I need your help

Question

I thought I was going to get a shot at a trial at the U of Penn for harvoni relapsers.I called to see when they were bringing me in and its not looking good.She told me that Gilead was probably going to go with non cirrotic patients( I am stage 4)Plus I am having big time problems with itching which means my bilirubin is up and they wouldn't accept me if my bilirubin is out of range.I learned about 2 treatments that could benefit me.The first is 12 weeks of elbasvir/grazoprevir with sofosbuvir and ribo,the second is daclatasvir and sofosbuvir.Since my insurance company has swept me under the rug my only chance would be to purchase one or the other on my own.Does anybody have information as to who might have either of these drugs for purchase? 
                                                      Thanks  Glen

susan400 · Answer

I'm hoping to one day use the Grazo/Elba, too.  I'm hoping that Merck has some kind of patient assistance program like the Gilead people did.  I actually was going to be doing the Grazo/Elba trial, until my regular doctor told me that he didn't want me to do any more trials.  I just feel that I would do better with Grazo/Elba/Riba, than I would with Harvoni, since I was already exposed to the Sovaldi part of Harvoni.  Yes, I know, many people on this site, did the Sovaldi and then, when they relapsed, retreated with the Harvoni and cleared.  But, my insurance is another problem because of the fact that they paid out all that money for the triple treatment w/Sovaldi/SOC and then, I relapsed.  The Cigna from my husband's work did that, they paid like $80,000 on that treatment, plus 2-3 shots of Neupogen that I needed.  The P.A.N. (Gilead's pt assist program), paid the remainder of the cost of the meds.  The Cigna told me that unless I had and increase in damage, like a bump of of my stage, or developed cirrhosis, that I would have to appeal the denials if I proceeded with wanting to get it..(or something like that, not those exact words).  On my last fibrospect blood work, it's only showing me to be about a stage 2, possibly 3.., but on the range F2-4, I was on the low side of the range. Also, because I've treated like 12 times, there's not a lot of excitement about paying for this stuff. But, with waiting this big chunk of time since my last treatment and with this being a different company, didn't drug mix, I'm going to think about bringing it up with my doctor like in Aug. 2016 and see if it works out.  Don't have any idea what my liver would show on a fibroscan since I can't get one. They aren't offered in my county and I'm on a Medicare Advantage HMO/PPO. If I go out of the network, it's not covered.  I am not interested in any kind of out of the country shipments of meds.  Primarily because my out of pocket would be too high for me to afford, and secondly, sort of nervous about the idea of what kind of quality of meds I'd be getting.

GP7852 · Answer

Sue
I will definitely make that suggestion to him.We would have nothing to lose by doing so and the denials that will be coming are a very safe bet.Thanks again Sue.
                                             Glen

SurfsideGal · Answer

Thanks for the laugh, Glen. I probably have enough knowledge to be dangerous. I am wondering if your doctor would be willing to appeal to Merck's Patient Assistance by telling them that medically you cannot wait to go through the appeal process. I don't have any idea if that might work, but it's worth a try. I have not yet been able to reach our contact at Merck due to the fact that pharma gives everyone a long holiday vacation this time of year. However, I will be on the phone to him next week to see if I can get any information for you regarding assistance.

Try and have a good New Year. You will get this worked out. I have confidence.

GP7852 · Answer

Thanks Sue
I should make a doctors appointment with you.I think you are more knowledgable than my doc.The earliest I could get in to my doctor was Feb 11.If these drugs are approved before that date I will call his nurse and tell her to have the prescription people there to put the order in with my insurance company.I should get my first denial not long after.There will definitely be a 2nd denial coming after that.I wonder if the 1st 2 denials would be enough to go to the patient assistance program with.I will be in touch when I get further details.
                                         Thanks Sue    Glen

SurfsideGal · Answer

Yes, it means the target date is January 28th and they do stick on or around that date. So, it could be a few days earlier or later.

Your bone marrow is not what is suppressing your platelets. If you were treating with interferon, than that would likely be true. When a person has cirrhosis, the spleen is enlarged and it sequesters the platelets and traps them so they do not circulate in your blood stream. Also the liver is not making enough of the hormone to hormone to regulate the production of platelets.

I wish there were an easy way to encourage your body to make more platelets but sadly there is not. Hang in there buddy, it's only a few more weeks til that FDA approval. Have you asked your doc to go to bat with you with your insurance company if need be?  Also, as soon as we get word regarding patient assistance, I will let you know. I promise.

