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WebMD Health News Reviewed by Laura J. Martin, MD
In early research, a combination of two experimental, oral, direct-acting antiviral drugs dramatically reduced levels of the virus in the blood of infected patients over two weeks of treatment.
And studies of other experimental drugs that also directly target HCV are under way.
For decades, injected interferon and oral ribavirin have been the only treatment options available, but only a small fraction of patients have access to the drugs. And many patients who start them soon stop due to side effects.
Today's standard HCV treatment -- combination pegylated interferon and ribavirin -- cures about half of patients with genotype 1 HCV. Genotype 1 is the most common HCV type in the U.S. and the hardest one to treat.
"We are on the eve of a new era in hepatitis C virus (HCV) treatment," HCV expert David L. Thomas, MD, of Johns Hopkins School of Medicine writes in an editorial appearing in the Oct. 15 issue of TheLancet.
He adds that in the foreseeable future, "nearly all those who are treated might be cured."
Avoiding Drug ResistanceResearchers say the newly published study represents a "proof of concept" that the combined oral direct-acting antiviral therapy similar to that now used to manage HIV can dramatically lower virus levels. But longer studies are needed to determine if the approach can cure patients by completely eradicating the virus.
Direct-acting antiviral drugs work by blocking viral replication. When the drugs are given as single agents, patients typically become resistant to them, often within as little as two to four weeks, study researcher Edward J. Gane, MD, tells WebMD.
"The point of this approach was to use a combination of direct-acting agents that have different mechanisms of action to avoid resistance," he says.
The study included 88 patients with chronic HCV infection living in New Zealand and Australia, treated for up to 13 days with various doses of a combination of the experimental antiviral drugs RG7128 and danoprevir or placebo.
All the patients had genotype 1 infections. Some had been treated unsuccessfully with interferon and others had never been treated before.
Over the course of treatment, HCV levels in the blood of some patients who took the experimental drugs dropped so low that they were undetectable.
Few treatment-related side effects were reported, even at higher doses. And none of the patients developed drug resistance.
New Treatments ComingPerhaps most significantly, patients who had been treated unsuccessfully with interferon responded almost as well as those who had never been treated.
"Right now we really have nothing to offer patients who have failed interferon," Gane says. "This would be a big step forward."
The researchers estimate that the total treatment time to eradicate HCV infection would be about 8 to 12 weeks -- about one-fourth the length of a standard course of interferon treatment.
They hope to confirm this in future studies and to determine if adding ribavirin to the treatment regimen improves outcomes.
Thomas says it remains to be seen whether this combination or another combination of direct antiviral drugs will prove most effective.
"But there will be interferon-free treatment of hepatitis C. It is just a matter of time," he tells WebMD. "This is the first study to be published that moves us in that direction, but it won't be the last."View Thread

This article:
http://www.webmd.com/hepatitis/news/20100526/hepatitis-c-drug-telaprevir-ups-cure-rate?src=RSS_PUBLIC
was in May 2010 ? Only 5 months ago ? No mention of anything "NEW" coming in November 2010? It says like everything else I have read that it was applying for FDA approval in the second half of 2010 ? There are only 2 months left in 2010 ? The "NEW" article that just came out Oct 25th.
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=522614
saying the new trials would begin in November 2010 ? November is 3 days AWAY ? & they have NO information about WHERE ? or HOW to apply & the maker Vertex just says to check the Gov.Trials website:
http://www.clinicaltrials.gov/
& there is NOTHING there about it. That is EXACTLY how HARD it has been for 9 years for me to find out ANYTHINGView Thread

Eight and a half years after my Liver Transplant and the Diabetes, Massive Deep Vein Thrombosis, Small Bowel Resection, Basal Cell Cancer Operations, and the Inguinal Hernia repair that followed. I celebrated my 56th birthday on Saturday July 24th, 2010 at the YMCA in Winnipeg, Canada.
Please follow the YouTube link below and watch my video titled "Thumbs Up for God". If you believe in Miracles, I believe the clip will strengthen your belief. And if you don't believe in Miracles, I believe you may change your mind after watching it. I hope it brings a little encouragement and inspiration to those who are currently facing some of life's tough challenges. Please feel free to pass the link along to someone you know that may be down in the dumps, and needs a boost.
http://www.youtube.com/watch?v=uU2n6tkVZbw
Read more: http://messaging.myspace.com/index.cfm?fuseaction=mail.readmessageV3&userID=91354177&type=Inbox&messageID=440055601#ixzz0vad1rg14View Thread

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Agenda: 1:00 - 1:05...: Welcome 1:05 - 1:15: Appropriations update 1:15 - 1:20: Legislation update 1:20 - 1:25: Q & A 1:25 - 1:35: August recess advocacy/Action Alert 1:35 - 1:45: Advocacy success stories 1:45 - 2:00: Questions, discussion, close Webinar Details: Title: Advocacy in AugustDate: August 5, 2010 Time: 10AM Pacific Time / 1PM Eastern Time Join this webinar:Join Link: https://caringambassadors.ilinc.com/join/jchwrbj Primary Dial-In: 1-800-201-2375 Alternate Dial-In: 1-469-759-7753 Passcode: 327238 Want to prepare your system ahead of time? https://caringambassadors.ilinc.com/register/jchwrbjView Thread

SUMMARY: The Food and Drug Administration (FDA) announced on June 25 that it has approved the first rapid test for hepatitis C virus (HCV), known as the OraQuick Hepatitis C Rapid Antibody Test. The test -- already available in Europe -- uses whole blood drawn from a vein, does not require laboratory processing, and returns results in about 20 minutes. A positive result should be followed up with a confirmatory test using traditional HCV testing methods, according to the FDA. OraSure Technologies expects to begin shipping the new test by early August. OraSure has also developed and is awaiting decisions on HCV tests that use a small amount of blood from a finger stick or oral fluid, as currently exist for HIV.

