Any news, idea (based from previous approval process) or approximate timeline as to when Bepirovirsen will be approved by FDA? I believe it was submitted earlier this year, is that right?
Hi @Kr2025,
I’m not too confident on the processes of the FDA, but there has been recent news that Bepi has been given Breakthrough Therapy Designation (Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA | GSK). My understanding is that it’ll fast-track things quite a bit - there is a line at the end that “26 October 2026 assigned by FDA as PDUFA date”.
Maybe @john.tavis can cast a bit more light on the process.
Cheers,
TT
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Hi,
My understanding is that based on the 6 month fast track priority clock, Beprovirsen can be on the market as early as the end of this year/early 2027, but I could be wrong. Especially considering the current situation at the HHS/FDA.
Cheers, A
For me, the question isn’t just when it will be available, but what concrete things to expect from this medication.
Awaiting further information.
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For me it’s the long term effects of taking Bepirovirsen
At this stage I would rather stay on Entercavir.
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Hi, I understand your concern. It would be interesting to find out how many Hep B patients would be willing to start Bepirovirsen treatment as soon as it becomes available, and I assume it will be. In my case, after almost 25 years of taking different HBV antivirals every day I think I am ready to take the risk, if not right away then very soon!
Cheers, A
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I’m not sure what the approval timeline would be. Even if it does get approved, it could be a while before it’s actually available in local pharmacies. I really hope it doesn’t turn into a situation like with Hepcludex (which has been available in Europe since 2020, and is still not approved in the United States). I was on Bepirovirsen last year (through a clinical trial), and my most significant side effect was an increase in ALT. I’m told that the ALT flare is a less common side effect. My primary investigator said that I’m the first patient he’s personally treated who has had that side effect, though it has been documented in the medical literature, and current data suggest that it happens to less than 10% of patients. I also experienced a slight drop in platelets, and some injection side redness. My ALT has come back down now, but it took a while. I don’t regret trying bepirovirsen, but I acknowledge it’s not for everybody. If you are not able to commit to having a liver panel and blood counts tested every 2 weeks during the active treatment phase, I’d actually probably recommend not using it.
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Hi,
Is your HbsAg still negative and are still taking antivirals?
Cheers, A
@Ace yes, so far still negative. They will allow me to stop antivirals if it stays negative for a few more months, but for now, I’m still taking TDF.
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@et5656 How long did it take for you to achieve HbsAg negative after starting Bepirovirsen on clinical trial?
Week 6. It happened really quickly for me.
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Wow, that’s really impressive! What was your HbsAg level before you started the treatment?
Around 400. So it was already kind of low, but not super low.
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God willing HBsAg stays negative, then will you take Vaccine to build antibodies ?
Hello, personally I have an HBs antigen level of around 50,000 IU despite my entecavir treatment (for 7 years). I have two questions. Can I take bepirovirsen? Can it work on high levels? Thank you.
The Phase 3 trials of Bepirovirsen only included patients with HBsAg < 3,000, but there was a phase 2 trial that included people with any HBsAg level. That trial found that no patients with HBsAg > 10,000 had a sustained virological response, so I would say that Bepi alone is very unlikely to work for you. However, researchers are looking at treatment regimens involving Bepirovirsen, plus other drugs, to see if that can boost overall cure rates, and offer a path to functional cure for people with very high HBsAg like you.
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Is the load with or without being on current meds? I ask because before i started vemlidy my load was around 11000. With vemlidy its nondetectable. If i were to take this new drug, i suppose it may not do much due to my high viral load?
@dotbammer The most reliable predictor of success that we have been able to identify so far is baseline (before starting Bepi) HBsAg level. Current medications like Vemlidy have little to no effect on HBsAg (though they are very effective at suppressing HBV DNA, often to undetectable levels).
Do you happen to know what your HBsAg level is?
you talking about Viral Load, which is different from HBsAg level, the level they are talking is HBsAg, most of us don’t know the level of HBsAg as lot of countries they don’t even have this test.
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Hello Suresh786
I had that confusion a few years ago. Agree there’s also hbsag among other things that need to be considered.
Which is why it makes it a complex illness*. We wish it was all much simpler!
*I don’t understand much of it but do appreciate it’s complex.
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