Aa
what is the news with replicor?
2013 and they are all awfully quiet. I think it is time people for a massive online action against these companies. What in the hell are they doing not releasing cures now. At least.to expose them. People are not aware of hbv or how much we suffer and what is really going with with these companies how they go about saving lives.
We dont need more Baraclude or simvastin to remedy it. We need cure or best available which they have but wont release it hiding behind eugenics laws that violate human rights - and delay cures.
I am just saying if we will be silent nobody will help us. This forum should be about this. Taking an action and making these companies accountable. And also raise public awareness. So in 2013 lets all make a push - those of us that want live.
We dont need more Baraclude or simvastin to remedy it. We need cure or best available which they have but wont release it hiding behind eugenics laws that violate human rights - and delay cures.
I am just saying if we will be silent nobody will help us. This forum should be about this. Taking an action and making these companies accountable. And also raise public awareness. So in 2013 lets all make a push - those of us that want live.
Read between the lines guys. 2017 and they are still talking about making of now generic tenofovir.
This is just insane! All they are planing to make is maintenance therapy for us. :(
This is just insane! All they are planing to make is maintenance therapy for us. :(
Tue Feb 19, 2013 11:05pm EST
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130220:nBw197259a
FOSTER CITY, Calif.--(Business Wire)--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead and Teva
Pharmaceuticals have reached an agreement in principle to settle the ongoing
patent litigation concerning the patents protecting Viread (tenofovir disoproxil
fumarate), a treatment for HIV infection and chronic hepatitis B. Under the
terms of the settlement, Teva will be allowed to launch a generic version of
Viread on December 15, 2017.
"We believe strongly in the validity of our intellectual property," said John
Milligan, PhD, Gilead`s President and Chief Operating Officer. "This settlement,
however, removes some uncertainty and minimizes further distraction and
investment of human and financial resources associated with this litigation."
The trial in this litigation, which was scheduled to begin on Wednesday,
February 20 in the District Court for the Southern District of New York, has
been adjourned pending completion of activities necessary to finalize the
settlement.
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130220:nBw197259a
FOSTER CITY, Calif.--(Business Wire)--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead and Teva
Pharmaceuticals have reached an agreement in principle to settle the ongoing
patent litigation concerning the patents protecting Viread (tenofovir disoproxil
fumarate), a treatment for HIV infection and chronic hepatitis B. Under the
terms of the settlement, Teva will be allowed to launch a generic version of
Viread on December 15, 2017.
"We believe strongly in the validity of our intellectual property," said John
Milligan, PhD, Gilead`s President and Chief Operating Officer. "This settlement,
however, removes some uncertainty and minimizes further distraction and
investment of human and financial resources associated with this litigation."
The trial in this litigation, which was scheduled to begin on Wednesday,
February 20 in the District Court for the Southern District of New York, has
been adjourned pending completion of activities necessary to finalize the
settlement.
I googled up some about GILEADs TDF and the information is contradictory. I think they try to renew it with some modifications right now.
out of curiosity, may I know when the patents of the currently available drugs will expire?
well there is also some truth to that brand name companies pay off smaller companies not to release generics.. so anything can happen. After all as you say, this is a Market.
As for not enough data for Rep9. There is not enough data on the safety of NUCs that got quickly approved. That does not worry you? :) that they don't stop the virus on the cellular level and they approved these drugs based on the HIV data they had.
Here we have something that really brings down the surface antigen fast, and combined with interferon or zadaxin causes svr in people. How much more data is needed? Think about it if they were developing technology as fast as they release these drugs we would still be without Internet.
replicor showed a remarkable result. It is not fraud, it is all documented. Who can show better at this point?
The question is why they are not going public with this, why they are not releasing it, why not taking patients that want to try it? That is what we should be asking. And why nobody from this company comes here to this forum and speak with us?
HepB cure development Cannot be operated like a military classified project you see.. And that is how these companies run it. Doesn't that bother you?
