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Myrcludex B development

Does somebody know the progress of Myrcludex B development? There are materials mentioning that this drug can potentially eradicate HBV.
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Avatar universal
Read the first line of the results from the Turkish study you posted:

"NO STATISTICALLY SIGNIFICANT DIFFERENCE"!

I rest my case.  Stephen said it well enough.

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lamivudine is not an hbv drug anymore since years, it doesn t work and worsen hbv infection by making hbv mutations some of them even untreatable (cytoxic hbsag mutants)

hbv approved drugs are: interferon, tenofovir or entecavir, all others make more damage than good so best no drugs if those are not available in your country
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also change doctor right away
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My ALT/AST Normal HBV DNA 35000 copies/ml (6013 IU/ml) Ultrasound Normal as Fibroscan is not available here.... is there chance that my virus clear with intf...? i m 25 year old and recently diagnosed HBV

my dr suggest Lumvindin ..is it right ?
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My ALT/AST Normal HBV DNA 35000 copies/ml Ultrasound Normal as Fibroscan is not available here.... is there chance that my virus clear with intf...? i m 25 year old and recently diagnosed HBV

my dr suggest Lumvindin ..is it right ?
Helpful - 0
Avatar universal
For the record: Turkish is not Japanese and Turkish is not Cuban. "Statistically insignificant difference" is not "Efficacy rate close to 100%"
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"as an excuse when they can't figure things out.  But, that's just my opinion"

Well if they get all their info at the conference sponsored by the drug company A, or get info from a salesman from that same company, and or do research that is also sponsored by that A company - each year they will be able to figure out less and less on their own. And want to do less as the result on their own.

I asked for this kind of study to be done on me several years ago.. Peg + vaccine and university level doctors said NO. So they would rather not use a drug or a treatment regiment that has 30-40% chance to clear hbv at one year.. but prefer to  give TDF or ETV that has has 1-2% chance per year to clear. And we are supposed to think it is not a conspiracy up there.

Knowing what I know now, I always ask Hepatologists I see here in the US as to why they are so quick to prescribe anti HIV antivirals instead of doing a therapy with immune modulators? And I don't really get a clear answer, some just day Well that is what we use now.. :)  duh... sometimes I am just speechless.

I firmly believe we don't need to take anti HIV agent chemotherapy for prolong time as a mono therapy based upon what they have shown. These are highly, highly toxic, and dangerous drugs. I have developed high blood pressure as the result of ETV.. 150/90 is not normal.. so now I have to take another drug to treat it, that will stress my liver and kidneys... thank god that there are natural treatments of BP that seem to work.

But my question is why do antivirals do this run up BP in some individuals? It has been long reported on HIV forums that nucs cause heart attacks and strokes in some people in their 30's and 40s.. but HBV is not HIV thank god.. Why does the FDA looks away from all this?

Yet they won't approve Zadaxin that has no sides, and long terms negative effects and is beneficial to the immune enhancement treatment..Why is Alinia is not approved that lowers hbsag?  so I am raising normal questions because I want to know.. We the patients want to know why this is the way it is.. Why only nucs dominate hbv arena in terms of use?

What we need is immune enhancers, that rescue the immune system.. - interferon, zadaxin, molyxan + vaccines that are available today can be used in a combo with a 30-50% chance to clear HBV per year.
It is a whole a lot better then 1-2% per year on nucs that have highly questionable long term safety record.

Studies need to be done in a military type schedule to get results. That is why I said clinical trials to be done in one year..

Attacking the virus from all the angles and stimulating the immune system. I am not saying not to use antivirals at all they have their purpose too, mainly ability to bring down HBV DNA.. and maybe keep it a bay for a year or so at undetectable levels.

We need this immune therapy that has a finite treatment timeline for people while they develop/release better agents that directly work against HBsAg like Replicor drug..

And Cubans went this way knowing this. That immune system here is the key to success to seroconvert to anti-hbs, cubans just went further and have developed what looks like a therapeutic vaccine. So that is in itself an exciting news to look forward to..

but we need these new meds now folks.. That is why I urge people to get pro active, and stand up, to get the system to pay attention. To get doctors to be more accountable for what they do. A reform is needed in how clinical trials proceed for such a deadly virus as HBV..  We CAN't wait 3-5 years while they go through all the legal procedures that defy simple logic..  

