Best of luck to you, Maddie!  Let us know how it goes, we`re here for you! 

Maddie, Good Luck! will keeps fingers crossed for you,

Hi Maddie,

I'd like to wish you the very best of luck and offer you all the support I (we) can possibly provide. You're one of our first pioneers of this off label treatment and are fortunate to have been approved for them. The goal we all share is to defeat this disease on our terms and see the Dragon's fire snuffed out for good! Keep your eyes open for potential Sx during the weeks ahead and if you need help finding solutions, there are many Hep Warriors here to assist. Remember to hydrate, eat well, stay active and above all else, don't miss any doses! Again, good luck and onward to SVR!!

Tig

Well...started the Sovaldi and Olysio yesterday morning.  Fingers crossed.  Hope we all get our miracle!

Suziq, good luck with EOT bloods

Suziq,  18 weeks !!!    Hope the EOT blood work is UND. 

Thanks for the idea, I am going to move that second Riba up to 4:30, I am taking  that now at 6:30 or so. 

From everything I read, I am glad I am not taking the Interferon either.

Let us know on your EOT blood work.

Thanks Cinnamon Girl,   You are right, it is red blood cells they are checking for. 

Hi Dragon Slayer,

I just finished 18 weeks of a Merck trial without interferon, but with riba yesterday. I go for EOT bloodwork today.

My coordinator suggested taking the evening riba around 4PM so I would have less night side effects.  Check with your doctor if that would be ok.  I felt ok until about week 12, but not so great since.  I didn't feel fatigue either, but I have a lot less energy.  Sort of like dis-interest in doing things.  I am seeing a lot of things I have let slide during these 18 weeks. My Hgb dropped, but only to 11.1 and was 11.3 at week 16.  My brain has definitely slowed down, but am hopeful it will recover.  I am grateful that I did not have to take interferon. 

I feel optimistic that I will remain UND.  The earlier trial was 100% SVR. 

Keep us posted on your progress.

SuziQ  

Hi Dragon Slayer, good to hear things are going well for you and your side effects are manageable so far. 

I used to find ginger ale helpful for nausea, when I was on tx, and that`s a common sx of Ribavirin, as is insomnia.  It also lowers your red blood cell count (not the white blood cells), and that often causes some degree of anemia as treatment goes along.

All good so far, best of luck with your viral load test! 

Just took day 9 of triple tx.  Sovaldi / Olysio and Riba. 

Insomnia for sure,  lay awake until 4:00 am (funny thing not feeling fatigue !) , nausea only at night when I take the second Riba and some ginger ale cures that.  So far tx very tolerable.

Blood work last Saturday after week one of tx,  showed no signs of anemia (Doc concerned that the Riba will lower white cell count).

This Saturday another Viral Load test !!!!

Thanks for the update, Gator Man, we`re very interested in hearing from all of you doing this off label combo.  Hopefully many more will have the opportunity to go with this treatment before the insurance companies tighten up, if that turns out to be the case.

Best of luck, hope you continue to have minimal side effects! 

Hi Gator Man,

Thanks for keeping us informed of your Sx and general well being while you get started on these new medications. It's very valuable information to share as you're one of the first to know what it's like. The info you're sharing mirrors some of the data from the trials and it's good to know that it indeed has fewer Sx than the Interferon/Riba treatments. Hopefully your light Sx will continue through Tx. Please keep us informed, I certainly appreciate your help! Best of luck!

Tig

I've just taken day 7 Sovaldi/Olysio and still feel pretty good. Any sx so far appear minimal and may not relate to the tx. 

Hi Bones,

Not on the tx yet but supposed to start the two drug combo without Riba late next week, I believe.  There are not many others on this treatment yet. Most people on this combo are only starting now since the two drugs were only FDA approved in Dec. 2013.  Prior to this, the same combo was only administered during a phase  2b trial, Cosmos Trial.  However, both drugs were independently in phase 3 trials with Inf. and Riba, and this is how they got FDA approval.  This two drug combo for GT1 is being prescribed off-label.

I noticed that you said you have headache and nausea.  Just wondering if you might be on any other medications that are contraindicated along with Olysio.  There are many.  Something called CYP3A inhibitors or inducers.  Inhibitors increase blood plasma concentrations of Olysio, Inducers decrease blood plasma concentrations of Olysio. Below is an exerpt from the package insert for Olysio.

Potential for Other Drugs to Affect OLYSIO

The primary enzyme involved in the biotransformation of simeprevir is CYP3A. 

