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

[pooh55811]

I have a problem posting the link because I am logged in and when I type in clinical care options, it will always have me logged in (even if I log out).

I would suggest typing in clinical care options and do a google search. When you get to their webiste, you have to register, but it is free.

Then search for Hepatitis C conference coverage 2014. You want the AASLD conference coverage. Then search for capsul summary. The go to the capsule summary entitled:

"Ledipasvir/Sofosbuvir Regimens Highly Effective, Safe, and Well Tolerated in Patients With Genotype 1 HCV and Compensated Cirrhosis"

Wish I could give you a direct link, but that is the best I can do.

Maybe someone else has a direct link.

[jules2551]

Pooh thanks for posting the information.  I've been reading up on this and I guess I am in the Harvoni + Riba camp for 24 weeks.  And I really love the 100% SVR #.  Surely this new tx can't be as bad as the VIC, Riba, and INF.  Time to bring it on!

Jules

[AWorriedMom]

Hi. I did not read the whole thread so please forgive me if I repeat what others have said. I did not do Sovaldi so can't make a comment on that part of your question. I can only share my treatment experiences.

I treated numerous times, the first being in 1992 with intron A. Every time a new drug, or a new type of interferon was approved, I tried it. I even tried thymosin from South America,  with pegasys and ribavirin. I also did some of the interferon in doses that were 3 times higher than the recommended dose. I am a genotype 1a, cirrhotic, with long-standing infection (1966) and a previous null-responder, which not only means I didn't clear, but I never even had a two log drop in viral load. So you can see that I have never been a good candidate for clearing the virus.

I did the Abbvie turquoise trial and got the 6 month arm. In the latest report from AASLD, there were three things that made for a poor response....obesity, previous null-responder and TT genotype. While I am not obese, I can stand to lose 15 pounds and I am a TT and null-responder. My viral load was 7 million when I started.I was undetected rapidly and got my SVR last October. I had used ribavirin many times previously and the last time I ended up in the hospital with no neutrophils, a white count of .2 and a hemoglobin of 7.0. However, because there was no interferon in the turquoise trial, my hemoglobin stayed in the normal range.

My point in telling you my story is to say that I wouldn't be afraid of using ribavirin, and in fact, think it necessary for those of us who are very hard to treat. I also would seriously consider the Abbvie drugs since you have already relapsed on sovaldi.  That being said, there is a small study that showed previous relapsers to s/o  do respond to Harvoni. These decisions are never easy. I wish you lots of luck and an SVR.

[hepcandme]

"Highest SVR12 rate (100%) in treatment-naive and treatment-experienced patients treated with ledipasvir/sofosbuvir and ribavirin for 24 weeks"

So, this is the one that probably has the greatest chance of getting me to SVR

Pooh, can you send me the link where you pulled this information? It's very helpful and I would like to share it with my team and my friends and family whose eyes sometimes begin to glaze over when I am trying to explain this

Thanks for posting. I think it will be helpful for lots of people in this support group

[pooh55811]

This is from Clinical Care Options ..... Capsule summary:

Here are the most recent findings presented at the AASLD.

***** Note:  Highest SVR12 rate (100%) in treatment-naive and treatment-experienced patients treated with ledipasvir/sofosbuvir and ribavirin for 24 weeks


Ledipasvir/Sofosbuvir Regimens Highly Effective, Safe, and Well Tolerated in Patients With Genotype 1 HCV and Compensated Cirrhosis

Summary of Key Conclusions

    High SVR12 rates with ledipasvir/sofosbuvir with or without ribavirin in pooled analysis of treatment-naive and treatment-experienced patients with genotype 1 HCV infection and compensated cirrhosis who participated in phase II/III clinical trials of ledipasvir/sofosbuvir
        Overall SVR12 rate: 96%
        High SVR12 rates observed in all patient subgroups
        SVR12 rate in treatment-experienced patients lower with ledipasvir/sofosbuvir for 12 weeks vs 12 weeks with addition of ribavirin or with 24-week treatment duration without ribavirin
    Safety outcomes in patients with cirrhosis similar to those previously reported for patients without cirrhosis
        Addition of ribavirin resulted in higher incidence of adverse events (AEs) and hemoglobin declines
        Albumin, ALT, bilirubin, and platelet count all significantly improved from baseline to posttreatment Week 4 with ledipasvir/sofosbuvir therapy

