January 7, 2013

HCV IFN-Free Therapies/Regimens

Provided by NATAP

In phase 3 studies now include new proteases TMC435, BI335, BMS032, NS5A BMS052, nucleotide GS7977, the Abbott IFN-free combination of 4 oral drugs. Roche, Vertex & Merck are in phase 2 with multi-oral drug regimens (see below). Vertex announced recently, in phase 2 with 3 drug oral regimen: ALS2200, their new nucleotide like GS7977 + GSK's NS5A + Janssen protease TMC435 currently in phase 3. Also, new in phase 3 & recruiting: Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of HCV......Multicenter, Randomized, Open-Label......Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection......Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of HCV........http://clinicaltrials.gov/ct2/show/NCT01701401?term=gs-5885&rank=2

This new study is recruiting: Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin in HCV Genotype 1 Subjects.....phase 2.....8 or 12 weeks therapy.....in subjects who had previously received a regimen containing a protease inhibitor for the treatment of HCV.....Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin in HCV Genotype 1 Subjects......http://clinicaltrials.gov/ct2/show/NCT01726517?term=gs-5885&rank=1

9 & Soon 11 New HCV Drugs in Phase 3

Interferon-Free 12-Week 2, 3, 4 Drug Oral Regimen Studies, 95-100% SVR Rates, Results Presented in Nov 2012 at liver conference AASLD......

AASLD: EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF FALDAPREVIR (BI 201335) + BI 207127 ± RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH HCV GT-1 AND COMPENSATED LIVER CIRRHOSIS: RESULTS FROM THE SOUND-C2 STUDY - (11/14/12)

AASLD: INTERFERON (IFN)-FREE COMBINATION TREATMENT WITH THE HCV NS3/4A PROTEASE INHIBITOR FALDAPREVIR (BI 201335) AND THE NON-NUCLEOSIDE NS5B INHIBITOR BI 207127 ± RIBAVIRIN: FINAL RESULTS OF SOUND-C2 AND PREDICTORS OF RESPONSE - (11/14/12)

AASLD: High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3 - (11/13/12) with 12 or 24 weeks 2-drug therapy 100% cure rates

AASLD: An Interferon-Free, Ribavirin-Free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection - (11/13/12)

AASLD: Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial - (11/14/12) 100% Cure rate: GS7977+GS5885
AASLD: GILEAD ANNOUNCES 100 PERCENT SUSTAINED VIROLOGIC RESPONSE RATE (SVR4) FOR AN INTERFERON-FREE REGIMEN OF SOFOSBUVIR (GS-7977), GS-5885 AND RIBAVIRIN IN TREATMENT-NAïVE GENOTYPE 1 HEPATITIS C INFECTED PATIENTS
- (11/14/12) press release

AASLD: A 12-week Interferon-free Treatment Regimen With ABT-450/r, ABT 267, ABT-333, and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-naïve Patients and 93% in Prior Null Responders With HCV Genotype 1 Infection - (11/13/12)

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New Protease by Roche who recently started the AnnaPurna Study which looks at 4-drug oral regimen IFN-free:

AASLD: Up to 100% SVR4 rates with ritonavir-boosted danoprevir (DNVr), mericitabine and ribavirin with or without peginterferon alfa-2a (40KD) in HCV genotype 1-infected partial and null responders: results from the MATTERHORN study - (11/13/12)

AASLD: Safety and efficacy of ritonavir-boosted danoprevir (DNVr), peginterferon alfa-2a (40KD), and ribavirin with or without mericitabine in HCV genotype 1-infected treatment-experienced patients with advanced hepatic fibrosis: the MATTERHORN study - (11/13/12)

ANNAPURNA: 3 & 4 Oral IFN-Free Roche HCV Regimens Studies, Treatment Naïve or Null Responders: setrobuvir+mericitabine+danoprevir/r+rbv. ANNAPURNA Study... - (09/4/12)

ANNAPURNA: A Study of The Combination of RO5466731 ...4 oral HCV drugs IFN-free in gt1a & 1b (NNRTI ANA598 + protease danoprevir/r + nuke mericitabine + RBV, study started in Spring 2012)

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NEW NUCLEOTIDE, the same class as drug as GS-7977, this is the only other drug in the same class. these are results from 7 day monotherapy study of this drug ALS2200 showing it is potent, the company Vertex just signed a deal with 2 other companies to begin IFN-free combo studies: with GSK & their NS5A & with Janssen & their new protease TMC435:

AASLD: ALS-2200, A Novel Once-daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity Over 7 Days in Treatmentnaïve Genotype 1 (GT1) Patients - (11/13/12)
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Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus - (11/08/12)

MERCK is developing these 2 potent drugs, their 2nd generation NS5A & their 2nd generation protease - AASLD: Safety and Sustained Viral Response of MK-5172 for 12 Weeks in Combination With Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks in HCV Genotype 1 Treatment-Naive Noncirrhotic Patients - (11/13/12)

AASLD: A Combination Containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) Demonstrates High Barrier to Resistance in HCV Replicon - (11/13/12

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