Author Topic: Doctor says no to another 12 weeks of Sovaldi and Olysio (Read 27131 times)

Rubye · « **on:** December 01, 2014, 08:29:36 pm »

I asked my doctor for another 12 weeks of Sovaldi and Olysio because I have read on the forums that if you have cirrhosis you should do 24 weeks of treatment with these drugs. However, I can't find where the AASLD says this, only where people in forums say the extra 12 weeks are necessary. My doctor said that with only the 12 weeks I have a 93% chance of reaching SVR, but I can recall seeing only 86% odds elsewhere. I think in the COSMOS studies.

Should I just let it go and be grateful for the 12 weeks I have or fight for more time? I was not undetected until my 8th week and I do have cirrhosis.

BattleTheBeast · « **Reply #1 on:** December 01, 2014, 10:19:38 pm »

I think I already posted the study link here with all the results and recommendations. I can also ask my ID to email me a copy of that presentation he reviewed with me from the conference in Boston in November. It's definitely recommended but it's also based upon your starting VL if it was under 6,000,000 Cirrhosis or not it's 12 weeks VL starting over 6,000,000 it's 24 weeks with cirrhosis

That's what I paid closest attention to when we reviewed it because it impacts me since my starting VL was 8.3 Million.

~Mel~

Bucky · « **Reply #2 on:** December 01, 2014, 10:39:49 pm »

Quote from: Rubye on December 01, 2014, 08:29:36 pm

I asked my doctor for another 12 weeks of Sovaldi and Olysio because I have read on the forums that if you have cirrhosis you should do 24 weeks of treatment with these drugs. However, I can't find where the AASLD says this, only where people in forums say the extra 12 weeks are necessary. My doctor said that with only the 12 weeks I have a 93% chance of reaching SVR, but I can recall seeing only 86% odds elsewhere. I think in the COSMOS studies.

Should I just let it go and be grateful for the 12 weeks I have or fight for more time? I was not undetected until my 8th week and I do have cirrhosis.

I think that it was the FDAs guidelines wasn't it?
Bucky

Bucky · « **Reply #3 on:** December 01, 2014, 10:40:47 pm »

Mike,
Could you help us out here.
Bucky

Rubye · « **Reply #4 on:** December 01, 2014, 10:50:13 pm »

Oh wow Mel, that's really good news cause I was only at 2.5 million.
I've just heard a lot of people say that if you have cirrhosis and were still detected at week 4 you should do 24 weeks of S/O according to the AASLD. I'm just so disoriented and spacey today that I can't find the link for the life of me. Plus, I keep getting this forum confused with another one.
Lots of fog. Smiling through it though.

For some reason, intuitive?, I just feel like I need 4 more weeks. I seriously doubt that I'll have another chance to treat because of my medicaid.

Thank you for your support.

Rubye · « **Reply #5 on:** December 01, 2014, 10:52:37 pm »

Ah Bucky, maybe that's why I can't find it. Duh.

lporterrn · « **Reply #6 on:** December 02, 2014, 12:14:32 am »

The problem with the COSMOS study is that the # of subjects was very small, so it makes big swings in the percentages. Here you go:
The recommended treatment duration of Olysio with sofosbuvir is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis.

http://www.drugs.com/newdrugs/fda-approves-olysio-simeprevir-combination-sofosbuvir-genotype-1-chronic-hepatitis-c-infection-4107.html

Here are slides: http://depts.washington.edu/hepstudy/presentations/uploads/82/cosmos.pdf

Rubye · « **Reply #7 on:** December 02, 2014, 12:42:00 am »

Thanks for these Lucinda.
I suppose another one of the factors that causes me to be concerned is I was positive for Q80K. That, plus, I've had such a hard time with these drugs that it makes me wonder. What will be will be.

BattleTheBeast · « **Reply #8 on:** December 02, 2014, 04:48:46 am »

Thanks so much Lucinda, I had the report from Harvoni mixed up with the one for S/O. Harvoni recommendations discuss VL

Here's the Harvoni information I found:

http://depts.washington.edu/hepstudy/presentations/uploads/103/pptx/ledipasvir_sofosbuvir_master.pptx

It can all get confusing especially with my slightly muddled brain

~Mel~

Lynn K · « **Reply #9 on:** December 03, 2014, 04:14:04 am »

Sovaldi Olysio was originally off lable usage and per the AASLD guidelines it was recommended for 12 weeks. Meanwhile Olysio asked the FDA for approval to allow Olysio to be prescribed with Sovaldi. That was approved by the FDA and now the current packeg insert for Olysio includes the updated prescribing information.

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
o Treatment-naïve or treatment–experienced with cirrhosis:
24 weeks.

Show that to your doctor it comes in every package of Olysio

Good Luck
Lynn

Rubye · « **Reply #10 on:** December 03, 2014, 11:23:43 am »

Thanks Lynn. They already know. They just don't want Oregon to have to pay any more money. I have Medicare with Medicaid and the doctors here are more concerned about the state money than they are about patients. I was actually very fortunate to get what I got.

Lynn K · « **Reply #11 on:** December 03, 2014, 03:08:32 pm »

Sorry to hear that guess they want to spend money twice if their gamble doesn't work. I hope the 12 weeks work for you and you don't have to fight to get approved for Harvoni for 24 weeks if you relapse like I did after 12 weeks Sol Oly. I'm GT 1a, prior null responder, with cirrhosis.

Man makes my blood boil how stupid they are......

Good luck hope you make SVR the odds are still in your favor for a good outcome.

Lynn

Rubye · « **Reply #12 on:** December 03, 2014, 04:35:53 pm »

Thanks Lynn. It took me awhile to realize that the bottom line is politics and money and nothing to do with patient care. So, it's not that they're stupid but rather that they are political beings rather than caring beings. People in poverty have never gotten decent medical care on anything other than a very basic level. That's why we have the ACA. Problem with that is people get to have insurance but no one will take their insurance. There's simply no access to care and this is a prime example.

UndetectableC · « **Reply #13 on:** December 03, 2014, 05:16:20 pm »

Quote from: Rubye on December 03, 2014, 04:35:53 pm

Thanks Lynn. It took me awhile to realize that the bottom line is politics and money and nothing to do with patient care. So, it's not that they're stupid but rather that they are political beings rather than caring beings. People in poverty have never gotten decent medical care on anything other than a very basic level. That's why we have the ACA. Problem with that is people get to have insurance but no one will take their insurance. There's simply no access to care and this is a prime example.

I totally understand your frustration with the system. I was denied for years until one day I wasn't denied. That was a bittersweet & scary day. We are very fortunate to have made it this far with these new drugs in our hands. We have to have faith right now that we'll fall into the larger, successfully cured percentage. It's a good bet. I'm rooting for ya.

Rubye · « **Reply #14 on:** December 03, 2014, 09:02:17 pm »

And me for you UndetectableC.
I am out-of-this-world grateful and lucky that I have the wherewithal to understand the system.

sunrise · « **Reply #15 on:** December 03, 2014, 09:32:17 pm »

Hey Rubye
I asked my doctor last night about this. He said first off that cirrhotics are harder to treat. That is why they do longer treatment. I had a vl load of 5 million at dx in June at stage 1 inflammation. I got 12 weeks of s/o. My vl load was undetected at 4 weeks and enzymes dropping consistently down to 17 ,13 from originally 46, 25. So I would tbink tbat if you have cirrhosis you should be adamant to doc about this.IMO

Rubye · « **Reply #16 on:** December 04, 2014, 01:16:35 am »

Honestly, I think I would have to get an attorney to make any difference.
I agree with you and I'm still waiting to hear back on my second request for only 4 weeks. At the clinic, I go to you don't get to ever talk to the doctor or even the nurse, only medical assistants--the gate keepers. Sad but true.

Lynn K · « **Reply #17 on:** December 04, 2014, 02:19:58 am »

Another possibility could be to suggest you are considering going to the news media. I did that with express scripts I said I was frustrated to the point of contacting the media to bring to light their cavalier and indifferent attitude towards their customers and their health. The next day they contacted me to ask where to send my meds overnight express.

I know that would be a bold move and very brave, but it is you and many others you would be fighting for. Also if treatment doesn't work because they don't follow the current FDA recommendations they will have to pay again so long run costing more by taking half measures now with you and patients like you.

Good luck
Lynn

sunrise · « **Reply #18 on:** December 04, 2014, 06:08:24 am »

Wow Lynn that is a bold move. I give you props for being so brave. You did the right thing. I wonder why Rubyes doc wouldnt follow protocol. So frustrating...

Lynn K · « **Reply #19 on:** December 04, 2014, 06:25:40 am »

Hi sunrise
What happened was I found a site from express scripts where they had a peer to peer article about how to reduce hepatitis C relapse. I decided I would like to make a comment on their article. I had to register with my email address to be able to post to the site. My question was how is Express scripts best serving the client with cirrhosis who was just denied a prescription for Harvoni. Because of the way the message was set up they didn't have my direct contact information. So they posted a message after my comment asking me to contact them in an email address. The next day I wrote a long email describing my medical situation. That was when I added the remarks in my closing comments implying that I was considering contacting my local media. They had also asked for my direct contact information which I provided in that email I said I would be available after 10 am PST the next morning. I was quite surprised when they called me at 10:01 the next day.