As for not enough data for Rep9. There is not enough data on the safety of NUCs that got quickly approved. That does not worry you? :) that they don't stop the virus on the cellular level and they approved these drugs based on the HIV data they had.
Here we have something that really brings down the surface antigen fast, and combined with interferon or zadaxin causes svr in people. How much more data is needed? Think about it if they were developing technology as fast as they release these drugs we would still be without Internet.
replicor showed a remarkable result. It is not fraud, it is all documented. Who can show better at this point?
The question is why they are not going public with this, why they are not releasing it, why not taking patients that want to try it? That is what we should be asking. And why nobody from this company comes here to this forum and speak with us?
HepB cure development Cannot be operated like a military classified project you see.. And that is how these companies run it. Doesn't that bother you?
Not sure for what reasons but seems like at this point Replicor isn't really attracting big companies. Maybe it's because of the cost of the med, maybe they don't have enough data or maybe their even a fraud company (certainly hope not).
But trust me if Replicor works, big pharmas would be in LINE to buy them out. In a few years patents are expiring so whoever wants the $1 Billion per year market share for Hep B, they have an easy opportunity.
Seriously will all the patents expiring, the money is in curing patients with Hep B. also the market for people who would be willing to try a cure is WAY bigger than people willing to go on antivirals.
But trust me if Replicor works, big pharmas would be in LINE to buy them out. In a few years patents are expiring so whoever wants the $1 Billion per year market share for Hep B, they have an easy opportunity.
Seriously will all the patents expiring, the money is in curing patients with Hep B. also the market for people who would be willing to try a cure is WAY bigger than people willing to go on antivirals.
GS 9620 I wanted to try and was on the list of to be participants last year. Waited six months. Then they forgot about me. Then I was told only TDF takers were included. Things they say on the phone differs somewhat to what is in fine print.
Everything is very impersonal at how these companies look at us and the medical staff that does these trials. That is how I feel based on my experience. Yet there is a rule and a law that makes all this acceptable medical practice.
Nobody is really after hbv cure. If they were Replicor stuff would be already integrated into therapy. working out the details how long to keep person on interferon or zadaxin can be worked out as they go about treating people.
They say that there are doctors out there that are not afraid of regulations that have access to new agents. If this is the case we all like to hear from you.
Everything is very impersonal at how these companies look at us and the medical staff that does these trials. That is how I feel based on my experience. Yet there is a rule and a law that makes all this acceptable medical practice.
Nobody is really after hbv cure. If they were Replicor stuff would be already integrated into therapy. working out the details how long to keep person on interferon or zadaxin can be worked out as they go about treating people.
They say that there are doctors out there that are not afraid of regulations that have access to new agents. If this is the case we all like to hear from you.
I meant that it is good that this substance stimulates interferon. For us whatever new they try is a good news anyway. Our own body interferon may be more effective then synthetic they give us. And may do less damage to the body so revovery after treatment will be faster.
Of course they could move faster with this. They give higher doses to cancer patients already. So why not just based on their doses give us the same amount of imiquimod? After all with nucs they give us doses that were developed for HIV.
As for side effects we should not worry to much about. The damage that hbv causes slowly is the major side effect that ruins life and its experience. We are not really living with this you know.
So as far as me I am ready to try anything provided I believe in this.
Of course they could move faster with this. They give higher doses to cancer patients already. So why not just based on their doses give us the same amount of imiquimod? After all with nucs they give us doses that were developed for HIV.
As for side effects we should not worry to much about. The damage that hbv causes slowly is the major side effect that ruins life and its experience. We are not really living with this you know.
So as far as me I am ready to try anything provided I believe in this.
Did you read the dosing in there. It's far dorm good news. 2mg/kg. it would be at least over 100mg per person, and in the human study 12mg was the highest they gave which had similar sides as interferon.
This is also great news. Now the way I see it. Why not begin to give this medicine to those that want to try it. And follow people. Say somebody takes it 6 -12 months. 1000 or more people take it and report their results. They could just mail that stuff out to people. It is cheap. http://www.alibaba.com/trade/search?fsb=y&IndexArea=product_en&CatId=&SearchText=imiquimod
Here are some news on gs9620
GS-9620, an Oral Agonist of Toll-Like Receptor-7, Induces Prolonged Suppression of Hepatitis B Virus in Chronically Infected Chimpanzees.
