TMC435 Phase 2b 24-Week Interim Results

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TMC435 Phase 2b 24-Week Interim Results

See full study July 11 : Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus

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Medivir presented a 24 weeks end-of-treatment and in interim SVR4 and SVR12 results. In the research, no clinical difference between TMC435 treatment groups has been found for adverse events.The 5-arm phase 2b response guided pillar study is based on the treatment of 386 patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).Medivir and Tibotec Pharmaceuticals have developed TMC 435 in collaboration. This medicine is dosed as one pill every day to cure the hepatitis C virus infections (HCV).In the study, a patient was given 75mg or 150mg TMC435 for 12 to 24 weeks in combination of ribavirin and pegIFNalpha-2A. The results have presented that in the TMC435 treatment groups, a number of 83% of all the patients were able to end the treatment at week 24.About 92% of patients who took TMC435 and Peg-IFN/RBV acquired the undetectable HCV RNA levels at week 4. The viral penetrate rate and relapse rate

both have been found to be low in the treatment groups of TMC435.While considering the specific unfavorable event of interest, pruritis, GI side effects, anemia and the incidence of rash were usually mild by nature. During this experiment, use of erythropoetin-stimulating agents was not permitted.The safety and efficacy data of the treatment will be shown at the scientific meetings in the year 2010.

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Also See: July 12 Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus

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From This Blog:

April 14-18, 2010 The 45th Annual Meeting of theEuropean Association for the Study of the Liver (EASL 2010) Vienna Austria

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TMC435

lnTibotec's investigational hepatitis C virus (HCV) NS3/4A protease inhibitor TMC435 demonstrated good antiviral activity and appeared to be safe and generally well-tolerated in a Phase 1 placebo-controlled clinical trial, according to a report in the March 2010 Gastroenterology.Side Effects : Generally well-tolerated.The Studies.TMC435 & Drug Interactions: Evaluation of metabolic interactions for TMC435 via cytochrome P450 (CYP) enzymes in healthy volunteers -Combination of TMC435 with two novel NS5B inhibitors increases anti-HCV activity and results in a higher genetic barrier in vitro -HCV Inhibitor TMC435

http://Hepatitis Cnewdrugs.blogspot.com/2010/07/tmc435-phase-2b-24-week-interim-results.html