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Replicor Discloses Continued Improvement of the Antiviral Response ...
Replicor Discloses Continued Improvement of the Antiviral Response in Patients with HBV / HDV Co-Infection Receiving REP 2139-Ca Based Combination Therapy
November 16, 2015 08:00 AM Eastern Standard Time
NEW YORK--(BUSINESS WIRE)--Replicor Inc., a privately held biopharmaceutical company targeting a cure for patients with chronic hepatitis B virus (HBV) and chronic HBV and hepatitis delta virus (HDV) co-infection, disclosed updated interim safety and efficacy data from its ongoing REP 301 trial (NCT02233075) at the 2015 meeting of the American Association for the Study of Liver Disease (AASLD) being held from November 13-17 in San Francisco, USA. The REP 301 trial update was presented (Abstract 31) on Sunday November 15th in Parallel Session 4: Hepatitis B: Novel Treatments and Treatment Targets.
Previously reported HBsAg reductions with REP 2139-Ca monotherapy continued to improve during combination therapy with pegylated interferon alpha-2a, becoming > 6 logs in 4 patients (0.01 IU / ml), > 5 logs in 2 patients, > 3 logs in 2 patients and 0.5-2.78 logs in the remaining 4 patients. HDV RNA continued to decline in all patients and is now currently undetectable in ten patients (~5-8 log reduction from baseline). Importantly, the addition of pegylated interferon alpha-2a to therapy was associated with dramatic increases in free anti-HBs (to levels as high as 20,665 mIU / ml) and liver flares, but only in those patients who achieved serum HBsAg 4 log reduction from baseline) at the start of immunotherapy. These results continue to demonstrate the clinical potential of REP 2139-Ca in HBV / HDV co-infection and begin to shed light on the importance of achieving multilog reductions in serum HBsAg to improve the antiviral effect of immunotherapy.
A copy of the presentation made will be made available at http://replicor.com/science/conference-presentations/.
November 16, 2015 08:00 AM Eastern Standard Time
NEW YORK--(BUSINESS WIRE)--Replicor Inc., a privately held biopharmaceutical company targeting a cure for patients with chronic hepatitis B virus (HBV) and chronic HBV and hepatitis delta virus (HDV) co-infection, disclosed updated interim safety and efficacy data from its ongoing REP 301 trial (NCT02233075) at the 2015 meeting of the American Association for the Study of Liver Disease (AASLD) being held from November 13-17 in San Francisco, USA. The REP 301 trial update was presented (Abstract 31) on Sunday November 15th in Parallel Session 4: Hepatitis B: Novel Treatments and Treatment Targets.
Previously reported HBsAg reductions with REP 2139-Ca monotherapy continued to improve during combination therapy with pegylated interferon alpha-2a, becoming > 6 logs in 4 patients (0.01 IU / ml), > 5 logs in 2 patients, > 3 logs in 2 patients and 0.5-2.78 logs in the remaining 4 patients. HDV RNA continued to decline in all patients and is now currently undetectable in ten patients (~5-8 log reduction from baseline). Importantly, the addition of pegylated interferon alpha-2a to therapy was associated with dramatic increases in free anti-HBs (to levels as high as 20,665 mIU / ml) and liver flares, but only in those patients who achieved serum HBsAg 4 log reduction from baseline) at the start of immunotherapy. These results continue to demonstrate the clinical potential of REP 2139-Ca in HBV / HDV co-infection and begin to shed light on the importance of achieving multilog reductions in serum HBsAg to improve the antiviral effect of immunotherapy.
A copy of the presentation made will be made available at http://replicor.com/science/conference-presentations/.
updated slides available here:
http://replicor.com/wp-content/uploads/2015/11/Replicor-REP-301-AASLD-2015-Abstract-31.pdf
http://replicor.com/wp-content/uploads/2015/11/Replicor-REP-301-AASLD-2015-Abstract-31.pdf
Seems then they managed to cure some 40% of treated.
So when optimised and when only HBV success rate should probably be > 60%
So when optimised and when only HBV success rate should probably be > 60%
Thanks studyforhope.
Even I asked the doctor although her HBsAg is 0.01 iu/ml, why her test is negative. He said, the value is lesser than reference range i.e 0.05 iu/ml. Even I thought that after 3 years of exposure, if she is really infected HBsAg value should be more than 0.01 iu/ml(I am not sure if my thought is correct).Thats what my guess. Even Stephen also explained about the scenario in previous discussions. I will test her antibodies in next month end (After 3rd dose out of 4, Accelerated vaccination). I will keep you posted after her antibody test. Thanks for your time.