Lanford RE, Guerra B, Chavez D, Giavedoni L, Hodara VL, Brasky KM, Fosdick A, Frey CR, Zheng J, Wolfgang G, Halcomb RL, Tumas DB.
Source
Department of Virology and Immunology, Texas Biomedical Research Institute, San Antonio, TX 78227, USA; Southwest National Primate Research Center, San Antonio, TX 78227, USA. Electronic address: ***@****.
Abstract
BACKGROUND & AIMS:: Direct-acting anti-viral agents suppress hepatitis B virus (HBV) load but must be given lifelong. Stimulation of the innate immune system could increase its ability to control the virus and have long lasting effects, after a finite regimen. We investigated the effects of immune activation with GS-9620-a potent and selective orally active small molecule agonist of Toll-Like Receptor (TLR)7-in chimpanzees with chronic HBV infection. METHODS:: GS-9620 was administered to chimpanzees every other day (3 times each week) for 4 weeks at 1 mg/kg and, after a 1 week rest, for 4 weeks at 2 mg/kg. We measured viral load in plasma and liver samples, the pharmacokinetics of GS-9620, and the following pharmacodynamics parameters: interferon (IFN)-stimulated gene expression, cytokine and chemokine levels, lymphocyte and natural killer cell activation, and viral antigen expression. Clinical pathology parameters were monitored to determine the safety and tolerability of GS-9620. RESULTS:: Short-term oral administration of GS-9620 provided long-term suppression of serum and liver HBV DNA. The mean maximum reduction of viral DNA was 2.2 logs, which occurred within 1 week of the end of GS-9620 administration; reductions of greater than 1 log persisted for months. Serum levels of HB surface antigen and HB e antigen, and numbers of HBV antigen-positive hepatocytes, were reduced as hepatocyte apoptosis increased. GS-9620 administration induced production of IFN-ą and other cytokines and chemokines, and activated ISGs, natural killer cells, and lymphocyte subsets. CONCLUSIONS:: The small molecule GS-9620 activates TLR-7 signaling in immune cells of chimpanzees to induce clearance of HBV-infected cells. This reagent might be developed for treatment of patients with chronic HBV infection.
GS-9620, an Oral Agonist of Toll-Like Receptor-7, Induces Prolonged Suppression of Hepatitis B Virus in Chronically Infected Chimpanzees.
Lanford RE, Guerra B, Chavez D, Giavedoni L, Hodara VL, Brasky KM, Fosdick A, Frey CR, Zheng J, Wolfgang G, Halcomb RL, Tumas DB.
Source
Department of Virology and Immunology, Texas Biomedical Research Institute, San Antonio, TX 78227, USA; Southwest National Primate Research Center, San Antonio, TX 78227, USA. Electronic address: ***@****.
Abstract
BACKGROUND & AIMS:: Direct-acting anti-viral agents suppress hepatitis B virus (HBV) load but must be given lifelong. Stimulation of the innate immune system could increase its ability to control the virus and have long lasting effects, after a finite regimen. We investigated the effects of immune activation with GS-9620-a potent and selective orally active small molecule agonist of Toll-Like Receptor (TLR)7-in chimpanzees with chronic HBV infection. METHODS:: GS-9620 was administered to chimpanzees every other day (3 times each week) for 4 weeks at 1 mg/kg and, after a 1 week rest, for 4 weeks at 2 mg/kg. We measured viral load in plasma and liver samples, the pharmacokinetics of GS-9620, and the following pharmacodynamics parameters: interferon (IFN)-stimulated gene expression, cytokine and chemokine levels, lymphocyte and natural killer cell activation, and viral antigen expression. Clinical pathology parameters were monitored to determine the safety and tolerability of GS-9620. RESULTS:: Short-term oral administration of GS-9620 provided long-term suppression of serum and liver HBV DNA. The mean maximum reduction of viral DNA was 2.2 logs, which occurred within 1 week of the end of GS-9620 administration; reductions of greater than 1 log persisted for months. Serum levels of HB surface antigen and HB e antigen, and numbers of HBV antigen-positive hepatocytes, were reduced as hepatocyte apoptosis increased. GS-9620 administration induced production of IFN-ą and other cytokines and chemokines, and activated ISGs, natural killer cells, and lymphocyte subsets. CONCLUSIONS:: The small molecule GS-9620 activates TLR-7 signaling in immune cells of chimpanzees to induce clearance of HBV-infected cells. This reagent might be developed for treatment of patients with chronic HBV infection.