GP7852 · Answer

HI Sue
I went to the Merck page and I copied this line for you. The FDA granted priority review for grazoprevir/elbasvir 100mg/50mg with a prescription drug user fee act (PDUFA)action date of January 28,2016.Would'nt this mean that it would be approved on this date?I really hope so.I am going nuts with the itching and my energy is at an all time low.Everything I eat is platelet friendly but after hearing Chet tell me that my problem is my bone marro I don't think vitamin k and a lot of healthy veggies and fruits are gonna be enough to qualify me for the trial.Made an appointment with my doc to try and get the ball rolling if I don't get in.Its so frustrating knowing these meds are sitting somewhere and could end this misery and I cant get to them.

SurfsideGal · Answer

You are right, Glen. There really is nothing except Promacta to get the platelets up. And, as Mac says, watch your level of hydration before testing. 

As I have said before, getting the meds out of country is a risk and should only be considered as a last resort. The problem with doing that is there is no quality control that  you can count on and you do not really know what you are getting. At best the pills would not work and at worst they can make you very ill.

How did you learn that Jan 28 is the date of FDA approval? That is usually not made known until after it happens. Although we know that there is a conference call for the advocates on February 1st and that never happens until approval. Just curious.

GP7852 · Answer

Apparently the Austrailian site is playing games with me.After reading their email I went and examined the site and they are only selling harvoni.I didn't see anything about the graz-elb pills on there.The fda will be approving them on Jan 28.I would purchase right now if I could.It is going to be a long wait.I am not real hopeful about getting into the trial after your explanation that its the bone marro.I don't see how vitamin k and some healthy veggies and fruit are going to help my bone marro get my platelets up.

GP7852 · Answer

Mac
I am geno 1a stage 4 with a very difficult strain.I asked Austrailia for verification that this was going to be MK3682B that I was purchasing.That would be the meds in the trial by Merck-16 weeks of that with ribo or 24 weeks without ribo.Was that the same number that you did on your trial?I would like to know the difference if it wasn't.
                                Glen

mac790 · Answer

Glen- $1600 for #84 tabs is actually extremely reasonable considering the MSRP prices. There was no difference in the 12 week and 24 week trial outcomes, with or without RBV. 12 weeks should do the trick, unless you have the misfortune of having a hard to treat Genotype. Do you know if you are GT1 or GT1a? Grazo/Elbas works on GT1, 1a, 3 and 6 (if memory serves). Harvoni is every bit as good if not better, but the SVR rates are so high on all these new generation DAA/protease inhibitor meds it makes little difference. If you fail @ HUP, and have a treatable GT, the Merck combo (one large brown pill in my case) is suspiciously reasonable. If this place in AU is legit, they will insist on a valid Rx, so you'll have to find a hepatologist willing to assist you. That price is so low I wonder how they are doing it, as it still hasn't been released here in the States. There is some bootleg/fake pharma out there, so if you have to go this route, please check them out thoroughly. Hopefully the supplements will give you the extra 13K platelets you need. 48 hours prior to the blood draw I would go very easy on the fluid intake, hemodiluting yourself will not help your cause.    mac

GP7852 · Answer

Thanks Mac-I just got an email from Austrailia.The graz-Elbasvir duo I am looking for is available to me.$1600.00 for 12 weeks and $3200.00 for 24 weeks.So I do have an out if I don't qualify for the trial.If I did end up buying them I would ask my doctors office for the necessary bloodwork to keep tabs on my platelets.If they refuse I must roll the dice.Unless they feel they can get these meds for me.I do not see my insurance company paying the money for a 2 time relapser. Worst case scenario is I can buy the meds.If I cant get the bloodwork I would roll the dice.Its the only way I can get better so I figure what do I have to lose.I know the outcome if I don't take them.Have a great holiday. Glen

mac790 · Answer

Glen, Thrombocytopenia should be expected in people who have Hep C. Why it is an exclusionary item has never been explained to me, I'm guessing they are worried the HCV meds will lower it even further. You platelet count is quite low, 47K is not even 50% of the lowest number that is considered WNL. Gilead is being liberal in their standard of 50K minimum. As they are produced in the bone marrow, it is one of the more difficult values to elevate w/o Rx drugs. Anything that can improve your entire hematology panel should help. If the supplemets are water soluble, your body will eliminate what it doesn't use. The supplements that are fat soluble can build up in your system, so I would exercise more caution in the dosage of those. Even w/ large doses, these OTC supplements will take time, something unfortunately you don't have an excess of. Good luck on the next blood panel.    mac

GP7852 · Answer

Mac
I am at work and do not have the paperwork in front of me but the Merck trial was the grazoprevir and elbasvir with the ribo for 16 weeks or the 2 of them without the ribo for 24 weeks.So it would be 2 drugs or 3 depending on which 1 you are chosen.I have no shot at these cause Merck requires your platelets at 70,000.I am trying to get to 50,000 to be eligible for this same offices Giliad trial.I started vitamin k today along with my vitamin c and d.I bought the supermarket out of every item the internet said would raise my platelets,all very healthy stuff so at least I am improving my diet.I was at 47,000 on my 2nd bloodwork so I am praying that everything I am doing will get me to 50,000 by the 1st Monday in January which is my last shot at getting in.I will keep you posted when I get the results from D-Day 
                                                              Glen

mhudnall · Answer

Hi Glen, There is an FDA-registered, IRB-approved Phase 2 Human Clinical Trial currently enrolling in Phoenix that includes an arm for unresolved HCV - including Harvoni treatment failures. The Clinical Trial is measuring the anti-fibrotic effect of a medical food formula, so while liver fibrosis staging may be reversed, the formula being studied will not eradicate the virus. For details call The LiverLab Fibroscan Clinic in Phoenix Az. Their website is on the internet. Best of luck to you!

mac790 · Answer

Glen, I thought your platelets were the issue? Regardless, the inclusion/exclusion criteria vary from trial to trial. I would counsel you to only acquire these potent DAA/new gen protease inhibitor meds under direct medical supervision. Combining the Merck combo of grazoprevir and elbasvir (MK 5172) w/ sofusbuvir and RBV is something I have never even seen in print.There were two arms of the MK5172-068 HUP trial I went through that used RBV also, but never have I seen all 4 drugs administered concomitantly. I an no MD, and neither are you. I would strongly advise you to only acquire and take a regimen of meds recommended by a board certified Hepatologist. If you check my posts, one of AbbVie's DAA combos had a warning issued about use in advanced cirrhotics. These are extremely powerful meds, and are so new I don't feel there is an accurate understanding of the long term effects. I know all to well the frustration you are feeling, I was excluded from a clinical trial @ HUP because my Hematocrit/Hemoglobin levels were just barely below what was acceptable for that particular medication. When you were screened @ HUP, they should have given you information as to what the inclusion/exclusion criteria were, what medication was being tested, whether a placebo was involved, etc... The inclusion of cirrhotics is something that should have been set in stone before any candidate screening even began.    mac790

Livelife777 · Answer

Glen.  So sorry you keep hitting brick walls.  If in your shoes I would likely try to get the meds thru clinical trials in a comprehensive transplant center outside of Penn.  Have you considered Mayo Clinic in Rochester NY?
How sad is it that you so need to be treated, and met with resistance for all the wrong reasons.
Hoping and praying for you.
......Kim

GP7852 · Answer

Thank you
I appreciate the info but I am a Harvoni relapser and it is of no use to me.

GP7852 · Answer

Thanks Dim
I emailed Greg Jeffries but never heard back.I wasn't aware of Dr Freemans and will look into him.I am not officially out of the trial at Penn yet but she didn't make it sound like I had much of a chance so I have to explore every option.She is waiting to hear back from Giliad to see if they are going to allow cirrotics in so I am still holding hope.I know I am deterioriating and I really have to act soon.I did make a doctors apt today to find out what would serve me best as far as meds and then try to find them online.
                                                 Glen

GP7852 · Answer

Thanks Marc
I was on the phone with Gilead today.She told me about 3 different foundations they have.I have a conference call with them tomorrow.They want to also talk with my insurance company.They said if I have insurance I wouldn't be eligible which is why they told me about the foundation.My doctors office would not even call my insurance after the last two struggles which were both failures.They said I was beating a dead horse.
                                               Glen

GP7852 · Answer

Thanks Pat
I will go looking for that now.I just hope these people are trustworthy.
                                                 Glen

Dim37 · Answer

Hi Glen
I am sory that you didn't manage to be part of this trial . But they are some good news . At last  Indian authorities have approved the generic daclatasvir and harvoni. Sofosbuvir is on the market since May. In two weeks time you will be able to by them. You can either fly there your self and get them or order them trough this Australian byers club . As i said in a previus post you can check Greg Jefferys site for info or Dr. Freeman's  fix hepc . Good luck my friend, i am sure you will find cure one way or another. Things are getting easier.

virt111 · Answer

Certainly check the threads that Pat has pointed you to, but, and I know it's a long shot, contact Gilead support and explain your circumstances...Maybe they will make an exception.

Good luck, Glen.

Marc

patra_ · Answer

Glen, while it really irks me that people can't just get a prescription and get the medication, for all the reasons that everyone already knows, on to positives.

Have you been following the two or 3 threads focused on purchases in and / or from India.  It seems to have so excellent information.  Two of the threads are on the first page of the Hep C Forum.

Please check it out.  I pray that the information will be valid, and a help for you and others!

Blessings,

Pat

I need your help

Over 9 million RNC's quantitative viral load of Hep C

I need to find medical consultant who will work with my case

DR VISIT

HCV to HCC (warrior)

Over 9 million RNC's quantitative viral load of Hep C

I need to find medical consultant who will work with my case

DR VISIT

HCV to HCC (warrior)

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