So not a real risk exactly maybe just a forceful message delivered to the people who could actually get something done. Prior to that I have been bounced back-and-forth from one service rep to another service rep who didn't even know how to pronounce the names of the drugs.
But any way it worked and I just received my second bottle of Harvoni today.

sunrise · « **Reply #20 on:** December 04, 2014, 09:05:41 am »

Its good to see that advocacy in helping yourself and others. I would not be surprised if you helped change their protocol in treating hep c. Rubye I hope you can straighten this out. Have you gotten a 2nd opinion?

BattleTheBeast · « **Reply #21 on:** December 04, 2014, 09:26:01 am »

Rubye,

Stay Strong! You can handle this little bump in the road, just call your insurance company and ask where to go for a second opinion. Even with Medicare they have to have that available!

You can do this, remember we have to advocate for ourselves and no one is going to be as effective as we are for ourselves!

Just so you know you aren't alone, I am sitting on HOLD for the 3rd Time in 3 days trying to get my new Harvoni prescription straightened out. First it's good, then they need to talk to the dr again, then they can't get the dr, then they did, then they didn't. All in 3 days! I am not hanging up until I get a straight answer and a delivery date! Have to love Accredo!

Ok latest is now the Harvoni is NOT approved. I guess it's going to be a long day of phone calls

M

sunrise · « **Reply #22 on:** December 04, 2014, 09:29:19 am »

Hi Mel
Did you get you 8 week vl bloodtest?

Rubye · « **Reply #23 on:** December 04, 2014, 01:58:23 pm »

Lynn, I did almost the same thing. I left a comment on an article in the Portland paper about the new Hep C drugs and the Oregon Health Plan. The reporter contacted me and did an article about my position in this mess 3 months ago. I don't think this is what helped me to get the drugs in the first place but it certainly didn't hurt. The thing with giving myself to the media is I felt quite raw and exposed because the reporter said that I had been a counter-culture IV drug user and then went on to name a couple of the places I had worked at. I've kind of been shunned by the people in my apartment building since then but that's really no big deal. When I told the reporter I got HCV from drugs I didn't know he was going to tell the world, thinking he would run the article by me before publishing but no. I could still use him to get this new message out but I really do not want to.

I did receive a letter from my doctor today and he said that he is aware of all the AASLD stuff since they were all there (kind of a shot at me for quoting AASLD I guess) but the problem is because the AASLD has not added 24 weeks for those with cirrhosis to their guidelines yet, the insurance would not pay because they use these guidelines as their basis for denials. He also said we could go for a couple of these denials and then seek funding but odds are we would run out of time since my 12 weeks is up on December 17.

I am okay with all this because although last week I was good I feel like crap again today. Possibly from the stress of all this but who really knows. I am okay going with my 12 week odds as good, or as bad, as they may be. 4 out of 5, rather than 1 out of 5, kind of like the glass being half full.

Anyway, thank you all for your support. I appreciate all of you so very much and hope everyone reaches SVR soon.

Bucky · « **Reply #24 on:** December 04, 2014, 02:17:06 pm »

Hi Rubye,
My last few weeks I had up and down days. I was actually glad to finish the S&O and see what happened. Of course this was before the FDA guidelines came out but I tried to put a positive spin on it for my own peace of mind. I did what was thought to be correct at the time and if I were to relapse then that will be my argument for 24 weeks of something. I would not be at all surprise if the guidelines for all the med combinations aren't revised as time goes on. We are still in a big learning curve against the Dragon but we now have many swords.
Bucky

BattleTheBeast · « **Reply #25 on:** December 04, 2014, 02:49:05 pm »

Quote from: sunrise on December 04, 2014, 09:29:19 am

Hi Mel
Did you get you 8 week vl bloodtest?

I will get my blood test done next Wednesday, I will actually be at 9 weeks but it's all good. Just need to win the battle, none of these really matter anyway. I feel like the meds keep the numbers down, it's what happens after the meds are gone that counts. Waiting to see if that one tiny little cell is left and replicating itself at 26 weeks after....

Still fighting the Harvoni battle, this is a total mess and my doctor was apparently yelling at the incompetence of Accredo on the phone with them this morning. He isn't happy with them at all! The somehow managed to Void out the approved script and are now making him go through all the paces again. He asked to speak to someone who knew what they were talking about, I wish I could have heard that conversation but his Assistance told me he was all over them.

Now we wait some more but meanwhile I will continue the S/O and the itchy rash....

