Aa
Myrcludex B development
Does somebody know the progress of Myrcludex B development? There are materials mentioning that this drug can potentially eradicate HBV.
i ve read about it and it lowers hbsag probably so it is a cure for hbv and not only liver damage but research seams very slow and we have seen all research to cure hbv gets blocked even when it reaches human trials
i believe drug makers want us to use antivirals which don t cure hbv for life which make them make a lot of money while a cure for hbv makes lose money (also considering vaccines and lack of future customers for hbv drugs.....) so i don t see any new drug which can cure hbv in the future begin produced, they will keep discovering but none will produce them
Well, business and humanity run against each other. I tend to agree with you. It is discovered by the German. You probably know better since you are close to them.
By the way my mom got hbv dna undetectable and seroconversion. She is HBe positive and has fibrosis. Can she take milk thistle in addition to entecavir? She is taking entecavir.
By the way my mom got hbv dna undetectable and seroconversion. She is HBe positive and has fibrosis. Can she take milk thistle in addition to entecavir? She is taking entecavir.
coffee (at least 3 cups x day), cocao (after meals) and bluberries (160gr per day) are stonger to reduce fibrosis and alt and action has been proven i'd choose these instead since milk thistle has been found to interfere with antivirals
i just read about a vaccine found by chinese researchers, thats good since their markets are not foucused on drug making at all so maybe it ll come out someday
i have known a researcher who could not make trials paying herself or pubblish her discoveries, so at the 3rd compund discovered she quited research, that s why i am so angry when i see things from hbv research stoppped or desaperaring
http://ihlpress.com/pdf%20files/resistance10_presentations/02_Locarnini.pdf
Myrcludex B looks like this is the closest drug to get on market soon, human trial should start this year in germany
Myrcludex B looks like this is the closest drug to get on market soon, human trial should start this year in germany
Normally, how long it takes for the drug to be approved. I'm afraid that if a patient who fails with Tenofovir cannot get a new drug to replace.
it depends on the drug makers and market mainly but when the drugs allows to make a lot of money they are superfast entecavir took about 5 years even if they found cancer on rodents but not on primates
so i'd say about 5 years if they want it
you shouldn t worry about tenofovir resistance if you have reached hbvdna und you don t get resistance easily plus there re combos to prevent that:
entecavir+tenofovir or tenofovir+ftc or addition of nitazoxanide if you have lam or adv resistance
Phases of Clinical Trials
Drug research involves many stages. Much of the knowledge about drugs is derived from initial laboratory research in animals. Animals are used during the drug development phase, primarily to confirm lack of toxicity. Laboratory primate animals are protected by a separate set of regulations governing the care and use of animals. If it looks like a drug has potential therapeutic value without major toxicity in laboratory tests, it is then time to advance to the next stage. The researchers must submit an application to the FDA; this application process is very extensive. If the FDA grants permission to proceed after careful review of the preliminary data, then drug testing – clinical trials – can begin on humans.
Clinical trials can be divided into four phases. The process begins with a Phase I trial – the initial introduction of an investigational new drug into humans. These tests may be conducted in patients, but are usually conducted in healthy volunteers (usually 20 to 80 subjects). The goals of a Phase I trial are to evaluate safety and tolerability (i.e., lack of major side effects) as well as the dosage range. This is determined by testing a range of doses (called a dose-ranging trial). Study participants initially receive a low dose of the drug; this is gradually increased as long as the drug appears to be safe. Phase I studies may provide early indications of the drug’s effectiveness, but whether or not a drug works is the primary focus of later Phase II and Phase III studies.
In Phase II trials, early controlled clinical studies are conducted to obtain preliminary data on the effectiveness (also known as efficacy) of the drug for the particular indication, such as treatment of chronic hepatitis C. This phase also allows further collection of data on the common short-term side effects and risks associated with the drug. Phase II studies are conducted in a relatively small number of patients, usually involving several hundred people.
After preliminary evidence of effectiveness is confirmed in phase II studies, expanded controlled and uncontrolled phase III studies are conducted to gain additional information on effectiveness and safety. In this phase, the study drug is given to several hundred to several thousand of patients. In Phase III studies, the new drug may be compared to current standard therapy.
Phase IV trials are post-marketing studies conducted after the drug has been approved and marketed, often to further confirm safety. These studies are done in order to gain more specific information about the drug, such as how the drug interacts with other drugs or how it works in people with other diseases. Phase IV trials may include large numbers of patients (some Phase IV trials are small), and may reveal uncommon side effects that are too rare to show up in Phase II or III studies.
Laboratory testing is performed regularly while an experimental drug is being tested in humans, thus new information about the drug’s safety and effectiveness comes from blood tests as well as patient interviews and physical examinations.
Before a drug is approved for marketing, it is called an investigational new drug (IND). The total time it takes to bring a drug to market can vary. The preclinical laboratory phase averages about five years, and the length of time an investigational drug is in clinical trials averages seven years. According to an article published by the FDA in 1999, only one in 1,000 compounds make it from the laboratory to human testing, and only one in five of these receive FDA approval for marketing (www.fda.gov).
