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Author Topic: Clinical trial Abbvie G/P  (Read 6599 times)

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Offline easygoing1

  • Member
  • Posts: 12
Clinical trial Abbvie G/P
« on: June 28, 2017, 03:22:20 pm »
Just got home after a visit with my Dr. of Hepatology. My numbers are Geno 1a, Fibro F2, VL 7.5 iu/ml.  AST 24, ALT 43. I failed 8 weeks Harvoni in June  of 2016. Here it is a year later and still waiting for a new drug that will cure those of us that failed Harvoni. My doctor wants me to wait until new drugs are available. FDA is to approve Abbvie's G/P by August and Gilead's triple by maybe August.I will be on Medicare as of August 1 2017. My guess is at least another year before these new drugs will be available for prescription and who knows if Medicare will cover the drugs. I had a long battle to get Harvoni. I have a chance to get in a phase 3 clinical trial for Abbvie G/P very soon. I'm looking for opinions or experience with clinical trials and the safety
of these new drugs. Any thoughts are appreciated. Getting tired of waiting .
Thanks


Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Clinical trial Abbvie G/P
« Reply #1 on: June 28, 2017, 05:50:51 pm »
Waiting is hard! We should know more soon, and hoping to support you while you gather info to help you make your decision.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline gnatcatcher

  • Member
  • Posts: 1,372
Re: Clinical trial Abbvie G/P
« Reply #2 on: June 28, 2017, 08:20:26 pm »
Hi, easygoing1. I'm glad Lucinda is keeping an eye out for the latest info on this trial. Although I don't have personal experience with clinical trials, a few thoughts:
1. Phase 3 trials are the least risky of the three phases. Phase 1 determined a safe dose, and phase 2 provided a lot of information about side effects. I assume the trial doc won't accept you into the trial if there is a known danger in your case.
2. Has your hepatologist had you do resistance testing to get a better idea of what may have caused your Harvoni failure? If not, I wonder if the clinical trial doc would do so as part of deciding whether you qualify.
It certainly seems like the clinical trial is worth a further look.

Good luck.

Gnatty
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline easygoing1

  • Member
  • Posts: 12
Re: Clinical trial Abbvie G/P
« Reply #3 on: June 28, 2017, 10:24:40 pm »
Hi Gnatty, I did have resistance testing and the test found a Q80k RAV. Hopefully
I get called for screening and should know more at that time. My Doctor suggested
it is a personal choice to get in a clinical trial and told me to go for it if I didn't want to wait. I'm just a bit undecided if it is worth the risks of taking an unapproved drug. But if I wait it could be a long battle just to get the drug once it is approved.
Thanks for the support
Easygoing1
 

Offline gnatcatcher

  • Member
  • Posts: 1,372
Re: Clinical trial Abbvie G/P
« Reply #4 on: June 29, 2017, 03:27:46 am »
easygoing1, your hepatologist sounds like a true partner who supplies the medical knowledge you need while honoring your autonomy (wish there were more doctors like that). Believe me, I understand your indecision -- it wasn't fully within my comfort zone to be starting Harvoni only nine months after the FDA approved it, but I had reached a point of being able to move forward without anticipating regret. We owe a lot to the people who were willing to enter a phase 1 or 2 trial!

Wishing you the inner clarity that brings peace,

Gnatty

P.S. Dag Hammarskjöld, a long-ago United Nations Secretary-General, kept a pithy journal that contains a quote that helps me in times of indecision:
   "What must come to pass should come to pass. Within the limits of that must, therefore, you are invulnerable."
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline easygoing1

  • Member
  • Posts: 12
Re: Clinical trial Abbvie G/P
« Reply #5 on: June 29, 2017, 07:58:18 am »
Gnatty,Yes I think I have a very good Doctor at this time. I was referred to him after failing Harvoni. Your numbers are very encouraging. I see your firbosis score has dropped. I believe I've been HCV since 1973. Wasn't deteced until 1992 when I gave blood. I have been very lucky in that my fibrosis score is still at F2 which is why my doctor says I still have time to wait for a new drug. I had no side effects while taking Harvoni and I have no after effects. Hopefully these new drugs will be just as tolerable.How are you feeling? Any effects from Harvoni other than the joy of being cured?
   Thanks for your encouragment
   

Offline gnatcatcher

  • Member
  • Posts: 1,372
Re: Clinical trial Abbvie G/P
« Reply #6 on: June 29, 2017, 08:28:42 am »
easygoing, I'm glad your liver is in such good shape. Answering your question is a bit tricky because I have other medical issues that cloud the issue. For example, I have even more neuromusculoskeletal pain now than before treatment, but that can be explained by the fact that (on the advice of my eye doctor, encouragement of my hepatologist, and concurrence of my PCP) six months after the end of Harvoni tx I was weaned off a medicine that minimized that pain. It's now clear that the cause of that pain is a separate malady rather than its being an extrahepatic manifestation (EHM) of the HCV (my hepatologist and PCP both said that the only way to find out was to go off the anti-inflammatory medicine and see what happened).

The much better lab numbers are indeed heartening. My liver seems to be the least of my problems now, and I like being able to say "I had HCV" rather than "I have HCV." In due time, you'll get to say that, too.

P.S. I see that you've already participated in the thread about HHburme's successful clinical trial experience.
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline easygoing1

  • Member
  • Posts: 12
Re: Clinical trial Abbvie G/P
« Reply #7 on: June 30, 2017, 09:40:16 am »
Gnatty, I am happy to hear you were successfully treated. I hope you beat your other pain problems. Thank you for your response. Best of luck to you.
Easygoing1

 


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