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REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection

REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection

Purpose

REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act synergistically with immunotherapeutic agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host immunological control of HBV infection.

HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.

This study will examine the safety and efficacy of REP 2139-Ca therapy when used in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.

The primary hypothesis to be tested is that this combined dosing regimen is safe and well tolerated in patients with HBV / HDV co-infection which will be assessed by examining the number of patients with adverse events (including reported symptoms and laboratory abnormalities).

The secondary hypothesis to be tested is that this combined dosing regimen will have an antiviral effect against HBV / HDV co-infection in these patients which will be assessed by examining the following outcomes:

    The number of patients with reductions in serum HBsAg.
    The number of patients with reductions in serum HDAg and HDV RNA
    The number of patients that experience a sustained antiviral response after treatment is stopped (reductions in serum HBV DNA and HDV RNA).

The secondary hypothesis to be tested is that this combination approach can have an effective

Condition Intervention Phase
Hepatitis B With Hepatitis D Superinfection
Drug: REP 2139-Ca + Pegasys (TM)
Phase 2

Estimated Enrollment: 12
Study Start Date: September 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Detailed Description:

Nucleic acid polymers (NAPs) utilize the sequence independent properties of phosphorothioated oligonucleotides to target apolipoprotein interactions involved in the formation of HBV subviral particles (SVPs) which are comprised mainly of the hepatitis B surface antigen protein (HBsAg). The effect of NAPs is to block the formation of SVPs inside infected hepatocytes which prevents their secretion. As SVPs account for > 99.99% of HBsAg in the blood, NAPs are an effective approach for clearing HBsAg from the serum of HBV infected patient.

Previous clinical trials have demonstrated that treatment with the NAP REP 2139 results in the rapid and effective clearance of HBsAg from the blood. This HBsAg removal has the immediate effect of unmasking the underlying, pre-existing anti-HBsAg (anti-HBs) response, allowing clearance of HBV virus from the blood.

HBsAg has important immunosuppressive effects in HBV infection which have been shown to block both adaptive and innate immune processes. Removal of HBsAg from the blood of patients removes this immunosuppressive effect.

Thus, an important additional effect of removal of HBsAg from the blood is to greatly enhance the effect of immunotherapeutic agents like pegylated interferon alpha-2a or thymosin alpha-1 to stimulate recovery of complete immune control of HBV infection.

HDV superinfection can only occur in patients with HBV infection because HDV requires the HBsAg protein for its assembly. Therefore, it is expected that the removal of serum HBsAg (from HBV SVPs) and unmasking of the anticipated, pre-existing anti-HBsAg response by REP 2139 will result in the clearance of HBV and HDV from the blood. Furthermore, the enhanced effect of immunotherapy in the absence of serum HBsAg has the potential to provide a durable control of both HBV and HDV infection that will persist after treatment.

Locations
Moldova, Republic of
Infectious Clinical Hospital ( n.a. Toma Ciorba) Not yet recruiting
Chisinau, Moldova, Republic of, 2004
Contact: Victor Pantea, MD    +373 69 37 11 27    ***@****  
Contact: Valentin Cebotarescu, MD    +373 79 50 51 46    valentin_cebotarescu***@****  
Principal Investigator: Victor Pantea, MD        
Sponsors and Collaborators
REPLICor Inc.
50 Responses
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Avatar universal
Why only Moldova?  I wish somebody from.Replicor would respond! 400 million people are sick and they are treating only 12. :(

This is unbelievable. Drug companies do not think of us. No.
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Avatar universal
money, money, money...nobody puts money in this, as simple as that
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Avatar universal
this is great, approval may be fast and easy with little money if hdv is cured especially in countries where corruption and interests may have less impact
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Avatar universal
Hope this thread stays pure as a discussion on Replicor and not evolving into yet another thread (like many others already) corrupted by incessant accusations against drug companies and their 'perceived' conspiracy to keep cures off the market.
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Avatar universal
This is their strategy as HDV is an orphan disease, hard to treat and no drugs. I hope it will work to get fast track approval then it can be prescribed off-label to treat HBV.
Just my understanding.
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Avatar universal
How can it stay pure of discussion about corruption? When this is obvious!

Here is the company that has an HBV cure. A Nobel .price nominee.  400 million people are sick. Living with shattered lives. . And you think we should be silent!?

It is impossible to have a discussion when such injustice is taking place.

HbV patients world wide should turn every HBV thread on every forum and demand a cure to be released. New drugs Now!  That is what we want!

12 people are getting the drug. When 400 million are sick! Well how on earth cant this be all right!  
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Avatar universal
Sure!  In what countries it can be prescribed off label? I asked for Alinia even said I will pay cash for it so my health insurance.wont find out! These bastards can drop coverage on people for using none standard drugs. That is what I was told. So that is again real world how it works folks.