 Clinically relevant effects of other drugs on simeprevir pharmacokinetics

via CYP3A may occur.

Co-administration of OLYSIO with moderate or strong inhibitors of CYP3A may significantly increase the plasma exposure of simeprevir. Co-administration with

moderate or strong inducers of CYP3A may significantly reduce the plasma exposure of simeprevir and lead to loss of efficacy (see Table 5). Therefore, co-administration

 of OLYSIO with substances that are moderate or strong inducers or inhibitors of CYP3A is not recommended.

http://www.pharmacytimes.com/publications/issue/2008/2008-09/2008-09-8687

Not saying that drug interaction is the reason for the nausea and headache, but just possible.  Might want to read the lists.

Hi I am on day two of treatment with sovaldi and olyison first i hard a mild headache during the evening then during the night i got sick but felt better afterwards I will see what happens on day three. Anyone Else on this treatment just wondering what to expect.

Thx Gator Man and Dragon slayer for your info.  I"ll let you all know when I begin the two drug protocol...Have the meds but waiting for appointment next week before starting.

Thx. Suzieq, for the link.  Appreciate everyones help.

Today was day 5 of my treatment. 

I take Olysio and Riba (600mg) in morning around 7:00 am with a muffin or toast and juice.  Two hours later I take the Sovaldi and at 7:00 pm I take the second 600mg Riba.

I was getting a little nauseated when I was taking the Olysio, Sovaldi and Riba all together in the morning so my doctor spread out the Sovaldi (mainly due to being able to take that one without food).

Third day of treatment I had a small head ache that lasted 3 to 4 hours so I started drinking more water.  I just hate plain water.....but I know..... I now drink 100 ounces a day and flavor it with Cyrstal Light or MiO !!! No head aches since drinking more water.

Had a little insomnia Tuesday, Wednesday and Thursday could not fall asleep until 3:30 or so. My doctor said that is from the Riba.  Next week I am going to add the gym into the evening hours and maybe that will knock me out at a reasonable time ! If it does, my wife will be happier and get her full nights rest !

Had a blood test Wednesday, funny thing, the lab tech wrote down HcG not HcV so it was good to find out today that I am not pregnant...... 

So far so good on the new combo tx.

I'm on day 3 of the Sovaldi and Olysio combo.  I take both in the morning-oatmeal, banana and ~$1800.00 worth of meds. to start my day.

I was a little more fatigued than usual last night, although I still made it to the gym before dinner. Outside of that, no side effects to this point. My next doctor's appointment is on the 22nd, so I will get an updated viral load shortly thereafter. I'm keeping my fingers crossed.

Gator Man

Eric J. Lawitz, MD: Digestive Disease Week 2013 Late-Breaker
  http://video.healio.com/video/Dr-Eric-J-Lawitz-DDW-2013

I posted this separately but decided to add it to this discussion as well. It is short video discussing the trial with Sovaldi and Olysio.  Sorry about double posting.

SuziQ

Hi Bones,

Just wondering what GT you are?  I am scheduled to start the same combo in a week to 10 days from now, and am glad that you are feeling pretty good so far.  I know its early but 2 days down, right? 

Do you take the meds in the morning?

Thx, Maddie

I am on day two of the SOVALDI OLYSIO combo and I got good nights sleep, I feel good and have lots of energy this morning. I am so thankful I got this medication. I just wish it could be made available to everyone. I can not belive how good I feel. I went through 52 week of interferon rib before and felt terrible after first shot.   

Welcome Gatorman!

Glad you've joined the forum, it's a great group of like minded people. I'm anxious to hear how you do with this new Tx regimen and agree with Matt that it's good that you're developing a group here that can support each other through Tx. Know that we're all here for you, but sharing stories and symptoms with those on the same Tx program can be very helpful. I encourage you to all stay in touch during and after. Good luck!

Tig

Thanks for the replies. I start the Sovaldi and Olysio medications tomorrow. I had pneumococcal  and hepatitis b shots yesterday, so my doctor wanted to be sure of no side effects prior to starting the meds.

I am the first post COSMOS patient that my doctor has received insurance approval for the off label combination. He is convinced this is the right course and urged me not to delay given prior experience with insurance. He relayed a few stories about carriers "kicking the can down the road" in the hope that when you finally reach end stage liver failure, you're with another insurance company or uninsured. 

After 30+ years, I am looking forward to starting what I hope will be my final hepatitis c treatment regimen. I will be happy to share my progress, the good and the not so good, if it should occur. 