Drug research involves many stages. Much of the knowledge about drugs is derived from initial laboratory research in animals. Animals are used during the drug development phase, primarily to confirm lack of toxicity. Laboratory primate animals are protected by a separate set of regulations governing the care and use of animals. If it looks like a drug has potential therapeutic value without major toxicity in laboratory tests, it is then time to advance to the next stage. The researchers must submit an application to the FDA; this application process is very extensive. If the FDA grants permission to proceed after careful review of the preliminary data, then drug testing – clinical trials – can begin on humans.
Clinical trials can be divided into four phases. The process begins with a Phase I trial – the initial introduction of an investigational new drug into humans. These tests may be conducted in patients, but are usually conducted in healthy volunteers (usually 20 to 80 subjects). The goals of a Phase I trial are to evaluate safety and tolerability (i.e., lack of major side effects) as well as the dosage range. This is determined by testing a range of doses (called a dose-ranging trial). Study participants initially receive a low dose of the drug; this is gradually increased as long as the drug appears to be safe. Phase I studies may provide early indications of the drug’s effectiveness, but whether or not a drug works is the primary focus of later Phase II and Phase III studies.
In Phase II trials, early controlled clinical studies are conducted to obtain preliminary data on the effectiveness (also known as efficacy) of the drug for the particular indication, such as treatment of chronic hepatitis C. This phase also allows further collection of data on the common short-term side effects and risks associated with the drug. Phase II studies are conducted in a relatively small number of patients, usually involving several hundred people.
After preliminary evidence of effectiveness is confirmed in phase II studies, expanded controlled and uncontrolled phase III studies are conducted to gain additional information on effectiveness and safety. In this phase, the study drug is given to several hundred to several thousand of patients. In Phase III studies, the new drug may be compared to current standard therapy.
Phase IV trials are post-marketing studies conducted after the drug has been approved and marketed, often to further confirm safety. These studies are done in order to gain more specific information about the drug, such as how the drug interacts with other drugs or how it works in people with other diseases. Phase IV trials may include large numbers of patients (some Phase IV trials are small), and may reveal uncommon side effects that are too rare to show up in Phase II or III studies.
Laboratory testing is performed regularly while an experimental drug is being tested in humans, thus new information about the drug’s safety and effectiveness comes from blood tests as well as patient interviews and physical examinations.
Before a drug is approved for marketing, it is called an investigational new drug (IND). The total time it takes to bring a drug to market can vary. The preclinical laboratory phase averages about five years, and the length of time an investigational drug is in clinical trials averages seven years. According to an article published by the FDA in 1999, only one in 1,000 compounds make it from the laboratory to human testing, and only one in five of these receive FDA approval for marketing (www.fda.gov).
no to prevent resistance for life treatment, once resistance to tnf happens it is too late but until now 3-4 years no mutations have been detected even in those with hbvdna detactable
so resistance will be difficult on tnf and will require many years
the most used combos are tnf+ftc (embricitabine) and tnf+etv, results of a trial tnf+etv on naive patients started on 2007 will be presented at the liver meeting in boston on october/november, this trial will be finished in 2012
we are lucky it is germany the country for the trials, i don t trust USA FDA at all...
in italy they have currently connected research and human testing immediately for cancer drugs......we are in 2010 and all those years can be avoided most of the time, the toxicity testing is not exactly a matter of time
Thanks, Stefano. My friend has switched from Entecavir to Tenofovir recently. Dr said she was resistant to entecavir. DNA has kept going up from 1,000-2,000 and then 30,000 copies. We are worried that we don't know what happens with Tenofovir in the future. We are asking ourselves whether Tenofovir is the end of the world or not. I also asked Dr if he knows something about Alinia and he said just believe in Tenofovir.
I don't know what facilities are available in your city... anyway... I strongly recommend that she immediately get tested to identify the mutations that her HBV has undergone. This is not possible once TFD reduces her viral load. Once she knows about the mutations, she'll be in a better position to assess whether to just use TDF or she can use a combo of ETV+TDF. A combo would be more potent because TDF and ETV work on different sections of the virus to hinder its reproductive cycle. She can do a combo as long as her HBV has undergone three specific mutations that render ETV completely useless.
Even if she does not end up doing a combo therapy, it is always a good idea to know the exact progression of ones disease: this info may become very useful someday... maybe someday she'll be in a situation where she has to consider coming back to ETV... maybe they release a new drug that's very potent, and will not work against some specific mutations.
The "just believe in" attitude is what led your friend to ETV resistance in the first place. There is a specific rate at which VL should decrease on ETV. Anything worse, and I would seriously consider comboing.
