Bepirovirsen treatment

I was just informed by my gastroenterologist that I will be starting bepirovirsen early next year once it is approved in Canada. Hopefully, it goes well

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Are you in Canada as well?

I wonder if Vemlidy’s price will go down, and what Bepirovirsen’s price will be.

Yes I am. If it works, then no more concern about the cost of vemlidy

I doubt Bepirovirsen will be much cheaper though. Do you mind I ask how to get coverage for Vemlidy? Thanks.

Wow!! I didn’t know that Bepirovirsen was approved. Last I heard it was in phase 3 trials, which is not a guarantee that it will be approved, if I understand correctly.

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My understanding is that @Walenat hopes that they will be functionally cured by a course of Bepirovirsen, which would allow for cessation of both Vemlidy and Bepirovirsen treatment

Thomas

Yes. At worst case , I will return back to vemlidy. But definitely not both at the same time for longer period. I just say, my doctor mentioned that the cost of the new drug will be very expensive. Hopefully it will worth it

If you are in Canada, you can get coverage using employer drug benefit or if you a low income, get in touch with your province drug coverage plans for low income or senior citizens.

I understand that. I just haven’t heard anything about this drug being available next year, as I have not even seen the results from the phase 3 study yet. I agree that if it is approved, it will likely be very expensive.

In my experience, the government drug programs in Canada usually do not cover brand name medications, and if you need to take a brand name medication, you need to submit a special request, which may or may not be approved. Honestly, for something like Bepirovirsen, I don’t really see them covering it, given that TDF/entecavir are so much cheaper. Yes, I understand that the aim of Bepirovirsen is a functional cure, where you would only take it for a finite duration of time, but still, you could get many years worth of TDF or Entecavir for the cost of one course of Bepirovirsen.

Indeed. TAF is 5x more expensive. So one has to be powerful or rich (paid out of pocket).

With single digital cure rate, I see Bepi as an alternative which also might help bring down prices of Vemlidy, Viread, and Baraclude.

Also, Gilead also has benefit programs which offers around $2000 per year for discount on those who cannot afford it… I have used the card programs for years. I have used them in the past. You have to be creative about getting TAF if you are paying out of pocket.

I am under the impression not every GI has access to or is willing to use such program. Do you have to find a specialist who prefers new drugs? Do you as a patient prefer new drugs? Some doctors/patients have more conservative approaches.

I am not sure what you mean by new drug? If you are referring to vemlidy, I have been using vemlidy for years and my former GI was the one who got me the card several years back. As for the upcoming new drug, I will go with the advice of my doctor, if she recommends it for me, I am 100% going with it. I will sort out the money for the drug at that time even if I have to take a loan (lol)

In terms of drugs still under development (like Bepirovirsen) oftentimes, only research hospitals (often those associated with academic institutions) will have the ability to get patients into clinical trials. For example, UHN in Toronto does a lot of clinical trials. They offered me a spot in the phase 3 trial for Vemlidy back in 2014 when they were comparing its efficacy to Viread. Back then, Viread was retailing for about $800/month in Canada, as it wasn’t available as a generic until 2017. I ended up being able to get coverage for Viread through private insurance, so I didn’t end up enrolling in the trial due to the time commitment.

If you are interested in Bepirovirsen, I’m currently in a trial investigating sequential treatment with a new study drug (DAP/TOM), followed by Bepirovirsen. I don’t know for sure if that study is still recruiting, but that is currently the only way that I know of to get Bepirovirsen.

EDIT: it seems like it is no longer recruiting ClinicalTrials.gov

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@availlant @ThomasTu
Hope ya’all doing fantastic!!

Question…. My Doctor will put me Bepirovirsen next year if approved…
What is your takeaway? Are we expecting cure rate to increase or drop from 10%? Assuming phase 3 still in progress..

Am I a good candidate if my HBSA level is 1200iu??

Dear @Nass,

Becuase low HBsAg is so rare in patients, the recruitment of patients into the bepirovirsen phIII trial has been very slow. We have not yet even seen preliminary response data from this trial yet. I dont think it is likely that approval will come in 2026.

I expect cure rates to be 10% or less. However, we do know that functional cure holding longer than 1 year appears to be durable.

As you likely know, bepirovirsen only works in patients with low HBsAg. HBsAg of 1200 IU/mL is borderline low so you will have a decent chance.

@availlant

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Dear @availlant,

This 10% FCR was based on the results of Phase 2. Can this FCR increase on the basis of results from phase 3.

Dear @Nawab ,

The phase II trial already included a large proportion of unicorn (HBsAg < 1000 IU/mL) patients in the study.

If phIII data gets a higher FCR, it will only be becuase their are many more unicorn patients in this trial than the phase II trial, not becuase of any change in the efficacy of bepirovirsen. Recall the phase III study is designed to essentially only recruit unicorn patients.

@availlant

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I have some questions if you don’t mind.

it is my understanding that NA treatment reduces Hbsag level. Is this correct? So what do you mean by “low HBsAg is so rare in patients” if a lot of people are taking NA ?

I don’t recall if my doctor has done my HBsAg quantitative test before but I do know that the last test is reactive/detected. So for my doctor to suggest I am a good candidate to start the medication, what does this mean?