Sorry, Darkstar.  Just saw your post to my question.  Thx for your reply. 

Welcome Gator Man, Dragon Slayer, Maddie

You guys will be able to progress together and encourage each other during your treatments.

It's quite fantastic that both your doctors and the insurance companies would recommended and approve this combo as we did not think the insurance side would capitulate.

i guess it shows the power of the doctors recommendation and their convincing nature.

i am very excited for you guys as this will be very important for the future for many patients to come.

matt

Hi Gator Man,  Thank you for sharing your status.

Started my combo treatment today of Sovaldi, Olysio and Riba (1200 mg).  

Doc changed my 12 week to 20 weeks today based on insurance approval and was concerned that the door will close very soon on the off label approvals.

Little bit of nausea and lots of gas this evening is only effects today.

This 54 year old has one day down 139 to go.....

 20 weeks to hopefully be Hep C free ! 

I am new to the forum so I will introduce myself. I am a 53 year old male diagnosed with Hepatitis C  (1b) in 2001, almost certainly the result of numerous blood transfusions in 1982. I was a null responder to Interferon/Ribavirin in 2001 and have been waiting for better treatment options.

I have compensated cirrhosis, although maintain an active life with no overt health issues at this point.

I just received my initial month supply of Sovaldi/Olysio (no ribavirin) from my gastroenterologist who participated in the COSMOS trial. Anthem has picked up the cost and only have a $55.00/month co pay. My gastro is of the belief that there is a small window for insurance approval with this off label combination and has already seen some push back from the major carriers. I was approved for rx mid December, but did not have an appointment until today to pick up the meds.  Given the fluctuating landscape with these new treatments, I would encourage everyone who is considering an off label combination to strike now before insurance companies become more intransigent.

Thanks so much for your answer, Tig.  I think I will go ahead and try the dual combo Sovaldi and Olysio.  I was hesitant because of the possibility that I might not be able to retreat with the Sovaldi if I failed Sovaldi and Olysio.

maddie wrote:

---

My doctor has suggested prescribing Sovaldi and Olysio without the Ribavirin.  I am not totally convinced that the Q80K polymorphism, if present, will not have an adverse impact on svr even with the combination.  In the linked article, the following exerpt has me questioning that supposition: 

"In both cohorts, 100% of people with HCV subtype 1b or with subtype 1a but lacking the Q80K mutation achieved SVR12 or SVR4. Three relapsers in Cohort 1 and one in Cohort 2 had subtype 1a with the mutation (SVR12 of 89% and SVR4 of 91%, respectively)."

What do you all think?

---

 Olysio/simeprevir response is affected by the polymorphism and it is referenced in the package insert.  But the effectiveness of Sovaldi/sofosbuvir does not appear to be affected by the polymorphism.  So at least in theory the combination should be effective irrespective of the presence or absence of the Q80K polymorphism.

Hi Maddie,

Welcome to the forum! I'm glad you found us and encourage you to share your story with us in the New Members section when you can. We'd love to hear more about you and look forward to being here to provide support and information should you decide to treat.

While I'm just learning about these new medications, the article referenced by Mallani seems very encouraging for all groups on the dual or triple combo's with these drugs. I don't know why after reading this article in particular you would question the effectiveness of these meds even with the Q80K morph. The number of relapsers is so low that regardless of the reason the odds are extremely high and with a short duration course of Tx. The reason for relapse could or couldn't be related to the polymorphism. Since the failures were people with it, it may well have been responsible IMO but the majority reached SVR in short order and that was even with cirrhosis in many cases. I think the odds are extremely high and would be very confident in achieving SVR were I lucky enough to get the opportunity to treat with either dual or triple therapies. 89-100% SVR with or without the G80K pm across these two Cohorts is pretty promising to me. Good luck with your decision!

Tig

My doctor has suggested prescribing Sovaldi and Olysio without the Ribavirin.  I am not totally convinced that the Q80K polymorphism, if present, will not have an adverse impact on svr even with the combination.  In the linked article, the following exerpt has me questioning that supposition: 

"In both cohorts, 100% of people with HCV subtype 1b or with subtype 1a but lacking the Q80K mutation achieved SVR12 or SVR4. Three relapsers in Cohort 1 and one in Cohort 2 had subtype 1a with the mutation (SVR12 of 89% and SVR4 of 91%, respectively)."

What do you all think?