Below is an excerpt from a press release issued by OraSure describing the Hepatitis C Rapid Antibody Test and its approval. OraSure Technologies Receives FDA Approval for
OraQuick HCV Rapid Test, the First Rapid HCV Test
Approved for Sale in the U.S.
Bethlehem, Pa. -- June 25, 2010 -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States. "The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."
"We believe that the OraQuick HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Obtaining FDA approval of our OraQuick HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company."
OraQuick HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick technology platform, provides results in 20 minutes. The OraQuick HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.
In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention ("CDC"), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.
In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the Company has obtained approval.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the company, please go to www.orasure.com .
7/2/10
Sources
R Klein and K Struble (Food and Drug Administration). FDA Approves Rapid Test for Antibodies to Hepatitis C Virus. Press release. June 25, 2010.
OraSure Technologies. OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S. Press release. June 25, 2010.
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SUMMARY: The investigational hepatitis C virus (HCV) NS4B inhibitor clemizole demonstrated synergistic antiviral activity with the HCV protease inhibitors telaprevir and boceprevir -- meaning the combined effect was greater than the added effects of the 2 drugs used separately -- without increased toxicity, according to a laboratory study published in the July 1, 2010 Journal of Infectious Diseases .
The study also found that clemizole showed an additive, rather than synergistic, effect when combined with interferon, ribavirin, or the HCV polymerase inhibitors valopicitabine and HCV-796 (both discontinued).
The study authors, led by Jeffrey Glenn from Stanford University, founder of Eiger BioPharmaceuticals (the company developing clemizole), concluded that "Inclusion of clemizole in future anti-HCV cocktails can represent an attractive paradigm for increasing current virologic response rates."
Below is the text of a press release from Eiger BioPharmaceuticals providing more information about the study.
Eiger BioPharmaceuticals Announces New HCV Synergy Data
Publication describes high level of synergy of clemizole with protease inhibitor class
Palo Alto, Calif. -- July 1, 2010 -- Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today the publication of research from the lab of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, MD, PhD and colleagues entitled, "The Hepatitis C Virus (HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors.""This work demonstrates that clemizole can yield high-level synergy with the protease inhibitor class," said David Cory, President and CEO of Eiger. "Inclusion of clemizole in future anti-HCV cocktails represents an attractive paradigm for increasing virologic response rates and may minimize unwanted side effects and combat drug resistance to HCV protease inhibitors."
"Clemizole appears to be able to dramatically increase the in vitro efficacy of other agents such as the NS3 protease inhibitors in advanced clinical development," said Jeffrey Glenn, M.D., Ph.D., Founder of Eiger. "The addition of clemizole to regimens may allow protease inhibitors to be used at lower doses, thereby maintaining the desired antiviral efficacy while avoiding the toxicities associated with the protease inhibitors such as severe rash and anemia. Clemizole has the potential to be an ideal component of future anti-HCV cocktails."
About NS4B and Clemizole
Binding of the non-structural protein NS4B to the 3' terminus of the HCV negative RNA strand is a recently identified target for drug intervention. The requirement of this target for viral replication has been genetically validated. The two component nature of this target, involving interaction between NS4B and HCV-RNA, creates mutational constraints that should decrease resistance to pharmacologic inhibitors, compared to agents designed against a single component target such as the NS3 protease. Clemizole hydrochloride was identified as a specific inhibitor of NS4B-RNA binding. The anti-HCV activity of clemizole is currently being investigated across genotypes in multiple HCV clinical proof of concept trials as a cocktail component with standard of care medications.
About Eiger BioPharmaceuticals, Inc.
Eiger is focused on the discovery and development of new antiviral agents against novel targets for the treatment of hepatitis virus infections. Eiger's pipeline includes repurposed clinical stage therapeutic agents as well as preclinical NCEs from discovery that exhibit antiviral activity against Hepatitis C, Hepatitis D, and other viruses. Eiger investors include InterWest Partners (www.interwest.com) and Vivo Ventures (www.vivoventures.com).
For more information see www.eigerbio.com .
Investigator affiliations: Divisions of Infectious Diseases & Geographic Medicine and Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA; Veterans Administration Medical Center, Palo Alto, CA.
7/9/10
Reference
S Einav, HD Sobol, E Gehrig, and JS Glenn. The hepatitis C virus (HCV) NS4B RNA binding inhibitor clemizole is highly synergistic with HCV protease inhibitors. Journal of Infectious Diseases 202(1): 65-74 (Abstract ). July 1, 2010.
Other source
Eiger BioPharmaceuticals. Eiger BioPharmaceuticals Announces New HCV Synergy Data. Press release. July 1, 2010.
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