harvoni sofosbuvir ledispasvir cirrhosis 12 or 24 weeks ?

[johnny679]

harvoni sofosbuvir ledispasvir cirrhosis 12 or 24 weeks ?
The vast majority of people who need this more urgent have cirrhosis or advanced scarring so  will insurance companies allow for 24 weeks at $ 189 000 USD ?
if the have failed previous treatment ?
Gilead recommend 24 weeks for cirrhotic previous failed treatment patients
I was accepted into a sofosbuvir ledispasvir trial I have not received results yet as I am in still in trial .
I have failed previous treatment telaprevir interferon ribavirin and have cirrhosis ,so what does that mean for me ?
Seems odd that they will only allow me to stay on meds for 12 weeks when it is obvious it would be much better for me to take these meds for 24 weeks and with cirrhosis not a time to be playing games with the possibility
of resistance if I fail and then I may not be able to treat for years which will be to late .
I wonder if I gilead would allow me stay in trial for a further 12 weeks , any thoughts , can this happen ? or should I just continue and just hope for the best seems I don't really have a choice anyway just seems odd all this time I thought 12 weeks was going to be for all regardless of history , cirrhosis , etc  

[flyinlynn]

Just released news FDA Approves Olysio-Sovaldi Hep C Combo

The FDA recommends 12 weeks of Olysio-Sovaldi for people without cirrhosis and 24 weeks of the combination therapy for those with cirrhosis.

http://www.aidsmeds.com/articles/Olysio_Sovaldi_approval_1667_26373.shtml

It is already on the Olysio Prescribing Information Sheet. I did not see that the Sovaldi infromation sheet has changed to reflect this update.

https://www.olysio.com/shared/product/olysio/prescribing-information.pdf

-----------------------DOSAGE AND ADMINISTRATION-----------------------
• One 150 mg capsule taken once daily with food. (2.1)
• OLYSIO should be administered in combination with other antiviral
drugs for the treatment of CHC infection.
• Recommended treatment duration (2.1):
• OLYSIO with peginterferon alfa and ribavirin: 12 weeks, followed
by 12 or 36 additional weeks of peginterferon alfa and ribavirin
depending on prior response status.
• OLYSIO with sofosbuvir:
o Treatment-naïve or treatment-experienced without cirrhosis:
12 weeks

[johnny679]

That's great news very happy for you also you give many of us hope  

[sue4hula]

Congratulations on your good report!  

[secondtimesacharm]

Hang in there. I failed my first time around too. Life sucked and so did my outlook.
I just went through the 12 week- pegintron-sovaldi and ribivirin.
Had same   type as you and a high viral count and I'm overweight. My chances were 75% and I found out today I won the fight.
Regardless of everything-stay positive and keep telling yourself from your soul that you are going to beat this ****.

[johnny679]

I am in trial sofosbuvir/ledipasvir , harvoni  for 12 weeks .
I do have cirrhosis and I have failed peg ribavirin and telaprevir .
I wish I could treat for 24 weeks but I have no choice in this matter as I am in trial .  I was slightly detected at week 4 <15 detected , my week 8 result came back undetected .  I just hope I don't relapse as soon as I stop treatment , 86 % does sound good but I think my chances are closer to
70 % as  I have all going against me , genotype 1a , started high viral load  , failed treatment plus PI , cirrhosis . The only factor I have in my favour is that I am slim ,  that extra 12 weeks treatment total 24 weeks would be great , but I don't think they would extend my trial .

[HectorSF]

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HARVONI® safely and effectively. See full prescribing information for HARVONI.

HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use
Initial U.S. Approval: 2014

-------------------------------INDICATIONS AND USAGE-------------------------
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults

------------------------DOSAGE AND ADMINISTRATION-----------------------
 Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food (2.1)

Recommended treatment duration

Treatment-naïve with or without cirrhosis: 12 weeks *
Treatment-experienced without cirrhosis: 12 weeks **
Treatment-experienced with cirrhosis: 24 weeks **

* HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL
.
**Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin.
------------------------------------------------------------------------------
Study ION-1: Response Rates after 12 Weeks of Treatment in Treatment-Naïve Subjects with Genotype 1 CHC with and without Cirrhosis

No Cirrhosis
12 weeks SVR 99% (176/177)

Cirrhosis
12 weeks SRV 94% (32/34)
------------------------------------------------------------------------------
14.3 Clinical Trials in Subjects Who Failed Prior Therapy

Study ION-2: Response Rates after 12 and 24 Weeks of Treatment in Subjects with Genotype 1 CHC with or without Cirrhosis who Failed Prior Therapy

No Cirrhosis
12 weeks SVR 95% (83/87)

Cirrhosis
12 weeks SRV 86% (19/22) (No better than current Sovaldi + Olysio treatment)
24 weeks SVR 100% (22/22)

If you are "treatment experienced" (peg-INF+RBV or with the addition of a PI) you MUST do 24 weeks of treatment as indicated in the FDA prescribing information document.

Hector

[keepingOnkeepingOn]

Everyone should be given S/O. It's the bomb. Treatment naiive or not. Has it ever been given to relapsers? It's $190,000 for 12 weeks 2 pills per day.

[patra_]

You are welcome but I meant every word of it and to so many others.  I aspire to help others the way I have been helped.  Each of us brings a little something different to the mix:  Website addresses so people can read studies, articles, reports for themselves, general knowledge, summation of what we have gleaned from the Forum form the experiences of wach of us, some over a number you years, and multiple treatments - things doctors don't, or don't know to tell patients.  What symptoms we have experienced, some very small but bothersome, some unusual etc., so people can feel either comfortable that what they are experiencing is a normal part of treatment, or something they need to pursue, either as an unusual side of hepc, or as something unrelated to the dragon.

Those things can make a tremendous difference in the lives of people!  It did for me.  I want to share that with others, so like you, SVR or not, I expect to be around the Forum in the future.

Sorry - I always just go on and on.  Don't mean to be so wordy - just am!

: -).  Pat

I just really wish some interning Dr, or nurse, or medical researcher, would do a study of all the protocols, and all of the sides we list on here so somewhere ther would be a Study, Report, whatever, documenting everything - something that patients - and maybe, more important, doctors could refer to.

[Dee1956]

I am so sorry to hear that you relapsed, it is really hard on the soul when that happens.  I hope you can get the new tx asap.

[Dee1956]

Thank you so much!  That is the nicest thing anyone has ever said to me.

I was helped so very much when I first came here alone, afraid, feeling very isolated. I only knew one person who had HCV and she had failed tx 3 times. That was back when they kept treating with same thing expecting different results. This forum helped me get back up after relapsing.

While I have been cured for 2 years, I, like many others on here are helping others behind us as we were helped when we first came here.  Paying it forward.  One person on here said we are standing on the shoulders of giants who came before us.

The others are much more knowledgeable than I am, I just have my experience to share.
Thank you again
Dee

[patra_]

And you are one of thereasons we are stronger than we think!  Your counsel and support has been a blessing to me, and to all of us.  Thanks!  Pat

[Dee1956]

You are so right, we are all stronger than we think we are.
I pray that all of you will get to SVR.
After failing a tx I was very lucky to get to SVR with Incivek, Peg, Rib 2 years ago
I had the beginning of cirrhosis and was treated for 24 weeks.
Others had to do 48
New meds are supposed to be much easier though they come with sx, just not as harsh
Good luck to you all :) Dee

[patra_]

I am on a 24 week protocol right now (Sol/Riba) - not the same as you had, or are talking about, BUT, trust me on this, the 24 weeks is flying by.  I really expected time to drag for the tx period, but that has not been the case and I have had the extreme fatigue.

It is my understanding that the new combo (Sol/Led) has less sides than all previous meds.  YOU CAN DO THIS! Or anything else you have to.  You are a part of this community of heppers who, by coming together and sharing knowledge, caring, concerns and questions/answers, make each of us stronger and more empowered, because, as a group we are strong!  I really like what neptune said, If I have to do treatment again (in my case, PROBABLY Sol and daclatasvir as I am Gt 3), I, too, will be able to do it standing on my head (or, IF I have to, laying in my bed), to get rid of this disease.

You are stronger than you think!  Praying for SVR for you - and all of us - now, but if now, it is truly comforting to KNOW there is an even better alternative out there.  

Hang in there, one step at a time!  Pat

[flyinlynn]

Fred
24 weeks not 24 months
Just 6 months limited sides what other choice do we have?
Beats dying from liver disease

48 yeah sorry typo relapsed after Sovaldi Olysio hoping to be treated with Harvoni for  24 weeks as soon as possible

Lynn

[neptune235]

Sending good thoughts for success your way, Fred.  Interferon is largely now, and soon will be universally, a relic of the past.  I'm hoping your side's are tolerable, and I think (read hope like h*'ll) I can do 24 weeks of Harvoni standing on my head.

Cheers,
--Paul

[FRED220]

Everytime I read post of  members like you that have been treated so many times and failed I pray for me to have the courage you all have,  I am a big chicken when it comes to meds. I am currently on  S & O  and it was really hard to start, dont want to think of failing and having to treat for 24 months, I hope I reach SVR.  

[neptune235]

ION-2 data showed a 4% relapse rate for tx-experienced cirrhotics for 12 weeks of Harvoni.  For 24 weeks, there was a 0% relapse rate, meaning a 100% SVR rate.

Fred220, I've failed tx 5 times. Interferon + Rib, peg-interferon + Rib, daily Consensus interferon (Infergen) + Rib, peg-interferon + Bocepravir + Rib, and most recently, peg-interferon + Sovaldi + Rib.

Personally, I'm going to fight like h*'ll for the 24 weeks.

[johnny679]

I am in a 12 week trial with sofosbuvir ledipasvir with cirrhosis previous treatment failure so if it fda approved at 24 weeks for tx - experienced cirrhotics. why I am in a 12 week trial . I am going to ask them to extend my trial I highly doubt they will but will try it does not make sense for me to only treat for 12 weeks when my chance of svr is about 70 % when if I treat for 24 weeks it will be closer to 90 % big difference .
Before anyone tries to correct me the reason I say 70 and 90 % is because we all know  svr will be less than in trials it always is .

[FRED220]

I think if you where treated with S & O and failed then it would be 12 weeks for cirrhotics. If you were treated with a PIs + inter and riva or peg/inter/riva then its 24 weeks,  thats what I understood.

[neptune235]

The recommendation in the FDA approved package insert says 24 weeks for tx - experienced cirrhotics.  The way I see it is that anything less would violate the FDA recommendation.

I don't think that ultimately the insurance companies can legally do that.  "I don't want to" is not a position they will be able to justify. They may try, so I'm gearing up for a fight.

I'll bet any lawyer would agree.

[johnny679]

I cant believe that most people who really need this will end of costing insurance companies etc $ 189 000 usd for a 6 month course

[johnny679]

Looks like gilead is even more expensive than olysio and solvadi combined

[48weeks]

Hello Lynn
Did you mean to say you relapsed on Sovaldi+Olysio, or did you relapse on Sovaldi+Ledipasvir?

"I sure hope my insurance will be ok with 24 weeks. I am also 1a cirrhotic and relapsed on 12 weeks Sovaldi Ledipasvir after completing treatment in June"

[flyinlynn]

Hi Johnny

I have seen for the ION 2 study which included 20 % patients with cirrhosis the results were 86% SVR and 99% for those participants. Gilead has also written in relapse patients no viral resistance to Sovaldi was noted so there's that

http://depts.washington.edu/hepstudy/presentations/uploads/121/ion2ledipasvir_sofosbuvir.pdf

Not sure how your trial would feel about changing you from your cohort but you could ask for compassionate reasons I guess never hurts to ask.

I sure hope my insurance will be ok with 24 weeks. I am also 1a cirrhotic and relapsed on 12 weeks Sovaldi Ledipasvir after completing treatment in June

It also says 8 weeks can be considered in treatment naive patients so there is the cost savings our insurance companies are looking for.

Good luck on SVR
Lynn