Globe Immune just got a milestone payment from Gilead. It will make it to market in 3-5 years
You are right in many ways. What are your thoughts on the following...
1. Considering HBV treatment is a very lucrative business, and patents are expiring, drug companies will have to come out with something better otherwise the generic markets will take in all the revenue.
2. With the success of TDF and ETV, their only options are stronger and safer antivirals or a cure. Otherwise they lose to the generics.
3. Looks like Replicor is looking for a big pharma to invest in them or buy them out. Why are they struggling so much, while others are struggling less?
4. Seems as if Hepatera and Globe Immune are having more success with financial investors than Replicor?
1. Considering HBV treatment is a very lucrative business, and patents are expiring, drug companies will have to come out with something better otherwise the generic markets will take in all the revenue.
2. With the success of TDF and ETV, their only options are stronger and safer antivirals or a cure. Otherwise they lose to the generics.
3. Looks like Replicor is looking for a big pharma to invest in them or buy them out. Why are they struggling so much, while others are struggling less?
4. Seems as if Hepatera and Globe Immune are having more success with financial investors than Replicor?
Something to keep in mind. First use of what is called now antivirals was to treat cancer. It is a chemotherapy. Which prolonged use causes cancer from toxicity. They knew that.
Then they started to use these compounds to treat HIV. Despite the fact that even in the 80s bone marrow transplants that seem to cure hiv as we know now were suggested back then.
As for combo therapy with immuno inhanser like interferon or Zadaxin they also new it that it works better. But this option only now is at least being discussed more widely.
As for giving antivirals to hbv naive patients with healthy livers as the first line of treatment - it is a bad idea. It does nothing but slowly kill the patient. Toxicity - cancers- kidney and dna damage to name the few are the result of prolonged therapy. Or indefinite therapy as the current standard for us is in place. Plus the development of drug resistant super viruses that then no one knows how treat.
Approving the so called antivirals to treat us was a strictly done for expanding the comercial use of anti hiv agents.
Honest doctors - who are a minority these days. Will tell you - that it is just popular and easy to give a patient a NUC and that interferon is still your best bet.
But I am not really talking about all this. Interferon as a general immune system booster and antivirals are really old news medications. Old school you can say. The agents they have now are should be used.
We all keep forgetting that Replicor has the drug that cures. And it is available now but cannot be released do to some economic and legal factors. And for us HBV chronics this should be the main focus. As to how we can get this drug available for us. There just must be a common sense dolution to release something that cn cure us in 7 weeks or so.
Then they started to use these compounds to treat HIV. Despite the fact that even in the 80s bone marrow transplants that seem to cure hiv as we know now were suggested back then.
As for combo therapy with immuno inhanser like interferon or Zadaxin they also new it that it works better. But this option only now is at least being discussed more widely.
As for giving antivirals to hbv naive patients with healthy livers as the first line of treatment - it is a bad idea. It does nothing but slowly kill the patient. Toxicity - cancers- kidney and dna damage to name the few are the result of prolonged therapy. Or indefinite therapy as the current standard for us is in place. Plus the development of drug resistant super viruses that then no one knows how treat.
Approving the so called antivirals to treat us was a strictly done for expanding the comercial use of anti hiv agents.
Honest doctors - who are a minority these days. Will tell you - that it is just popular and easy to give a patient a NUC and that interferon is still your best bet.
