Olysio & Sovaldi

[jen322]

Hello all, I am starting the Olysio and Sovaldi treatment tomorrow for my Hep C. Anyone have any info on it what to expect as I hear there are few sides. What are you eating when you take Olysio as it needs to taken with food.'I am so stoked about the treatment and can't wait until my box gets here tomorrow. I will start as soon as I rip it open!! 40 years and ready to move on.
Look forward to getting to know everyone and learning from you all

thanks
jenne

[Savannah12]

I take them with my first meal of the day, usually around 11-12. Sides are nausea, insomnia and headache although I have headaches without the two pills. I just got my 4 week results back as UND so at least I know what I am doing is working. Good luck with starting treatment. You will start to feel better before you know it.

[ms maddie]

Been on these meds about 7 wks now.  No real problem with sides.  Minor joint aches first couple of weeks, slt nausea first couple days, some increased gas but that's about it. Take meds following breakfast which is usually cereal/banana.  Best of luck to you.  May we both reach SVR.

[mike716]

Can you tell me, please, how you were able to get a prescription for both Sovaldi and Olysio, and most importantly how you got coverage for them?

Thanks!

Mike

[GP7852]

HI Jene
On my 9th day of Sovaldi and Olysi and as far as side effects-nothing,nada,zilch!  I have not experienced anything at all.Still have my taste buds,my sense of humor,been going to the gym so no lack of energy.No problems at work,not even a headache-just take them with food and stay hydrated for smooth sailing-this sure beats the heck out of all the poison we had to endure before this-don't miss that anemia at all.
                                  Good Luck    Glen

[Groupergetter]

Hi Jen, hope this goes well for you.  I just started my treatment two days ago.  Have headaches, insomnia and a bit more joint pain.  You may not even experience this.  Being different individuals, the side effects will also differ.  I pray for you, and all with this pernicious disease that we reach SVR.   Be Thankful for every morning.  

[sljl]

Hi Jen,

I'm getting my box tomorrow too.  I can't wait to start.  From everyone's replies and what I've read, it is way better than the 48 weeks of interferon/ribavirin I did 3 yrs ago.  

sljl

[Ms_Transfusion]

Hi!
  Can you tell me how you got Sovaldi and Olysio and did insurance pay for it?  
I am in a rush as time is short.  I do not tolerate ribavirin, interferon, and teleprevir. I am stage 4 low platelets,varices and giant spleen.  

Can you tell me what state you are in? I was told insurance's were not approving both protease inhibitors???  Ribavirin and one protease inhibitor for 6 months would be the treatment, with lowered results.  

Already lost a family member to this disease.  HELP.

[Ms_Transfusion]

Glenn,

How did you get approved for two protease inhibitors?  If possible can you tell me what insurance or doctors you have?  I have cirroshis stage 4, low platelets and varices. They are checking on sovaldi and ribavirin for 6 months.  This treatment is less effective than Sovaldi and Oysio.  Anemia is a problem,as well as heart problems and riba rage.

What say you?

[flyinlynn]

I have the same question how ate people getting approval for this.

I have GT 1a with cirrhosis diagnosed in 2008. Had grade 3 esophageal varicies that I had banded 3 time null responder to interferon with ribavirin.

My hepatologist at a transplant center in Seattle submitted for Sovaldi Olysio off label for me. I have supposed to be excellent insurance through my employer BCBC Express Scripts but received this in the mail for them:

Letter from Express Scripts well actually 2 letters. One for each medicine I have combined them here.

We reviewed your request to obtain Sovaldi ( or Olysio) under your plan. We informed your doctor, we are unable to approve this request for the following reason:

-Sovaldi will be used with Olysio.
(-or Olysio will be used with Sovaldi)

In accordance with your plan provisons for drug coverage, a review has been performed. The review uses the plan's rules and is based on FDA-approved prescribing and safety information, clinical guidelines and uses that are considered reasonable, safe and effective. Details of drug coverage are contained in your plan documents, and the review guidelines are available on written request.  


Any suggestions?

Good luck to every one on the medications SVR to all
Lynn

[Ms_Transfusion]

  Hi Mike,
   I want to know the exact same thing!  Sovaldi and Olysio how do you get these two drugs.  

[pooh55811]

Welcome to the forum.

Olysio is a Protease Inhibitor.

Sofosbuvir (Sovaldi) is NOT a Protease Inhibitor. Sofosbuvir is a Polymerase Inhibitor. It inhibits the RNA polymerase that the Hepatitis C virus uses to replicate its RNA.