But, if we have to wait this long please treat us with better treatment strategies then just give Baraclude or TDF indefinitely.. That is what I mean and wish for USA HBV program.

That is why when they so and so is a big HBV expert and researcher, we want to see him doing advanced things. Not just sponsored product testing. which is also fine btw to test what brings funds to the university or clinic one works at. I mean some of these agents will be the future.

From my experience based on who I saw at the university level physicians, they are knowledge of hbv, awareness of what is out there is very poor, very poor. And they are not doing anything interesting. Saying things like well many things we can't do because of regulations to a patient seem very illogical. So you mean something that can help me live better and save my life can't be used because of the law? Does that make sense? I thought laws were to protect people.
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Avatar universal
Ok I get it those that dare to critise big pharma and expose their recruiting  agents on the forums need to be rediculed. Kind of lame you see.. That is why I say as HBV patients have to be just as active as they are not not to be bullied around.  

Here is the Turkish study from 2004, the one they did in Japan sorry I can't locate in my book marks. The Japanese were giving more vaccines shots and in shorter intervals..

http://www.ncbi.nlm.nih.gov/pubmed/15209626

Efficacy of hepatitis B vaccination and interferon-alpha-2b combination therapy versus interferon-alpha-2b monotherapy in children with chronic hepatitis B.
Helvaci M, Kizilgunesler A, Kasirga E, Ozbal E, Kuzu M, Sozen G.
Source

Department of Pediatrics, Social Security Tepecik Teaching Hospital, Izmir, Turkey.
Abstract
BACKGROUND:

Although interferon (IFN) has been approved in the treatment of chronic hepatitis B in children, it is effective only in 30-40% of patients. In some studies it has been suggested that therapeutic use of anti-hepatitis B virus (HBV) vaccine may be beneficial in patients with chronic hepatitis B. The aim of the present study was to compare the efficacy of hepatitis B vaccination and IFN-alpha-2b in combination and IFN-alpha-2b monotherapy in children with chronic hepatitis B.
METHODS:

Fifty treatment-naive children with chronic hepatitis B infection were randomly assigned to receive either 5 million units/m(2) recombinant IFN-alpha-2b subcutaneously three times per week for 9 months, and pre-S2/S vaccine at the beginning and 4 and 24 weeks after initiation of IFN therapy (n = 25) or recombinant IFN-alpha-2b (5 million units/m(2) subcutaneously thrice weekly) alone for 9 months (n = 25). Children were followed for at least 6 months after the end of therapy.
RESULTS:

There was no statistically significant difference in the mean alanine aminotransferase levels, histologic activity index and fibrosis scores between combination and IFN monotherapy groups at the end of the therapy and end of the follow-up period. When combination and monotherapy groups were compared, the mean HBV-DNA values were significantly reduced in combination group at the end of the therapy (P = 0.004), but no statistically significant difference was found at the end of the follow up. Sustained HBeAg seroconversion with clearance of HBV-DNA was obtained in 13 of 25 children (52%) treated with combination therapy, and in eight of 25 patients (32%) treated with IFN monotherapy (P = 0.251).
CONCLUSION:

Although the difference was statistically insignificant, the sustained response rates were better in the combination therapy group than in the monotherapy group. The potential benefit of combining IFN and hepatitis B vaccine should be investigated in further studies with different regimens of combination therapy.
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Avatar universal
"For the record the japanese were doing studies of interferon plus vaccines. People were given if I remember correctly a shot every two weeks. It worked for some people."

Give us the links and let everybody judge it for themselves.


"I have read have read on cuban forums that they use this vaccine with interferon."

So it's 'he said, she said' from some faceless people on the internet without any real evidence.  Kind of makes it hard to put one's faith on it.  