This is not the way to go. The laws dont make sense!. Cures should not be stopped. And Replicor needs to go public about it! And openly say what is going on today with medicine. As some people do.
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Avatar universal
http://m.youtube.com/watch?v=RzFcN3oH-qk
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Avatar universal
Here we go again...
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Avatar universal
Haha HK_1966 you know it :)
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Avatar universal
you are off topic
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Avatar universal
Wonderful news!! Thanks Stephen for this update.
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Avatar universal
Full details of this study

Link: https://trialbulletin.com/lib/entry/ct-02233075
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Avatar universal
Stefan. I am always on the topic.

And it is strange, and bothersome that medication that works is still in clinical trials of only 12 people, with a scheduled completion date of 2016.

And that is phase 2. Phase 3 about as much time. So we are technically looking at medication release date of 2018-2020. That is OK with you too?

So what is the point to even discuss these studies? It is obvious that these drug companies don't care about us. They are not willing to go extra step to challenge the corruption in the medical industry, they way drugs are approved.

We HBV patients virtually have no real medicine except interferon! NUCs yes block HBV but they cause so many other diseases that you don't know what is better being on them or off them.

400 million people are sick, and they are doing 12 people at a time over a period of 2 years.

Given the nature of our grave disease. Clinical trials should not even be a question here. Not to speak that observing 12 people really does not prove any safety positive or negative. Only when medications are approved and used in masses, then we can know the real sides of meds.

But this is  not even a question here. They test medications on mice that are similar to human beings. works there, test on healthy volunteers. Safe for them, test on people that want to try. Not 12 people buy 1,000 or even more. Recruitment can openly be done on the forums.

That right there is being transparent and being committed. What is done now the so called clinical trials, I am sorry to say it is a circus. We have HBV not just some stomach gas symptom. For us is key to knock out Hbsag as you said. And here is the medication that does that,in as little as 2 week if I remember correctly.

Whatever Replicor and others do, to us hbv infected feels ridiculous! Some of you that don;t have HBV and collect info here sure don't understand that.

But I will tell you. To me it feels like I am a monkey sitting in a cage and starving to death. And some dude in a white medical rope, is showing a nice chocolate cake with a table full of food. And says well, you can have it doggy in 3-5 years when so and so allows it.

I say it is again, it is a moral obligation for these companies that have functional cures to release them. Stop teasing people living in misery. Or that are about to die or have a liver transplant.

Because all this is, how the clinical trials are done now, is nothing but hype to excite investors! Nothing more.

Being an informed patient, knowing what I know, and what you know Stefan is going on. Please tell me how can we be silent!

Replicor can safe people Now with their work! What regulations can stop that!? And why should they?

Eugenics practices that are put into laws, people don't buy anymore. There is not industry out there like this that prevents an invention from  going public to make a world a better place. If it was we would still carry a mobile phone with a huge battery in a brief case.

Every thread on every forum. Should be about educating new patients about the true nature of where things are today with HBV treatment. So we all have a big voice, and hold these drug companies accountable for their actions. Because what they are doing is amoral. They have better meds now that work! So why can't we get them? Why nobody from any drug company comes here and openly engages in a dialog with patients?!
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Avatar universal
Drug: REP 2139-Ca + Pegasys (TM)

    15 weeks of REP 2139-Ca (500mg QW IV) followed by: 15 weeks of REP 2139-Ca (250mg QW IV) + Pegasys(TM) (180 ug QW SC) followed by: 33 weeks of Pegasys(TM) (180 ug QW SC)

they are talking about 7 months of therapy here till finish! NOT 17 years of tenofovir and good by to kidneys.
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Avatar universal
Mike there is NO HAHA people are dying because of these ridiculous laws that act as eugenics.

Because this is what this is and where we are eugenics. There are cures that can save lives now. But because of some laws cannot be given to the public.

They broke these laws with Ebola though. What worked on mice was tried on real  life subjects. And proved to work. And that again proves why they test medications on mice!

Naziz that were sending people to gas chambers some of them were going HAHA as well and taking pictures for their personal albums.  You want to be in the same category by what you are saying?

The way I see it based on experience, we are being slowly killed off, and given drugs that really don't do much, only make profits for their makers.

And if you were a real patient here you would know. That most of us have forgotten the last time we felt like HAHA actually.

So when I read about these clinical trials of 12 people over several years time, I can say nothing but SHAME to these companies. That know the dire need for HBV meds, that they have,  but yet not doing anything.

It would be nice for some one from Replicor, Gilead, Arrowhead to actually come here and openly engage HBV patients and think how can this system be changed for the better of humanity. Everything is available to cure HBV.. now not in 2020 Then why wait!?

What can be done to change this? What we the patients can do? Who we need to write? How much money is needed to be generated for this to go forward independent of the system that knowingly or not kill abuses people and shatters their lives?

We like to hear your point of view dear drug companies! Why things the way they are today with HBV treatment!
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Avatar universal
HK_1966 - we speak about it, because it continues. http://www.youtube.com/watch?v=RzFcN3oH-qk&app=desktop

We don't want maintenance therapy! http://www.youtube.com/watch?v=RzFcN3oH-qk&app=desktop
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Avatar universal
I think we have said everything there is to say here about NUCS. About TDF, ETV, LAM, and the like.

