Non-responder stopped taking UCDA/Urso

[Kateb17]

Hi, I’ve been told I’m a non-responder to ucda after taking it for 13 yrs! My LFTs have progressively worsened in stages with plateaus in between. I’ve recently stopped taking the ucda since I’m a bit despondent and don’t see the point taking it. I do feel worse but my symptoms have been worsening and flaring intermittently for past couple of yrs, so not sure if this is coincidental or in my head! My consultant has been talking about trying to get me a trial of OBCA but the itching side-effect concerns me. Due back to see consultant in December. Just wondered if any one else had stopped their urso and if so, how you got on? Thanks!

[butterflyEi]

Hi Kateb17

Not sure which country you are in but you may be interested in having a look at the following study into "Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid"

clinicaltrials.gov/ct2/show...

Perhaps it may be something to speak to your specialist about. Back in 2014 there was a study into the use of fenofibrates for PBC but I cannot locate that document to reference it to you. Perhaps someone else will come along who knows more.

best wishes

[Kateb17 in reply to butterflyEi]

Hi butterflyEi, thanks so much for your response, I’ll certainly look into it. I’m in the UK.

[emerich in reply to Kateb17]

Hi Kateb17,

I had to stop urso after a severe allergic reaction. I was put on fenofibrates over 2 years ago, primarily as a substitute for statins, due to the effect on my liver. So far so good, pbc hasn't progressed, and cholesterol slightly lowered.

[Kateb17 in reply to emerich]

Wow that reassuring! Thanks.

[kimphoebe]

Hi kateb17

I also am a nonresponder to the uso but still taking it as advised by my doctor. Currently on a clinical trial which seems to be showing positive results.

[Kateb17 in reply to kimphoebe]

Hi kimphoebe

Thanks for your response. Good to know we’re not alone in this “non-responder” category. I hope my consultant can offer me a trial of some sort just to feel like we are at least trying to tackle it. I guess I should continue the Urso. I’ll see what difference it makes to my results when they’re next checked! Good luck with your trial.

[kimphoebe]

Think you should even being a nonresponder it still helps with the flow of bile through liver

[Kateb17 in reply to kimphoebe]

Thanks, that’s actually given me a different perspective on it. I’ll restart it!

[kimphoebe]

Being a nonresponder for most clinical trials you usually have to be taking a stable dose of uso so that good news.

[Q8Cooper]

Hi Kate 17,

First try on Urso I had a severe reaction. Waited a year to try Urso again and was classified as a non responder. I quit work to rest, body, mind and spirit and tried to use nutrition as well as I could as I had no options. Nine months ago I started Ocaliva. My liver numbers are coming down slowly but I am responding. I had the "crazy itch" (I call it) a few days in for 3-4 days. I thought it would drive me insane. What I found out for me was it was short acting then gone until we increased the dose from 5mg to 10mg daily. The crazy itch came back again. But once again it went away. I would say to anyone it is worth a try and if you start itching, I think it would be helpful for your doctor to titer increasing your dose more slowly. Lesson we learned the hard way. Also if you are in stage 3-4 The dose needs to be much lower. I think the drug company is recommending 5-10mg Weekly. So it is important to know what stage you are in. There has been some deaths attributed to latent stage PBC and doctors prescribing too high a dose in these patients. Everyone's different you may not want to go this route. My story was that I was untreated for five years and was more afraid of PBC advancing than of trying Ocaliva. Today I scratch a little but it really doesn't bother me.

Hope this helps.

Kathy in Colorado

[Kateb17 in reply to Q8Cooper]

Hi Q8 Cooper

Thanks so much for your reply. It really has helped. I have tried a plant based diet, yoga and meditation. I haven’t been able to quit work but have cut my hours. Unfortunately, it hasn’t altered my blood work but at least I feel better! Like you, I felt I had to take any action I could since there is no current alternative available to me. I lost my dad to HCC after his struggle with PBC and the worrying part was that his 9cm tumour was missed on a liver ultrasound just weeks before it was incidentally found on a CT. His bloods were almost normal as he clearly responded to the ucda, so they gave no indication of any problem. I lost faith in the follow-up process and being told I was a non-responder was almost like a death sentence - a little dramatic perhaps. I see now that any possible side effects are probably worth it if I can help slow this down. I just have to be able to actually get hold of it! Fingers crossed I might be lucky when I’m next reviewed in December. Like I said, I really appreciate your response, it’s helped put a lot of things in perspective for me. Good luck with your progress.

Kate, Liverpool

[Lucky4]

I was diagnosed with PBC in 2007 and told at the time that I likely had it for 10-15 years. Initially I was a responder to Urso but over the past couple of years my numbers have steadily worsened and I'm now a "partial responder". I never had side effects to the Urso.

Eventually I was given some Ocaliva. Now, I do get unusual side effects to medication, I suspect related to this illness, particularly the drying effects. I started Ocaliva at 5 mg in the morning. Within a couple of days, I had the worst taste in my mouth; completely intolerable and some atypical GERD symptoms. After discussion with my doctor, I'm now taking the Ocaliva every second day as well as Zantac. This seems to be helping. I do find significant fatigue (added to the extreme fatigue from the illness) but I suspect that over time that may improve. I'm thinking eventually of increasing the Ocaliva very gradually per my doctor. First labs on this medication not until next month so I don't know how I've responded.

