Navigation Links
Positive Phase 2 Results Reported with Boehringer Ingelheim's Investigational HCV Protease Inhibitor in Both Previously Treated and Untreated Patients
Date:4/1/2011

ive genotype-1 (GT-1) HCV patients were randomized (1:1:2:2) to receive either:

  • Placebo plus PegIFN/RBV;
  • BI 201335 120mg once-daily (QD) with a three-day LI of PegIFN/RBV;
  • BI 201335 240mg QD with a three-day LI of PegIFN/RBV; or
  • BI 201335 240mg QD plus PegIFN/RBV without LI

  • Patients were given BI 201335 for 24 weeks in combination with PegIFN/RBV, which was given for 24 or 48 weeks. Patients in the two BI 201335 240mg QD groups who achieved extended rapid virological response (eRVR, defined as plasma viral load less than 25 IU/ml at Week four and undetectable at Weeks 8-20), were re-randomized to discontinue PegIFN/RBV at Week 24 or continue PegIFN/RBV to Week 48.Treatment Outcomes in SILEN-C1 (Treatment-Naive Patients)Placebo
    (N=71)120mg
    QD/LI
    (N=69)240mg
    QD/LI
    (N=142)240mg
    QD
    (N=142)eRVR, %

    16

    80

    78

    87SVR, %

    56

    71

    73

    83Breakthrough*, %

    3

    6

    4

    3Relapse**, %

    14

    7

    11

    8*Rebound on treatment with BI 201335

    **Rebound after the end of all treatment Overall SVR rates reached 83 percent in the 240mg QD group (plus current SOC). A three-day lead in with SOC prior to initiation of BI 201335 was seen to reduce responses by 12 percent and 10 percent in 120mg QD/LI and 240mg QD/LI patient groups.  The LI was also associated with higher rates of viral breakthrough.  Of the patients in the 240mg QD dose group who achieved extended rapid viral response (eRVR, defined as plasma viral load less than 25 IU/ml at Week four and Weeks 8-20) and were re-randomized at Week 24, 93 percent achieved SVR with 24 weeks of SOC (PegIFN/RBV) treatment.  

    The most frequent dose-dependent adverse events (AEs) in BI 201335 treatment groups were gastrointestinal disorders, rash or photosensitivity, and jaundice resulting from isolated unconju
    '/>"/>

    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    Related medicine technology :