Even I asked the doctor although her HBsAg is 0.01 iu/ml, why her test is negative. He said, the value is lesser than reference range i.e 0.05 iu/ml. Even I thought that after 3 years of exposure, if she is really infected HBsAg value should be more than 0.01 iu/ml(I am not sure if my thought is correct).Thats what my guess. Even Stephen also explained about the scenario in previous discussions. I will test her antibodies in next month end (After 3rd dose out of 4, Accelerated vaccination). I will keep you posted after her antibody test. Thanks for your time.
I expect her to develop antibodies. There are many different tests for hbsag , so the meaning of her 0.01 might not be to be positive. It is hard to say without knowing the background and negative noise conditions for a particular test.
Hi studyforhope,
I am inactive HBV carrier. After 3 years of marriage I was dianosed with HBV.HBsAg is 4400 iu/ml. When my wife was tested for HBsAg it was 0.01 iu/ml(Cut off value is 0.05 iu/ml) and HBsAb is 0. WIth only these two tests doctors said she is not infected and recommended to take vaccinations as she has not taken before. She is taking vaccinations now. Do you think that she will not develop antibodies as she is already infected? Or she may develop antibodies? Please clarify. Thanks.
I am inactive HBV carrier. After 3 years of marriage I was dianosed with HBV.HBsAg is 4400 iu/ml. When my wife was tested for HBsAg it was 0.01 iu/ml(Cut off value is 0.05 iu/ml) and HBsAb is 0. WIth only these two tests doctors said she is not infected and recommended to take vaccinations as she has not taken before. She is taking vaccinations now. Do you think that she will not develop antibodies as she is already infected? Or she may develop antibodies? Please clarify. Thanks.
0.01 iu/ml is still infected. If antibodies are very high at the same time the patient is considered seroconverted and internal spread of hbv reinfection will be very very slow, likely supported by occasional t cell bursts that will reduce the growing clusters to small remnants again.
6 month of tenofovir, then TDF plus naps plus peg ifn or Zadaxin for one more year, then one year follow up.
Hi studyforhope,
In HBV test if HBsAgs is 0.01 iu/ml, we cannot say that he is not infected?
In HBV test if HBsAgs is 0.01 iu/ml, we cannot say that he is not infected?
Only 4 patients show the very high antibody response that makes them candidates for a sustained seroconversion after cessation of therapy.
But it needs to be undestood that this trial was obviously not designed for an optimal response outcome. The nap treatment phase and more so the overlap with ifn was much to short.
the trial starting now has a whole year of triple combo therapy planned, the hope is for a much better outcome at the end of follow up.
But it needs to be undestood that this trial was obviously not designed for an optimal response outcome. The nap treatment phase and more so the overlap with ifn was much to short.
the trial starting now has a whole year of triple combo therapy planned, the hope is for a much better outcome at the end of follow up.
1 Comments
nucs + naps + peginf ?
The patients with the high antibody responses, more than 1000 miu/ml, are certainly the best candidates for a permanent stable hbsag seroconversion after stopping therapy. But at least one year of follow up is required to ascertain this stability, as was seen in the second replicor trial.
The limit of 0.01miu/ml for the hbsag quantitation is already below the 0.05 of the hbsag Quant test limit. Sometimes the background signal in these tests can be quite high. Anything below the 0.01 would however be considered und for the hbsag.
all these patients are e neg. It is worrisome that the response of about 50% with the hbsag is below the magnitude needed for a true seroconversion. The e ag pos patients in trial 2 and 3 responded better.
The limit of 0.01miu/ml for the hbsag quantitation is already below the 0.05 of the hbsag Quant test limit. Sometimes the background signal in these tests can be quite high. Anything below the 0.01 would however be considered und for the hbsag.
all these patients are e neg. It is worrisome that the response of about 50% with the hbsag is below the magnitude needed for a true seroconversion. The e ag pos patients in trial 2 and 3 responded better.
1 Comments
You mean that 50% of the HBe- patients got response which may be sustained seroconversion ?
We hope so. Thanks for the post sorte.
Lets keep ouf fingers crossed
I certainly start see replicor coming to the market and i hope it will be in the near future.. It's the first treatment for hdv that has a great reaponse, this should boost it into the market sooner i hope. For hbv+hdv patients this could save their lifes, for the moment they can't treat the coinfection with anything .. Great news
studyforhope: do you think there is still a danger of relapse after finishing peg course in those patients with HBsAg 0,01 IU and that very high HBsAb ?
btw, what means HBsAg 0,01 IU/ml ? Is it the level of accuracy for the test so you can not say 100% sure its undetected ?
btw, what means HBsAg 0,01 IU/ml ? Is it the level of accuracy for the test so you can not say 100% sure its undetected ?
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