Non-responder Genotype 1b - Telaprevir and Boceprevir

[ChrisDDD]

Hello, everyone.  I had anxiously awaited the FDA approval of these drugs, but dismayed that for non-responders the cure rate is no better than Pegasys and Ribavirin, 37%.  It always seems like the drug companies are bragging about their new drugs, then casually mention that their new 87% cure rate is for treatment-naive patients.  Well, so what?!  I thought the whole point for Vertex and Merck was to find something for us non-responders genotype 1a and 1b.  Sorry to rain on anyone's parade, but have I missed something in the numbers?  I have friends calling and e-mailing me with this great news, and my response is, "I'm not doing it because it's not going to work."  The numbers seem to bear me out.

[MJfromok]

I am stage 4 grade 4 genotype 1b. That was 3 years ago. Haven't really been to the doc after finding that out. I'm a non responder and took the highest dose back in the day, lost almost all of my hair, had to continue to work because I was raising 3 kids on my own with no child support and refused to get state help. I'm not going through treatments again. I think they made me worse than better. I still work, I contracted it giving birth to my daughter and had to get blood transfusion. She is now 22 and I am going downhill. Spend my evenings in bed after work. Lost 30 pounds in 3 months. Have nerve damage in both arms, tinnitus, and all kind of grandulomas in my lungs, kidney pole, spleen and a several nodules on my liver that I haven't gotten checked. I have celiac too. My family doc seems unconcerned and I'm sick of doctors. Just going day to day. I know God will keep me here as long as I have purpose so I do what I can for others on my good days and do for me on my bad ones.

[MJfromok]

I am stage 4 grade 4 genotype 1b. That was 3 years ago. Haven't really been to the doc after finding that out. I'm a non responder and took the highest dose back in the day, lost almost all of my hair, had to continue to work because I was raising 3 kids on my own with no child support and refused to get state help. I'm not going through treatments again. I think they made me worse than better. I still work, I contracted it giving birth to my daughter and had to get blood transfusion. She is now 22 and I am going downhill. Spend my evenings in bed after work. Lost 30 pounds in 3 months. Have nerve damage in both arms, tinnitus, and all kind of grandulomas in my lungs, kidney pole, spleen and a several nodules on my liver that I haven't gotten checked. I have celiac too. My family doc seems unconcerned and I'm sick of doctors. Just going day to day. I know God will keep me here as long as I have purpose so I do what I can for others on my good days and do for me on my bad ones.

[MJfromok]

I am stage 4 grade 4 genotype 1b. That was 3 years ago. Haven't really been to the doc after finding that out. I'm a non responder and took the highest dose back in the day, lost almost all of my hair, had to continue to work because I was raising 3 kids on my own with no child support and refused to get state help. I'm not going through treatments again. I think they made me worse than better. I still work, I contracted it giving birth to my daughter and had to get blood transfusion. She is now 22 and I am going downhill. Spend my evenings in bed after work. Lost 30 pounds in 3 months. Have nerve damage in both arms, tinnitus, and all kind of grandulomas in my lungs, kidney pole, spleen and a several nodules on my liver that I haven't gotten checked. I have celiac too. My family doc seems unconcerned and I'm sick of doctors. Just going day to day. I know God will keep me here as long as I have purpose so I do what I can for others on my good days and do for me on my bad ones.

[ChrisDDD]

Thanks!  I did forget to include my viral load, 4,900,000+ a few months ago.

[frijole]

Thanks for filling in the blanks.  In your postion I would be reluctant to treat too -- I think it is the eyesight loss that would do it.  With a compensated liver you may have time to wait until medicines are out that can be done without interferon.  I wish you luck in your pursuit of an answer.
frijole

[ChrisDDD]

I was infected in '76, diagnosed in '92, failed Interferon only in '98, failed Interferon/Riba in '01, had to be taken off Infergen/Riba in '05 after just 12 weeks because I developed retinal hemorrhaging, making me ineligible for any further clinical trials that used interferon.  Then I had a mild stroke in 2009, completely excluding me from any clinical trials at all.  My last biopsy in '05 showed Stage 2/3 with some bridging fibrosis.  My ALT's combined a couple of months ago was 71!  I thought that was fantastic!  I will be 57 in October and my health is otherwise good.  I'm told my liver is well compensated, no varices, no portal hypertension.  I'm on two blood pressure medications and my blood pressure is well-controlled.

My local doc is hesitant/reluctant to ever give me Interferon again because we don't want me to lose my eyesight.  However, a doctor in Boston wanted me to get treatment this year when I saw him this past December.  He does feel comfortable putting me back on Interferon with very careful attention to my eyes.  He's chief hepatologist of the Liver Center at Beth Israel Deaconess Hospital in Boston.

