Presentations:
http://replicor.com/wp-content/uploads/2016/02/Replicor-REP-301-APASL-2016-O-130web.pdf
http://replicor.com/wp-content/uploads/2016/02/Replicor-APASL-2016-Combo-NAPS-In-vivo-P-0329.pdf
change.org can be used for a petition.
i open another post on zadaxin, see answer there
the problem with this drug/company is that we have no info on hbsag quant, they only reported hbvdna.
it would be great to see its effect on low hbsag or combo with cuban vaccine
studyforhope...
Could you please provide your opinion on the most effective long-term approach to treatment, taking into account the available options such as entecavir/tenofovir, pegasys, zadaxin (thymosin alpha), etc....
Basically, my question is, what would be the advised or seemingly most-effective sequence of the treatment options and when (e.g. at what hbsag level) would each of these medicines be best to be initiated.
Lets say one starts with tenofovir/entecavir...at what time would be the most effective to add pegasys and/or thymosin alpha?
Thanks in advance...
Thanks. Any theories why in that case with naps it's better than interferon and in other cases not ?
it worked this way on nap but who knows monotherapy
So basically its good when someone has lost HBsAg but has problems with developing antibodies ?
it doesn t work but when hbsag is unde or less than 1iu/ml works
it would be good to know if it can help also for hbsag less than 1000iu/ml when on tdf since 6 years, although very expensive i d use it if there was any data it can help in these cases but all trials i have seen it did n t work
Good to know that thymosin alpha has no sides. I'm on interferon now and I don't worry about temp sides but rather long term ones in case I'd have to repeat it in a few years.
Btw, so why thymosin alpha is not used as monotherapy or with nucs ?
6 month of follow up is barely enough to confirm a stable svr.
I do not b think that any agency will give approval based on 12 patients. They will, for hdv, negotiate a registration trial design with replicor.
BTW the current trial in Moldavia was NOT DESIGNED to achieve a functional cure. It's pupose was to show that the nap component was independently causing a strong, objective positive effect, BEFORE the interferon overlap.
The new trial, starting now is designed to achieve a functional cure in the hope that a full year of naps plus a simultaneous interferon or thymosin alpha treatment, all combined with TDF and with a TDF pretreatment period of 6 month, will achieve hbsag seroconversion in a high percentage of patients.
Those will be e neg patients again, but without hdv.
What is most fascinating is the thymosin alpha arm, since this has almost no side effects compared with interferon and seemed more promising in the second Bangladesh trial than interferon.
So it's 15 weeks on peginf left and than 6 months of observation ?
Small trial is for orphan drugs I think, fast track is:
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
I wonder if hdv drug has chance for that procedure ?
First one needs to await the stability of the HDV CLEARANCE after stopping the treatment. This can only be judged after at least 6 month of follow up.Currently it seems plausible that 5 out of the 11 fully treated patients might have a true SVR for hdv and hbv. But even in these cases we will need to wait and see.
If it is possible that the currently hdv neg patients that are not expected to stably seroconvert the hbsag will still have selectively lost hdv remains to be seen. It is unlikely and would represent a true sensation if possible.
i dont know fast track. is it requiring little money and small trials for approval?
I don't think so cure for hdv may be treated as orphan drug, because it's a lof of people infected to test on. I think we should aim for fast track procedure.
i am not expert on those website but we just need to put out a text for hdv that can have orphan drug approval and then mention this drug can cure hbv too
of course they cannot split hdv from hbv and orphan drug can be achieved anyway
we can also mention that this cure will cut many drug makers income from antivirals so it needs to be pushed by us
Stef and Stephen What do you think of Mer971 suggestion?
Just to play devils advocate for a moment.
Why do a petition whilst Replicor are clearly moving forward with their trials?
I'll sign your petition if you put one together guys.
I haven't checked those sites yet, but it would be important feature that petition would have language versions, most of hbv infected people are non english speakers I guess.
other site for petitions https://www.change.org/
is it european community like romania?no customs?
I am in. I am in Romania, and next to us on the right side border is Moldova. Both country speak the same language. If it is any help let me know.
OK thanks Sorte at least we knew now whom to send the petition.