PBC Foundation

For people who did not respond to Urso, has Ocaliva had a more positive effect?

My partner has been taking Urso for several years and it has not appeared to be helping at all. We went to see the liver consultant recently following another biopsy and there has been progression in the condition and urso has not been working.

Anyway, the consultant has prescribed my partner with Ocaliva; we are now waiting for the pharmacist to source it, as its apparently quite a new drug in the UK, or at least one thats not often prescribed.

The reason I am posting this is really to ask how well this drug has worked for other people who did not respond to urso?

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Hi djws. Welcome to you and your partner.

I was diagnosed with PBC 14 years ago when I was 38 and prescribed Urso immediately. I partially responded to Urso and must admit almost forgot I had PBC for the first 7 years - very busy working as a nurse and raising my 4 children with my husband who, like you, has been a pinnacle of strength and support.

However, I became very unwell in 2010 when blood tests, extensive imaging including US, MRI, fibroscan and, finally liver biopsy revealed my liver was cirrhotic and my disease had progressed significantly. I was extremely fortunate to be recruited into the OCA ( obeticholic acid ) trial in 2013 and after spending the first year taking the placebo !!, I was swapped over to the active arm of the trial and have taken 10 mg of OCA since. My LFTs improved dramatically and I have definitely stabilised, feeling much better than I did. As you would know, the damage wrought by cirrhosis cannot be reversed and mine is extensive but the Drs believe I was on the edge and OCA has pulled me back and bought me time.

The prospect of a transplant is still there but I endeavor not to dwell on it and am grateful I am still working and loving life and my beautiful family.

OCA is not commercially available here in Australia where I live so the fact that I am only one of a couple of people taking it ( as part of the long term safety extension arm ) in Aus is another reason to feel thankful.

I understand your partner's anxiety and concern for the future as those of us with advancing disease ( rather than stable) are rowing a different boat but OCA has certainly lived up to its reputation and I wish you both great luck and warm wishes in hopefully commencing it as soon as possible.

Hope the above helps a little. Sending good wishes from Australia.

Karaliz

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Karaliz...so you’ve been on Ocaliva since 2013? I’m happy to see someone who has taken it for that long have positive results. I’ve been taking it about 6 months.

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Hi gwillistexas

As the trial was double blinded with random allocation , I was allocated the placebo for the first year - 2013. My LFTs deteriorated throughout that year with the Drs all convinced ( correctly as it transpired) I was on the placebo as the early trials of OCA had been so promising.

In 2014,I was swapped to the active arm and took 5mg for 6 months and then 10mg since.

So this is my 5th year taking OCA and have had zero side effects and positive results.

Take care

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Thank you. This is encouraging to hear from someone in a clinical trial. Please stay in touch & let us know how you are doing. Those of us on Ocaliva really appreciate the info. 😊

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Karaliz...I know you’re probably limited as far as the information you can give, but can you say if you’re in the clinical trial that will eventually tell if Ocaliva prolongs our life? I understand that trial is ongoing & they may not have the answer for couple more years.

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Hi gwillistexas

The purpose of the trial as set out in the document I received is below:

Title : A Phase 3, Double Blind, Placebo Controlled and Long Term Safety Extension of Obeticholic Acid in Patients with PBC.

Purpose of study:

To see if OCA will improve liver function in people with PBC. The safety of OCA will also be looked at. People who are currently taking the standard treatment for PBC - URSO - will continue to do so throughout the study. In these people the study will look at whether taking Urso and OCA together can improve liver function more than taking URSO alone. The safety of taking Urso and OCA together will also be looked at.

This is a very straightforward purpose as I imagine most trials have at their core.

The analysis, later will be complex and will hopefully provide answers we all seek.

Take care

Karaliz

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Karaliz...thank you. So at this point, we all need to pray for a positive outcome. Please stay in touch & hope the remainder of the trial goes well for you. This is really kind of scary, especially when Ocaliva is all some people take. Would be heartbreaking to have taken it a few years & then find out it’s not working for the better. 😊

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Thanks for your response gwillistexas. From the researchers' point of view there IS a positive outcome. OCA is the first drug in 25 years to tackle PBC and it has had remarkable results.

The point is we are all unique and respond differently to treatments and I don't think enough is known about autoimmune diseases to explain why some respond and others don't.

For example why did I respond to Urso ( although admittedly not completely) for 7 years and then suddenly stop responding?

This is such a capricious disease and I believe we will not find the key to unlock it until we have a better understanding of what makes our bodies turn on themselves ( autoimmune). To prevent AI diseases developing is surely one of medicine's holy grails.

Perhaps the results of this and other trials will yield some such answers.

Take care - bed for me down under !!

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Karaliz...thank you. We all appreciate this info, those who take Urso as well as Ocaliva. We all wish you positive results In the trial. Hopefully there will be an answer in time to help others. Have a great day & stay in touch. 🦋

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Thank you !

Except it is 10pm here - hehe!

You have a great day though x

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6am here. Before we go, thank you for participating in the trial. 💕

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You're up early! I am beyond fortunate to be in this trial you know - my Dr says my liver would have failed without it - I was so sick, my husband was scraping me up off the floor after work and I was struggling on a daily basis. OCA has bought me time I would not have had otherwise and I will always be grateful for that - trials are for the greater good but I also have benefited enormously - 3/12 hospital visits, bloods etc etc ( trial stipulations) are a small price to pay.

Really going to bed now -liver ultrasound first thing in the morning -make sure my cirrhotic liver is not growing any nasties.

Take care x

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Karaliz...I’m happy for you that things turned around for the better. Good luck with the ultrasound. Will you let us know how that turns out? G’night 💤

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Karaliz...also confusing if that FDA approved its use. I knew trials were ongoing as far as if it actually helps PBC patients live longer. Oh well, we pray for the positive. Thank you so much. 🌸

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I'm not quite sure what you mean? I know your FDA fast tracked approval for its use based on the earlier phase 2 trials which showed such positive results in reducing ALP in particular. Here in Australia it is still not available as is the case in many countries I believe.

The part of the trial I am still in is termed the LTSE - long term safety extension to ascertain safety of the drug over many years. However there is no word when it will actually be available here in the land of Oz!

Hope that makes sense?

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Lol! Yes you’re right, it was fast tracked. I have all the articles saved in my email archive. It’s like a library, lol!!! I need a new iPhone that has large capacity GB😀👍

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I’ve just been prescribed it as well. Ocaliva is it’s brand name (Obethocolic Acid). It is new and very expensive. It costs £2500 a month and my community pharmacy will only dispense on a consultants prescription not the GP because of the cost. The results on NICE were positive when taken in conjunction with the Urso.

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Hi Diane,

Just to clarify, are you taking Ocaliva as well as still taking some Urso? I'm confused about what the current prescription regime is. There are people on this site taking both, and some just taking Ocaliva. However, I am sure there were some reports on here, a while back, suggesting that Urso should be continued with Ocaliva, as there had been some adverse reactions to Ocaliva on its own. I cannot (yet) find where I read this, though.

Any advice appreciated, take care,

Gritty.

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You can search Intercept Pharmaceuticals & click on the link where they got approval from FDAin August 2017. That will answer your question

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GrittyReads. Everyone knows Urso is an old drug. My dr said been around 30 plus years. I feel certain there are people who had & are still having problems taking it. But the public isn’t alarmed about it every time. Ocaliva is still the new kid on the block so with every little quirk, everybody gets in a panic. If dr’s do what they’re advised to do, they will run labs monthly at least the first few months, to be sure as they can, Ocaliva is working to patients benefit. After 3 months of goood results, they can space labs out a little more. It’s no different than any other new drug.

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Hi Gritty

The advice is to take both Urso and OCA as the thought is that even a minuscule benefit from Urso is better than none at all.

It is a different story, of course, for those who cannot tolerate Urso and would therefor be prescribed OCA alone.

The adverse effects were to do with incorrect dosing of OCA by some clinicians ( ie those with Child Pugh score B and C require very specific dosing of OCA) not the fact that OCA was taken in isolation.

Hope you're keeping well.

Karaliz

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Hi Karaliz,

Thanks for that info, you have clarified my (only half-) remembered alarm bells. I knew I'd seen some news reports, somewhere - possibly on one of the US or Canadian websites I follow, as I couldn't find it when I looked back on the 'PBC F' site. I think I had only recalled the earlier reports about Ocaliva, on its own ... but then forgotten the later explanation about the wrong dosage of the Ocaliva being the real issue.

Thanks again. Much more heartening to know that those who suffer so much from Urso now have another route.

You take care!

Gritty x

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Thanks Gritty

Best wishes too

Karaliz

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The cheapest you can get it where I live is 6,257 mo & that’s with Good Rx discount card.

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Insurance won't cover ocaliva?

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Janelng, at the present I am uninsured. I have read posts here in the past, someone’s insurance wouldn’t approve it unless they had a biopsy. I feel certain some insurance companies cover it.

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Sorry. My empathy for the uninsured. Hope there are some solutions soon. Best luck to you.

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I’m able to move forward & I do have the Ocaliva. Tks😊

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Maybe once clinical trials are complete, the cost will be more affordable. I don’t know if that makes any difference.

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Thanks for the replies, really encouraging for me and my partner to hear that Ocaliva is helping.

Karaliz whrn you mentioned 10mg is that a weekly dose or daily? I think the consultant mentioned that my partner would start on 5mg but I can’t remember whether that was daily or weekly.

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Hi djws

I was prescribed 5mg for the first 6 months - daily dose - which was then increased to a 10mg daily dose. I still take 1gm Urso daily in conjunction with OCA as my Dr believes it is worth taking even if the benefit is minimal.

Take care.

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I started on 5mg per day and after 5 days the itching was unbearable. I spoke to a liver nurse and then my consultant who told me to stop taking it. Besides unbearable itching my face felt puffy and I got a rash on my back

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I started OCA last August (new in Canada) at 5mg and increased to 10mg after 6mths. I was a non responder to Urso (lowered my #s just so much and then stopped).

I take 500mgx2 of urso and 10 mg of OCA per day. Bloodwork pending to see how 10mg is working in a month (Dr said it doesnt usually make alot of diff). I am lucky as no side effects or itch. I am still 2x normal alp (but thats better than 3x!)

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Just started on 5mg Octaliva a day plus 1500 mg of Urso. My ALP levels were stuck at over 200 so given to get them down. Hoping for good results.

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I unfortunately have not had any luck with either the Urso or ocaliva

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Diagnosed March 2017, began urso. Determined urso non responder 9/17. Had fibroscan and biopsy, began ocaliva 11/2017. Initial huge improvement has flatlined ... I’m itchy but dealing with it. and while my liver enzymes are higher than I would like they are within the outer band of acceptable according to my hepatilogist (1.67 times upper band). So that is good. I’m 49 and staying positive. Hope this helps! Best to you both, Ottley.

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Hi. I have just started ocaliva 3 months ago after being on URSO for 11years. My LFT’s are now normal! The first time in years. Am still only on 5mg daily and continue to take urso also.

Good luck.

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