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:
Partial cure: HBV DNA < 2000 IU/mL with normal liver function in the absence of antiviral therapy. This is akin to “inactive HBV infection”
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.
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:
Andrew,
Hope you are doing as well.
It has been a while and haven’t heard from you.
Was wondering if Replicor got to the finishing line yet, because from every other trials out there I believe Replicor might be potent enough to clear the SBAg.
Hope all is well
We have just presented our latest results at the EASL meeting this year, you can look at them here.
Our current compassionate use program is on going in the most difficult to treat patients with advanced liver disease and impaired liver function and also who have failed on other antiviral treatments. This is also helping us to make some improvements in the formulation of the REP 2139-Mg drug product (not REP 2139 itself) to improve its efficacy in all patients world wide.
Once this is ready we expect to begin the final trials required for approval.
I appreciate the quick response.
I am a shareholder and get the updates as well.
Just can’t wait till the final approval so I can use it. I don’t know when but, if you have an idea please let me know.
It is great to hear that from you, Andrew! The more I read about Rep 2139 mg and other Replicor drugs, the more hopeful I am. I’ve been getting through a lot of bad sentiments and situations that I have never thought I would experience in my life, but when I look to what is happening in the science field, this helps me think positive. Thank God we have people like you, Thomas and others. Maybe in the near future, we, people living with hepb, will be looking to the recent past and saying “Yeah! We got it”
Thanks for your job, sir!
We always greatly appreciate comments from patients, thank you.
Just to clarify, there only one NAP drug in development: REP 2139-Mg. Others have been used in clinical trials in the past but these are not longer in development.
@availlant
It’s so blessing to see that one of your patients was waiting for a transplant and after few weeks of rep. 2139 -mg and other therapy is now removed from the transplant waiting list!! It’s worth mentioning!! This is a big deal!!
Thanks for highlighting that interesting study. This is a pre-print, which hasn’t been through peer-review yet, but it does look interesting. If it can be shown by other independent groups in larger, controlled trials, then it might be something really worth being excited about.
It’s extremely interesting. Does anyone know if (in the case that this study were to be validated in the future and turned out to be correct) it may be possible that aspirin could have the same effect on endogenously produced interferon?
I was watching a presentation about NAPs where it says that, in animal models, cccdna was removed from the liver. My first question is “is it true?” And second “is that possible to be the case for humans?”
I not sure which presentation you are watching but we have never demonstrated that cccDNA was removed entirely from the liver. We do have data showing inactivation of cccDNA and substantial reduction in copy number in the liver.
I do not believe it is possible for cccDNA to be eliminated from the liver (there are many reasons for this which I won’t go into in the post). However, we do know that functional cure is achieved by > 75% of people who get acute HBV infection. Although cccDNA persists in these individuals (likely at very low levels), they have excellent control of cccDNA activity as a result of the absence of HBsAg in their blood. We know that people with functional cure of HBV live long happy lives with no therapy. They do not develop liver disease or liver cancer and are not infectious.
Dear Availlant, even if cccDNA persists in the liver, I think your work and the results achieved are amazing! A 56% functional cure is, in my opinion, a huge leap in the field. We’re almost there, and I believe this percentage can increase because, from what I know, the trials were performed on the most difficult HBV genotype to treat.
Thank you for answering me and for your time devoted to finding a cure for HBV.
We appreciate your comments and share your optimism.
We expect upcoming trials with our modified REP 2139-Mg drug product will demonstrate higher rates of functional cure with a convienent once weekly subcutaneous injection.
It’s so assuring knowing such brilliant minds are at work and getting such good results but all of us have that one lingering question when will we see the cure’s in the market?
Can you give us a timeframe seeing that REP 2139-Mg is doing so great with the numbers being gained we all are sure it’s going to get approved and be sold in the market but do you have time frame as to when that can happen, maybe in 5 - 7 years or can take more ?
I am specially kind of concerned because I am from India and i dont even have the opportunity to take part in clinical trials as there are none happening and has not yet happened in India sadly
