I guess FDA approved it for PBC but the firm says it’s going good for PSC too. Is anyone can predict when do they approve it for PSC if everything goes well?
And the drug seems so costy for now? Is it ever going to fall? Is anyone know the procedure for these?
2 years ago i’ve asked to my local doc about vancomycin and showed him some articles but he don’t accept me to use it. And he asked me once a while “are you still checking the literature?” etc. He is in a mood of we’ll wait for your liver failure and transplant you again no big deal , i guess.(that’s my second psc, i transplanted once in 2002) but few months ago he said just watch obeticholic acid that could be the answer. Don’t know if it is. Is decreasing the alp numbers will be enough to end it? Not sure but hope like you all.
I’m not that convinced about only using ALP numbers as end point. Increased ALP is the result of PSC, not the cause. By decreasing its level, it could mean the direct effect on PSC, or simply the change of some test numbers. I know there is study showing the lower ALP number represents better prognosis of PSC. But that’s still just a strong correlation, not necessarily cause and effect relation.
But you know what, I hope I’m wrong.
And I have to declare that I have a conflict of interest since I own stocks of ICPT.
I’ve been in three clinical studies. My doctor explained why they use alk phos and other blood tests. The reason is the slow, irregular progression of PSC. How do researchers establish baseline rate of bile duct damage and how do they prove damage has slowed. They can check liver stiffness but liver damage can take many years. So there is really no practical way to measure impact on PSC except blood tests combined with stiffness tests. The last trial I was in was open label and should be published in abaut a year. I started with high AST, and ALT and extremely high ALP-1680. My CBC had high white blood cells and other indicators of infection/inflamation. By the end of the study, CBC was all normal (first time in 17 years) My AST and ALP were near normal. My ALP fell almost 50%. This drug definitely helped me. But, my liver has not improved. In one year it went from severe fibrosis to earl cirrhosis. My doctor says even he has to wait for the public report on how all the subjects did. My theory is this drug stopped the autoimmune attack but my bile ducts and liver were so badly damaged they have not regenerated.