Background

    Interferon-free treatment options needed for HCV-infected patients with cirrhosis
        Cure rates with interferon-based therapy in cirrhotics reduced, tolerability poor
        These difficult-to-treat patients often underrepresented in clinical trials
    Combination therapy with fixed-dose, once daily, single-tablet, all-oral ledipasvir/sofosbuvir 90/400 mg a new treatment option for patients with genotype 1 HCV infection, including patients with cirrhosis
        Sofosbuvir: nucleotide NS5B polymerase inhibitor with potent activity against genotypes 1-6 HCV
        Ledipasvir: NS5A inhibitor with potent activity against genotype 1 HCV
    Ledipasvir/sofosbuvir combination approved by US Food and Drug Administration in October 2014
        Indication for cirrhotics is 12 weeks for treatment-naive and 24 weeks for treatment-experienced patients, both without ribavirin
    Ledipasvir/sofosbuvir, with or without ribavirin, previously demonstrated high efficacy in several clinical trials among patients with genotype 1 HCV infection with or without cirrhosis[2-6]
    Current study analyzed safety and efficacy of ledipasvir/sofosbuvir, with or without ribavirin, among patients with genotype 1 HCV infection and compensated cirrhosis included in clinical trials[1]

Summary of Study Design

    Treatment-naive or treatment-experienced patients with genotype 1 HCV infection and compensated cirrhosis who participated in phase II/III trials of ledipasvir/sofosbuvir pooled for analysis
        Studies included LONESTAR,[2] ELECTRON,[3] ELECTRON-2,[4] 337-0113, ION-1,[5] ION-2,[6] and SIRIUS
    Patients received one of 4 regimens
        Ledipasvir/sofosbuvir for 12 weeks (n = 118)
        Ledipasvir/sofosbuvir + ribavirin for 12 weeks (n = 204)
        Ledipasvir/sofosbuvir for 24 weeks (n = 133)
        Ledipasvir/sofosbuvir + ribavirin for 24 weeks (n = 58)
    Cirrhosis confirmed using 1 of the following
        Liver biopsy
        FibroScan > 12.5 kPa
        FibroTest ≥ 0.75 and AST/platelet ratio index (APRI) > 2 at screening

Baseline Characteristics

    513 patients included in pooled analysis
    Majority of patients were treatment experienced (69%)
    Fewer than 10 patients had international normalized ratio (INR) > 1.5, albumin  2.0 mg/dL at baseline

Main Findings

    Overall, 96% of patients with compensated cirrhosis attained SVR12
        High SVR results regardless of previous treatment experience, treatment duration, and inclusion of ribavirin
        Lowest SVR12 rate (90%) in treatment-experienced patients who received ledipasvir/sofosbuvir without ribavirin for 12 weeks
            12-week regimen with ribavirin had slightly higher SVR rates in this group
        Highest SVR12 rate (100%) in treatment-naive and treatment-experienced patients treated with ledipasvir/sofosbuvir and ribavirin for 24 weeks


There is more in this capsule summary but it is in charts and graphs and won't copy and paste well.

[hepcandme]

My team includes Dr. Terrault from UCSF. (Hector's doctor) who we all know is The Best. It seems the Kaiser docs are working better as a team with the transplant center. More so than a year ago when I started this journey and kept demanding that I be seen by a Hepatologist.

All the docs here went to the Liver Conference and they kept referring to my case as unusual because I am "difficult to treat". Though I can think of a number of friends in this group who could probably also be labeled as such.

I am still compensated, however, and some of the worse symptoms that I had last fall - ascites, edema, pruritus and insomnia have gone away

I actually feel pretty good lately

So, leaning towards going with the Riba but here's a few practical questions for those who have taken Riba.

If you have to take a med 5  times a day, you're pretty much taking a pill every couple of hours, right? Seems much easier to miss one or at the end the day say, uh oh, I have 2 Riba left. Much easier to take 1 Pill at the same time every day. Also, I don't know what the Riba pills look like (I think they are capsules) but I can see getting really tired of swallowing them 5 times a day for 6 months. I feel kinda nauseous just thinking about it. Definitely am not a pill person - even worse with capsules but everything I take now is a teeny tiny pill (vitamin B12 and Spironolactone)

My team said they would only reduce the amount of Riba if I had an adverse reaction. Otherwise, why not start on 3 a day? Since Riba's "job" is to kill red blood cells, that sounds like some serious chemo to me

Yes, I am still working and that is another concern. My job is very rewarding and I have a big event in May that requires a lot of energy and time. I pulled it off last year while undergoing treatment with no problems

Thanks to everyone for your input