Navigation Links
AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration
Date:5/6/2013

. Leonard , M.D., senior vice president and chief scientific officer, AbbVie. "Our HCV program is one part of our advancing pipeline which is focused on delivering innovative therapies to address pressing areas of unmet clinical need."  

New results from Aviator were recently presented at the 2013 International Liver Congress® in Amsterdam. These results continued to demonstrate high SVR rates against GT1 HCV with the 12-week, triple-DAA regimen with ribavirin, across patient types. Specifically,

  • 99 percent of treatment-naive patients (n=79) achieved SVR12, 96 percent achieved SVR24 in an intent-to-treat analysis
  • 93 percent of prior null responders (n=45) achieved SVR12 and SVR24
  • A single relapse with this regimen occurred at post-treatment week two
  • Of the 247 patients treated for 12 and 24 weeks with triple DAA with ribavirin, four patients (1.6 percent) discontinued the study because of drug-related adverse events. Serious adverse events were noted in four patients (1.6 percent), with one (arthralgia) considered possibly drug-related. Other events reported in more than 10 percent of patients included headache, fatigue, nausea, insomnia, and diarrhea. Grade 3-4 laboratory abnormalities in total bilirubin (six patients) and ALT (one patient) were noted; all resolved with continued dosing.
  • AbbVie's all-oral, triple-DAA combination is currently being studied in Phase 3 clinical trials. The Phase 3 program includes 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 durations under investigation are 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
    '/>"/>

    SOURCE AbbVie
    Copyright©2012 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5

    Related medicine technology :

