Hi @ Sorte,
I do appreciate your question and concern. Hopefully you will understand that these kinds of questions simply cannot be answered.
Rest assured the development of NAPs continues…
Best regards,
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These are not ethical questions!!
I am a member here… I do believe there lot of resources and info in this forum regarding NAPs… please search the forum before ask questions…
My two darn cents!!
Thanks
Nass
Availant: of course I understand 
thanks for sincere answer.
Nass: In my opinion my questions were normal questions who people concerned about most promising therapy may ask. Unfortunately money is important.
Also you don’t need to delete your posts, I’m not offended easily 
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To the entire HepB Community forum,
With my involvement in the HepB Community forum, I knew there would inevitably be questions about NAPs like “Why is it taking so long?” and “Can you continue the development of NAPs?” and “What about fundraising?”.
There have been a lot of promises from KOLs and from the industry regarding the potential of different approaches for HBV cure and of course a great deal of frustration in the community following the failures of these therapies. Is therefore very reasonable to get questions like the above from community members.
I appreciate the support of members like @Nass but I also appreciate questions from members like @sorte (which I also take as a form of support and concern). I want all community members to feel comfortable asking any kind of question regarding NAPs. This is an important part of the the process of communicating with the community about NAPs and the obvious delays in the development of NAPs.
I will provide direct answers when I can and take no offense.
Best regards to all,
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@availlant thanks I like it and I’m really grateful for detailed and open (as possible of course) communication. It makes Replicor look different in positive way from other companies.
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Congratulations for the explanations and for deepening with cutting-edge knowledge about HBV infection. Reading the explanations makes me hopeful that we will soon have effective treatment for a functional cure for HBV infection.
Here in Brazil, we have the Unified Health System that guarantees free and universal treatment for various diseases, including treatments for Hepatitis b. Certainly, when we have the NAPs approved, the Brazilian Unified Health System will be required to purchase this medication.
We are looking forward to that moment.
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Out of curiosity, are you also studying liver cancer after treatment for those who get functional cure i.e the 50% or so… How significant? is it comparable to HCV cured?
Dear @CNN,
In the long term follow up data we recently presented in April at the Global Hepatitis Summit in Paris, patients also received liver ultrasounds which confirmed the absence of liver cancer in all patients, including all patients with functional cure of HBV and HDV. This includes at the 7.4 year follow-up in patients with HBV / HDV co-infection (REP 301 study) and at the 5.3 year follow-up in patients with HBV monoinfection (REP 401 study). The presentation can be seen here.
The risk of HCC following SVR in patients with HCV is 0.33% per year based on this study) where ~10,800 patients with SVR were followed for an average of 3 years. We cannot really compare the results with NAPs in HBV given the much smaller preliminary numbers and given the HCV population in the study above (these are veterans with different risk factors for HCC) but these early results with NAPs are definitely encouraging.
In HBV, the primary driver of HCC is integrated HBV DNA and in order to achieve HBsAg loss during therapy and functional cure after therapy, hepatocytes containing integrated HBV DNA must be removed (if not completely at least close to complete). In principle this should have a very positive impact on HCC rates long term but this has not yet been examined.
Best regards,
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So this is already very encouraging. What prevents you from going for approval for the drug? Or what are your general opinions on timelines? What else do you need to do to begin applying for approval? Nothing specific.
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Dear, André Vaillant
I would like to know, please, if you would have any news to share about Replicor’s studies for the treatment of Hepatitis B.
Thank you very much.
Dear @ availlant please update us on any news regarding naps
Dear @Kenyan and @RicardoMachado ,
Thanks for your interest. We are currently deploying REP 2139-Mg in compassionate use in numerous countries in Europe and, Oceania and North America. This compassionate use is reserved for persons with HBV / HDV co-infection who have very advanced liver disease (cirrhosis) and have failed on other antiviral therapies. HDV co-infection has a much faster progression to advanced liver disease than any other form of viral hepatitis and as such is a critical unmet medical need.
This deployment is being performed to expand the safety envelope of REP 2139-Mg and to demonstrate transition of REP 2139-Mg to a convenient subcutaneous formulation which can be self administered. It is also providing access to potentially lifesaving therapy to these very sick patients on a humanitarian basis.
This work will pave the way for phase IIA trials with subcutaneous REP 2139-Mg in both HBV mono-infection and HBV/HDV co-infection and even in persons with HBV / HDV / HIV co-infection.
The early data from these compassionate use cases has already shown that REP 2139-Mg is very safe and effective (even in patients with HIV co-infection) and can achieve functional cure of HBV and HDV in these very sick patients (even those with decompensated cirrhosis) and also that REP 2139-Mg can clear the liver of infection (at least in the case of HDV).
You can check out the latest presentations on compassionate use at http://replicor.com/conference-presentations/.
Best regards,
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Wow, this looks promising.
I pray that this results into a cure for many of us are living a nightmare reality.
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@availlant thanks you for the update, just wondering if it will have same effect on HBV patients without HDV counfection!
Thanks you again for your time.
Dear @Gregory
Yes NAPs (in combination with NUCs and pegIFN) have been shown to achieve high rates of functional cure of HBV in patients with HBV monoinfection. The most recent long term (5.3 years) treatment free follow-up results from this study can be found at http://replicor.com/wp-content/uploads/2023/04/Replicor-GHS-2023-REP-301-REP-401-extended-follow-up-LB-O105.pdf.
NAPs are unique in that they have antiviral properties which act directly against both HBV and HDV infection.
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Dear @availlant,
I took a particular interest in this study thanks to your thorough explanation. A few questions I have, please:
How many phrases or clinical trials will be happening from this point on that you can foresee?
Does the approval process differ by country? And how long would it take to be approved in China and the USA ?
For the current clinical trial, would length of treatment still be 48 weeks?(correct me if I am wrong)
This community has given much hope since my diagnosis I can’t thank you all enough for the space you’ve created for someone like me, newly diagnosed and looking for answers and hope!
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Dear @Stephanie23,
The gratitude of people dealing with HBV infection like yourself is very much appreciated; the main reason we are here is to try to make a difference in the lives of persons like yourself.
However, it should be noted that the idea and credit for this Community Forum and its creation and ongoing curation goes to Dr. Thomas Tu (whom you will see takes a very active role in the day to day here). The rest of us scientists are “playing in his band” as it were!
We expect that for NAPs, phase IIA trials in EU and the US will demonstrate the results required for rapid entry into phase IIB studies which will accelerate the approval process. A phase IIB trial is a much larger trial designed to include a more diverse participant population with selected dosing regimens based on earlier phase IIA studies in order to provide a larger safety and efficacy data base for evaluation by regulators. This process is similar for the USA and China but both require trials to be conducted in their respective jurisdictions for approval. I cannot comment on how long this will take but rest assured we are working hard to move the development process along as quickly as possible.
We expect the that the initial approved NAP-based treatment will be 48 weeks in duration (with once weekly dosing) and trials will be designed to examine this length of treatment.
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Thank you @availlant !
Wishing much success during these phases, this would be life changing for us chronic carriers when approved.
@ThomasTu has indeed created this space with great minds and humanitarians… thank you all once again for what you do in all ways, always.
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Dear @availlant thanks you.
I understand that you cannot provvide an exact time frame, but how long a phase llB trial would be?
and what are the requirements for a patient to be part of it?
again thanks you so much for taking the time to answer me.