Anybody know the future of REP 9AC on HBV treatment result recently?

[Skyclimber]

Heard that REP 9AC is a new drug for HBV and it can remove HBsAG at a high ratio. Pls check whether there is new information.

[veteranB]

Dont think of it as a market. Because they think of it as a market we still dont have cure.

Healthcare for profit is criminal. A reflection of an amoral society we all live in.

[newtr]

is it really true and coming to hit the market?when any guess.

[calebz]

this is great news that there are no side effects

[veteranB]

that is what I am telling you guys all the time here..

We need to stop talking about NUCs, and ask for this therapy..

I am mean why nobody from Replicor comes here? We wrote them many times! This medicine works with interferon so why not use it..

Everybody write them here http://www.replicor.com/debut_anglais2.htm and demand answers. We need this drug now..

[joc2011]

Exciting news!!!! we need to demand to have this drug now at any cost

[jonny168]

cool development. this thread is a bit long now, perhaps the news needs a new one.  

[djxpress]

exciting news!!!

[The_PS]

Title Short Term Immunotherapy Following REP 9AC'-Induced HBsAg Seroclearance, Induces Durable Immunological Control of Chronic HBV Infection

Speaker: Andrew A. Vaillant

Author: Mamun Al- Mahtab1, Michel Bazinet2, Andrew Vaillant2
Affiliation: 1Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, 2REPLICor Inc., Montreal, QC, Canada

Session: Oral Session: Late Breakers

Date: Saturday - June 08, 2013 16:50-17:00

Location: Hall 9

Background: REP 9AC' is a nucleic acid-based polymer (NAP) that clears serum HBsAg by blocking HBV subviral particle formation and release. The effect of add-on immunotherapy after HBsAg clearance in chronically infected patients receiving REP 9AC' was examined.

Methods: Add-on immunotherapy to existing REP 9AC' therapy was initiated in patients who had cleared their serum HBsAg but with persistent serum HBV DNA. Immmunotherapy consisted of thymosin a1 (Zadaxin™) or pegylated interferon a-2a (Pegasys™). Virologic responses were monitored by measuring serum HBV DNA (Roche Cobas™), serum HBsAg and serum anti-HBs (Abbott Architect™).

Results: REP 9AC'-induced HBsAg seroclearance is accompanied by the appearance of anti-HBs and reductions in serum HBV DNA. However, the continued production of anti-HBs in most patients never exceeded 50 mIU/ml and serum HBV DNA levels in most patients persisted in the range of 1000-3000 cpm. Addition of either Zadaxin™ or Pegasys™ to REP 9AC' therapy resulted in dramatic increases in anti-HBs titers with as little as 5 weeks of immunotherapy to levels comparable to or greater than titers observed in healthy patients with a strong vaccine response. Combination treatment was halted in 8 patients after 12-27 weeks of immunotherapy. In these patients, anti-HBs levels are persistently between 400 and 1000 mIU (5 of 8 patients) 12-24 weeks off treatment. HBV DNA levels are also persistently below 116 CPM (Cobas™ LLOQ) in 6 of 8 patients and > 250 CPM in the other two patients.
Conclusions: REP 9AC'-induced HBsAg seroclearance appears to potentiate the immunostimulatory effects of either Zadaxin™ or Pegasys ™ in all patients. Short term exposure to immunotherapy in the absence of HBsAg may induce permanent immunological control of HBV infection in most patients.

[The_PS]

REPLICor presents clinical efficacy and toxicology results in patients with chronic hepatitis B with short term exposure to immunotherapy after REP 9AC’ induced clearance of serum HBsAg.

14 May 2013, Boston, U.S.A.

Montreal, Quebec – Tuesday , May 14th, 2013 – REPLICor has previously undertaken a proof of concept trial to examine the efficacy of REP 9AC monotherapy in patients with chronic HBV infection.  A second proof of concept trial is currently underway in patients with chronic hepatitis B (HBV) undergoing treatment with REP 9AC’ in combination with Zadaxin™ or Pegasys™.

Efficacy and toxicology results in REPLICor’s proof of concept trials from monotherapy exposure to REP 9AC or REP 9AC’ were disclosed on Tuesday May 14th, 2013 at the 15th annual TIDES meeting held in Boston, U.S.A.

Both REP 9AC and REP 9AC’ were shown to rapidly and effectively remove HBsAg from the blood of patients with HBV infection.  While REP 9AC monotherapy led to the establishment of control of infection off treatment in 2/7 patients, the addition of immunotherapy (either Pegasys™ or Zadaxin™) after REP 9AC’ mediated HBsAg clearance led to profound increases in immune function in all patients and in 8 out of 9 patients, control their viral infection has been maintained for 12 – 24 weeks after all treatment is stopped.

Toxicology results from weekly monotherapy exposure to REP 9AC or REP 9AC’ in many cases > 1 year resulted in no observable drug related effects on liver and kidney function or in lipid or hematological function.  Major reported symptoms were shown to be related to the development of mineral deficiency likely due to the mineral chelation properties of these compounds and were controlled or prevented with proper mineral supplementation during treatment.