The combination of Sofosbuvier and Olysio is an off label combination. Although both drugs are approved by the FDA, they are not yet approved as a combo by the FDA. Doctors are using them together off label.

If you have Cirrhosis, you should be under the care of a Hepatologist at a large medical center/transplant center. Hepatologists are the doctors who should be managing patients with Cirrhosis. Other doctors are not qualified to manage the intricacies and possible complications of people who have Cirrhosis. I see you live in California. There are many competent Hepatologists in California. Any competent Hepatologist will know about the Sofosbuvir and Olysio combination for treating Hepatitis C.

Here is some information on the Cosmos trial (the Sofosbuvir and Olysio (Simeprevir) trial):

Interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4

" In Hepatitis C patients with advanced liver fibrosis or cirrhosis (METAVIR F3 or F4) 12 weeks all oral treatment with simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of 96% and 100%, respectively· Once-daily simeprevir and sofosbuvir with or without ribavirin was generally safe and well tolerated"

"Medivir AB (OMX: MVIR) today announced interim results from the second Cohort in the ongoing COSMOS study evaluating a once daily combination of simeprevir and sofosbuvir in hard to cure hepatitis C (HCV) patients.

SVR4 results from the 12 week arms of Cohort 2, including treatment naïve or previous null responder HCV patients all with METAVIR score F3-F4 were reported. Treatment for 12 weeks with simeprevir and sofosbuvir, with or without ribavirin, led to SVR4 rates of 96% and 100%, respectively.

Interim results from Cohort 1 of the COSMOS study, which include only prior null responder HCV patients (METAVIR F0-F2) have been reported earlier and demonstrated SVR8 rates of 96% and 93% after 12 weeks treatment simeprevir and sofosbuvir with and without ribavirin, respectively.

"The high SVR rates seen in genotype 1 prior null responders and treatment-naïve patients with advanced liver disease, in the COSMOS study and the safety profile of the combination are highly encouraging. We look forward to the final results of this study in difficult to cure patients." says Charlotte Edenius, EVP Development, Medivir AB."'

http://www.natap.org/2013/HCV/082913_01.htm


If you let us know which large city you live near, people may be able to direct you to specific Hepatologists.

[pooh55811]

PS: Your Hepatologist will have to write to the insurance company and explain why you need these two drugs (as opposed to the Sofosbuvir, Riba, Interferon combo).

[flyinlynn]

Hi Pooh

So I have all that Hepatologist at a transplant center in Seattle. I have Hep C GT 1a with cirrhosis am a  null responder. But still denied by my BCBS express scripts because it is off label any ideas?

Lynn

[pooh55811]

Is your Hepatologist going to re-submit an appeal to the insurance company?

Sometimes there is something in the paperwork that they filled out incorrectly or that they forgot to fill out. I had that happen when I treated. They filled out the paperwork incorrectly and denied the remaining 6 months of treatment. My doctor submitted and appeal with the correct information and the insurance company approved the remaining 6 months of Tx.

However, I realize that some insurance companies do not want to pay for these new drugs so they are "going by the book" and are balking at paying for off label  drug combos. Hopefully they will see that is it cheaper in the long run to pay for off label combos than it is to pay for a liver transplant and the life time care  and medical expense that goes with a transplant.

[flyinlynn]

Yes thay have submitted an appeal for me and hopefully it will be approved this time.

I am just kinda surprised/shocked/ dissapointed they didn't approve me on the first try

Thanks
Lynn

[jen322]

Good Morning,

I take Olysio and Sovaldi after  I eat in the morning about 9, today is day 6 day has been the worst day for far. You have to take them at the time everyday.
A DR can write a script OFF LABEL which is what is happening.
My sides have been:Mild but enough to keep me home,Tired,Insomnia little shortness of breath but thats gone,irritable,and just a feeling of not feeling well, the tiredness is a different tired it's like your body is fighting off something not like you just don't have energy. I just go take a nap and I'm all better
Remember anyone on these your body is working hard in the beginning so gentle to yourself, I did a pretty aggressive workout day 2 and really paid for it so don't be out there try to do the same things you last week. Theres are FB page where their a lot of us on Savoldi it   Savoldi-sure my hep c
Have a beautiful day

[mike716]

Hi! Are you getting anywhere?

I read in another thread that BC/BS are not approving Sovaldi + Olysio. I think a lot of other insurers are also turning people down. More every day, it seems. I've read conflicting reports about Medicare, too. It's a lottery.

Things are not going to get better until more DAAs (Direct Acting Antivirals) are approved and the prices start to drop, hopefully later this year, when Gilead's Ledipasvir (replacing Olysio) and  BMS's Daclatasvir + Asunaprevir should be approved.