Hi Dragon Slayer,

Welcome, and you are the first Forum member to try this combo.  If you look at the link, you will see Cohort 2 is the one for you.  As it is a Phase2 Trial, the numbers are small, and we have not been given the SVR 12 results. However, the figures are impressive, and the presence of the Q80K mutation doesn't seem an issue.

http://www.aidsmap.com/Simeprevir-sofosbuvir-produces-high-sustained-response-rates-for-hard-to-treat-patients-in-COSMOS-trial/page/2787623/

As a cirrhotic, I'd prefer the Ribavirin arm, and 24 weeks would be my preference. We will be interested to hear how you progress.

I'm impressed you had this off-label combo approved by Insurance.  I am not sure how this works in the USA.  Here, about 50% of the population have private insurance, and there are only 5 main players in this field.  Top-level cover for a couple is ~ A$5,000 per year, and patients have a choice of doctor, and the InsuranceCo is obliged to pay for any treatment prescribed.  It seems that, in the USA, the InsuranceCo has some discretion, or is it up to the Company. I'd appreciate any info.

Good luck with the SVR and the subsequent Rx for sarcoid. Hope the side-effects are minimal. Cheers.

The COSMOS trial looked at the combination of the two drugs.  Although the numbers were small, there was no additional benefit for the addition of ribavirin.

It doesn`t surprise me at all that you had trouble getting approval for this combo from your insurance company, the cost is really quite outrageous.  The price tags of these 2 new drugs has been the subject of much discussion here on the forum lately, and Sovaldi in particular.  You`re lucky to be getting these 2 new drugs, especially so soon.

If it`s not suitable for you to take interferon then this should be a powerful combo.  I would have thought that the longer you could stay on it the better though, as you have cirrhosis, although I guess the treatment duration will depend on how quickly you respond. 

Not everyone knows exactly how and when they became infected with Hep C, but the main thing is that it was eventually picked up and now you have an excellent chance of clearing it.  One step at at time, you`ll get there!

Best of luck, do keep us posted! 

ps  - You`ll find the full prescribing details for both Sovaldi and Olysio in the `Knowledge Base` section, at the top.

-- Edited by Cinnamon Girl on Friday 3rd of January 2014 11:20:58 PM

I have Genotype 1 and the treatment is being planned for 12 to 20 weeks.  We are hoping for the 12 week answer ! 

I am still bafilled as to how I contracted Hep C, monogamus marriage for 32 years, never was a drug user or any major surgeries, very physically active and was very healthly until recently.

A three year sinus infection cause a new ENT assigned to me whom ordered blood work found a high level of ANCA and sent me to a Auto Immune doctor whom found the HEP C and sent me to a Internal Medicine and Gastroenterology doctor. The Cat Scan and biopsy confirmed the cirrhosis and sarcoid.  6 months later, here I am. 

After researching blood lab reports for last 15 years the first time a sign of Hep showed up was in 1998 when local blood bank said I had enzymes that said they could not use my blood. Family doctor saw high bilirubin levels but said they have been consistent for several years and diagnosed it as Gilberts disease.

Thank you for explaining "off label". I had a little trouble getting my insurance to approve the medications because of the off label issue.  After my doctor had a conference call with some Highmark insurance folks, I was approved.  The cost is overwhelming.  All three drugs are over $50,000 a month.

As soon as I am cleared of the Hep C, I can start the mega prednisone to get rid of the sarcoid (Liver, lungs, eyes and ears) and sinus infections.

Looking forward to 2014.....  180 days and back to normal.....

Hi Hep-C Dragon Slayer, welcome to the forum.

Well, that`s an interesting combination, and actually you`re the first of our members to be prescribed this combo.  Both of these 2 new drugs, Sovaldi and Olysio have been given individual FDA approval fairly recently, and prescribing them together in this way would be described as an `off label` treatment.  Meaning that they haven`t had FDA approval for use together.  They have been studied together in clinical trials with excellent results though, so you should do very well.

Anemia is certainly a possibility, but your doctor will monitor your red blood count carefully and take appropriate action if necessary.  For example by lowering your dose of ribavirin.

Could you give us a bit more information, please, for example, what is your genotype and how long will your treatment be for?

Getting ready to start taking the new Hep C drugs.  My doctor has me taking both Sovaldi and Olysio which has me confused along with Ribavirin.  I cannot take the Interferon because my Biopsy shows Sarcoidosis in my liver which also has caused cirrhosis. So I will be taking the combination of these new drugs starting Monday 1/6/14 after a base line blood test, they are concerned that I will become anemic !

I know these are new drugs, has anyone heard of taking both Sovaldi and Olysio together with Ribivirin ?