  They were accurate as I was UND at 2 weeks and have remained so since Jan 15 of this year.
Not going to lie, as it was a little tuff.  But would not hesitate for 1 second if I had to do it again.  With Riba I was a hot mess emotionally, but other then that fatigue was my only complaint.  Didn't get the rashes and nausea or the other issues the Olysio folks suffered.  Wish I had asked for an antidepressant, and then I would have been fine.  Never had taken them before and had no idea what depression and rage felt like.
So all that being said, I would go for it if it were me.  I do believe as everyone else has pointed out, the interferon and Riba sounded brutal.  I do think the Riba alone, with 1,000 mgs instead of 1,200 would be worth the the payoff.
As far as Hmg, the lowest mine went was 10.3.   Very doable.
I'm super excited for you regardless of which way you go.  In the end I just want you to be free of this devastating illness.
Take care
......Kim

[hepcandme]

You mean, adding the Riba makes it off label? Or failing S/O makes it off label?

You're still starting the Harvoni, right?

See, haven't even begun treatment and I'm all confused

~ Linda

[flyinlynn]

I spoke with Express Scripts. For them it would be off label and would require another approval and appeal.

Sigh just not up to it again I will just hope I fall in the correct data point after 24 weeks of Harvoni. Per the ION 2 trial the group for previous non responders with cirrhosis (all 22 of them) made SVR for 100% so I hope tat stat holds

Lynn