Hepatitis C Research and Clinical Trial updates

Updates @ NATAP

This study is currently recruiting participants

 Dose Ranging of NS5A GSK2336805 (vs telaprevir) in Combination Therapy 
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection.....

NS5A Review - Small molecule inhibitors of the hepatitis C virus-encoded NS5A protein 
"NS5A-targeting molecules are probably the most potent antiviral molecules ever discovered"

"At least 4 NS5A-targeting molecules are being evaluated in combination with pegIFN/RBV: BMS-790052, GS-5885, ABT-267, and GSK23368005 (Table 1 and Table 2)."

"BMS-790052 serves as the prototype molecule for this class of HCV inhibitor; defined by exquisite low picomolar EC50 values for HCV genotype 1 (Table 1.). These molecules are over a 1000-fold more potent than the current licensed HCV protease inhibitors in cell culture-based HCV replicon assays ( Flint et al., 2009, Gao et al., 2010 and Lin et al., 2006); they are probably the most potent antiviral molecules ever discovered."

"Both Achillion's and Merck's NS5A inhibitors (ACH-3102 and MK-8742, respectively) retain substantial levels of in vitro potency against NS5A resistance polymorphisms that plague early NS5A inhibitors, such as BMS-790052 and GS-5885 ( Liu et al., 2012 and Yang et al., 2012). Accordingly, they can be viewed as 'second generation' NS5A inhibitors and time will tell whether these favorable preclinical profiles will also translate to superior clinical efficacy."

ClinicalTrials.gov -Updated in the last 30 days

Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
‎Thursday, ‎February ‎21, ‎2013, ‏‎12:00:00 PM

Condition: Hepatitis C
Interventions: Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Placebo matching Daclatasvir; Drug: Daclatasvir
Sponsors: Bristol-Myers Squibb; Bristol-Myers Squibb
Not yet recruiting - verified February 2013

 

A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

‎Monday, ‎February ‎11, ‎2013, ‏‎12:00:00 PM

Condition: Chronic Hepatitis C
Interventions: Drug: VX-135; Drug: Ribavirin
Sponsors: Alios Biopharma Inc.; Alios Biopharma Inc.; Vertex Pharmaceuticals Incorporated
Recruiting - verified February 2013

 

Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

‎Wednesday, ‎January ‎23, ‎2013, ‏‎12:00:00 PM

Condition: Post-transplant Recurrent Hepatitis C
Intervention: Drug: Sofosbuvir + RIbavirin +/- Pegylated Interferon
Sponsors: Gilead Sciences; Gilead Sciences
Available - verified January 2013

 

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