Need TX advice

[sandysf]

Hoping for some expert advice as I know so many of you have helped others here.  I was diagnosed two years ago and chose to wait for treatment as I knew new drugs were on horizon.  I had no fibrosis in biopsy, am 1a, VL 1.5million.  Healthy female.  BUT I want this virus out of me and have been offered to participate in gilead study of GS9190 and 9451 with SOC.  50% chance of 4 drugs, 25% chance of just GS 9451 (NS3 protease inhibitor).   I have fairly decent insurance, but not sure which path to take here.

Any recommendations?  Should i try the study or wait a few weeks for telaprevir/bocaprevir and hopefully insurance to sort itself out.  By the way, called blue cross today and they were clueless about new drug.  

Sandra

[sandysf]

Good idea Susan.. I will do just that.  Thanks!

[sandysf]

Sounds to me like your doctor is busy and she is attempting to reduce her patient load in advance of the onslaught of people waiting for these new drugs.  I think you were on the right track is seeking out a doctor who can fit you in.  

[James10500]

I just talked to Merck what uor doc told you is not true.  I spoke to Lorrain at Merck #800-674-6372 she said they just had a briefing on Victrelis (Bocep) this morning, the drug is shipping today as noted by Magnum and there is no "rationing".  She also said the doc because they don't secretively inform docs about there drugs.  A web-site will be up next week www.victrelis.com offering product info as well as coupons.

Please call them it might be nice to hear it directly from them, ask for Lorrain she was super nice and informitive.

[James10500]

The wait blows me away !  Obviously I know nothing about pharma production but it seems the drug companies woould want to sell as much as they could as fast as they could.  I'm going to call Merck and see what they say.  I'll post the responce and PM you.

[Susan_1a_CC]

In lieu of another biopsy perhaps a fibro-sure test could give you an idea of the state of your liver today.  Maybe your new symptoms aren't related to your hep?  You might want to have your doc run a C-reactive protein test and a sed rate to rule out some other possibilities:

  "What conditions affect the erythrocyte sedimentation rate and C-reactive protein level?

The ESR and CRP level are raised in many inflammatory conditions. For example:
Certain infections (mainly bacterial infections)
Abscesses
Certain types of arthritis
Various other muscular and connective tissue disorders
Tissue injury and burns
Cancers
Crohn's disease
Rejection of an organ transplant
Heart attack
Some conditions lower the ESR. For example, heart failure, polycythaemia, sickle-cell anaemia, and cryoglobulinaemia. "

Just my 2 cents...

[sandysf]

Thanks to each of you for your help and guidance as I weigh this option.   My biopsy is two years old, should I have another before I decide?   Part of me just wants my life back.. to have this worry out of my head once and for all.  But yes, I do not want to damage my body in the interim with the toxic drugs especially if new and improved treatment methods are on the horizon.  

Good info @spectda - I didn't know that average movement was 6 years between stages.

So you don't think I should be worried that my disease is progressing due to recent and severe pain in hand joints?  I have always been so healthy and active, so when these new symptoms exhibited themselves, I think I started freaking out a bit.

Your advice, input is much appreciated!  I have some serious thinking to do.

Sandra

[spectda]

I am not sure, but I don't believe there is an increased risk of HCC in patients with HCV over the general population unless they are at stage 3 or above. The average movement from stage to stage with HCV is 6 years. Of course no one is average and for some damage occurs more rapidly, but at the same time for many it happens much more slowly.

You have many options and you are a long way from having serious liver damage. You are in a great position to wait for better drugs then boceprevir or telaprevir and to treat privately rather then in a trial.  

Interferon and rivavirin have a long list of their own risks both short and long term. It's important to take that into consideration when making treatment decisions. Most likely you could wait until interferon free treatment is available, success rates are much higher, and treatment in general is less debilitating.

Many of us waited many many years after diagnosis to treat with better drugs.
good luck with your decision,
Dave

[can-do-man]

"In the beginning when I thought I was stage 0 (thanks to my PCP doc) I wanted to treat regardless. But having known what i know now - I would not have at all. And believe me the guys in here can attest to the fact I was VERY pro-tx and VERY aggressively minded about it......."

Yes nygirl i remember that well, and over the years there have been many who also felt that way only later to wish they had waited........... sandysf best to you, i agree with not being in any hurry.

Cando

[nygirl7]

As someone who got stuck doing 72 weeks of treatment (stage 3) if I had a stage 0 I would completely advise that you wait a while and see how things pan out. What will happen when the new meds are released...will insurance cover them if you are treatment naive? Things like that.

Your liver is in such good shape that you might be one of the fortunate folks who can wait to see about non IFN, Riba medications even and for some of us - they were quite rough all on their own without anything added to the mix.

I would at least wait a few months and see about tela and boce - why chance it if you can get those odds.

In the beginning when I thought I was stage 0 (thanks to my PCP doc) I wanted to treat regardless. But having known what i know now - I would not have at all. And believe me the guys in here can attest to the fact I was VERY pro-tx and VERY aggressively minded about it.......

Whatever you decide good luck.

[Susan_1a_CC]

Just wanted to pop in and say that entering a trial is a difficult decision to make.  My stats are similar to yours.  I went into a trial because it didn't use alpha interferon and promised to not have many of the sides associated w/ alpha ifn.  It's been a 24 week tx for 1a's, with the CC allele.  I'll know in 6 months if I SVR and sooner if I don't.  What I want to express is that having only recently changed from a stage 0 to a stage 1, if this tx. doesn't end in SVR my plan is to do much as Will has mentioned - kick back and wait for 5 or so years to see what comes down the line believing that the drugs will be less toxic and much more tolerable.  In whatever you choose I wish you the best of luck.

BTW, I also wanted to get rid of the virus asap when I found out - this would've put me on 72 weeks of SOC by way of the 1st GI I saw.  I can not tell you how happy I am that I backed out of that decision (found a better doc), especially after finding this forum and understanding much more about what can happen.

[willbb]

" bases"

[willbb]

No sandy ,,,you are not being too optimistic:),These trials with the new P.I"s are having very good results and with a 75 % chance of getting one or a combo of them  the odds are decent.

I guess my hesitation for you ,is because of the fact you have NO liver damage..stage 0 damage is the ultimate position to be in as it affords that person to have a waiting period of  probability of at least 5 years or  possibly longer before there was any damage worth being concerned about,in regards to time to treat.  My opinion is  and a few knowlegable Hepa"s that I talk to regularly feel that treatment protocols in 3 to 5 years out will be so much more improved than current,and like I mentioned before if they get INF. out of the mix,then you may never need to be exposed to it.

In answer to your question about whether your reg. G.I will treat  shortly after you left the trial(if your response was less than stellar)  No..a good doc would not as he would wait to see what drugs you had been taking in the study....there possibly could be resistance issues to monitor and so forth.

Anyway Sandy....don"t get me wrong here ..trials can be great..as a number of folks here will  attest. just make sure that with absolutly no liver damage to be concerned about you know the answers to all the guestions before  joining up is all I am saying.  The thread that Specta posted that I have added above is a good guide to cover all your basis.

  Will

[sandysf]

Will,   yes, from the protocol docs I got,  I would know I was in Arm1 at week 16 but only if I get stopped at week 16.  Otherwise, you are right, I would not know for potentially 18 months or more.   So your feeling is that my regular GI would not treat with the new stuff until he knew what I was taking on the trial?  I will have to send him an email.  Good things to think about.

I guess my thoughts are, why not give it a go?  Maybe I would be UND at 2 and 4, if not, I would stop myself or they would stop me.  I would know fairly quickly if I had RVR.  Then I could decide.   Am I being too optimistic?  

[willbb]

Hi sandy....yes deciding when exactly to treat and if it is best to enter a trial or not is always a work in progress...I went thru all the same  self debate myself.

I realize that some in that trial will be able to cease tx. at week 16 ,however I think I saw on here it would be just a few and certainly not the majority. Also I realize that taking whatever meds (IF taking the P.I) will end at a certain time during your course ,however you say that you would know what they gave you at that point. I may be mistaken ,however that is usually no the way it works. Usually they don"t unblind the study until the entire study is finished ,which often takes in the vicinity of a year and a half or so and often even longer.

Just make sure to ask all these questions ,.of the trial co-coordinator

Best....
Will

[sandysf]

Yes, thanks Will, all valid points.  I honestly change my mind day to day.  The study I am considering is similiar to Debra's.  I have only a 25% chance of getting placebo and if I am not mistaken we will know what protocol we are on at week 16,   it is a response guided treatment so we get a chance to stop treatment at week 16 and they reveal your drugs.  I wish I could put the HCV out of my head and wait a few years.  Something for me to think seriously about. I agree with you, their are so many game changing drugs on the horizon.

@Debra- good to know you are doing so well and I will keep my fingers crossed that you will be UND at next blood check.   The docs at University of Miami Liver Research were very clear with me on possible side effects from the Riba/Int,  and I have read too many pages of information on what to expect.  Not looking forward to it.

@brianmo -  What city do you live in?  I find it strange a doc is telling you that you have to wait 6 months to get a script?  My GI will write it tomorrow if I ask.   Might want to visit every GI in your area.  I would if I really wanted to treat.  But why waste time on SOC?  Sorry to hear that your doctor was the bearer of bad news yesterday!  

[researchmonkey326]

First of all @ Will - you always have such valid points.  Thanks for that.  I did not read the protocol for the trial sandra is considering.  For mine, you had a 50% chance of getting two real drugs, 25% of getting one real and one placebo and 25% of getting two placebos.  I have my theories about what I have but won't know for sure until much later.

@Sandra - I am in my 8th week.  I will have my 8 week blood draw next Monday.  I was <25 but detected at four weeks so of course I am hoping for und at eight.  I started at 2.3 mil.  If I am und at 8 weeks and it holds, there is a good chance that I will have 24 weeks of treatment which is a pretty good prospect if you ask me.  Not feeling badly other than pretty much wanting to jump out of my skin most of the time out of some weird agitation/irritability thing.  Some call it Riba Rage but from what I've read, it is actually from the INF.
Good luck with whatever you do.  Keep us up to date with your results.
Debra

[willbb]

  It sounds like you have already made a decision,and it is always a very personal one.

Just like to mention a couple of things tho.If I remember correctly the Gillead trial is like you say a 75 % chance of placebo and you say you would stop at week 8 if not UND. I believe your trial is blinded( someone will correct me if I am wrong on that) so you won"t know your drug until the end of the trial..which could be a year and a half from now.if you are not UND. at week 8 and then leave you realize you could not treat again until that year and a half goes by as you would need to know what you  were taking. Also in  that trial there are no rescue drugs allowed, so you give up a lot of control on that aspect of your treatment.

You may be having some joint pain and fatigue from the virus,however you have no more chance of that pain in your side being a tumour than someone without HCV as it is only an increased  risk with HCV if you have cirrhosis  and it can easily be checked with ultrasound. anyway.

Not trying to dissuade you....just pointing some things out . Interferon is a very powerful drug that can have many side effects,,some severe and some long lasting.even long after treatment ends..you can see many posts here to attest to that.

with no liver damage  you could literally have many many years before any significant damage occurs .. and the treatments years from now will look entirely different IMHO  and  most likely with much better efficacy and very possibly W/O Interferon.

The doctor that told you to run to the trial..hopfully was not one of the doctors that also believes these meds are not v toxic  and in that telling you they are not at all harmful.Unfortunately there alots of thses docs  even some of the G.I."s.

Again ..not trying to dissuade you . just some things to ponder,so you can make the best desicion.

Good luck ..with what you decide...

Will.

Best to you..
Will

[brianmo]

I am female, Geno Type 1A, high viral load, Stage 2. run, bike and very healthy. I thought I was going to be able to get the new drug tx also, been waiting a year since I last  visited my Doctor at the Liver Clinic and today she told me during our visit I would not be able to get the Drug due to all the people who are sicker than I who need it more. The wait?? 6 months to  a year. I sat and cried. I booked this appointment a year ago hoping it would be close to the release of new tx. Now this. She suggested I do 2 things. Have the ILB28 gene test done, and, considering doing the regular tx of a year. If the gene test proves in my favor then the One year of tx would be more favorable. If it does not, then wait another year. I suggested I look around for a doctor who will give me the new tx and she said that this will happen in all clinics. So, keep that in mind.

[sandysf]

Thanks to each of you for responding.  I have weighed the idea of waiting until even better drugs are out.  I am 54 and although I could probably wait a few years (yes, my biopsy was zero two years ago) I am starting to have some symptoms,  joint pain, fatigue.  I don't know if I can deal with several more years of always wondering.. if that pain in my side means a tumor.

@willbb:  Yes, we have no idea just yet how insurance will handle these new drugs.  I called Blue Cross today and they were clueless.   Thanks for the list!  

@researchmonkey:  I had a similar experience, my trusted GI said run don't walk into this study if they will accept you, which got me thinking.  I have a 75% chance of getting the good stuff and NO way I will do the entire study with only SOC, if I am not UND by week 8, I would stop and go to the new drugs.  How far along are you in the study?  

[willbb]

http://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138

[researchmonkey326]

Although not the same study, I am in a Gilead study with the 9190 (Tegobuvir) and 9256.  I have pretty good insurance at work but opted to go for the study not knowing if my insurance would pay for the new drugs when they are actually available and also knowing that the level of care that I would get in the study would be exemplary and it has been.  Also, my doctor suggested that the Gilead drugs held better promise for me with perhaps fewer sx (you always have to remember that the docs are compensated for these studies so they have their own agendas too).  I guess what convinced me was that I was dx four yrs ago and my doc knew I had no interest in SOC.  Until this study was recruiting, she never even suggested any other trials for me so i felt that maybe she did think it would be good for me.  Anyway, I have had fairly good results and some others on this board were und at week 1 with the Gilead trials.  The one thing I like about the Giead is that they are response guided so if you have a quick response, your tx time could be shorter.  Ask lots of questions.  There is a comprehensive list of questions somewhere on here to ask before entering a trial.  Wish I would have had that list before I started.  It is a crap shoot though with getting the real drugs but you could get the real thing later if you have poor response by qualifying for the open label study.
Debra

[willbb]

I would tend to agree with James also..especially if as you say your insurance coverage is decent. However having said that ,at this point it seems there are no definites on how much Insur  co. will cover.  

More importantly tho ,you say  you have no fib.  does that mean stage0? Because if that is the case and you are having no or few symptoms from HCV..you might be well advised to wait ...maybe even a few years,,as meds are just going to get better and better  and there are many trials going on right now that are looking to tx. without interferon.

Emotionally we all want to get rid of this nasty thing. as soon as we can..however with no liver damage  you would have the option of waiting.

best to you ..

Will

[James10500]

Bceprevir is outand shipping to pharmacies tomorrow 5/17 per Magnum.  Why do a trial now when you have a access to a proven winner....jmho