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.
All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. In 8 out of 9 patients who have achieved this therapeutic vaccine-like response, they continue to control their viral infection 12 – 24 weeks after all treatment is stopped.
I dont understand what else they have to prove.FDA has to grant accelerated approval to this drug and not pushing people on lifetime drugs. At least give this on compassinate basis to people who suffer the most, liver cancer patients, cirrhosis patients who do not have other alternatives. But once again big pharma wins and we can do nothing to change that. What a pity...
is there a poster about this?
i am not confortable with some words used because a little generic.this treatment is wonderful but we need to understand how our immune system control cccdna in the liver cells fter hbsag is negative and hbsab is high, this is important because a relapse at this stage can be connected with an hbsag mutation
so to sum up:
rep9ac in combo with peg and zadaxin:
12weeks combo all develop hbsab, hbsag und and what about hbvdna values?
8 control infection even after all therapies are stopped, does this mean hbvdna und?
what i am unsure of is:
hbsg is cleared by blocking the release of the particles and hbsab becomes detactable but what about cccdna in the liver cells?
was that cleared by peg?was that cleared by our immune system when hbsag und?or it is all there in balance with hbsab......
time will tell if hbvdna by high sensibility pcr is less than 10iu/ml after 48weeks i think the infection should be well controlled and definitely over or maybe a biopsy to check cccdna in the patients so we know 100% the infection was cleared
in any case this is the fastest drug we have to clear hbsag and a long period with tdf would be able to ensure there are no relapses whatsoever after we clear hbsag and develop hbsab
will this ever get to clinically available for more patients?
Replicor website states "Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment."
My understanding is that increase in anti HBV antibodies or immune function 24 months after treatment is enough to proof that the treatment is working.
in this case hbvdna is important to understand if cccdna inside liver cells is still active.
the difference with the other treatments is cccdna is slowly decreased so that hbsag decreeases, with replicor it is different hbsag decreases because secretion is blocked but we dont know about cccdna so remaining hbvdna at very low titers might reflect cccdna is still there
in any case making hbsag und in the blood activates our immune system so even if we have cccdna in the liver cells the immune system should be able to take care of that.
i guess studyforhope is the only one here with enough knowledge to know what happens
i m not saying that its bogus data. i am only suggesting why don't they publish in good journals to get scince community attention and publish it in media to get public, government, investors attention.
The recommend-ed dose of ZADAXIN (thymalfasin) for chronic hepatitis B when used as a monotherapy or in combination with interferon (at the labeled dose and schedule for interferon) is 1.6 mg (900 µg/m2) administered subcutaneously twice a week for 6 to 12 months. Patients weighing less than 40 kg should receive a ZADAXIN (thymalfasin) dose of 40 µg/kg.
replicor replicor and replicor , it is the the solution those people are putting in their locker for god sake who can contact them or the people who were in trial ,please contact them and try to find out some thing usrful for us people.we need this at any cost this community has to pay. USA people please wake up u r the hope of world.
thats very good idea MHMD. why not we start a new our own website ,funding can be come from inside us mebers. then further members can register for free. this will help a lot to put our voice and making people aware. So members who are from software or have knowledge of web hosting should take initiative without having a doubt in mind, we all are with you. at least we shoud try as collective power, instead of individual. we can force those greedy pharma to follow their responsibility towards society.
Well lets have one thread opened here on this board. We all sign it. Give links to it on others forums in your country so they come here and sign it. And lets appeal to these drug companies. I am telling you guys this for a long time.
I think the fastest way to select some candidates from this forum or any other advocates .. to visit and try to convince some wise open-minded .. kind .. millionaire .. billionaire.. to help Replicor staff in completing their trials ..
Mohammad bin Rashid ... Dubai Ruler
Tamim bin Hamad .. Qatar Emir ..
Bill Gates .. Microsoft founder
Any other wise and helpful human ..
Replicor is still working on it. I don't know why they don't move forward to the FDA approval process. Seems current clinic trail is informal. A formal clinic trail monitored by FDA is required to get approval. The data published by Replicor seem so promising, does anybody know what stop them move forward to a FDA process? Money? Safety?
let us have a look on hep c progress, they have found an interferon free regiem, a lot is going on and whats new in hep b, entacevir and tenofovir aah. nothing from 6 years, our researchers are sleeping with their profits and grants from nucs companies. may be they will ate dollers in place of food.
Faldaprevir and Deleobuvir Cure 95% of Hep C Genotype 1b
Boehringer Ingelheim’s investigational hepatitis C virus (HCV) therapies faldaprevir and deleobuvir (BI 207127), plus ribavirin, cured 95 percent of the participants with genotype 1b of the virus in a Phase IIb study. However, the therapies cured only 17 percent of those study participants who had genotype 1a of hep C. Called the SOUND-C3 study, it was presented at the Asian Pacific Association for the Study of the Liver (APASL) Liver Week in Singapore. Included in the study were 20 genotype 1b participants and 12 genotype 1a participants who took the combination therapy for 16 weeks. Four of those with 1b had cirrhosis of the liver.
Nineteen out of 20 (95 percent) of those with genotype 1b achieved a sustained virologic response (SVR) 12 weeks after completing therapy, which is considered a cure. All of those with cirrhosis were cured. Just two out of 12 (17 percent) of the genotype 1b participants achieved an SVR.
“These promising results indicate the potential of our interferon-free combination treatment to address an unmet medical need, and confirm our decision to focus on [genotype] 1b patients in our pivotal Phase III interferon-free HCVerso trials,” said Klaus Dugi, MD, PhD, senior vice president of medicine at Boehringer Ingelheim.
Three participants (9 percent) in the trial discontinued treatment as a result of adverse effects. Mild rash and nausea were the most common side effects. Among the most-common moderate- or higher-intensity side effects were anemia (16 percent), fatigue (9 percent), vomiting (9 percent) and nausea (9 percent).
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