HCV Treatment
FDA Suspends Trials of Experimental HCV Regimen IDX184 plus IDX320 Due to Liver Toxicity Concerns
- Details
- Category: Experimental HCV Drugs
- Published on Friday, 10 September 2010 00:00
- Written by Press Release
Idenix Pharmaceuticals announced this week that the U.S. Food and Drug Administration (FDA) has placed a hold on clinical trials evaluating the experimental hepatitis C virus (HCV) protease inhibitor IDX320 and the nucleotide analog prodrug IDX184. This decision came after Idenix reported that 3 healthy HCV negative volunteers who took IDX 184 plus IDX320 in combination experienced serious liver enzyme elevation. The company indicated that it considers the 2 drugs to be safe based on early trials looking at hepatitis C patients, and it intends to submit data from completed preclinical and early clinical studies to the FDA for further analysis.
Addition of HCV Protease Inhibitor Telaprevir Can Shorten Interferon-based Treatment
- Details
- Category: Experimental HCV Drugs
- Published on Friday, 13 August 2010 14:02
- Written by Vertex Pharmaceuticals
Adding the investigational hepatitis C virus (HCV) protease inhibitor telaprevir (formerly known as VX-950) to standard hepatitis C therapy using pegylated interferon plus ribavirin can potentially shorten treatment from 48 to 24 weeks for people with hard-to-treat HCV genotype 1, Vertex Pharmaceuticals announced this week. In the Phase 3 ILLUMINATE trial, previously untreated patients who showed good virological response at weeks 4 and 12 of therapy did just as well with a 6-month course of treatment as with the standard 12-month duration, reaching a sustained virological response rate of 92%. Vertex plans to file for Food and Drug Administration (FDA) approval of telaprevir during the fourth quarter of this year.
House of Representatives Holds Hearing on the 'Secret Epidemic' of Viral Hepatitis
- Details
- Category: HCV Treatment
- Published on Friday, 25 June 2010 13:41
- Written by AASLD
One June 17 the U.S. House of Representative Oversight and Government Reform Committee held a hearing on viral hepatitis, a largely "silent epidemic" that has begun to receive more attention in the wake of the Institute of Medicine's report on liver cancer and hepatitis B and C. Assistant Secretary for Health Howard Koh and John Ward, director of the Centers for Disease Control and Prevention's Viral Hepatitis Program, participated in the meeting. The committee urged Congress to pass legislation introduced by Rep. Mike Honda and a bipartisan coalition of co-sponsors (H.R. 3974) that will increase funding for hepatitis B and C education, testing, and treatment.
Treating Hepatitis C in People with Compensated Cirrhosis Is Most Cost-effective Approach
- Details
- Category: HCV Treatment
- Published on Friday, 02 July 2010 13:54
- Written by Liz Highleyman
Interferon-based combination therapy for chronic hepatitis C virus (HCV) infection is most cost-effective -- saving more than $55,000 compared with no treatment -- when initiated in patients with compensated cirrhosis rather than waiting until progression to decompensated cirrhosis or HCV recurrence after a liver transplant, according to research from the University of California at Los Angeles reported in the June 2010 issue of Liver Transplantation.
75% of Treatment-naive Genotype 1 Hepatitis C Patients Achieve Sustained Response with Telaprevir Combination, Most with 24 Weeks of Therapy
- Details
- Category: HCV Treatment
- Published on Tuesday, 08 June 2010 14:02
- Written by Vertex Pharmaceuticals
Vertex Pharmaceuticals recently released findings from the Phase 3 ADVANCE study showing that three-quarters of previously untreated chronic hepatitis C patients with HCV genotype 1 achieved sustained virological response (SVR) with a combination regimen consisting of the investigational HCV protease inhibitor telaprevir plus pegylated interferon and ribavirin. Standard therapy for genotype 1 hepatitis C lasts 48 weeks, but the majority of participants in this study achieved a cure with 24 total weeks of treatment (12 on triple therapy plus 12 on pegylated interferon/ribavirin alone). Telaprevir is the direct-acting oral HCV agent furthest along in development; Vertex has indicated that it expects to request U.S. regulatory approval in the second half of 2010.
More Articles...
- EASL 2010: Achillion Announces Additional Promising Data from Phase 1b Trial of HCV Protease Inhibitor ACH-1625
- EASL 2010: European Study Finds More than Half of HIV/HCV Coinfected Patients Do Not Receive Treatment despite Advanced Fibrosis
- EASL 2010: PROTECT Study Finds One-third of Liver Transplant Patients Achieve Sustained Response to Pegylated Interferon plus Ribavirin
- HCV Polymerase Inhibitor IDX184, Protease Inhibitor IDX320 and Triple Combination Show Promising Antiviral Activity
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