M

sunrise · « **Reply #26 on:** December 04, 2014, 05:57:19 pm »

Well best of luck with that. I'm sorry you're still dealing with the rashes. Man, it really is sad what people have to go thru to get help. And what the heck. The media should protect folks that aren't hurting anyone, and not try to advance the stigma of hep c. Like it's not bad enough we have it sheesh...

Lynn K · « **Reply #27 on:** December 04, 2014, 10:24:35 pm »

Hi Mel
The email address I have that I actually got a live person and got approved right away was

ExpressRxHelp@express-scripts.com

The woman who fallen said she was an express scripts/accredo manager. My prescription drug coverage is express scripts but they have Accredo handle the speciality pharmacy. Even if that is not correct exactly for your situation they maybe able to get you in touch with the correct people.
Express scripts has a face book page where they also list that address so it is kind of an open secret. Also some not so happy patients posting on their facebook page kinda surprised they even have the page.

Lynn

BattleTheBeast · « **Reply #28 on:** December 05, 2014, 12:10:56 am »

Thanks so much Lynn!! I will send an email tomorrow. I will also check out the Facebook page!!

~Mel~

Lynn K · « **Reply #29 on:** December 05, 2014, 12:30:22 am »

Here is the link read some of the posts and you won't feel alone having to deal with these people

https://m.facebook.com/ExpressScripts

BattleTheBeast · « **Reply #30 on:** December 05, 2014, 12:51:30 am »

Hi Lynn,

Just sent an email and will be calling again in the morning.

Thanks again for the info

~Mel~

Vicky · « **Reply #31 on:** December 05, 2014, 05:46:15 pm »

I got approval yesterday and will receive my meds on 12/12! I have read many, many of your comments and really appreciate your honest info and experiences, especially side effects. I am scared of the side effects since I went thru hell 3 times, and had no luck. I think that after that and cirrhosis and liver cancer and a liver transplant, this ought to be a piece of cake! Thanks to all!
Has anyone gone on harvoni after a transplant?

BattleTheBeast · « **Reply #32 on:** December 05, 2014, 06:14:09 pm »

Welcome Vicky!

Congrats on your medication approval! It sound like you have quite the story to tell and are one strong lady, I am in awe and this is going to be a cakewalk for you!

You can do this!

~Mel~

Vicky · « **Reply #33 on:** December 05, 2014, 07:12:14 pm »

Thank you for your encouragement!

Lynn K · « **Reply #34 on:** December 05, 2014, 08:09:28 pm »

Any news yet Mel?

BattleTheBeast · « **Reply #35 on:** December 05, 2014, 11:36:11 pm »

Quote from: Lynn K on December 05, 2014, 08:09:28 pm

Any news yet Mel?

Lots of it Lynn!!

http://forums.hepmag.com/index.php?topic=1835.new;topicseen#new

Lynn K · « **Reply #36 on:** December 06, 2014, 01:07:09 am »

All right !!! That is fantastic!!!

It looks like I found the key to the kingdom with that email address.

So happy the golden key worked for you as well!

Doing the Snoopy happy dance for you arooooooo!
Lynn

BattleTheBeast · « **Reply #37 on:** December 06, 2014, 02:23:39 am »

Quote from: Lynn K on December 06, 2014, 01:07:09 am

All right !!! That is fantastic!!!

It looks like I found the key to the kingdom with that email address.

So happy the golden key worked for you as well!

Doing the Snoopy happy dance for you arooooooo!
Lynn

You sure did!! Anyone dealing with Express Scripts and Accredo should go that way for any issues; huge difference in 24 hours!! Thank you !!

Lynn K · « **Reply #38 on:** December 06, 2014, 02:41:18 am »

Glad to help hope the info can help others too :-)

jimmyD · « **Reply #39 on:** December 09, 2014, 12:13:51 pm »

I have been on O/S/R since the end of September. My gastro Dr. originally prescribed 12 weeks, then said " the rules had changed ", and extended my treatment to 24 weeks because I have cirrhosis. I am being treated by the V. A., without them I doubt I would be getting treatment at all.

Bucky · « **Reply #40 on:** December 09, 2014, 12:31:11 pm »

Quote from: jimmy D on December 09, 2014, 12:13:51 pm

I have been on O/S/R since the end of September. My gastro Dr. originally prescribed 12 weeks, then said " the rules had changed ", and extended my treatment to 24 weeks because I have cirrhosis. I am being treated by the V. A., without them I doubt I would be getting treatment at all.

jimmy D,
Welcome to the forum,

I am glad that the VA has stepped up with extra treatment. At least with the VA you aren't having to fight with an insurance company.
Bucky

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Author Topic: Doctor says no to another 12 weeks of Sovaldi and Olysio (Read 27131 times)