LIVDELZI

[ninjagirlwebb]

is anyone on this new pbc meds? If so, what did your doctor say about it. I did read about it but curious to see what doctors have to say about this vs the other new pbc drug.

[DonnaBoll Administrator]

The other name for the drug Seladelpar. I believe it was put on the market very recently. I know a couple people who participated in the clinical trials. It was proven to be very effective in bringing numbers down as well as helping the itch. They spoke about it at both PBC Foundation Summits that I've attended. The drawback is the price...It has a list price of $12,000+ for 30-day supply. Gilead got FDA approval to market the drug. What 'other' PBC drug were you referring to?

[ninjagirlwebb in reply to DonnaBoll]

Thank you. IQIRVO is the other. Just reading up on these.

[gwillistexas]

I met with the NP yesterday and she went into great detail about this new drug. I was not able to stay on Iqirvo and she said this drug should be easier tolerated. My hep will discuss it end when I see him November 8th. I read about it and I think I’m ready to try it. There didn’t seem to be as much a danger taking statins as long as they are spaced at least 4 hours apart. The Iqirvo warning with statins was it could cause toxicity either in the Iqirvo or the statin. Ocaliva isn’t keeping my ALP down. My last 2 labs it was 177.

[ninjagirlwebb in reply to gwillistexas]

My hepatologist stopped prescribing Ocalivia to his patients. It has been pulled off the market as researchers say it does not work.

Good luck with the new meds & let us know how you fare

[gwillistexas in reply to ninjagirlwebb]

It is still on the market in the US. I’ve been getting it with no problem and no mention of it being pulled.

[ninjagirlwebb in reply to gwillistexas]

I heard it was pulled. In any event, he is no longer prescribing it to his patients. He said the new meds are better with less side effects.

[gwillistexas in reply to ninjagirlwebb]

I’ve not been able to find anything about Ocaliva being pulled in the US. I knew they were struggling with it in the European countries.

[ninjagirlwebb in reply to gwillistexas]

Good point on the statins. Have to ask my hep about that.

[gwillistexas in reply to ninjagirlwebb]

Yes please do. It recommended if you’re on a statin to lower the dose. My internist lowered mine to 5 mg but I went back to 10 mg when I stopped Iqirvo. I also found that anyone with lung problems, asthma etc, should not take it. Said it can lead to respiratory depression which could potentially be fatal.

[ninjagirlwebb in reply to gwillistexas]

Thank you. I will add to my discussion list. What other questions will you be asking your hep? I want to cover all the bases as well.

[gwillistexas in reply to ninjagirlwebb]

I’m not sure what I will ask. I have a little time to get it together.

[ninjagirlwebb in reply to gwillistexas]

I googled. They make a final decision on 10/15/24. I feel like fda will pull it off market.

Without sufficient data to work with, FDA advisors were strongly inclined against recommending full approval to obeticholic acid (Ocaliva or OCA) in primary biliary cholangitis (PBC).

On Friday, the agency's Gastrointestinal Drugs Advisory Committee members voted 10-1 (with three abstentions) that the farnesoid X receptor agonist did not have a favorable benefit-risk profile when used as a second-line treatment for eligible adults with PBC and no contraindications.

[gwillistexas in reply to ninjagirlwebb]

That’s too bad. Studies were positive in the first few years of me taking it. It showed it could reverse fibrosis. In that study they actually did biopsies which proved it. If I remember correctly, 40% chance of reversal.

[ninjagirlwebb in reply to gwillistexas]

Yeah but i think because the new drugs are deemed better for pbc treatment.

[gwillistexas in reply to ninjagirlwebb]

Could be but I personally think it more “we’ve got all these new drugs so let’s try the latest and greatest”. I will trust my heps judgment. But I have such a sensitivity to drugs so just because they’re the lad test thing does mean they’re for everyone. Ocaliva is the only drug I’ve been able to take with no problems.

[gwillistexas in reply to gwillistexas]

Meant “latest thing.

[ninjagirlwebb in reply to gwillistexas]

Just trust the specialists…they know more than us.

[gwillistexas in reply to ninjagirlwebb]

True