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

[Dee1956]

Up above I had given a link to a new study presented in Boston, I thought I would just cut and paste the pertinent part. This is brand new information that just came out Nov 11th.

Study GS-US-337-0121 (Late Breaker Oral #LB-6) evaluated 155 genotype 1 patients with compensated cirrhosis who had failed prior treatment with pegylated interferon (PegIFN)/RBV and subsequently PegIFN/RBV plus a protease inhibitor. In this study, patients were randomized (1:1) to receive Harvoni plus RBV for 12 weeks or Harvoni alone for 24 weeks. Ninety-six percent (n=74/77) of those receiving Harvoni plus RBV for 12 weeks and 97 percent (n=75/77) of those receiving Harvoni for 24 weeks achieved SVR12.

In a second study (Oral #235), 51 genotype 1 patients who previously failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment regimen received Harvoni plus RBV for 12 weeks. Twenty-nine percent of study patients (n=15/51) had cirrhosis. Ninety-eight percent (n=50/51) achieved SVR12 following 12 weeks of treatment with Harvoni plus RBV.

In all of these studies, Harvoni was well tolerated and its safety profile was generally consistent with that observed in clinical trials of Harvoni. Adverse events included fatigue, headache, nausea and anemia, which was more common among patients taking RBV. Grade 3/4 laboratory abnormalities were infrequent and included decreases in hemoglobin, which is consistent with RBV-associated anemia.

The safety and efficacy of Harvoni have not been established for the investigational uses described above.
- See more at: http://www.gilead.com/news/press-releases/2014/11/gilead-announces-harvoni-study-results-in-chronic-hepatitis-c-patients-with-advanced-liver-disease-and-those-who-failed-prior-treatment#sthash.zrQbsRVK.dpuf

[Dee1956]

Hi I think that it is called Riba Rage because it sounds better than Riba Irritability.
I was iritable the first time I did a 48 week tx of Interferon, Riba and a polymerase inhibitor.
The second time I did the Incivek, Riba and Peg, it was weight based so I only had to take 800 mg a month of the Riba and 135 of the Interferon but the Incivek was a real game changer for me. I didn't relapse like the first time and I am grateful to be cured.

I think you should do what ever your doctor is recommending.  It is almost funny, when I treated I thought everyone said it was the interferon that gave such a bad reaction, maybe it was a bit of both.
I don't really know.
I wish you and everyone else doing the tx the very best
Dee

[nan535]

You have the right attitude. Thankfully, so does my husband.  I don't wish this on my worst enemy. Keep up the good fight.  Praying that you reach SVR12.
Best wishes,
Nan

[AugustineMama]

I don't know about everyone else, but I would do anything to get rid of this monster. I am now in the waiting game after s/o. My head is clear and I feel much better than I have in years. Hopefully, that is a good sign. Either way, I said I would not, but I will do it again. I have cirrhosis and all the ugliness that goes with it, HE, splenomegaly, neuropathy, varices and am at a transplant center now. Whatever I have to do I will.

[nan535]

I am excited for you!
I know this treatment will finally rid you of this monstrous virus.  Here is a quote from Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences (after recent Liver Meeting, 2014)
"Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options. The data presented this week demonstrate that Harvoni provides high cure rates for patients with advanced liver disease, as well as for those who failed prior treatment with other antivirals, including sofosbuvir-based regimens."

Read more about the data presented here:
hepatitiscresearchandnewsupdates.blogspot.com/2014/11/gilead-announces-harvoni-study-results.html

My husband is seeing his doctor on Friday. If you recall he is a post liver transplant patient with severe recurrent Hep C and now has symptoms of decompensated cirrhosis again.  He suffered through 6 months of Sovaldi and Ribavirin with ongoing bouts of HE throughout treatment.  Based on what I learned in the webinar presented from the Liver Meeting on November 9, 2014, the trial data showed of those post transplant patients who were treated with  Harvoni + Ribavirin for 12 weeks (with CPT B)  85% achieved SVR12 results and of those who treated 24 weeks  83% achieved SVR12.  So basically there was no difference between treating 12 or 24 weeks.

Needless to say, we are not thrilled at the prospect that he will need to treat with Ribavirin again.  We'll see what his doctor has to say. Given his prior treatment failure, I expect him to have to treat for 24 weeks again.

I wish you the very best results with this new treatment. I think your doctors are right to treat you for 24 weeks given your treatment history.

Nan

[can-do-man]

Just thinking out loud here. My guess would be the reason adding Riba is not on the prescribing information sheet is because when it was submitted to the FDA for approval these latest facts were not complete. Therefor they can only include what was given to the FDA. This is just one reason why as patients it is important to go to well informed Hepatologists if possible. They keep up on all these things as with other doctors they just go by the label.

hepcandme, yes you are being treated by one of the best and most informed doctors out there. Best to you.