But I am not really talking about all this. Interferon as a general immune system booster and antivirals are really old news medications. Old school you can say. The agents they have now are should be used.
We all keep forgetting that Replicor has the drug that cures. And it is available now but cannot be released do to some economic and legal factors. And for us HBV chronics this should be the main focus. As to how we can get this drug available for us. There just must be a common sense dolution to release something that cn cure us in 7 weeks or so.
I respectfully disagree. Antiviral is an option that is not better nor worse than Interferon. Plus it is cheaper with less sides for naive patients. And without it how can we do combo which is arguably better than mono?
Yeah it is all so sick. Cancer is an industry. Hiv and our virus. Which is btw in the old days was treated better. At least they did.not waste time and treated us with interferon.
Now these news anti aids drugs only complicate things.
Now these news anti aids drugs only complicate things.
I totally agree with you, I think we deserve better and they are playing with peoples lives. The only thing thatll help is getting this out to the public and rallying behind it. If somehow we can get someone in the right profession to create a non profit organization and a petition soley towards pushing these drugs quicker I bet we'll see some action
And a lot of it is do to us patients. We seem to be ok labeled as low social economic groups - or injecting drug users.
I am really tired I tell you reading about Etv and TDF. For us interferon was better anyway.
I am really tired I tell you reading about Etv and TDF. For us interferon was better anyway.
Drug companies see it as a business. And that is fine and they should make money. But what I hope CEOs of these companies realize that saving lives is really not the same as making - developing a new car model.
Why talk about FDA and blaming them? Their decisions are influenced by lobbyists in many ways. People that sit on that board of members approve drugs for many diseases without looking into specifics. I really doubt if a company or a group of doctors approaches them and tells them I think I have a cure for HBV just give me green light - I doubt that they would deny it. After all we the patients are grown adults and can decide to enter the trial or not.
I would like to see larger human trials that are open for volunteers. We can even pay some portion of treatment too to make the process go faster.
What bothers me is this. Why there is no regulations regarding software and electronics development but making advances in medicine in treatment of incurable disease is?
Why talk about FDA and blaming them? Their decisions are influenced by lobbyists in many ways. People that sit on that board of members approve drugs for many diseases without looking into specifics. I really doubt if a company or a group of doctors approaches them and tells them I think I have a cure for HBV just give me green light - I doubt that they would deny it. After all we the patients are grown adults and can decide to enter the trial or not.
I would like to see larger human trials that are open for volunteers. We can even pay some portion of treatment too to make the process go faster.
What bothers me is this. Why there is no regulations regarding software and electronics development but making advances in medicine in treatment of incurable disease is?
You are over there with Dr.Gish have all the info.
I can take charge alright. I just need to know who to talk to so we can put a team of people like me for them to test these drugs. I would even pay. And I am sure many people will too.
But to me it just does not make any sense whatsoever that regulations stop cure developments or better treatments.
Think about it. They give anti HIV agents that are highly toxic and that happen to damage our immune system too because of it. But clearing HBV or containing it requires a strong immune system.
The new agents that you listed offer a lot of promise but at this current rate of development is just to slow.
I think Replicors drug is ready for use based on the data they showed. Like I would have no problem paying 24000 and going through treatment if they are willing. These companies need to understand that some people with advanced hbv disease are desperate.
I can take charge alright. I just need to know who to talk to so we can put a team of people like me for them to test these drugs. I would even pay. And I am sure many people will too.
But to me it just does not make any sense whatsoever that regulations stop cure developments or better treatments.
Think about it. They give anti HIV agents that are highly toxic and that happen to damage our immune system too because of it. But clearing HBV or containing it requires a strong immune system.
The new agents that you listed offer a lot of promise but at this current rate of development is just to slow.
I think Replicors drug is ready for use based on the data they showed. Like I would have no problem paying 24000 and going through treatment if they are willing. These companies need to understand that some people with advanced hbv disease are desperate.
Globe Immune is in partnership (and being financed) by Gilead - so Gilead is calling the shots.
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