Back HCV Treatment Experimental HCV Drugs

Experimental HCV Drugs

FDA Suspends Trials of Experimental HCV Regimen IDX184 plus IDX320 Due to Liver Toxicity Concerns

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.

Read more:

Addition of HCV Protease Inhibitor Telaprevir Can Shorten Interferon-based Treatment

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.

Read more:

HCV Polymerase Inhibitor IDX184, Protease Inhibitor IDX320 and Triple Combination Show Promising Antiviral Activity

Two investigational direct-acting drugs for hepatitis C virus (HCV) infection -- the polymerase inhibitor IDX184 and the protease inhibitor IDX320 -- demonstrated good antiviral activity in a Phase 2a clinical trial and in laboratory and animal studies, respectively, researchers reported at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) last month in Vienna. Another in vitro study showed that these 2 drugs plus IDX375 (another polymerase inhibitor that works a different way) or an experimental NS5A inhibitor exhibited enhanced or synergistic viral suppression.

Read more:

EASL 2010: Achillion Announces Additional Promising Data from Phase 1b Trial of HCV Protease Inhibitor ACH-1625

Achillion Pharmaceuticals this month announced further interim data from an ongoing Phase 1b trial of the company's investigational hepatitis C virus (HCV) NS3 protease inhibitor ACH-1625. At the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) last month in Vienna, researchers presented early data showing that in patients with genotype 1 chronic hepatitis C, ACH-1625 monotherapy at doses of 500 mg and 600 mg twice-daily for 5 days decreased HCV viral load by approximately 4 log and was generally well-tolerated with no drug-related serious adverse events. The latest data extend these findings to people taking doses of 200 mg twice-daily and 600 mg once-daily.

Read more:

HCV NS5A Inhibitor BMS-790052 Suppresses Viral Replication in Combination with Pegylated Interferon/ribavirin

BMS-790052, Bristol-Myers Squibb's investigational hepatitis C virus (HCV) NS5A inhibitor, demonstrated potent early antiviral activity at 4 and 12 weeks when combined with the standard regimen of pegylated interferon plus ribavirin in previously untreated patients with HCV genotype 1, investigators reported at the at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) this month in Vienna.

Read more: