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6708370 tn?1471493810

Harvoni Treatment for Cirrhotics Complications

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
40 Responses
6708370 tn?1471493810
Oh, and the photo is a cormorant on a lake log with some turtles - just, cuz
683231 tn?1467326617
Hi Hepcandme

I just got Harvoni this morning after some difficulty with express scripts.

Kinda surprised at th eriba as that in not per the prescribing information sheet. I too had concerns about riba but mant here have assured me that it isriba with interferon that causes the problems and riba with say Harvoni is not as much of a concern I do still remain somewhay leary of riba but not as worried as I was before.

There is a small amount of data for Sovaldi relapse although not Sov/Oly here is a link:

http://medicalxpress.com/news/2014-11-sofosbuvir-ledipasvir-effective-hcv-genotype.html#nRlv


quoting from the link:

"The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 [who] relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease," the authors write. "Larger studies are needed to confirm these preliminary efficacy results."

My doctor hasn't said anything about a cooling off after Harvoni if it doesnt work for me but maybe that is a conversation we might have if we arrive at that point.

I believe AbbVie is expected to be approved on December 21 from what I have read. I can't find a specific link right now just references to the date.

I am still more impressed with Harvoni than Abbvie the numbers just come in a bit higher with for Harvoni for treatment experienced with cirrhosis for 24 weeks at 99-100% I feel pretty good about it.

Also the FDA just approved Sovaldi Olysio as an on label with 24 weeks recommended for patients with cirrhosis. Might have made the difference for me but when I treated the recommendation was 12 weeks only.

So I suppose that could be one advantage of waiting for more data to come in.

What ever you do good luck I will be starting Harvoni next week on Thurdsday

Lynn
6708370 tn?1471493810
So, just to be clear, you are taking Just the Harvoni, then? Without Riba?

I mentioned today, when the docs were reviewing with me my liver labs while undetected during S/O treatment (pretty much Normal! As in, the same as people with no liver disease!)  that I might have been cured if I had gone the full 24 weeks

Their response was - yeah, we believe that you're probably right

Sigh...the ups and downs of being part of the Big experiment but at least our chances are so much better than before - way better

Wonder how you are able to have the drugs available straight away in Seattle when there is a shortage here in SF - where they make Harvoni (South San Francisco or Burlingame or something? Maybe your insurance company was hoarding the drug or there is more demand here?

thanks for the link too
10175413 tn?1427173851
Hi there. You know when I went to treat I had asked my Dr about S/O and he was so against it because of all the resistance issues. I'm so happy I didn't do it. I understand the concerns you have about Riba rage, rash but this time I barely had any side effects that I wasn't able to manage. When I did triple therapy in 2012 I had a rash so bad it drove me nearly out of my mind. Later I found out it was the dreaded Incivek which has now been linked to Steven Johnson's Syndrome and other fatal skin issues. So I would give the Riba a chance and they can always lower the dose without compromising your chances of SVR if you show signs of anemia as they did for me. These newer drugs are so powerful no need to worry. That being said we are now witnessing the slow disappearance of the old school Tx which will include Riba. I'm just repeating what my dr has told me as I had your same concerns.
GILEAD is also working on a 4wk protocol for all GT's. I wish you the best of luck and sending you virtual hugs!
Take care
Deb
Avatar universal
Given how you must do it now, it sounds like a winning combo. Harvoni-(Ledi/solvadi) and riba. A friend at group took riba with solvadi for 24 weeks and cured. Could 24 weeks time be key on these treatments? Needing it now is going to influence your decision. AbbVie will start distributing a new drug on Jan 1 2015 as the Abb Pharm told me. It's supposed to cut cost. I wouldn't count on it because I just read that Gilead is trying to get them to stand down. It's a replica of Harvoni if my memory serves me right as per the Abb Pharm. I'll post more once I find out more in a couple weeks.
Granted S/O doesn't have 100% success rate but it's higher than past treatments. Anyway I can't see why that combo wouldn't work for you unless other factors prevent you from doing riba.
Avatar universal
I seem to agree with your doctors. Keep in mind there was all this hype every time a knew drug comes out or is about to come out and the real world results never end of being as great as the hype and more so in us with cirrhosis. Besides to many people give Riba a bad rap here. For those who are cirrhotic and failed S/O just doing Harvoni are taking a risk. The clock is running on us to be cured so don't let any "hype" cloud your thinking and listen to your doctor... Best to you.

BTW there is about a 300 post thread here before on what has been on the market. All one has to do is read it. Odd those folks aren't around anymore hyping for a reason.
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