BTW, I often think doctors use "medicine is art instead of science" as an excuse when they can't figure things out.  But, that's just my opinion.
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Avatar universal
Let me first talk with cuban doctors that treat hbv before you too jump to a conclusion that it is fantasy. I simply posted what I have read. You of all  people should know best how good the cuban medicine is with limited tools they have. All their advancements in cancer treatment and viral infections. They have a Soviet health care system that is runned by the government just like the military. Thus equals good results. Russia is going back to that medical system btw too. Health care for profit is not very popular there. Because of it in Russia there became so much hepatitis b - because people were not checked routinely and many could not afford care like people in the US. That is why hbv spread. If HBV is caught early during the so called 30 day window and people are given interferon and their fluids are maintained along with needed minerals and vitamins hbv would never get chronic.

In the west this practise is not done and seems like a phantasy too. But I have spoken with all that were treated this way even as kids - and during that age hbv almost always gets chronic. And guess what  all of the people have forgot about hbv.

So just because it is not documented by the western researchers does not mean it is a fantasy. Some doctors and very good ones believe it or not dont do lectures  and dont care about fame they just treat people and try available approaches.
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Avatar universal
For the record the japanese were doing studies of interferon plus vaccines. People were given if I remember correctly a shot every two weeks. It worked for some people.

I have read have read on cuban forums that they use this vaccine with interferon. And it makes perfect sense too to use it together since interferon boosts the immune system. Zadaxin can probably be used imxo.

Medicine is more art then science you have remember it. And just because in the west they may be not aware of what can be done or is done somewhere without documentation does not make it a phantasy. But the japanese research was around using vaccines with interferons the cubans just have a better vaccine that  no one has.
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Thank you Ronny. That is what I called doing a clinical trial. Russia will do it as always when they start doing something.
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http://www.hv-info.ru/info/ki/gep-b-d/295-myrcludex-b.html

"Mirkludeks B» (Myrcludex B)

Updated 10/16/2012 18:50
"Mirkludeks B» (Myrcludex B)

Resolution № 231

Name of organization conducting clinical trials: LLC "Gepatera"

The goal of clinical research: The study of therapeutic efficacy of three different doses of the drug Mirkludeks B (selection of optimal dose of the drug), and its clinical safety, namely the assessment of changes in the level of HBsAg under the influence of treatment with 3 different doses of the drug evaluation virologic response to treatment (level HBV DNA), biochemical response to treatment, and to study the pharmacokinetic profile and immunogenicity of the drug in patients with HBeAg-negative chronic hepatitis B

Start 08/13/2012

Ending 31/12/2013

The list of medical institutions, which are intended for clinical research

1.Gosudarstvennoe institution Moscow Regional Research Clinical Institute. MF Vladimir, 129110, Moscow, ul. Shchepkin, 61/2, tel. (495) 681 55 85

2. Public health agency of Moscow "Infectious Clinical Hospital № 2 Moscow Health Department", 105275, Moscow, 8th Street Mount Falcon, 15

3. Federal State Institution "Scientific Research Institute of Influenza," the Ministry of Health and Social Development of the Russian Federation, 197376, St. Petersburg, ul. Prof. Popov St., 15/17

4. State budget institution of higher education "Chelyabinsk State Medical Academy" of the Ministry of Health and Social Development of the Russian Federation (Chelyabinsk)., Address infectious department № 2 and infectious services clinic: 454052, Russia, Chelyabinsk, ul. Cherkassy, ​​2., 454092, Russia, Chelyabinsk, ul. Thievish, 64

5. Limited Liability Medical Company "Hepatologist" 443011, Samara, October district, st. Glade 3, D. 157, tel. (846) 926 20 26

6. St. Petersburg State health agency "Center for Prevention and Control of AIDS and infectious diseases", 190103, St. Petersburg, nab. Bypass channel, 179

7. State health agency "Sverdlovsk Regional Hospital N 1" GOOSE "SOKB N 1", 620102, Ekaterinburg, ul.Volgogradskaya, 185.

