March 2014 - Passing along a 'good news' link to a press release supporting improvements with Obeticholic Acid (OCA) in patients with PBC

I'm sharing information I ran across today in regard to clinical trials with Obeticholic Acid or OCA. The study showed that patients who received OCA in combination with ursodeoxycholic acid (UDCA), experienced a clinically meaningful improvement in serum alkaline phosphatase counts (ALP) and other measures of liver function, which can significantly lower the risk of progressing to liver failure. These results, along with the positive data from Intercept’s Phase II studies of OCA in PBC, provide further evidence that this treatment has the potential to result in important clinical benefit to PBC patients. Woohoo!

This provides an overview of the topline study results: globenewswire.com/news-rele...

Source: Cheya M. Pope, Senior Director, Patient Advocacy, Intercept Pharmaceuticals

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  • Hello JennerLayne.

    I've previously read about OCA and the one thing that was noted that is of concern to me with regards to this is the fact patients on the trial were experiencing itching or worsened itching. Being with the itch myself to me this didn't sound favourable.

    I have also had thoughts since being prescribed urso just over 3yrs ago that as time goes on and new medications are trialled and then released for patient use, would I have to have a change in meds and in the event would I get side-effects or 'rock the boat' so to speak?

    I have a feeling that if this OCA goes ahead in time it will perhaps be combined into the one tablet with urso. Hopefully if patients are finding themselves feeling worse off (ie worsening itch) then a return to standard urso would still be an option.

  • Thanks for posting Jenner. I am on the OCA trial and I know the Drs are very excited with the positive results the trial has yielded. Considering it is the first real promise of a new drug for PBC in over 20 years, there is cause for jubilation.

    Karaliz.

  • Hello Karaliz.

    As you have probably read my posting and the mention of the itch (pruritis) and my concern about the OCA, can you tell me if you suffered from the itch prior to starting the trail and if so how you have felt taking OCA. Or if you didn't itch prior how have you been since?

    Also are you on a trial that combines a group taking a placebo and another the actual OCA. May sound silly thing to ask but trails do usually use 2 different groups, one on the actual drug being trialled and then later on all the drug.

  • I have explained about the trial several times but maybe you missed my posts Peridot ? At the risk of boring others here goes ! I was recruited into the OCA trial 15 months ago as have become a nonresponder to Urso. I don't know if you are familiar with drug trials but there is always a placebo arm and at least 1 active arm. In the OCA trial there were 2 active arms - 5mg and 10 mg - and a placebo arm. It was also double blinded meaning neither I nor my Dr knew which arm I was in. During the 12 months of the initial stage my ALP and GGT climbed higher and higher which led all concerned to think I must have been in the placebo arm as the results from small clinical trials of this drug have all been very encouraging. The unblinding will not occur until later this year so without waiting for confirmation my Drs switched me over to the 5mg drug in December and have just increased it to 10mg. My ALP has come down for the first time in years which is very encouraging. I have never experienced the itch and there has been no itch associated with my taking of OCA. As we've discussed before, trials are for the greater good and as this is the first real promise of a new effective treatment for PBC, it is quite exciting news. This is particularly true for people such as me who do not respond to Urso any more.

  • Apologies Karaliz have just read this post, the OCA certainly sounds promising. Are you only on the OCA now then? I have been off the Urso since Aug 2012 but unfortunately to cut a long story short, I am due to go for transplant assessment soon as my liver showing signs of failure. I asked my consultant about going back on the Urso (even though dont really want to go back on it as feel lot better and have a lot less itch since came off it and ironically apart from the chronic fatigue and few joint pains felt much better off Urso than I did during the 10yrs that I was on it) BUT my LFTS have went completely haywire including the Bilirubin (last reading 89) since coming off the Urso. However my consultant felt that for me the Urso had done as much as it was going to do (I never had normal or even near normal LFTS in the 10yrs I was on the Urso). I would love though to be able to try the OCA than have to have a transplant.

  • Hi littlemo. I have been wondering how you are, particularly as I know you are getting married this year. I'm awfully sorry that your LFTS have deteriorated even further - you must be daunted by the prospect of transplant assessment. I admire your grit and determination and really hope that things stabilise for you - you are a brave lady. I remember you have a little boy - how are you managing with him and are you still working part time ?

    I take the OCA in conjunction with Urso as this is what the trial dictates. After most likely being on the placebo for the first year, I have had one lot of bloods taken while on 5mg - ALP and GGT came down for the first time in years - and am now on 10mg. Yet to have bloods taken post dose increase. My Dr said he would like to see several sets of blood results before deciding that it is indeed the result of taking OCA. The question remains for people like you and me who are non responders to Urso, will it make a real difference in the long term ? This is an even more urgent question for you littlemo - I truly wish I knew the answer but I feel that your consultant is best placed to try and help you. I too wish you could give OCA a go and see how you fare with it - do you think you could apply on compassionate grounds ??

    Please let us know how you get on.

    Sending best wishes and thoughts from DownUnder.

    Karaliz.

  • Hi Karaliz thanks for the reply. I got married on Thurs 1st May and am delighted to report we all had a fantastic day. I was quite tired at various periods during the day but I think adrenaline and the desire to thoroughly enjoy one of the best days of my life kept me going . And thankfully had 3 glorious days of relaxation to look forward to after it as we had booked a 'mini-moon' in Donegal staying in a lovely 4star hotel so had plenty of time to recover. I have 2 children a daughter just turned 18 and a wee boy just turned 7 who is a bundle of energy and fun. I am still working part-time (18.75hrs/wk) though dont know for how much longer as next yr our schedule and travelling is going to be a lot more busy and will be doing a lot more travel which I know will really impact on my health as the chronic fatigue can be horrendous some days particulalrily if have not slept well the night before going to work. However I am seeing Occupational Health next week and will discuss all with them. I am just holding out hope and praying that some day soon a cure or prevention for PBC will be found. In meantime I have to leave my fate in the hands of God and pray that I will be around at least long enough to rear my little boy and I suppose thats most mothers greatest desire. Anyway must go only up this late as end up staying wake til my daughter comes in fom her night out. Joys of motherhood. Keep in touch let us know how u get on on the OCA. Bfn take care of you and yours. x

  • Congratulations littlemo and I wish you all the very best.

    Karaliz

  • Hello Karaliz.

    Thank you for posting your reply to your OCA experience. I have more than likely missed certain postings you have done if it's of a nature that I have no experience or perhaps knowledge of.

    I often end up repeating myself on this site but I sometimes think you have to if you are to give an adequate response.

    It's been awhile now since I have read about Clinical Trials and off the top of my head I seem to recall that it can take around 12yrs from a drug being thought about to get through all the processes to finally be manufactured.

    I have read about the stages but has been some time ago.

    Good to read that you are not experiencing the itch from using OCA which makes me suspect that the ones pulling out at trial have been patients who already experienced the itch. But that would be have to be answered by someone who did suffer from the itch prior to taking this.

    You have probably stated previously but are you in the UK or America (or somewhere else perhaps?).

    I still have reservations as though OCA could perhaps reach a presribed medication stage, I still think the way forward is to somehow take something that could keep the antibodies at bay that put the bile ducts under attack. Meanwhile we all have to do what we can to keep ourselves going. Wish you well using OCA, you never know yet it might just prove to be more beneficial than ursodeoxycholic acid is.

  • No worries Peridot. I am a long way from you in beautiful England - down under in Melbourne, Australia !

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