Newest Repac Abstract

[Aduiski]

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.

[studyforhope]

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.

[stef2011]

i dont know fast track. is it requiring little money and small trials for approval?

[sorte]

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.

[stef2011]

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

[needadvicewithhep]

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.

[StephenCastlecrag]

One or all of us can draft a petition. I will support any effort and will do my best to channel information to and seek support from the Chinese Hepatitis B forum. It will not be easy but not impossible.

[sorte]

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.

[Aduiski]

good point

[mer971]

I think that this petition should start from one of us, people who are doctors or have the knowledge of virus as steff or stephan, they know how to write and explain in medical language.
We all will support it