    1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
    2. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
    3. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
    4. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
    5. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
    6. NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia
    7. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
    8. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
    9. Kosans Second-Generation Hsp90 Inhibitor, Alvespimycin, Shows 42% Clinical Benefit in Phase 1 HER2-Positive Metastatic Breast Cancer Trial
    10. Pharmacopeia Announces Positive Results from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
    11. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:12/19/2014)... DUBLIN , Dec. 18, 2014 Research ... announced the addition of the "Micro Market ... report to their offering. ... dermatological treatment is progressing steadily, which has resulted ... diagnostic devices market. The main purpose of these ...
    (Date:12/19/2014)... Dec. 18, 2014  RESMED INC. (NYSE: RMD ... of fiscal year 2015 results on Thursday, January 22, 2015, ... release with ResMed,s results will be issued after 1:00 p.m. ... to discuss operating results and future outlook. The ... Pacific Time and the live webcast of the call can ...
    (Date:12/19/2014)... , Dec. 19, 2014  Eli Lilly and ... Paris: FR0011184241 – ADOC) today announced a worldwide licensing ... BioChaperone Lispro, for treatment in people with type 1 ... proprietary BioChaperone® technology and is currently in Phase Ib ... Lispro with the goal of optimizing glucose levels during ...
    Breaking Medicine Technology:Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3ResMed To Announce Second Quarter 2015 Results 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3
    ... ALR ), a global leader in enabling individuals to ... rapid diagnostics and health management, has declared a dividend of $3.00 ... ALR PR B).  The dividend will be paid ... equal to the quotient of (a) $3.00 divided by (b) 97% ...
    ... CVS Caremark Corporation (NYSE: CVS ) today ... will be making a presentation to investors at the ... 25, 2011. Mr. Merlo is scheduled to present at ... An audio webcast of the presentation will be broadcast ...
    Cached Medicine Technology:
    (Date:12/19/2014)... Wisconsin (PRWEB) December 19, 2014 After ... music performer is again returning to the stage to ... her husband for concert performances, and the successful tour ... was originally announced. , Visit Ticketability.com ... the newly-announced Detroit shows at fair prices. , Music ...
    (Date:12/19/2014)... -- A new study suggests a possible link between ... and night sweats -- and higher rates of hip ... during menopause, affecting about 60 percent of women. The ... since they then face a higher risk of weakened ... exhibit moderate or severe menopausal symptoms are more likely ...
    (Date:12/19/2014)... (HealthDay News) -- Prostaglandin analogue eye drops -- a ... risk of vision loss in patients with the eye ... by David Garway-Heath, of the Moorfields Eye Hospital and ... more than 500 people newly diagnosed with open-angle glaucoma ... one of the leading causes of blindness. About ...
    (Date:12/17/2014)... This prestigious award is given ... made outstanding and innovative contributions to the physical ... private practice physical therapy by the Private Practice ... On behalf of Performance Physical Therapy, Michelle Collie ... Performance accepted the award at the Private Practice, ...
    (Date:12/17/2014)... Crest Hill, IL (PRWEB) December 17, 2014 ... of 2015 Awards celebrate the best of the best ... States. The award is only given to communities and ... families through the SeniorAdvisor.com site. Of the nearly 100,000 ... with this award. Winners of the SeniorAdvisor.com Best of ...
    Breaking Medicine News(10 mins):Health News:Garth Brooks Tickets for Joe Louis Arena: Ticketability.com Becomes a Popular Destination for Discount Tickets for Garth Brooks’ Detroit Concerts Set for February 27-28 2Health News:Severe Hot Flashes During Menopause May Raise Hip Fracture Risk Later: Study 2Health News:Study Supports Benefit of Widely Used Glaucoma Drug 2Health News:Performance Physical Therapy Awarded with Jayne L. Snyder Private Practice of the Year 2014 2Health News:The Inn at Willow Falls - Crest Hill, IL Wins 2015 Best of Assisted Living Award from SeniorAdvisor.com 2Health News:The Inn at Willow Falls - Crest Hill, IL Wins 2015 Best of Assisted Living Award from SeniorAdvisor.com 3
    ... a verdict of $10.2 million in a medical malpractice ... the death of his patient. With interest, the ... was achieved by New Jersey medical malpractice lawyer David ... trial lawyers in the areas of professional malpractice, wrongful ...
    ... Diego Skin Doctor Supports Well-Being of Those with Multiple Sclerosis , ... San Diego, CA ... lot of ways. His passion is to treat your skin with love, but ... the creams and gels, and into the hearts of the community. Dr. Gram ...
    ... and Washington DC (March 9th, 2009) Ecstasy may ... their memories more effectively by encouraging a feeling of ... of Psychopharmacology published today by SAGE. , Studies ... exposure therapy where the patient repeatedly recalls the ...
    ... Selects Desktop and Production Messaging Solutions for Significant Savings, ... ... Norcross, GA (PRWEB) March 8, ... (NasdaqCM: ESIC)(easylink.com), a global provider of comprehensive messaging services, ...
    ... to kick-start efforts to unlock therapeutic potential , , SATURDAY, ... will lift the eight-year ban on embryonic stem cell ... A White House ceremony is scheduled for late morning, ... the federal funding limits imposed by his predecessor, President ...
    ... ARBOR, Mich.---Revered in India as "holy powder," the marigold-colored ... to treat wounds, infections and other health problems. In ... main ingredient, curcumin, has burgeoned, as its astonishing array ... been revealed. , Yet little has been known ...
    Cached Medicine News:Health News:$12 Million New Jersey Medical Malpractice Verdict for Wrongful Death of a 21-Year-Old Man After Having Wisdom Teeth Removed 2Health News:SKIN1 by Dr. Gram Cares About Skin and Community 2Health News:Ecstasy could help patients with post-traumatic stress disorder 2Health News:Ecstasy could help patients with post-traumatic stress disorder 3Health News:Email Fax Provider, EasyLink Services, Announces Prominent Bio-Pharma Signing 2Health News:Email Fax Provider, EasyLink Services, Announces Prominent Bio-Pharma Signing 3Health News:Obama to End Stem Cell Ban Monday 2Health News:Obama to End Stem Cell Ban Monday 3Health News:'Holy powder' ingredient makes membranes behave for better health 2
    ... is one of the world's ... with a 7 F introducer, ... is designed to lower the ... allow introduction in smaller, more ...
    Tendril DX active-fixation leads allows for lower thresholds initially and during the lead maturation phase....
    ... Guidant Flextend lead is ... lead with an extendable/retractable ... helix design offers various ... permanent implantation in the ...
    ... is a low profile implantable bipolar ... stimulation of either the atrium or ... supplied with a screwdriver shape stylet ... lead. The ring tip and fixation ...
    Medicine Products: