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Genotype in Medical Technology

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... C virus (HCV) infection. Patients with HCV genotype 1, the most common and hardest to treat form of ... Treatment Duration in Chronic Hepatitis C genotype 1-Infected Slow Responders: Final Results of the ... (ribavirin, USP) combination therapy in genotype 1-infected patients who have slow response to ...

Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C

... ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in ... In ACHIEVE 1, 1331 treatment-naive patients with genotype 1 chronic hepatitis C were initially assigned to ... and even death. Patients infected with the genotype 1 hepatitis C virus account for approximately 75% ...

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

... at 800 mg bid, 2.9 log10 (range of 2.2 to 3.4). genotype 1a patients demonstrated median reductions of 1.4 ... and 800 mg bid, respectively. In 10 of the 12 genotype 1a patients who received ANA598, viral load was ... at the end of the three days of treatment. genotype 1b patients demonstrated median reductions of 2.6 ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... patients with chronic hepatitis C virus (HCV) genotype 1 were presented at the 44th European Association ... of the Liver (EASL) 2009 Annual Meeting.(2) genotype 1 is the most common and hardest to treat form of ... and treatment-experienced patients with HCV genotype 1. In this study, low doses of ritonavir were ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... bridging fibrosis or cirrhosis, or HCV genotype 1 infection. It is estimated that more than ... Overall, previous relapsers, patients with HCV genotype 2 or 3, or those initially treated with ... bridging fibrosis or cirrhosis, or HCV genotype 1 infection. "Based on a patient's treatment ...

Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C

... alfa-2a dosed weekly in patients with genotype 1 chronic hepatitis C - - Patients ... with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C (p=0.0008). Albinterferon ... Phase 3 results in patients infected with the genotype 1 virus, evaluated together with the previously ...

ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients

... ANA598. Three patients who received ANA598 were genotype 1a and demonstrated a median viral load decline ... while five patients who received ANA598 were genotype 1b and demonstrated a median viral load decline ... Phase Ib study, treatment-naive genotype 1a and 1b patients are to receive oral capsules ...

Pharmasset Reports Fiscal Year End 2008 Financial Results

... patients chronically infected with HCV genotype 1 indicated rapid virological response (RVR) ... of 16) in the control group. Further results in genotype 2 and 3, non responder patients treated with ... study with R7128 in non-responder, HCV genotype 2 ...

Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008

... to 50 percent of patients infected with chronic genotype 1 HCV infection, the most common type in the ... first cohort of fifty (50) treatment naive HCV+, genotype 1, patients (once daily dose of 25 mg or 75 mg ... mg or 75 mg TMC435 versus placebo) in fifty HCV genotype 1 treatment-naive patients in an ongoing ...

Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients

... with chronic hepatitis C virus (HCV) genotype 1 were presented at the 59th American Association ... study are very exciting, especially given that genotype 1 is the most common and hardest to treat form of ... in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and ...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

... the PEGASYS group, the daily ribavirin dose for genotype 1 and 4 patients was 1000-1200 mg based on ... for black American patients with chronic HCV genotype 1. Hepatology. 2004;39(6):1702-1708. (6) ... Latino vs non-Latino Caucasian infected with HCV genotype 1: the Latino study. Presented at: 43rd ...

Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers

... a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral ... was seen over days three and four. In two HCV genotype 1a animals that each received a single dose ...

Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients

... In the Phase Ib monotherapy study, naive genotype 1 patients will receive ANA598 over three days, ... a substantial antiviral effect against both genotype 1a and 1b virus in HCV-infected chimpanzees. ... than 2 log viral load decline in each of two genotype 1b infected animals. Anadys has previously ...

Idenix Pharmaceuticals Advances HCV Discovery Program to Clinic

... single nanomolar in vitro potency against HCV genotype 1b replicon (EC50 = 2 nM) and against HCV genotype 1a and 1b polymerases. Additionally, cellular ... single nanomolar potency against HCV genotype 1a and 1b purified proteases and nanomolar ...

Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment

... infected with hepatitis C virus (HCV) genotype 1. One study will be in previously untreated ... untreated (naive) adult patients with chronic HCV genotype 1. The study is projected to enroll a total of ... for 48 weeks in adult patients with chronic HCV genotype 1 who failed prior treatment with peginterferon ...

Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders

... therapy in U.S. patients with chronic hepatitis C genotype 1 who have previously failed to respond to the ... patients with chronic hepatitis C infected with genotype 1 (STEALTH C-3). "Completing enrollment in this ... in 60 patients with chronic hepatitis C genotype 1, who are non-responders to prior peginterferon ...

Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C

... cohorts will evaluate R7128 1000mg BID in HCV genotype 1 treatment-naive patients and R7128 1500mg ... (BID) in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg ... medical need. If R7128 shows activity in HCV genotype 2 or 3 patients, this would demonstrate a ...

Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008

... nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained ... of Patients with Chronic Hepatitis C genotype 4," reported final 24-week post-treatment ... patients with chronic hepatitis C genotype 4 were randomized into three groups to receive ...

Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1

... patients with chronic hepatitis C infected with genotype 1. The primary objective of STEALTH C-3 is to ... patients with chronic hepatitis C infected with genotype 4 have shown that nitazoxanide improves virologic ... plus standard of care in patients with genotype 1. Future clinical trials will explore new ...

Synvista Therapeutics Presents New Preclinical Data Demonstrating the Value of Haptoglobin Genotype Testing In Diabetes at ACC Scientific Sessions

... of Mouse Model of Diabetes with Haptoglobin 2-2 genotype Show Modification of HDL Structure and Defective ... a study of diabetic mice with the Haptoglobin 2-2 genotype that show impairment in the clearance of the ... the combination of diabetes and the Hp2-2 genotype was associated with a two-to-three-fold increase ...

Pegintron(TM) Plus Weight-Based Rebetol(R) Resulted in Higher SVR Than Flat Dosing; Low Relapse Rates in Patients With Chronic Hepatitis C

... for patients with chronic hepatitis C virus (HCV) genotype 2 or 3. The revisions represent the first FDA ... flat-dosed ribavirin, especially in genotype 1 patients, and provided consistent efficacy ... The study also showed that for patients with HCV genotype 2 or 3, 24 weeks of weight-based dosed ...

Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response

... improved viral clearance rates at week 12 in genotype 1 hepatitis C infection compared to the control ... chronically infected with hepatitis C virus (HCV) genotype 1 in two large Phase II clinical studies, in ... in patients chronically infected with HCV genotype 1 who were nonresponders to previous ...

Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C

... chronically infected with hepatitis C virus (HCV) genotype 1. R7128 is a prodrug of PSI-6130, an oral ... in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The ... in up to 75 treatment-naive patients with genotype 1 hepatitis C virus. The primary objective is ...

Genetic Differences Predict Anti-Inflammatory Benefits From Nutritional Products

... of inflammation. In addition, in the genotype positive subjects, significantly more achieved a ... placebo. No CRP effect was observed in the IL-1 genotype negative subjects. "We have known for many years ... and significantly lower than placebo in both IL-1 genotype positive and negative subjects. Over the 12 ...

European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy

... is 24 weeks for naive patients with HCV genotype 1 and low viral load, or HCV genotype 2 or 3. The recommended duration of treatment is 48 weeks for naive patients with HCV genotype 1 and high viral load, HCV genotype 4 or HIV ...

Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States

... in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy ... and naive patients with chronic hepatitis C genotype 4, is a phase II randomized controlled trial ... States in 60 patients with chronic hepatitis C genotype 1 who have previously failed to respond to ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... and placebo-controlled study, in 30 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and ... with some nucleoside analogs. Like RG7128, PSI-7851 has demonstrated pan genotype activity in vitro . About Pharmasset Pharmasset is a ...

