Is Cure coming in future?

?? @availlant @ThomasTu @john.tavis

I want to echo Thomas’ annoyance with this kind of commentary from @H020. It is simply not productive, not accurate and ignorant of the countless hours of work that numerous labs from around the world are spending to try to help patients.

I also want to point that these kinds of posts are also quite disrespectful of the time, effort and commitment that Thomas puts into this forum., which otherwise would not exist.

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Completely agree! so grateful to all the researchers and specialists working towards this extremely difficult task of finding a cure. Very thankful to @ThomasTu @availlant and others for the valuable time and information that they provide on this forum.

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Thanks so much for the time, effort everything.Till when are the patients going to get the cure?

Hi @availlant,

Hi Andrew! I and I am sure others were starting to get a little worried about you! Hope you are doing well and are just busy. Glad to have you back if you are back.

-Paul

I think that badly put comment was directed at the big guys, like the FDA, who imho have shown some bias and corruption… especially over COVID

Certainly I can’t imagine it would be directed at the excellent people here who have been doing amazing work at actually making a cure for this thing (and doing extra work on top of that by making this community/posting to it and engaging with us)

In any case I’d like to thank you guys. Without your work, and without your communication, things would be far worse. So y’all mean a lot to me. Thank you truly

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Hi @PuallyHBV ,

I am always checking in but only responding if Thomas has not yet taken some responses. I appreciate the concern!

Best regards to you and everyone in the community!

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Hi @bob,

Patient frustration in the HBV space is of course very understandable as a lot of excitement and expectation have been created around many technologies in the past 3-4 years which have failed.

Expressing this kind of frustration as a patient is very appropriate on this forum as patient support is one of the key focuses here. In this regard the pharma industry and KOLs who are paid by these organizations bear the responsibility for these frustrations in the patient community.

However, we have to be careful with comments about bias and corruption that we don’t paint these organizations with too broad a brush: many of the people who work for these organizations or individual principle investigators (academic or clinical) are hard working individuals with integrity and a drive to make a difference.

Cheers,

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Hi @availlant its been a while we haven’t heard from you. I understand the stress and frustration some people are going throug waiting for cure to come,its difficult sometime but honestly i feel there’s some people working really really hard finding for cure. I am very optimistic with NAPS Replicator that @availlant is working with, just wondering how’s the progress.

Thanks.

Dear @12345678,

Thank you for your comments. Developmental progress of NAPs continues to be very successful in our current compassionate use program in patients with HBV / HDV co-infection who have failed to respond to pegIFN or bulevirtide. REP 2139-Mg continues to demonstrate excellent safety and efficacy in patients (including achieving functional cure of HBV and HDV) with very advanced liver disease (cirrhosis and decompensated cirrhosis). These studies are helping to convince everyone in the industry how safe and useful this drug will be in ALL patients with chronic HBV infection, regardless of disease stage or co-infection with other viruses.

You can check out the latest results from our clinical studies at http://replicor.com/press-releases/.

Best regards,

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@availlant

Thank you very much and we (the community) really appreciate you being a responsive expert and at the same time THE main driver of Replicor/REP 2139-M and I have no doubt many of us will be cured when this becomes available…Again Thank you!!
Nas

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Hello @availlant

I saw in the upcoming hepatitis conference there is going to be a presentation on NAPs mode of action on some new duck models which previously didnt show any effect of ducks but worked well in humans. Would Replicor use this to establish mode of action to larger community and push the development of NAPs?

I can imagine the concern’s people have. Living in the US, having insurance and medical facilities, as well as places to get medication (pharmacy) every 5 minute drive.

Then there are others who live in some parts of the world that just aren’t like that.

We are all in the same boat, but some of us are in the luxury suite and others are in in the hull of the boat. So I can see the frustration. Stay strong, stay healthy.

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Hi @Ash_Malhotra,

Since 2013, we have published the antiviral activity of NAPs extensively in the duck model please see here, here, here, here and here. The activity of NAPs in the duck model has always predicted their activity in humans.

I am not sure what conference you are referring to but there are no upcoming Replicor presentations with animal model data. We are presenting updated results from our compassionate access program at EASL next week in Vienna.

Best regards,

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@availlant I read one of the oral presentations. Good progress. Could you help shed light on

  1. 78% of patients maintain immune control / normal liver function off therapy
    Up to 56% functional cure at 5.3 years. Question is, has the 56%been changing. To mean at end of one yr the figure was high? If yes why. The time aspect, the 78 and the 56 confuse
  2. Do NAPs deal with the risk of HCC once and for all? and esp for all for those with functional cure as a result of this treatment?

Hi @CNN,

Unfortunately, the terminology surrounding outcomes from treatment are a bit confusing. There are currently two outcomes from therapy which do not require treatment under current guidelines:

  1. Partial cure: HBV DNA < 2000 IU/mL with normal liver function in the absence of antiviral therapy. This is akin to “inactive HBV infection”

  2. Functional cure: HBV DNA and HBsAg are not detectable with normal liver function in the absence of antiviral therapy. For this outcome to persist, removal of most of the liver cells with integrated HBV DNA has to occur.

Both of these outcomes occur because immune control of HBV infection has recovered. This recovery is obviously much stronger in the case of functional cure.

So in the recently presented extended follow-up from NAP treatment of chronic HBV infection, overall immune control was maintained at 78% (this was present at 1 year of follow-up) but the proportion of patients who had functional cure of HBV increased from 39% at one year to 56% at 5.3 years.

HCC risk is the lowest in patients who achieve functional cure after antiviral therapy. Can HCC risk be eliminated, we are not sure but HBV DNA integration is the primary driver for HCC; the removal of these hepatocytes leading to functional cure must be having a positive impact.

Best regards,

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Very promising outcome at year 5!!
Thanks @availlant for the update!!

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Pls help me understand some few questions

  1. Does functional cure means complete elimination of the virus including cccdna

  2. How possible is the cure such that it won’t reactive

  3. Can we be confident to have a cure in the next 2-5 years

  4. Will the various combinations of drugs in clinical trials help to achieve a sterilize cure

  5. What’s your view about promising drugs coming

Will be glad to know these answers

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I am not a medical professional, but I may be able to answer some of your questions as a lived experience person.

No it doesn’t. My understanding is the virus is not attacking your liver, functional cure. But it is still in your blood and can reactivate.

Dear @CSKAY,

I’ve moved your question into this thread about cure (please feel free to read the other responses to get a broader idea about what’s going on in this area). To answer your questions:

  1. The clearance of cccDNA from the liver is the definition of “complete cure”. We have made a video of it here: What do we mean by Hepatitis B cure? - HBV Cure FAQs
  2. Also explained in the video above.
  3. Explained in these video here: How possible is a cure for Hepatitis B? - HBV Cure FAQs; What could a Hepatitis B cure look like? - HBV Cure FAQs; What do we need to achieve a Hepatitis B Cure? - HBV Cure FAQs. Essentially, we are closer towards a cure, but I think having one ready and available to people within 5 years is going to be tricky and require a lot of investment in the area.
  4. Again, explained in the videos above. More than likely, the first few approaches to cure are going to require combinations of drugs.
  5. There are quite a few coming up: Hepatitis B Foundation: Drug Watch

Hope these help,
Thomas

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