Even if she does not end up doing a combo therapy, it is always a good idea to know the exact progression of ones disease: this info may become very useful someday... maybe someday she'll be in a situation where she has to consider coming back to ETV... maybe they release a new drug that's very potent, and will not work against some specific mutations.
The "just believe in" attitude is what led your friend to ETV resistance in the first place. There is a specific rate at which VL should decrease on ETV. Anything worse, and I would seriously consider comboing.
once you have etv resistance tnf might be not strong enough, it doesn t work on all cases, doctors have made the biggest mistake possible, i'd sue them if possible
your only hope is: tnf+alinia and possible new drugs, ftc is not potent enough if you have resistance
simvastatin, interferon and alinia are the only for now working on all hbv resistance strains, i strongly suggest to add alinia, it is not usefull to ask the doctor who made this mess he should pay all the damage he has done because of being so ignorant
and of course as Sharp7 sadi you need to check all mutations because ou also have lam resistance which makes a lot of mutations making etv resistance and possible reduced responce to tnf
do add alinia as soon as possibel also because you have no choices with all these mutations nucs like tnf, etv , lam ,ftc and adv don t work in all cases, you need a different type of drug in combo with tnf
please also do not believe in doctors only but try to study some medicine and hbv by reading articles
because doctors for hbv are a complete mess in most of the cases, you must have the knowledge to make choices and doctors will just help you with their experience in the field but the main choices must be yours.
this community saced many people from your situation especially thanks to HR, the researcher who developped the drugs and who warned us anbout the wrong us of them from doctors.
start here:
http://www.medhelp.org/health_pages/list?cid=153
and even if tnf works you must combo anyway, there is no field in medicine where you can use drugs for long time without resistance
TDF has reduced effect in ADV resistant HBV, but remains fully potent against ETV resistant HBV. So, not all is lost now. Also, I don't know if there is such a strong case for suing right now, given that the doc was "just" following guidelines. I do agree that the doc was somewhat lazy with homework.
fully potent against ETV resistant HBV
no in clinical practise the responce is much reduced and the percentage of hbvdna und is absolutely not 100% on etv R, and she has etv, lam mutations and maybe also adv mutations (lam makes also rt215s that i also have naturally not by antivirals, it reduces response on lam, adv and even tnf in vitro, only etv fully active on it, that's why i am already on etv+alinia)
she is in the worst case possible now so i think she must know that combo is abolutely a must in her case, i do hope tnf will make hbvdna und but i'd prevent new surprises now
the doctor made another big mistake, stopping etv makes a flare of hbvdna and alt because tenofovir takes time to block hbvdna, she should have combo etv+tnf for at least 1 month
i don t mean to scarry her but she is in a pretty bad situation and she must prevent the worst, also cancer risk doesn t lower with lam R on tenofovir even if hbvdna und, so i'd combo at least with alinia
no in clinical practise the responce is much reduced and the percentage of hbvdna und is absolutely not 100% on etv R, and she has etv, lam mutations and maybe also adv mutations (lam makes also rt215s that i also have naturally not by antivirals, it reduces response on lam, adv and even tnf in vitro, only etv fully active on it, that's why i am already on etv+alinia)
she is in the worst case possible now so i think she must know that combo is abolutely a must in her case, i do hope tnf will make hbvdna und but i'd prevent new surprises now
the doctor made another big mistake, stopping etv makes a flare of hbvdna and alt because tenofovir takes time to block hbvdna, she should have combo etv+tnf for at least 1 month
i don t mean to scarry her but she is in a pretty bad situation and she must prevent the worst, also cancer risk doesn t lower with lam R on tenofovir even if hbvdna und, so i'd combo at least with alinia
Thanks all. Doctor asked to continue ETV for one month with Tenofovir. So, after that she can add something else?
very good then, i didn t think that since hbvdna continued to rise.yes she can add alinia (nitazoxanide)
there are also studies of simvastatin, one of the oldest cholesterol drugs, very cheap and generic, but the studies are blocked so i'd not suggest the use of sim unless there are high cholesterol problems
we only know there is highest synergy in use etv+sim and that sim is active against hbv resistance strains and that it helps protect the liver in cirrhosis but there isn t other data
there is a doctor in a US university studying it but trial is not starting although ultra cheap and easy, drug makers are trying to block this drug since very cheap generic saying it has sides on liver but that's all bulls...., so no funds or help from them
there is also synergy with tnf+sim but only the doctor studying it can help on this, i don t remember university maybe oregon
I wasn't surprised when simvastatin was found to help. We (humans) have known for quite some time that cholesterol is needed for the production of HBsAg.
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WXR-4938MDK-C&_user=10&_coverDate=09/15/2003&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1410433543&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=7dde735cfcc7480f7defb576448d4ad6
Maybe they should start experimenting with other cholesterol drugs.
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WXR-4938MDK-C&_user=10&_coverDate=09/15/2003&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1410433543&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=7dde735cfcc7480f7defb576448d4ad6
Maybe they should start experimenting with other cholesterol drugs.
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