    1. Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
    2. Bayers Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
    3. Positive Preclinical Data for NKTR-214, an Investigational Cancer Immunotherapy Targeting the IL-2 Receptor Complex, Presented at AACR Annual Meeting 2013
    4. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
    5. Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
    6. Genocea Publishes Preclinical Data For Investigational Vaccine Candidate For HSV-2
    7. Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause
    8. Scioderms Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
    9. BHR Pharma Investigational Traumatic Brain Injury Treatment Receives European Medicines Agency Orphan Medicinal Product Designation
    10. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
    11. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:1/15/2014)... 2014  According to Millennium Research Group (MRG), the ... the United States and European ... expand moderately through 2022, with embolization particles representing ... interest in drug-eluting beads (DEBs) and radioembolization spheres ...
    (Date:1/15/2014)... Pharmaceuticals International, Inc. (NYSE: VRX and ... the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") with ... indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), for all ... Medical, Inc. (NASDAQ: SLTM ) ("Solta") at ...
    (Date:1/15/2014)... 2014  Zafgen, Inc., a leading biopharmaceutical company dedicated ... patients, today announced initial results from its Phase ... methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi ...  These results showed improvements in body weight, hunger-related ...
    Breaking Medicine Technology:US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4
    ... K-V Pharmaceutical Company (NYSE:  KVa/KVb) (the "Company") today announced that ... U.S. Healthcare II, L.L.C. (together the "Lenders") that grant Lenders ... Company,s Class A Common Stock, par value $.01 per share ... second warrant to Lenders that grants Lenders the right to ...
    ... /PRNewswire-Asia-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: ... diagnostic ("IVD") company, today announced its unaudited financial results ... ("2Q FY2010"). 2Q FY20 10 ... increased by 21.5% year-over-year to RMB201.8 million (US$30.2 million). ...
    Cached Medicine Technology:K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 2K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 3K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 4K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 5K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 6K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 7K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 8K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 9K-V Pharmaceutical Company Announces Reliance on Financial Distress Exception to NYSE's Shareholder Approval Policy 10China Medical Technologies Reports Second Fiscal Quarter Financial Results 2China Medical Technologies Reports Second Fiscal Quarter Financial Results 3China Medical Technologies Reports Second Fiscal Quarter Financial Results 4China Medical Technologies Reports Second Fiscal Quarter Financial Results 5China Medical Technologies Reports Second Fiscal Quarter Financial Results 6China Medical Technologies Reports Second Fiscal Quarter Financial Results 7China Medical Technologies Reports Second Fiscal Quarter Financial Results 8China Medical Technologies Reports Second Fiscal Quarter Financial Results 9China Medical Technologies Reports Second Fiscal Quarter Financial Results 10China Medical Technologies Reports Second Fiscal Quarter Financial Results 11China Medical Technologies Reports Second Fiscal Quarter Financial Results 12China Medical Technologies Reports Second Fiscal Quarter Financial Results 13China Medical Technologies Reports Second Fiscal Quarter Financial Results 14
    (Date:4/17/2014)... By discovering a new mechanism that allows blood ... at UC Irvine and the Salk Institute have opened ... prevent stroke-induced brain damage. , A complex and devastating ... and primary reason for disability in the U.S. The ... lets blood-borne material into the brain, causing the permanent ...
    (Date:4/17/2014)... Alliance, a nonprofit organization that focuses on conservation and ... examining the current state of knowledge of the deadly ... global surveillance strategies to combat the emergence of infectious ... West Africa that has claimed the lives of 122 ... According to the World Health Organization (WHO), the deadly ...
    (Date:4/17/2014)... Spending time online has the potential to ward off ... according to research published online in The ... Sciences . In the article " Internet Use ... States: A Longitudinal Analysis ," the authors report that ... by 33 percent among their study sample. , ...
    (Date:4/17/2014)... scientists and their partners have found that their proprietary ... transmission of multiple sexually transmitted infections (STIs) in both ... virus 2 (HSV-2), and human papillomavirus (HPV). The USAID-funded ... is effective against multiple strains of HIV, and has ... three viruses of at least eight hours prior to ...
    (Date:4/17/2014)... 17, 2014 Meaningful long-term survival is possible ... the abdomen when treated with cytoreductive surgery with ... first-of-its-size analysis by physicians at Wake Forest Baptist ... largest reported, single-center experience with cytoreductive surgery and ... and analysis of 20 years, worth of patient ...
    Breaking Medicine News(10 mins):Health News:Study IDs new cause of brain bleeding immediately after stroke 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 3Health News:Internet use may cut retirees' depression 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:20 years of data shows treatment technique improvement for advanced abdominal cancer 2
    ... homeless population among New Yorkers are more prone to go ... the population. // Detox centers will be established at some ... on the rise. Rapid HIV testing for women who are ... the Health Department. ,A large number of ...
    ... Copeman Healthcare of Canada has been warned of fines by ... insured health services. Copeman Healthcare intends to establish clinics in ... it will be charging a joining fee of $1,200, and ... ,The medicare law of the state says ...
    ... worst hit by AIDS. But now after bringing in changes in ... the initial sex // and using condoms have greatly reduced the ... ,It was found that among women in the age group of ... was witnessed among men in the age group of 17-29. ...
    ... model has been developed that can predict the occurrence of ... mild or severe can be told five months before it ... emergency measures to be done in advance. ,The ... officials these days. ,The problem is greatest ...
    ... by a House of Lords committee has revealed that 90 ... tested on them. Dangerous drugs like morphine, // thyrozine, the ... the treatment of children even though there was no valid ... ,The report also alleges that some high-risk medications like asthma ...
    ... recruit 50,000 people as a part of a large study called ... between lifestyle and genetics as regards the health of an individual. ... and is one of the largest healthcare projects in the UK. ... of information so that it would be easy to assess who ...
    Cached Medicine News:Health News:Prediction of malaria epidemics possible! 2
    ... Volk's super series ... lenses. Variable retinal ... unprecedented fundus diagnostic ... maximum potential field ...
    Volk indirect lenses. Wide field retinal diagnosis & treatment....
    Volk indirect lenses. High magnification views of the posterior pole....
    ... This contact class is particularly ... lamps which have a smaller ... the reduction prism than the ... fundus / iridocornea. Mirror angle ...
    Medicine Products: