Intercept Pharmaceuticals OCA

[NYLassie]

I have been paeticipating in the clinical trial for this drug. At my last visit to my hepatologist, I was told that Intercept applied for OCA to be fast tracked. It could be on the market in 10 to 12 months if this is the case. The research director at my doctor's office told me that if that happens, Intercept will continue the study but is likely to remove the double blind nature of it, so that those participating in the clinical trial will all be given the medication, no more placebo. I am very excited about this, as I don't know which I am taking now. In the previous phases of the clinical trial, OCA has been shown to reverse fibrosis significantly. I have F3. Dialing it down to F1 would be awesome. The liver has an amazing capacity for healing itself. Proper diet and exercise to remove fat from the liver go a long way. I am very hopeful both for me and everyone suffering from NASH and fibrosis.

[nash2 Partner]

Hello Lassie

You are correct on all counts. FDA will be considering OCA for licensing in a few months. We are certainly hoping this is but the first of several different therapies for NASH since it is such a complex problem. Thank you for your note. I tried to get in that trial but didn't qualify.

Wayne

[NYLassie in reply to nash2]

I was glad I qualified for the trial, though the liver biopsy was a nightmare. There seem to be several promising treatments being developed in addition to OCA

[Liverhead]

Proper diet and exercise is key.also helps to manage diabetes

[NYLassie in reply to Liverhead]

Absolutely. No magic pills.

[Jmaxley]

I was in the OCA trial for a year (Sept 2018 to Sept 2019.) At my one year mark, nonbleeding varices were found in my esophagus and stomach at endoscopy, but they went ahead and did the 2nd liver biopsy, etc. So, they took me off the trial. I was followed monthly during the trial, but when I went off, was told not to come back for 6 months. It has been very unsettling and was very sudden. No follow up for 6 months, even with being started on Xifaxin and Lactulose for HE. Fortunately, I have found a local GI with good knowledge of Hepatology, and he has been good to me. The suddenness of no contact with the study site was very disappointing to me.

[NYLassie in reply to Jmaxley]

I'm sorry your experience with the study was so disappointing. I am participating through my hepatologist's office and they are just awesome. I email the nurse in charge of the research department and she is very encouraging and she and my hepatologist are both great.

My first biopsy was awful. I had a bad reaction (vasovagal syncope). My pulse dropped to 24 and my BP had to be ascertained via doppler. I went to the ER and they kept me overnight. Intercept took care of the bill. No second biopsy yet. Intercept changed it, since they applied to fast track OCA, and the second will be done at the end of the study.

I am glad your doctor has a good knowledge of hepatology. My regular internist knows a good deal about nutrition and exercise and has been a great help to me.

This is an exciting time as there are several ongoing clinical trials for other NASH and fibrosis medications, as well as studies relating to the best nutrition and exercise for improving liver health.

Oh and the vasovagal syncope is something I never experinced before but that my mom did all the time. I thought OMG I am turning into my mother! My mom had NASH and lived to the age of 86 by the way, rotten diet and no exercise but her quality of life was awful and it was a blessing to her when she passed. I sometimes wonder how much better her final two decades could have been if she had taken better care of herself.

[Alterity]

I was told too that when the study was over I would get to continue on the pill. I'm either on it right now or I'm getting worst. I hope I'm so tired because the liver is working so hard to heal from everything. I have been itching more and they said if I was on the pill I would. Even so if I can hang on another year, I will have the right pill. I know I need to lose weight too. When first diagnosed I weight 283, I have gotten down as low as 220 and now I'm back up to 240, I need to get my head in the game, but it is so hard with all the stress. When I'm so tired I eat more to give me strength. I just need to rest more. I just started the blind study 3 months ago, so I have a long way to go.

[NYLassie]

I am tired a lot. I can take naps when tired. I know a lot of people can't do that though. When I can't take a nap, I have decaff coffee with soy milk and a non gelling soluble fiber powder. I also force myself to get on my exercise bike for at least 20 minutes. If I am at work, I take a walk sround the facility or go up and down the stairs a few times. Despite being tired, I find that it energizes me. Not sure you are in a position to do any of that but exercise can go a long way toward using up excess fat in the liver. That is what motivates me to do it.

[Moonsts]

I don't know how others feel. Harvoni was fast tracked and some of us feel it harmed us.

Back when it was released, we saw ads on tv for it. Then ads for all boomers to test for hep c, then Maryvet. Now nothing at all.

I'd be very cautious.