Hepatitis B Foundation to host online Patient-Focused Drug Development meeting

[StephenCastlecrag]

Tuesday, June 9, 2020, from 12:30-4:30 p.m. EDT

The primary goal of this virtual (online) meeting is to hear directly from patients about their perspectives on living with chronic hepatitis B and their experiences with treatments, to improve the development of new drugs in the research pipeline. The patient perspective is critical in helping the U.S. Food and Drug Administration (FDA) understand the context in which regulatory decisions are made for new drugs. This input will inform FDA’s decisions and oversight both during drug development and during its review of new treatments.

The meeting format will be very interactive and include information on current and future hepatitis B treatments, hear direct voices from patients on their perspectives living with the disease and hopes for clinical trials and treatments, and a live Q&A with the audience. Audience participants will have a chance to comment during the meeting via phone and email!

Please visit https://www.hepb.org/news-and-events/patient-focused-drug-development-meeting-virtual/
and https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-to-host-first-ever-online-externally-led-patient-focused-drug-development-meeting/
for details.

[stef2011]

is the live stream saved and linked somewhere?

[halt651]

They said that they would share the video link afterwards

[luckyman316]

There are a few things patients wanted. I actually participated in the survey but could not attend this. Of note, results were said as follows:

- We want a one pill cure, no injections, to this. No lifelong treatment and less sides
- We also said while a full cure is ideal, we would accept a functional cure (I'm not sure how I feel about this)

I have not seen the rest just yet, but the Hep B Foundation posts on twitter a lot and also share links there with any news etc.

[stef2011]

not good to ask for pills only, replicor will never be a pill....i really hope replicor gets fastrack approval, at least for hdv so we will use it off label for hbv

[melcul]

I'm curious about what's going on with replicor since their trials were actually the most promising at the moment and the only hope for HDV too. They are just following up the initial trials, nothing else  ?

[stef2011]

there should be a trial for IM injection route

[halt651]

stef2011, I commented the same question you asked.  to make the question more visible.

[stef2011]

halt651 thank you halt651

[halt651]

Stef, hepb told during live session that they had collected all the questions  and they would publish the response afterwards. I did not watch all the live session but one of the interesting point was that people from FDA has participated to the meeting too so maybe there will be some actions after this meeting.

[ArcturusAP]

I received a response that my question would be forwarded to the FDA
Not sure what that is worth

[Jatashankar]

They want us to buy the medicines lifelong and keep filling there pockets.

[stef2011]

i used PFDD Submission form to hepb.org and this was my question straight to the point:  why replicor rep2139 or rep2165 nucleic acid polymers are not approved yet?their remarkable safety and tolerability is known since many years plus these compounds are also the only cure for HDV infection yet no fast track approval.our hbv community does not understand the pushing of new compounds with poor safety and no results from other companies in 2018-2020 while we had already previous results from replicor, we can only think bad about this situation.thank you

[stef2011]

this was their answer, my guess is who answers has zero medical knowledge, so it might be useless to use this form.what do you think?maybe we should have a strategy, this is a very good opportunity to let them know we understand they did nothing to approve a cure until now maybe quite the opposite.

[stef2011]

Thank you for your message. We don’t have access to non-public information about replicor. There are a few other drugs that are now in clinical trial for HDV, and a total of 27 drugs in the drug development pipeline. We hope that some of these drugs prove to be improved treatments or a cure for HBV/HDV. For more information on our current perspectives on a cure, please visit our website here: https://www.hepb.org/news-and-events/commentary-on-the-cure/.

[stef2011]

they dont know anything about drugs on development or pretend not to.....

[ArcturusAP]

I am interested in a strategy, maybe they have zero medical knowledge, but why do they dismiss replicor and try to redirect the conversation to improving treatments?  How can we Orchestrate a strategy?  If we have questions about development on drugs, should they not find someone to discuss such questions?

[stef2011]

i think they have zero medical knowledge because they redirect elsewhere while replicor is the only one to have achieved a cure.so i assume they are just ignorant and not corrupt trying to move patients elsewhere

[stef2011]

as to strategy i have no ideas, i usually go straight to the point because that field is totally corrupt, maybe it is not the best move or maybe it is

[ArcturusAP]

I agree with going straight to the point.  We need more people to take part in this and go straight to the point.  A coordinated effort to get the message across.  

[StephenCastlecrag]

Thank you stef2011 for making a submission. Please remember HBV is not a drug development company, they aim to help Hepatitis B patients and their carers to get up to date information about Hepatitis treatments and potential cures. The meeting is a good opportunity to provide input to FDA. My PFDD was to enquire how FDA deals with the approval process for a drug combination when the individual drug in the combination will most likely not be able to gain FDA approval as a mono drug for HBV, because it is unlikely to be better than TDD, TAF, or Enetecavir.

[ArcturusAP]

@steff2011  I sent in a very similar question and borrowed your format, I didn't think you would mind.

[ArcturusAP]

The response I received

We are currently featuring responses to any of the following questions:

5. What are you currently doing to help manage your symptoms and your condition? (Examples may include prescription medicines, over-the-counter products, herbal remedies such as milk thistle, physical exercise, and alternative therapies such as acupuncture.)
6.      If you are currently taking a prescribed medication for hepatitis B, how do you feel it’s affecting your daily life? (Examples may include side effects, cost of medication, eating restrictions related to the drug, visiting the doctor every 3-6 months, taking a drug for a lifetime, not a cure, etc.)
7.      What do you consider the most important benefits of an ideal treatment? (Examples may include loss of surface antigen, a pill taken for less than a year, no stigma or discrimination, etc.)
8.      If you were to enroll in a clinical trial for an experimental hepatitis B medication, what routes of administration and what length of treatment would you be willing to accept? What side effects, if any, would you be willing to tolerate?  (For example ALT flares, etc.)    

If you wanted to answer – we would love to feature it.

Thanks!

[stef2011]

thank you sirius i couldn t make it online, i was having treatment for my shoulder at that time, so it was very helpful

[ArcturusAP]

Thank - you for always being awesome Stef2011!!!!

[stef2011]

as it is the only treatment that achieved good percentages of functional cure

[stef2011]

i will try to be there and i suggest anyone to storm them with replicor fast track request as hdv and hbv in combination treatment as it is the only one who achieved cure rates

[ArcturusAP]

For people who can not make it there is access to a form on both of these link to submit an comment in advance?  I wonder if we should also orchestrate requests about fast tracking replicor through this form.  If I can figure out how to listen in I will be there to listen to steff2011 because your awesome.  You and StephenCastlecrag and a few others have helped me stay centered through all of this.  My gratitude and appreciation for you all is abundant.  If a server would help to spread awareness I may have a solution for you.

[stef2011]

thank you for the link very interesting, hope this is a sign of political change (end or at least mitigation of FDA corruption)