8. Public health agency of Moscow "Central Research Institute of Gastroenterology," Moscow Health Department, 111123, Moscow, road enthusiasts, 86, tel. (495) 304 19 42

9. State Organization of Health of Moscow "City Clinical Hospital № 24" Moscow Health Department, 127015, st. Scribe, 10 10. Limited Liability Company "MedElitKonsalting", 121107, Moscow, Victory Square, 2, block 2
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Avatar universal

i agree totally

it is useless to just post our own fantasy here!we have to post only the studies with their results and of course never ever make confusion like this with fantasy

at the moment only antivirals for many many years 5-7years and then intf add on has shown hbv clearance and is available in most countries and this is what we can do to get cured today
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For the record, there is no evidence to support the following statements:

"From what I have heard it will registered in 2015 for use. And from what is reported it clears HBV with interferon also in like 2 months of therapy. Efficacy rate is close to 100%. "

They are just someone's imaginations. Please wait for the results of the clinical trial and hope for the best.
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If Nasvac in Phase III trail ..than it must be release in 2013..to save the life of million's people who are looking towards this vaccination...
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In the interest of fact: there is NO COMBINATION of NASVAC and Pegylated Interferon 2b BEING TESTED!  Pegylated Interferon 2b is the control or "placebo" arm of the trial.

Active Comparator: Pegylated Interferon 2b
Active Comparator: HBsAg and HBcAg combination
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Yes you are correct it will stimulate antibody production in us http://clinicaltrials.gov/ct2/show/NCT01374308 looks like in stage 3 they will look at giving it together with interferon to stimulate antibodies production.

this is a right approach at this to have a cost effective treatment.  
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Ok I'm new to this. So u mean nasvac is a vaccine that works for CHB by giving us antibodies? I thought hep b vaccines don't work for us?
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Nasvac is a Cuban development. It is a therapeutic vaccine. Adding interferon to it may even increase the benefit. So this is definitely a good tool to have.
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NASVAC = myrcludex?

I thought myrcludex is already on trials now, phase III and will be released in 2013 fall? No?
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2015 ....  :- (  y not 2013? ....com on ..
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This is an extract from a reply from Dr. Mamun-Al-Mahtab who is in charge of the clinical trial, in April this year. Please note a result of 50% of clearance of hbvdna is reported from the small phase II trial. Of course, results from the Phase III trial are unknown as it has not been completed. Please note Peg Interferon is used as a comparison, no combo of NASVAC + Interferon is used:

6. At this time, we found human consumable vaccine containing both HBsAg and HBcAg form CIGB, Cuba.

7. The vaccine has been used in a Phase I-II clinical trial in 20 treatment naïve patients in Bangladesh initially and 17-18 patients were followed up and assessed for immunological events of this HBsAg/HBcAg therapeutic vaccine.

8. It seems that HBsAg/HBcAg vaccine induced HBV DNA negativity in about 50% patients and caused normalization of liver enzyme (a feature of therapeutic effect) in almost all patients.

9. Now, we were conducting a phase III clinical trial with 160 patients, 80 patients with CHB would receive HBsAg/HBcAg vaccine and other 80 patients would get one of the most potent antiviral drug, pegylated interferon. The clinical trial is yet to be complete, but initial data shows that the HBsAg/HBcAg therapeutic vaccine that we are using, might be a prospective therapy for CHB patients.
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From what I have heard it will registered in 2015 for use. And from what is reported it clears HBV with interferon also in like 2 months of therapy. Efficacy rate is close to 100%.
====================================================
"Cuban experts are working on a vaccine candidate against hepatitis B, which encouraging results in clinical trials will be presented on Thursday at the Congress Biotecnologia 2012. During the clinical trials carried out in Cuba and Bangladesh, Nasvac reported a better response than any other compound to treat that illness, Doctor Gerardo Guillén, vice president of the Organizing Committee of the event told reporters.

Nasvac allows leading the patients' immune response to the virus and preventing the disease from worsening, the expert said.

Effectiveness and benefits are already palpable, he said.

Participants in the congress also learned about the results of clinical trials of anothr therapeutic vaccine against hepatitis C, as well as a drug against womb cancer."
====================================================
We have to write to Cuba also, maybe something can be worked out. That country has one of the best health systems in the world and totally free. So they may have ideas for us and help with the drug.
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