At this webpage you can see a chart showing the anticipated approval dates for the next DAAs:
http://onlinelibrary.wiley.com/doi/10.1111/liv.12408/full

One thing you can do now, if you haven't tried it already, is contact the Sovaldi and Olysio assistance programs:

http://www.gilead.com/responsibility/us-patient-access/support%20path%20for%20sovaldi

http://www.olysio.com/support/financial-assistance

Another option, perhaps, is getting approved for Sovaldi + Ribavirin. Riba doesn't cause as many side effects as Interferon. You might be able to handle it. For that matter, I've read that even Sovaldi alone can cure people.

And don't forget, as bad off as you may feel you are, there are others who are worse off. For example, I don't even have an MD in the States, and no insurance there either.

Whatever you do, don't give up. Keep plugging. Push your MD. If he can't or won't help, go see another. File appeals with your insurer. Make noise.

Mike

[mike716]

Any news on your appeal?

[flyinlynn]

Hi Mike

After many phone calls mostly with express scripts I got approved!
I picked up the meds just Sovaldi and Olysio on Thursday. Saw the nurse at my doctors office yesterday (Friday) had a blood draw for viral load and a few assorted other tests CBC, LFT etc.
I am going to start the meds on Wednesday 3/19 and will be done 6/11.

Good luck to everyone
Lynn the Dragon Slayer!

[JimmyMose]

So happy you got approved.

to All
My guess is that there are a lot of factors in play that may effect whether and when you get insurance approval for Olysio & Sovaldi off label.
-All the newly enrolled via ACA is straining the resources of the companies to respond quickly.
-Lower level prior approval process employees are normally rejecting initial requests.  
-Those who appeal with all the "dot the i's and cross the t's", a justifiably need to treat now with this combination and not another have the best chance of approval. The ability to deal with the "red tape" and demonstrate a strong resolve to get this treatment now. maybe also indicates that you will be a good candidate for complying with and completing this expensive treatment.
-The immediate availability of the drug in sufficient quantities for those starting treatment, the cost of the drug and the amount budgeted for this year are also involved in the decision of who to treat with what drugs and when.  

THE AASLD recommendation along with your doctor's treatment needed now at this time is your best chance for off label approval.  Remember if all appeals fail you and your doctor can apply directly to the drug companies for the meds.

http://hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility
Rating: Class IIa, Level B

This may limit some approvals
The safety and efficacy of simeprevir have not been studied in HCV-infected patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). The uncertain impact of cholestasis and the occasional association of SMV with elevated transaminases create potential for drug accumulation or impaired hepatic function during SMV use. Clinical trials with SMV have been limited to patients with compensated disease who have CTP class A, total bilirubin of 1.5 x ULN or lower, and transaminases 10 x ULN or lower. For these reasons, simeprevir use should be limited to patients with compensated liver disease. Use of simeprevir is not recommended in patients with moderate to severe hepatic impairment. The combination of PEG/RBV is contraindicated in patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C).

Remember it's only been a few months since these drugs received FDA approval separately.  New HCV tx is becoming an accelerated changing scene compared to the first 20+ years of treatment history. We all anticipate, wonder and hope for the new announcements and approvals forthcoming in the next 6 months to a couple of years..Hopefully more competition and pressure will drive down cost too.  Like electronics.but faster.  

[NYCMark]

So glad to hear you were approved!  I wish you the best during your treatment!
-Mark

[mike716]

Congratulations on the success of your appeal!

M.

[Caddyman04]

I started treatment 3-29-14 with Sovaldi & Olysio. No noticeable side effects. Before this I had not been treated in any way for Hep C. Was diagnosed with Chronic C Hep in the 1980's from blood transfusion needed due to a car accident. Diagnosed with Cirrhosis in Sept 2013. ITP diagnosed late 2006. Still have low platelets (ITP) count around 48-64. Had spleen removed for ITP. Helped a little, probably not worth the operation and severe complications of spleenectomy. Have esophagal varices diagnosed 2013. Take Nadolol for varices. I have United Healthcare Medicare Advantage plus. My Doctor used a company called Century Specialty Script to help get the scrips approved. I cannot emphasize enough that time is of the essence to begin treatment.

I hope this helps someone and good luck.

[mike716]

You are extremely fortunate to be able to get these two wonder drugs. They have had great cure rates in trials, even with people with cirrhosis. With a little luck you will be HCV-undetectable soon and your liver can start to heal. I wish you all the luck in the world.

Have a Happy Easter!

Mike