Navigation Links
Simeprevir Administered Once Daily as Part of Combination Therapy Demonstrates Sustained Virologic Response in Treatment-Naive and Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:11/2/2013

60;
In the pivotal Phase 3 PROMISE study, 79 percent of treatment-experienced hepatitis C patients treated with simeprevir in combination with pegylated interferon and ribavirin who previously experienced a relapse after prior treatment with pegylated interferon-based therapy achieved the primary endpoint of SVR12 compared to 37 percent of patients treated with placebo plus pegylated interferon and ribavirin. In this sub-analysis, 65 percent of patients with the IL28B TT genotype, 74 percent of patients with a METAVIR score of F4 and 70 percent of patients with genotype 1a HCV treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 19 percent, 26 percent and 28 percent of patients taking placebo plus pegylated interferon and ribavirin, respectively. Among patients with the genotype 1a Q80K polymorphism at baseline, 47 percent of patients treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 30 percent of patients treated with placebo in combination with pegylated interferon and ribavirin.

The most common adverse events in patients treated with simeprevir combined with pegylated interferon and ribavirin in the first 12 weeks were fatigue, headache and influenza-like illness. Three percent and 18 percent of patients treated with simeprevir combined with pegylated interferon and ribavirin experienced on-treatment failure and relapse, respectively, compared to 27 percent and 34 percent of patients taking placebo plus pegylated interferon and ribavirin, respectively.

"We are very proud of the depth and breadth of our clinical trial program," said Gaston Picchio, Disease Area Leader Hepatitis, Janssen Research & Development. "Following last week's positive vote from the FDA's Antiviral Drugs Advisory Committee to recommend approval of simeprevir, we look forward to making simeprevir available to patients living with chronic
'/>"/>

SOURCE Janssen R&D Ireland
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Simeprevir Data in Hepatitis C Patients to be Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
2. Primary Efficacy and Safety Findings from Phase 3 Study of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
3. U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
4. Janssen and Johnson & Johnson to Provide Webcast Presentation of Simeprevir Phase 3 Clinical Data Presented at The International Liver Congress of the European Association for the Study of the Liver (EASL)
5. Findings from Two Phase 3 Studies of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
6. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
7. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
8. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
9. MCOs Shifting Control Over Office-Administered Products from Medical to Pharmacy Benefit, Particularly Affecting Rheumatoid Arthritis Therapies
10. American Journal of Medicine Publishes Hypertension Study Comparing the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone versus Azilsartan Medoxomil Co-administered with Hydrochlorothiazide
11. Daiichi Sankyos Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... PHILADELPHIA , Jan. 23, 2015  Pete Rose, baseball,s all-time ... joint and arthritis pain reliever Myoflex, Ducere Pharma has announced. ... and we are excited to have him on board with ... . "He is a legendary player who is known across ...
(Date:1/23/2015)... Jan. 23, 2015  iMD Companies, Inc. (ICBU) has repositioned itself ... share and grab a foothold in the hydroponic, hemp and ... and a presence in the sector, and recently partnering with ... of hemp and medical marijuana, iMD is committing to bring ...
(Date:1/23/2015)... , Jan. 23, 2015   Leatt Corporation  (OTCQB: LEAT), ... equipment for all forms of sports, including extreme motor ... brace, announced today that the UISP Lega Motociclismo Lombardia, ... all riders to wear a neck brace during its ...
Breaking Medicine Technology:Pete Rose bets on Myoflex to relieve aches and pains 2iMD Companies Poised to Make Impact in Multi-Billion Dollar Medical Marijuana Sector With Recent Investments and Strategic Partnerships 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3
... China Medical Technologies, Inc. (the "Company") (Nasdaq: ... company, today announced its unaudited financial results for the ... 2Q FY20 10 ... 21.5% year-over-year to RMB201.8 million (US$30.2 million). Non-GAAP ...
... Tengion, Inc. (Nasdaq: TNGN ), a ... one-month, post-operative clinical assessment of the first implanted bladder ... completed as expected and has permitted the second patient ... initial clinical trial calls for each of the first ...
Cached Medicine Technology:China 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 14Tengion Advances Clinical Trial for Neo-Urinary Conduit™ in Bladder Cancer Patients 2Tengion Advances Clinical Trial for Neo-Urinary Conduit™ in Bladder Cancer Patients 3
(Date:1/22/2015)... (PRWEB) January 22, 2015 The federal court ... the U.S. District Court, Southern District of West Virginia has ... in that proceeding’s first bellwether trial. In an Order dated ... new trial after finding that C.R. Bard had not proven ...
(Date:1/22/2015)... 2015 Autocarinsurancebest.com has released a new blog ... auto insurance policy . , Auto insurance quotes help ... is no longer necessary to call an agent or visit ... online on a single website: http://autocarinsurancebest.com/ . , Every ...
(Date:1/22/2015)... NY (PRWEB) January 22, 2015 ... of Sports Medicine flagship journal Medicine & Science ... L-Citrulline before exercise may help reduce gastrointestinal (GI) ... 1 , Participants in the double-blind, placebo-controlled ...
(Date:1/22/2015)... Four years since the release of their debut ... the marriage of Avasa & Matthew Love – the duo are ... for release through White Swan Records on February 24, 2015. , ... sacred path available to all of us to walk out of ...
(Date:1/22/2015)... 2015 JJsHouse.com is a famous dress online ... business announces its latest collection of wedding dresses , ... important issue is the wedding dress on your big day; ... woman’s life. Every bride wants to find the most suitable ...
Breaking Medicine News(10 mins):Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... trained in the UK, is about to get a lot more ... have a work permit. // ,The new immigration rule ... a non-European doctor to have a work permit to train at ... work permit specifies that the employer would have to establish that ...
... that at least a third of dentists are refusing to sign ... what Prime Minister Tony Blair had said when he asserted that ... of the dentists are agreeing to the new contract, but it's ... I think around about 90 to 95 per cent of them ...
... UN findings that claim an extra 4,000 cancer deaths would ... which struck 20 years ago. Instead, the group says that ... ,Most of these victims would be in ... 1986 was one of the worst nuclear accidents in the ...
... study reveals startling results that 43 percent of older ... heart and kidneys. //This is when these two damages ... and ARBs, have been recommended by national diabetes-treatment guidelines ... there is strong evidence that they can prevent heart ...
... Hep C sufferers with the government ended with cheer as ... who fought the claim say that the Government would offer ... they would have received in lump-sum compensation from ACC in ... Waring who contracted hepatitis C from donated blood products in ...
... to their recommendations on what is good and what is ... This attitude has really got under the skin of many ... labeling and marketing strategies of these so called household brands. ... Adopting a sure shot strategy of appealing to the sensibilities ...
Cached Medicine News:Health News:New Immigration Rule Adversely Affects Indian Doctors 2Health News:Older Diabetics not taking kidney and heart protective drugs 2
For the quantitative in vitro determination of Microalbumin in urine....
Determination of the Thrombin Time by STA Analyzers. Freeze-dried human thrombin (1.5NIH units/mL) with calcium....
Quantitative determination of Fibrinogen by STA Analyzers (Clauss Method). Freeze-dried human thrombin (~100NIH units/mL) with heparin inhibitor and calcium....
Determination of Activated Partial Thromboplastin Time (APTT) by STA Analyzers. Cephalin reagent with kaolin activator....
Medicine Products: