My hbeag in negative hbv dna is 890 iu/ml
Alt normal, fibroscan 6.4kpa..!
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Dear @Guru777 ,
Yes you do have HBeAg antibodies.
If you are maintaining HBV DNA at 890IU/mL with normal ALT in the absence of therapy, you are doing very well.
Best regards,
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Hi just want to ask is it true that bepi can give us a functional cure if it is approved??
What are the chances of approval..!
What should be the hbsag level to get this treatment..!!
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Hi @Guru777 ,
Yes it is possible that Bepi could help some people achieve a functional cure. We don’t expect cure rates to be anywhere near what we see with the drugs that are approved to cure hep C, but we hope that cure rates are at least better than what we currently see with peginterferon. The data from the phase 3 trial have not been released yet, but they found from the phase 2 study that people with lower baseline HBsAg tended to respond better. The phase 3 trial was only open to people with HBsAg < 3000 for this reason.
It’s very hard to say what the chances are for approval, nor how long the review process will take.
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My understanding is that Bepi is getting closer to approval given the clinical trials will be generating publishable data soon.
Regarding the chance of functional cure, this will vary from person to person, but the research shows that if you have a low HBsAg level, you’re much more likely to experience a functional cure (e.g., very high chance if you are <10IU/mL).
Thomas
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Is it true that it’s beneficial for people with hbsag less that <3000 iu/ml also.. bcoz it’s written every where that people less than 1000iu/ml or 3000iu/ml have chances of functional cure with bepi..!!!
Hi @Guru777,
It depends on how you define beneficial. There are indeed a small proportion of people between levels 1000 and 3000 IU/mL that benefit, but my understanding is that this was this number was too low to be considered practical to test in a costly clinical trial.
Thomas
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@ThomasTu I actually think the phase 3 Bepi trial included people with HBsAg between 1000-3000. It was just people above 3000 where they decided that the success rate was too low to justify it. I’m sure that when the data from the trial is published, we will have a better idea of how the success rate in patients between 1000-3000 compares to people under 1000. It may be something like people under 1000 have say, a 25% success rate, and people under 3000 have something like 10-15% success.
Also @ThomasTu do you have any idea what the median HBsAg reading is for chronic HBV patients? My clinical trial investigator seems to think it’s somewhere in the 3000-5000 range, though some people on this forum are saying it’s much higher than that.
Beneficial what i mean is are chances of people with 1000-3000iu/ml more for function cure with bepi…???
@Guru777 I think what I’m trying to say is that we don’t really know right now, but we will probably know more when the data from the phase 3 trial is published.
Good points, @et5656. I stand corrected. Indeed let’s wait until the data is presented.
My reading of the literature is consistent with what the trial investigator is saying, but indeed it may vary across populations.
As mentioned by @et5656, there is some chance that these people will respond to bepi, but it is a lower chance compared to <1000. Exactly how much lower requires more evidence.
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Hi @Guru777,
Some patients will benefit, others will not. If your surface antigen quantification is over 5000 iu/ml, there is less chance of seeing any benefit. My hepatologist, who is also a principal investigator, already told me that it will not be effective for me, as my surface antigen is in the 20,000’s. Based on the results we are getting, we discussed that it would not be beneficial for me unless something radical happens.
While it might not work for every patient, it is a great tool to have. If 20% of all HBV patients could achieve long-term functional cure, I would not be mad about that at all. It is heading in the right direction, but at a very slow pace.
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Dear @Bansah1,
Do you have any idea about any drug currently under development that could clear HBsAg in the range of 50 thousands?
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No, there’s nothing currently like that. Usually, they start from the bottom and if successful expand to the top through either increasing dosage or doing something additional. But currently, there is nothing like that I am aware of. Sorry
Best, Bansah1.
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I agree with @Bansah1 . Though GSK has a number of other drugs in development for hepatitis B, and they are running trials to test other drugs sequentially, or in combination with Bepirovirsen, in hopes of boosting functional cure rates in people with higher levels of HBsAg.
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Dear @Bansah1,
But there are some drugs that can lead to a high reduction of HBsAg. For example, Pevifoscorvir, a first-in-class oral CAM-E can lead to a higher loss of HBsAg by reducing HBV antigens (HBsAg, HBeAg) and other markers (HBcrAg) from the source. And if combined with other drugs, it may lead to a steeper loss of HBsAg. I think the Combination Strategy is the most tangible path to a rapid functional cure. If CAMs, NAPs, and novel siRNAs are combined with ASOs or Monoclonal antibodys, they will lead to unprecedented results.
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@Nawab I agree. A complete treatment regimen will probably look something like that, combining multiple different classes of drugs. Unfortunately, we haven’t gotten there yet. We are testing combinations of 2-3 drugs to see if the functional cure rate is better than just one drug. Unfortunately, if we throw a whole cocktail of drugs together in one study, there are too many confounding variables. For example, let’s say patients start having side effects. How would we know which drug is causing the side effects if we haven’t assessed the safety of those drugs individually? We also want to test drugs individually to see if they lead to meaningful declines in surface antigen (even if they’re not shown to lead to functional cure on their own). That is the case with DAP/TOM (GSK5637608), which is currently being tested in sequential therapy with Bepirovirsen. My hypothesis is that the functional cure rate will be higher than Bepi alone, but how much higher remains to be seen. Please don’t lose hope, but I understand why it’s hard to be patient.
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Hi @Nawab,
For sure, I agree that it will definitely take a combination of 2-5 or more medications to achieve a complete cure for HBV. However, I am unsure if we have all those medications (pieces) available. I hope by the end of the next decade, things might be looking better. Fingers crossed. Best, Bansah1
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Dear @et5656,
You are right. There are many promising drugs in the pipeline. Let’s hope for the best.
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