These results show the well tolerated nature of long term treatment with the nucleic acid polymer compounds REP 9AC and REP 9AC’ and further show the promise of achieving well tolerated control of HBV infection with combination treatments using these agents.

For the 15th annual TIDES meeting:

[veteranB]

They need to give these drugs to us now! We have to ask for it.

[StephenCastlecrag]

Thanks for the AASLD links - I remember the itinerary way to see the program. I have a quick look, very exciting program, REP9Ac, Myrcludex, GS-9620, PegINTF + ETV/TDF are all there.

ISVLD proceedings are supposed to be published in Journal of Viral Hepatitis.

[4est]

I was not keep an eye on ISVLD. do you have any link to this ?

[4est]

http://aasld2012.abstractcentral.com/s1agxt/com.scholarone.s1agxt.s1agxt/S1A.html?&CONFIG_ID=2518&USER_ID=1593989&ROLE_ID=16365&ROLE_TYPE_ID=17&PERSON2ROLE_ID=17804403&WORKFLOW_ID=17&CURRENT_PAGE=BROWSE_THE_PROGRAM&ALLOW_EDIT_INSTRUCTIONS_FL=N&SESSION_ADMIN_PERMISSION_FL=N&REVIEWER_ADMIN_PERMISSION_FL=N&DIRECT_LOGIN_FL=Y&HASH_KEY=yrqbzS8yzVEezNSZD0XqU9xbfCw&STUB_ROLE_ID=0&TIME=1346080075691&SOURCE_URL=http://aasld2012.abstractcentral.com


or go to http://www.aasld.org/lm2012/2012/attendees/Pages/ItineraryPlanner.aspx and click on Itinerary Planner and you ca see the program (maybe not the final one but the latest one)

[StephenCastlecrag]

Is the program for AASLD 2012 out? Can you provide a link?

I am still waiting for the proceedings of ISVLD held two months ago to be published.

[4est]

indirect update:

"  REP 9AC’: A second generation HBsAg release inhibitor with improved tolerability. " - this is the title for a presentation that will came in AASLD in November (no other info available at this moment)

[stef2011]

well if he is a good doctor he must be aware already, it was presented in 2010 conference in berlin and 2011 in san francisco from two different hospitals

here is the thread about it, just look at the hbsag of those who didn t clear yet in 48weeks, it is so low that clearance is certain just  matter of time

http://www.medhelp.org/posts/Hepatitis-B/Add--on-of-peg-interferon-to-a-stable-nucleoside--hbsag-loss-40/show/1616137

[MHMD]

Hi stef,

Thank you for your help, I have one last question

Is the way of treatment you have mention above published or announced? if yes please give me the link for the study or the clinical trail so that I can give it to my doctor in order to convince..

  Thanks again and again..

[stef2011]

yes but it is sequential because you need to rescue some immune response towards the virus, so 1-3 years of tdf mono and then interferon add on

not 48weeks, it is 96weeks and more until hbsag gets und


what do you mean by vit d25oh>60ng/ml?
to have your vitamin d serum checked and it has to be higher than 60ng/ml, dont test in other units than ng/ml because confusing and poor sensibility machines are used.vitamin d test is called vitd25oh

[MHMD]

- Do you mean that I use tenofovir for maximum 2 years, and if I can not clear the virues then I go to compo?

- what do you mean by vit d25oh>60ng/ml?

-  is this protocol same as in the following clinical traile

  ( http://www.clinicaltrials.gov/ct2/show/NCT00973219?term=hepatitis+b&recr=Open&rank=1http://www.clinicaltrials.gov/ct2/show/NCT00973219?term=hepatitis+b&recr=Open&rank=1 )..

thanks a lot...

[stef2011]

we dont know how many years rep9 ac will take to be available so it is definitely better to start sequential treatment by tenofovir and then interferon add on, do not start combo imeediately go for sequential

tenofovir 1-2 years
interferon+tenofovir 2years
if available add alinia too

make also sure to have vit d25oh>60ng/ml

[MHMD]

Hi,

  what is your suggestion do i proceed for the new protocol Comp(Inteferon+tenover)... or wait for this new medicine(REP9AC')?? .

please notice that I am HBe  negative..

  Thanks a lot....

[MHMD]

Hi,

  what is your suggestion do i proceed for the new protocol Comp(Inteferon+tenover)... or wait for this new medicine(REP9AC')??

[StephenCastlecrag]

Off treatment, three of these four patients are currently experiencing a
sustained immunological control of their infection (HBV DNA less than 500 cpm, and HBsAg  less than 10 IU/mL) for 24, 12 and 12 months respectively. The other four patients are experiencing partial immunological control of their infection with sustained greater than 90% reductions in serum HBsAg and 3-7 log reductions in HBV DNA.

[StephenCastlecrag]

One more time:

Off treatment, three of these four patients are currently experiencing a sustained immunological
control of their infection
(HBV DNA < 500cpm, and HBsAg  90% reductions in serum HBsAg and 3-7 log reductions in HBV DNA