Personally, as an Urso partial responder, I want to continue taking it as I believe it's helping and has helped.

I wish you well.

[Kateb17 in reply to Lucky4]

Hi Lucky4

Thanks for responding. It’d be good to know how you get on with your results. For me the fatigue is the worst (I’ve been lucky in that the itch has only ever been intermittent and not too troubling), so the idea of possibly feeling more fatigued is a little alarming but I guess everyone is different. I’ll definitely give it a try tho, given the chance, after so many responses about it. I wish you luck with your results and hope the side-effects ease up. Like I said, it be great to hear how you get on!

[Lucky4 in reply to Kateb17]

Hi Kate,

Thanks for the reply. I also have disabling fatigue and it's changed my life totally. I'm no longer able to work, very rarely go out in the evening and have to really pace myself. However, I try to look to the positive and appreciate what I am able to do.

Glad the itch wasn't problematic for you. None with Urso for me and so far none with Ocaliva. However, I'm anti-generic so I've stayed on the Urso brand name so whether or not that makes a difference, I don't know.

I suspect the added fatigue will diminish. With other drugs that cause fatigue, this is usually the case. I did find it less with the lower dose but again, as I get used to the drug, I'll see if I'm better able to adjust to an increase.

Hope for the best with you too, Kate. Hopefully people will share how they get on with it all; the mutual support on the board is encouraging.

Joy from Canada

[SuziRae in reply to Kateb17]

Try Benedryl at night. I have found it calms the itchy flare up effectively.

[Q8Cooper in reply to Lucky4]

Hi Lucky4,

I just wanted to encourage you in your journey on Ocaliva. I have been taking it about nine months now. It was a slight emotional roller coaster for me. I saw good results the first month then my numbers bounced up and down thus the emotional roller coaster for me. My alk phos started at 400 and now is down to 190 and my doc and I are still hoping it will drop further. My GI kept encouraging me to give it a year to get a good feel for what it can do. Your doctor is wise to gradually increase dose. I started 5mg all at once everday and then 10mg every day and wham both times I got insanely itchy. Lesson learned. I tell my GI he needs to go slow and easy raising the dosage so another patient doesn't get to share this experience. My fatigue is slightly worse, but I would rather that than my PBC progressing faster taking no action at all. My stomach gurgles a lot! You can hear it across a room. (this is if I eat a fatty meal which I shouldn't anyway). But that particular side effect doesn't make me feel sick at all. I have to laugh as now my stomach "tells on me" if I stray from good nutrition. I also had bariatric bypass. Long story short..... I had a liver biopsy while in surgery and only found out about the PBC in recovery. So I don't know if the gastric noise is a general side effect or a combination of Ocaliva on a bypass. I know there is a lot of concern due to the recent report of deaths of patients on Ocaliva. Just wanted you to know I am several months ahead of you and doing well.

Hang in there and good luck!

Kathy in Colorado

[Lucky4 in reply to Q8Cooper]

Thanks Kathy for your encouraging words. My alk phos was hovering for a few years in the mid to upper 300's but now in the lower 400's. So, after a year wait was able to get the Ocaliva, I started a little over three weeks ago.

Fortunately I didn't get the itch but the taste in my mouth (dysgeusia) was like a dead rat 24 hours a day; just putrid. I've had changes in mouth taste with other drugs that were not essential so my doctor just discontinued them. Even calcium in any form causes a milder version. I'm quite determined to find a way to make this work as the alternative isn't good, to say the least. Upset stomach, a pain but now manageable and the mouth taste has improved

According to the FDA, 5 people with PBC have reported dysgeusia and 4 of them were on Ocaliva so I'm not alone.

After some time will try to up it to 2 days out of 3 and see how that goes and hopefully can one day go to daily but anything is better than nothing.

I'm glad to hear that there can be a delay in lab response. With the Urso, my labs decreased pretty quickly (were up to mid 800's) so I was lucky with that (the illness was discovered by accident after surgery when I had to return to the ER due to high fever). So, we both discovered it via surgery. I had been asking my GP at the time for a liver panel for a few years and she kept refusing. Sigh

I've heard about the deaths and that Ocaliva would be black-labelled but I understand that it was at higher doses.

Really appreciate the reply. I'm new on this board and to a PBC support group. Hope I haven't left anyone out of a reply inadvertently. I really appreciate hearing peoples' journeys.

Thanks!

Joy from Canada

[DonnaBoll Administrator]

I truly understand how frustrating and scary this all must be for you. Unfortunately, even in the best of circumstance sometimes the disease process continues. In my own case it took over 20 years before my PBC became more serious. Stopping the Urso is not helpful though. Even though your numbers may seem unchanged or even worsening, stopping it only increases the chances of bile duct and cell damage. I know how you feel. I've been there. Please feel free to reach out to me anytime.

[Kateb17 in reply to DonnaBoll]

Hi Donna, thanks so much for your kind words and encouragement. I continued urso and was fortunately started on OCA in 2018 which has proved really beneficial. I had minimal side-effects from it and it has reduced my numbers to the lowest they’ve been for over 10 yrs. Feeling much more positive. Hope you’re doing ok and once again thank you for your support ☺️

[DonnaBoll Administrator in reply to Kateb17]

go glad all is going well.... look forward to other chats here.