Clinical Update - Debio 025 in Hepatitis C

... alpha 2a (peg-IFNÿ±2a) and ribavirin in previously null-responder genotype 1 HCV patients. Results demonstrated that Debio 025 at doses of 400 mg ... peg-IFNÿ±2a at 180 micrograms/week and ribavirin at 1000/1200 mg/day in genotype 1 chronic HCV patients that were previously null responders (< 2 log10 ...

InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)

... in hepatitis C virus (HCV) treatment-naive patients infected with HCV genotype 1. ITMN-191 is an HCV protease inhibitor being developed in collaboration ... was conducted in treatment-naive patients chronically infected with HCV genotype 1. The study objectives were to assess the safety, pharmacokinetic and ...

Clinical Update - Debio 025 in Hepatitis C

... alpha 2a (peg-IFNalpha2a) and ribavirin in treatment-naive chronic HCV genotype 1 patients. During this 72 week trial, on top of the Standard of ... the SOC treatment. The trial will include 272 treatment-naive chronic HCV genotype 1 patients. Results of the study are expected in Q1 2011. "We ...

Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference

... Phase 3 Trial in Genotypes 2 and 3 Chronic Hepatitis C; Phase 3 Results in genotype 1 Patients Expected March 2009 In December 2008, HGS reported that ... comparable. The results of ACHIEVE 1, the Phase 3 trial of Albuferon in genotype 1 chronic hepatitis C, are expected in March 2009. Albuferon is being ...

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

... study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. "We are very encouraged by the strong boceprevir results to ... Phase III studies of boceprevir in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and the other in patients who ...

Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C

... days of combination therapy in treatment-naive patients infected with HCV genotype 1. This direct antiviral combination study represents an important ... factors such as genotype of the virus. For the most difficult to treat genotype 1 virus, a 48-week treatment course generally results in sustained viral ...

Pharmasset Reports Financial Results for Quarter Ended June 30, 2008

... added Mr. Price. "We look forward to the unblinding of our R7128 genotype 2/3 patient data and hope to see data that is consistent with the ... Pegasys(R) (peginterferon alfa-2a) plus Copegus(R) (ribavirin) in both genotype 1 treatment-naive patients and genotypes 2 and 3 treatment-experienced ...

Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C

... treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. R7128, a prodrug of PSI-6130, is a nucleoside analogue polymerase ... was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated potent short-term antiviral activity and was ...

Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients

... study of 595 treatment-nave patients with chronic hepatitis C virus (HCV) genotype 1. In a 48-week treatment regimen, the SVR rate at 12 weeks after the ... top-line results with boceprevir are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C," said Paul ...

Pharmasset Receives Notice of Allowance

... was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated potent short-term antiviral activity and was ... (BID) with Pegasys plus Copegus in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg BID with Pegasys plus Copegus in ...

InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C

... in treatment-naive patients infected with chronic hepatitis C virus (HCV) genotype 1 infection. InterMune also reported that results from the only cohort ... to approximately 50 treatment-nave patients chronically infected with HCV genotype 1. The study will assess the effects of multiple doses and regimens of ...

PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

... prospective study to evaluate the response of Latino whites infected with genotype 1 hepatitis C virus (HCV) to combination therapy with pegylated interferon ... 300 non-Latino whites between the ages of 18 and 65 infected with HCV genotype 1. All patients were treatment naive and were treated with PEGASYS 180 ...

Final Results of Ideal Study Presented at Annual Meeting of the European Association for the Study of the Liver (EASL)

... interferon therapy), 3,070 previously untreated U.S. patients with HCV genotype 1, the most common form of the virus worldwide and most difficult to ... the United States. The study treated 3,070 adult patients with chronic HCV genotype 1. Of these, 82 percent of patients had high viral load (greater than ...
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