I'm just so disappointed.  I'm sorry to be a bummer.  I was ready to buy Vertex stock.  I really thought I was finally going to get rid of this *@#!(&^ virus!!  So all the numbers come out and when you read further down, it's about every genotype BUT mine, 1b.  It's not that I'm not happy for those patients, but there's already a cure for the other types.  What about us?

I have my appointment with my doc in Boston in December and I'll see what he says, but I don't want to be sick for months on end, the depression, the nausea, the fatigue, the anemia, the rash (which I had to get medication for and it wasn't even VX-950), lose my hair, etc. for a 30% chance at a cure.  And treatment could worsen my condition along with not curing it.  86% chance?  Yes.  Even 51%?  Yes.  37%?  No.

[meakea]

Chris, I know of many people on HCV forums that failed their first attempt with SOC and then went on to SVR with their clinical trials that involved one of the new drugs.  Talk to your hepatologist and see what he/she says.  Don't let the numbers get to you.  Hector SF said it best!

[buggs1]

your stats are off - retreatment with peg/riba of nonresponders to peg/ riba is a dismal single digit number ( 3 - 7 %) - the addition of a protease inhibitor could increase svr chances 10 fold

[HectorSF]

Chris, treatment success is all relative. With only peg-interferon and ribavirin the chances of SVR when retreating were %0 for persons having cirrhosis. With telaprevir (Incivek) I believe the data shows about a 30% chance of SVR. At least there is a chance now. Previously it wasn't worth retreating. In the case of cirrhosis the only option was a liver transplant. If you know anything about getting a transplant, you know that it is a life and death situation where you will become so ill that you won't be able to take care of yourself anymore (eating, bathing, clothing, bathroom) and will need to be hospitalized while waiting for the life saving liver. Of course this depends on where you are located. In less populated regions of the US you may be able to get a transplant sooner. Having a transplant will profoundly change your life until the day you die.

So is it worth trying the new treatments? To me it is a no brainer. Are you giving up and decided to wait for a transplant? Are you aware how much you will suffer before ever getting a transplant in the best of circumstances. What does your hepatologist say? You will need to work with them on this. Treatment can cause liver failure in cirrhotics. Maybe 10%. You should be listed for a transplant as a backup. If your liver fails you will need a transplant very soon in order to stay alive.

What I'm I basing this on? I am in the same boat. Genotype 1b and with decompensated cirrhosis for the last 1 /3/4 years. So I understand your concern but what choice do we have? In my opinion none. I already know enough about the alternative (transplant) to know if there is any way I can slow my disease or stop it then maybe I wouldn't need a transplant. In the next few moths I will start treatment and see what happens. It is beyond my control how I respond but my attitude is believing it can work and until I see different I choose to "believe".

All my best to you! Please discuss your concerns with your hepatologist (the only one qualified to treat a cirrhotic) don't wait until it is too late.

Cheers!
Hectorsf

[somuchmore2]

I am still studying the numbers and all the labels. One importamt key I see is term of treatment and IL28B code cc, ct or tt. Appears to be more than I can understand so far. For me who treated in 98 then 2002 once peg came out, stage 4 but compensated, had varices bleed but survived it, developed DM and overall not getting any younger my lean is to give one of these drugs a shot at my hcv.

However, I do not know which would be best for me.....had always thought Vertex but now I do not know.

[nygirl7]

And look at it this way, when I treated I  went to week 72 because it gave me roughly a 30% better chance at clearing (I was not clear at week 12). I did it and SVR'd.  I figured that 30% chance was a pretty big chance and it turned out to be.

Hang in there. You dont know it wont work until you try - you might be pleasantly surprised to be in that 37% group.

What were your VL at 4 and 12?

[SusieS2010]

Actually the whole point was to find something better for genotype 1 patients as we are the ones who have dismal SVR rates. To my way of thinking, both Merck and Vertex succeeeded in this. The increased rate for null responders went from about 14% to 32+%. And the rate for treatment naive patients rose from 49% to approximately 86%, While not perfect, it is so much better than it was.

[frijole]

But remember, that is 37% of the nonresponders -- not 37% of the total treating population.  Anyway, according to table 11 in the labeling information, the SVR rate for prior null responders was 32% -- and that was 47/147.  That is not a very big sample size but still, it 32% of null responders did clear!  

One thing -- you will know after 12 weeks.  If you don't meet the criteria then, you are out and can wait until the next round of drugs is approved.

Can you wait?  What is your bx?  What were your VL tests results at 4, 12, 24.  

frijole