17 years according to their projection to clear HBV possibly!

Why do the new guys need this? When there is Replicor med. Speech about the wonders of nucs their doctor can reside them from the manual drug salesman has given them.

On wonderful forum such as this one. We hbv old timers should educate people about new drugs. But not just that, but also raise public awareness about things why it is so he or she can't get that real help that can cure them. So people can unite and challenge these laws, or at least tell their doctor that there are better things then NUCS that really work.

Or that I won't be taking NUCS, please don't give me those, give me interferon that can cure me faster and better.

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Avatar universal
I am depressed like u, cannot remember actually the last time been of myself, cannot concentrate, selling off my personal appliances just to raise  $1200 for 16 vials of alpha interferon. truly we need a medication that can knock out the hbsag.
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Avatar universal
Hopefully Replicor CEO gets to read this, to what length people have to go through to try to get their life back.

For me it has been 8 years. First year with HBV viral load of 246,000,000 copies I was denied health insurance. It took about a year to get one from government, and several state hearing to get the medicine to actually bring the viral load down. Nobody was worried, or a bit concerned for my safety, I mean medical people that is.  

I spend $13K in few months just on lab tests in 2007. Maxed out my credit card. Then I had no ability to pay medical bills, and I still have like $20K worth of blood tests and scan unpaid that have ruined my credit. So I cannot really finance anything. I take care of my old car as best I can and very fearful what I would do if it brakes down. :)

I am not able to work full time, because I get burned out easily, I need to take a nap. If I don't pay attention to my body and do more then I can I get chest pains with feeling lights out can come in soon. High doses vitamin C and D3 help with this a lot. So that is how I balance myself if I get over worked on a given day... So financial difficulty is unspeakable to the kind of life I had.

I have seen about 50 or so doctors, mostly because I had black hairy tongue that no one knows still why.. I thought I has AIDS. 40 or 50 tests for that really changes a person.

Plus I have heard so many comments from doctors " I don't know if your insurance will cover it" "You really make me push that insurance of yours asking me for those tests"  that I really have no desire to see them. A computer screen in a form of a human being that tells you - There is no sides from ETV or TDF is just getting old. And or NO you don't need interferon Tenofovir show similar results according to studies. Really? Are you kidding me?! And then they leave.

Actually now thank god to  new laws that prohibit health insurance companies to deny health insurance in the US for people with grave diseases, things have gotten better, but I really don't feel like seeing medical people based on past experience I have experienced from them do to lack of good paying to them health insurance.

Most people that dont have a serious illness that is incurable or poorly treated are not aware of this, the things that we are going through.

That is why to some it feels like a haha from a bunch of lunatics. And this is why I found a life regiment of a Tibetan monk that discipline philosophy appealing, you learn to be happy just seeing a sun everyday and singing of birds in the back yard, meditating for a better hope of tomorrow.

Society  sure is broken, if it cares about the sick this way. Money, in human relations and values based on money have poisoned everything even as something as basic of a right as health and human nature to help people.

So yes for some of you is very difficult to understand us.

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Avatar universal
Try going to Moldova. Maybe they will take you into a trial. $1,200 there goes a long way.

But so far there is really nothing better and safer then interferon for us really exists that is available. You can use even regular interferon just inject is daily. Ukranian, Russian and Chinese brands should be cheap and just as good as western brands. Not so as good as Pegasys I am told but can help.

So I feel your pain and frustration. Just go and treat it and don't look back it will work. Don't get caught into this nucs trend with 17 year hbsag clearing process. God only knows what they do. But hearing that there is a still remote possibility that these drugs are safe is disturbing. At least with interferon all is known. Main thing is to always lower or skip a dose if you feel you body is getting exhausted. A good doctor is a must have here, that will monitor labs.
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Avatar universal
thanks veteran, we will surely get back our laughter when the right times comes, but to depend on drug companies,  we will not go anywhere. my doctor told me I should go and continue with lamivudine, as it is working on my case I told him no, I proposed interferon she said it does not work, later she told me if only I want us to order it from abroad, I said I want.  $1500 for three vials of Pegasys, $1200 for sixteen vials of Alfa interferon 2b, I opted for 16 vials of Alfa interferon, she is only willing to give me one injection / week. hope it works in my case.
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Avatar universal
thanks veteran, we will surely get back our laughter when the right times comes, but to depend on drug companies,  we will not go anywhere. my doctor told me I should go and continue with lamivudine, as it is working on my case I told him no, I proposed interferon she said it does not work, later she told me if only I want us to order it from abroad, I said I want.  $1500 for three vials of Pegasys, $1200 for sixteen vials of Alfa interferon 2b, I opted for 16 vials of Alfa interferon, she is only willing to give me one injection / week. hope it works in my case.
Helpful - 0
9624973 tn?1413016130
I dont want to agitate spirits here, moldova is somehow part of my country romania, but 12 people trials ? Is this a joke ?how can there be just 12 people trial and not a mass of people ? also veteran, they accept people with coinfection, b+d..we cant try to join .at least lets hope it will work
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