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Trial Enrollment Begins for Abbott’s Hep C Trio

November 16, 2012

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Following a mid-stage study showing extremely high cure rates, the Phase III trial for Abbott’s direct acting antiviral drugs are now recruiting participants with Hepatitis C genotype 1.

Abbott Announces Phase 3 Hepatitis C Program Details

– Interferon-free Hepatitis C Regimens will be Studied in Broad Patient Populations across Multiple Countries

ABBOTT PARK, Illinois, Nov. 13, 2012 /PRNewswire/ — Abbott today released details on its phase 3 hepatitis C registrational program following promising results from its phase 2b clinical trial, known as Aviator, presented at the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. The phase 3 clinical trials are designed to evaluate safety and efficacy of a 12-week regimen of three direct acting antivirals (DAA), with and without ribavirin, for the treatment of HCV in genotype 1 (GT1) non-cirrhotic, treatment-na├»ve and treatment-experienced patients. An additional phase 3 trial will study triple-DAAs, with ribavirin, in patients with cirrhosis for 12 or 24 weeks.

The phase 3 program, which is currently open for enrollment, will include more than 2,000 patients with HCV genotype 1, with trial sites in 29 countries. The DAAs in the studies include ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor). Treatment duration will be 12 weeks in non-cirrhotic patients, and 12 or 24 weeks in cirrhotic patients. All patients will be followed for 48 weeks post-treatment. Co-formulated tablets of ABT-450/r and ABT-267 will be used in the phase 3 trials.

More information on the trials is available at www.clinicaltrials.gov [http://www.clinicaltrials.gov/].

Physicians and patients interested in participating in Abbott’s HCV Clinical Trials should visit www.discoverhepc.com/.

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HepatitisCentral.com provides information regarding hepatitis and liver disease. Comments are available to the community in order to discuss these topics and obtain answers to questions through community members. The Editors at HepatitisCentral.com will not be responding to questions or comments posed in article comments.

  • Debbie

    I live in Alabama, I am a relapser, I have genotype 1, would I be able to be in a clinical trial???

  • rav

    iam suffering from Geno typr-6, how far it treated, every one is telling about Geno type-1 only

  • Mohammad Mohsin

    I have genotype HCV infection. I am non responder to typical treatment of pegasys and Ribazole. Is there any drug for genotype 4 infectees

  • any trials in Delaware?

  • Rich

    I have advanced HCV Gen 1 and have undergone several treatments since being diagnosed in 1998 but was unresponsive. I am interested in becoming a trail member for this treatment and live in Worcester, MA.

  • andra hinkley

    I live in Kansas and have never been treated because I don’t have health insurance. Would love to participate.

  • habzz

    I live in Canada so is there any chance for getting in a trial? I am not aware of any site devoted to just Canadian Hep c patients. I have had it for about thirty years and at this point have not taken any medication for it other then some different types of herbs that I have been taking for years to try and control it. Am I have been told I have hep c genotype 1a and have enzime levels over four time the reference range. Thx Terry

  • Duane

    Am interested in being part of trial But!!! What would be the cost? Have C genotype 1. Duane in Phoenix, AZ

  • I am very interested in being part of the Abbott Hep C trials. I am in Seattle and have genotype 1. Have done the interferon/ribavirin once. Not successfully, Alice in Seattle, WA

  • kaizer durrani

    I am suffering from HEP-C for over 5 yrs and I would like to enroll for this treatment , I live in ABBOTTABAD , PAKISTAN . I would be very greatful if ABBOTT CO , puts my name on the list for trial treatment , can anyone guide me to abbot ?

  • KAIZER DURRANI

    I have hep-c for the last over 5yrs , I would be greatful if my name is incl in the list of trials in the world wide patients by ABBOTT, I live in ABBOTTABAD , PAKISTAN , it is third world country ,but it is highly educated , it has three medical collages , the litracy rate is is 88%. Pl help me , who ever is on the other end ,THANK YOU.

  • Ray Arguelles

    Ray Arguelles

    I have Hep C, Geno Type 1 and have participated in 2 different trails and was deemed a non-responder. The first trial I went through was Peg-Interferon with Ribavarin and I don’t recall what the medicine was on the second one. I am highly interested in this new study drug. I live in Cincinnati, OH and may be contacted at 513-829-072.
    Sincerely,
    Ray Arguelles

  • kiwi

    hi i have 1a have had interferon with ribavarin and failed would like to learn more about these trails i live in new zealand cheers

  • Macaque3

    Will the Abbott trials include ppl with concurrent HIV infection ? This is very exciting sounding but I wonder how diverse a population will be included…

  • SHOOT

    hi, just got my result this afternoon, anti HCV 251.40, C.O.V. 1.00 REACTIVE. WHAT DOES IT MEAN? I AM SO AFFRAID, PLS REPLY

  • Genotype 3a

    Would be great if other genotypes could be included in the trials. It is incorrectly assumed that, if genotype 1 is successfully treated the other genotypes will be too.