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Newest Repac Abstract

HBsAg and HDV RNA reduction with REP 2139-Ca and peg-INF alpha 2a in chronic HBV/HDV infection.

Nucleic acid polymers (NAPs) inhibit the release of HBsAg and the NAP REP 2139 can efficiently clear HBsAg from the blood of patients with HBV mono-infection. REP 2139-Ca therapy combined with pegylated interferon alpha-2a is being evaluated in Caucasian patients with HBV/HDV co-infection (NCT02233075).
Patients received REP 2139-Ca once weekly for 15 weeks (500 mg) by 2 h IV infusion, followed by combined therapy for 15 weeks with pegylated interferon alpha-2a (180ug SC qW) with 250 mg REP 2139-Ca. Patients then transition to 33 weeks of pegylated interferon alpha-2a monotherapy. HDV RNA, HBV DNA, HBsAg and anti-HBs are followed every two weeks using standard assays (Robogene RT- PCR, Abbott RealTime HBV, Abbott Architect).
On treatment, observed HBsAg reductions are currently *5 logs in 6 patients (all \1 IU / ml), *3 logs in three patients and *0.5 to 1.5 logs in three patients. HDV RNA is currently undetectable in ten patients (*5 to 8 log reduction from baseline) with *3 and *5 log reductions observed in the other two patients. Substantial elevation (389–15,408 mIU/ml) of serum anti-HBs and the development of liver flares were only observed with the onset of exposure to pegy- lated interferon alpha-2a and was only evident in patients with serum HBsAg \1 IU / ml at the start of immunotherapy.
REP 2139-Ca is able to achieve rapid reductions in serum HBsAg and HDV RNA in Caucasian patients with HBV/HDV infection. REP 2139-Ca may become an important new therapeutic option for patients with chronic HBV/HDV infection.
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Avatar universal
So basically its good when someone has lost HBsAg but has problems with developing antibodies ?
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3 Comments
Sci clone is a small company. It did not have the means to initiate trials to tests those other potential uses for thymosin alpha like sequential add on after antiviral therapy. It is approved in many countries for hbv, also cancer and as a vaccine adjuvant in some.

What matters here are the results it achieved in combo with naps in the second Bangladesh trial and the effects on svr stability,  which was better than interferon.
SciClone is a relatively small company but it is listed on Nasdaq. In recent years, it has a strong focus on marketing Zadaxin in China for HBV. Recently it entered a settlement agreement with the  "United States Securities and Exchange Commission (SEC) fully resolving the SEC's investigation into possible violations of the Foreign Corrupt Practices Act (FCPA)."  
It has always been a surprise to me why Zadaxin is used in Replicor's clinical trials.
It might have been some outside hepatitis expert. It surely led to surprising success. There is a huge difference between a year on thymosin and a year on peg ifn in terms of side effects. If it were not for the fact that Pegasys is approved in Europe and the USA and projects hope for much easier marketability,  they would use thymosin as their main immunstimulatory component.
Avatar universal
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
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Avatar universal
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 ?
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Avatar universal
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.
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Avatar universal
So it's 15 weeks on peginf left and than 6 months of observation ?
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Avatar universal
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 ?
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