Avaz and thise websites may easily push all their members to join the petition if you put it like this: hdv has no cure and people die from this (this cannot be said about hbv of course),this drug has shown it can cure hdv and mild sides effects, this drug must be approved!
the small private drug company needs orphan drug approval for hdv
Off label use then is allowed for hbv too
Yes it is and the difference between germany/italy or moldavia was only to save money while blood tests are made in labs in germany and us thats why i was thinking petition to get it approved
If you add hdv has no cure at all (hbv actually has a cure to block it) we may push all the public to join us.
For hbv they can say there are drugs to block it but this cannot be said about hdv, plus there are laws in some european countries that allows use of experimental drugs when there s no cure
I know there is a Facebook group its Admin most of the time in here with us, i believe about 5000 HBV members in that group so this ppl they 'll definitely do a difference in the petition. Good luck!
The third and last one:
Antiviral effect of therapy with REP 2139-Ca and nucleos(t)ide analogues against HBV in vivo
Treatment of human patients with chronic HBV infection with the nucleic acid polymer (NAP) REP 2139 results in the elimination of circulating HBsAg. In this preclinical study we evaluated a novel combination therapy associating REP 2139-Ca with tenofovir diso- proxil fumarate (TDF) and entecavir (ETV), in vivo, in the DHBV infection model.
DHBV-carrier ducks were treated for 4 weeks with normal saline (IP), REP 2139-Ca (10 mg/kg IP QD), TDF (15 mg PO QD), REP 2139-Ca + TDF or REP 2139-Ca + TDF + ETV (1 mg PO QD). Serum DHBsAg was monitored by ELISA and DHBV DNA by qPCR. After therapy cessation all animals were followed during additional 8 weeks. Total DHBV DNA and cccDNA were analyzed in autopsy liver samples by qPCR.
On-treatment antiviral responses were more marked when REP 2139 was combined with TDF or TDF and ETV. Sustained virologic responses (SVR) during 2 months off-therapy were only observed in the groups receiving REP 2139 alone or in combination with TDF or TDF and ETV but not in TDF-monotherapy. SVR consisted of stably suppressed serum DHBsAg and DHBV DNA and significant decrease in liver DHBV DNA and cccDNA that were more marked in com- bination-therapy groups. Importantly, SVR animals had undetectable liver DHBsAg as assessed by immunostaining analysis.
Antiviral performance of REP 2139 was sustained and enhanced by combination with TDF or ETV. Thus an interferon-free regimen of REP 2139 with TDF or ETV could improve antiviral response and shorten treatment regimens in HBV infected patients.
Serum HBV-RNA levels decline significantly in chronic hepatitis B patients dosed with REP2139-CA
Background and aims: The HBsAg release inhibitor REP2139-Ca may be a promising new treatment option for chronic hepatitis B (CHB) patients, however its effect on hepatitis B pregenomic RNA (HBV-RNA) is unknown. HBV-RNA levels during treatment with REP2139-Ca were determined and compared with HBV-DNA and HBsAg levels.
Methods: 12 Patients with HBeAg positive CHB participating in a phase 2 study were dosed with the nucleic-acid based amphipathic polymer REP2139-Ca for 20–38 weeks. Responders to REP2139 (defined as clearance of serum HBsAg) were subsequently treated with an add-on immunomodulatory agent (peginterferon alpha-2a and/or thymosin alpha-1). HBsAg, HBV-DNA, and HBV-RNA levels were determined at baseline, after 20–24 weeks of REP2139-Ca monotherapy, and either during a treatment-free follow-up (for responders) or during entecavir treatment (for non-responders). HBV- RNA was quantified by RT-qPCR using HBV-specific primers. Results: HBV-RNA levels were detectable in all 12 HBeAg-positive patients before treatment [mean 6.70 (SD 0.83) logC/mL], and were significantly associated with HBsAg (r2 0.33, p = 0.049) and HBV- DNA levels (r2 0.74, p \ 0.001). After 20–24 weeks of REP2139-Ca treatment, mean HBV-RNA, HBV-DNA, and HBsAg levels had declined significantly compared to baseline (all p \ 0.001). At week 20–24, HBV-RNA was undetectable in 8/12 patients. In 7 of these 8 patients, HBV-RNA remained undetectable during the treatment-free follow-up period (mean 21.9 weeks, range 7–27). HBsAg sero-con- version was achieved in 4/8 patients during follow-up (anti-HBs range 200–766 U/L).
Conclusions: In patients treated with REP2139-Ca, serum HBV-RNA levels declined significantly compared to baseline. REP2139-Ca may be a promising new treatment option for CHB patients.
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
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:
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.