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NasVac Opens A New Avenue for Hepatitis B Virus Treatment
http://www.newindianexpress.com/states/odisha/NasVac-Opens-A-New-Avenue-for-Hepatitis-B-Virus-Treatment/2015/07/29/article2946543.ece
BHUBANESWAR: Even as Hepatitis B virus (HBV) claims nearly one million deaths worldwide every year, a new drug holds immense promise for treatment and cure of the chronic infection.
With clinical trials in advanced stages across several countries in Asia, Asia Pacific region, Latin America, Europe and Australia, the novel therapeutic vaccine NasVac could be available for use in as early as 2018-19, hepatologist and secretary general of Association for the Study of Liver, Bangladesh Dr Mamun-Al-Mahtab said on Tuesday.
NasVac induces a much effective immune response to the virus in the body, leading to control of virus replication and ultimate elimination from the body. The therapeutic vaccine cannot be called a wonder drug but has shown to have a response rate of more than 50 per cent, Dr Mahtab said.
As of now, there is no cure for HBV and conventional treatment aims at suppressing the HBV proteins to slow down progression to complications like cirrhosis and liver cancer and improve long-term survival rates. However, the treatment has its side effects and even leads to drug resistance.
“NasVac opens a new avenue for HBV treatment. After successful trials, the drug is now set to be registered in Cuba and Latin American countries like Ecuador, Venezuela and Brazil this year. Europe is likely to register it by 2018 and hopefully by 2019, it would be open across the world,” the researcher and expert said.
BHUBANESWAR: Even as Hepatitis B virus (HBV) claims nearly one million deaths worldwide every year, a new drug holds immense promise for treatment and cure of the chronic infection.
With clinical trials in advanced stages across several countries in Asia, Asia Pacific region, Latin America, Europe and Australia, the novel therapeutic vaccine NasVac could be available for use in as early as 2018-19, hepatologist and secretary general of Association for the Study of Liver, Bangladesh Dr Mamun-Al-Mahtab said on Tuesday.
NasVac induces a much effective immune response to the virus in the body, leading to control of virus replication and ultimate elimination from the body. The therapeutic vaccine cannot be called a wonder drug but has shown to have a response rate of more than 50 per cent, Dr Mahtab said.
As of now, there is no cure for HBV and conventional treatment aims at suppressing the HBV proteins to slow down progression to complications like cirrhosis and liver cancer and improve long-term survival rates. However, the treatment has its side effects and even leads to drug resistance.
“NasVac opens a new avenue for HBV treatment. After successful trials, the drug is now set to be registered in Cuba and Latin American countries like Ecuador, Venezuela and Brazil this year. Europe is likely to register it by 2018 and hopefully by 2019, it would be open across the world,” the researcher and expert said.
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Hmmm why all this ads for Abx203 then if it doesn't cure hbv coz we already have good antivirals on the market that can suppresses the virus, i don't get it.????
It looks like the automatic editor does not know NASVAC while it knows NASCAR. ...
In the Bangladesh trial, no hbsag loss was reported. Thus expectations of a functional cure are unrealistic. As a combo treatment eg with replicor, it might have to be used in multiple rounds for max efficacy.
the core particles, probably by virtue of their geometrical shape and spikiness, are a superantigen that is perceived dangerous by the dendritic cells without any added adjuvants. In the mix with hbsag, they act as adjuvant for the surface particles, they also cluster together as was reported in a nature paper by the Cuban researchers. The effectiveness of the core particles, produced by recombinant technology in vitro, is further enhanced by the internal packaging with RNA, bonded to positive internal regions of the particle at the production process. Jörg reimann and Reinhold schirmboeck at the University of Ulm have performed and published extensive work on these vaccine preparations, showing among other findings that core particles, ladder with RNA can dramatically improve immune responses to hbsag particle preparations.
Thus the internal production of core inside virions is not comparable to the massive stimulation of dendritic cells outside the liver with an opportunity to recruit and activate new naive t cells of both classes against core and surface epitopes.
Furthermore the NASCAR uses in parallel an intranasal application of the mix, in the hope that mucosa type tells can be activated that were not previously used and might not be exhausted.
the core particles, probably by virtue of their geometrical shape and spikiness, are a superantigen that is perceived dangerous by the dendritic cells without any added adjuvants. In the mix with hbsag, they act as adjuvant for the surface particles, they also cluster together as was reported in a nature paper by the Cuban researchers. The effectiveness of the core particles, produced by recombinant technology in vitro, is further enhanced by the internal packaging with RNA, bonded to positive internal regions of the particle at the production process. Jörg reimann and Reinhold schirmboeck at the University of Ulm have performed and published extensive work on these vaccine preparations, showing among other findings that core particles, ladder with RNA can dramatically improve immune responses to hbsag particle preparations.
Thus the internal production of core inside virions is not comparable to the massive stimulation of dendritic cells outside the liver with an opportunity to recruit and activate new naive t cells of both classes against core and surface epitopes.
Furthermore the NASCAR uses in parallel an intranasal application of the mix, in the hope that mucosa type tells can be activated that were not previously used and might not be exhausted.
I wish I cud participate any of these trials. In India hardly any hep b trials are cunducted. This one sounds hopeful.
Any idea how often it will be applied ? You will need to "renew" it once a few years ? Or it's rather expected that one course should block HBsAg for good ?
Could you explain how mix of hbsag and core particles helps to cure hbv ? I don't get it cuz we all already have it :) Probably I'm not the only one who doesn't understand it.
Could you explain how mix of hbsag and core particles helps to cure hbv ? I don't get it cuz we all already have it :) Probably I'm not the only one who doesn't understand it.
Hope so studyforhope, yes you are right they didn't provide any explanation as the Vac therapy works both for hbeag+ & hbeag- and hope our problems halt 'th this vaccine.
what do you think of this treatment strategy for those on uncs and low hbsag like me
rep9ac+tdf for few weeks until hbsag is undetectable and some hbsab is formed
NasVac+tdf as long as very high and stable hbsab is achieved and then only on tdf for about a year just to be sure hbsab and hbvdna are stable and then slowly try to go off any treatment
this would be ideal and i guess cuba will not use superhigh prices for NasVac like the prices of zadaxin
lets keep an eye on these countries and there for hilidays as soon as approved, i guess cuba will be the first one
i dont understand resistance, maybe he means mutations but if we are fully hbvdna und by tdf or etv no possibility of resistance
i think the best thing for those with very low hbsag, on longterm nucs treatment, is rep9ac followed by the vaccine and always under nucs hbvdna suppression
This is the Cuban nasal vaccine, now known as ABX203. It has been discussed several times on this Forum. Dr Mumun-Al-Mahtab conducted the earlier clinical trials for NasVac, he also conducted the clinical trials for REP9AC in Bangladesh for Replicor.
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But no info was given regarding e antigen status and it might have been used in e ag pos patients, just like the first replicor trials.
Hopefully the abivax trial will clarify it's effect in the e neg population.
I think it will be a potent adjuvant therapy in rep9ac treatment, together with thymosin alpha. The length of the nap treatment in this combo will have to be substantial, stopping naps will quickly revert the hbsag negativity, as we will see in the ongoing Moldavia trial. If there is s role for antiviral mediated virion production reduction in these treatments remains to be seen.
It would be nice to have this NASVAC approved in at least a few countries.
But since it is basically a one to one mix of hbsag and core particles 100microgram each, it can also be made in other countries, since core particles are available commercially.