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HCV Experimental Treatments

ACH 806 (HCV Protease Inhibitor)
Albumin Interferon
BI 201335 (protease inhibitor)
Boceprevir (aka SCH 503034)
GS 9132 and GS 9190 and GS 9450
HCV 759 (HCV Polymerase Inhibitor)
HCV-796 (HCV Polymerase Inhibitor) *
Development Halted April, 2008
ITMN 191
IDX13, IDX316 and IDX184
MK-0608 and MK-7009
R-1626 and R-7128 and PSI-7851
STAT-C Agents
Telaprevir (aka VX-950)
TMC435350
Valopicitabine (aka NM 283)
Viramidine (aka Taribavirin)


ACH 806 (HCV Protease Inhibitor)

In Vitro Studies Suggest Promising Outcomes with New HCV Protease Inhibitor ACH 806 in Combination with Interferon, Telaprevir, or NM 107
5/05/07




Albumin Interfern

Review Finds Albumin Interferon for Chronic Hepatitis C Is Effective and Well-tolerated; Phase 3 Results Show Non-inferiority to Pegylated Interferon
3/20/2009


New Hepatitis C Treatment Trials: HCV Polymerase Inhibitor R7128, Nucleotide Prodrug IDX184, and Albumin Interferon (Albuferon)
1/20/2009


Albumin Interferon (Albuferon) Administered Once Every 2-4 Weeks May Be As Effective as Once-weekly Pegylated Interferon
9/23/08


Safety and Activity of Once-Monthly Albinterferon Alfa-2b (Albuferon) in Genotype 2/3 Chronic Hepatitis C Patients
- 5/23/08


Antiviral Activity, Pharmacodynamics, and Quality of Life in Genotype 1 Hepatitis C Patients Treated with Albinterferon (Albuferon)
5/23/08


Albuferon Dose in Ongoing Trials is Lowered Due to Safety Concerns
1/25/08




BI 201335 (protease inhibitor)


Investigational HCV Protease Inhibitor BI 201335 Exhibits Promising Antiviral Activity
11/11/2008


Safety and antiviral activity of BI 201335, a new HCV NS3 protease inhibitor, in treatment-naïve patients with chronic hepatitis C genotype 1 infection given as monotherapy and in combination with peginterferon alfa-2a (P) and ribavirin (R)
- 11/05/2008


Safety and antiviral activity of BI 201335, a new HCV NS3 protease inhibitor, in combination therapy with peginterferon alfa-2a (P) and ribavirin (R) for 28 days in P+R treatment-experienced patients with chronic hepatitis C genotype 1 infection
11/05/2008



Boceprevir (aka SCH 503034)


Experimental HCV Protease Inhibitor SCH 900518, with or without Pegylated Interferon, Appears Safe and Exhibits Good Antiviral Activity
5/01/09

Adding Boceprevir to PegIntron/Ribavirin Significantly Improves Sustained Virological Response in Chronic Hepatitis C Patients
5/01/09

SAFETY AND ANTIVIRAL ACTIVITY OF SCH 900518 ADMINISTERED AS MONOTHERAPY AND IN COMBINATION WITH PEGINTERFERON ALFA-2B TO NAIVE AND TREATMENT-EXPERIENCED HCV-1 INFECTED PATIENTS
5/01/09

HCV SPRINT-1 Final Results SVR 24 Boceprevir* plus PegIFN alfa-2b/Ribavirin HCV 1 Treatment Naïve Patients
5/01/09

Preclinical Characterization of SCH 900518, A Novel Mechanism-Based Inhibitor of HCV NS3 Protease

4/24/09


A Regional Gastrointestinal Absorption Study of the HCV NS3 Protease Inhibitor SCH 900518 in Healthy Volunteers

4/24/09


SPRINT-1 Study Design- Boceprevir

4/24/09


SPRINT-2 Design (Naïve Study) - Boceprevir

4/24/09


SCH 900518 Tablet Study Diagram (Phase 2) - Boceprevir

4/24/09


RESPOND-2 Study Design (Treatment Failure Trial) - Boceprevir
4/24/09

Schering-Plough Completes Enrollment of Phase 3 Trial of HCV Protease Inhibitor Boceprevir
1/30/2009


HCV Protease Inhibitor Boceprevir plus Pegylated Interferon/Ribavirin Increases Sustained Virological Response Rate: SPRINT-1 Study
11/04/2008


74 Percent of Genotype 1 HCV Patients in Experimental HCV PI Boceprevir Phase II Study Achieve Sustained Virologic Response (SVR) at 48 Weeks

8/05/2008


Schering Plough Initiates Phase 3 Studies with Experimental Oral HCV Protease Inhibitor Boceprevir in Treatment-naive HCV Patients and in Those Who Failed Prior Treatment
5/23/08


Boceprevir (NS3 Protease Inhibitor) Combination Therapy in Non Responders: Phase II Dose Finding Study

4/29/08


Interim Results from HCV SPRINT-1: RVR/EVR from Phase 2 Study of Boceprevir Plus Peginterferon alfa-2b/Ribavirin in Treatment-Naïve Subjects with Genotype-1 CHC
- 4/29/08

Boceprevir Added to Pegylated Interferon/Ribavirin Increases Sustained Response in Treatment-naive Patients and Some Prior Non-responders
4/29/08



GS 9132 and GS 9190

Safety, Tolerability, and Pharmacokinetics of GS-9450 in Healthy Male and Female Volunteers
4/24/09


Experimental HCV Polymerase Inhibitor GS 9190 Shows Promising Antiviral Activity but Possible Cardiac Side Effects in Phase 1 Study
12/11/07


Despite Promising Early Data, Companies Discontinue Experimental HCV Protease Inhibitor GS 9132
2/13/07


HCV-796 (HCV Polymerase Inhibitor)

Naturally Occurring Resistance to HCV Protease and Polymerase Inhibitors in Treatment-naive Hepatitis C Patients
1/09/2009


Natural Prevalence of Resistance to HCV Protease Inhibitors
9/25/08


ViroPharma and Wyeth Halt Development of
HCV-796
for Hepatitis C
4/24/08


Novel HCV Polymerase Inhibitor VCH-759
Monotherapy Demonstrates Promising Antiviral Activity
12/07/07


Experimental Polymerase Inhibitor
HCV-796 is Safe and Effective in Combination with PegIntron or Pegasys
12/07/07



HCV Polymerase Inhibitor VCH-759

Naturally Occurring Resistance to HCV Protease and Polymerase Inhibitors in Treatment-naive Hepatitis C Patients
1/09/2009


Natural Prevalence of Resistance to HCV Protease Inhibitors
9/25/08


Novel
HCV Polymerase Inhibitor VCH-759 Monotherapy Demonstrates Promising Antiviral Activity
12/07/07


IDX136, IDX316, IDX375 and IDX184

IDX184, A Liver-Targeted Nucleotide HCV Polymerase Inhibitor: Results of a First-in-Man Safety and Pharmacokinetic Study
5/01/09

Antiviral Activity of the Liver-Targeted Nucleotide
HCV Polymerase Inhibitor IDX184 Correlates with Trough Serum Levels of the Nucleoside Metabolite in HCV-infected Chimpanzees
5/01/09

Preclinical Pharmacokinetic and Safety Profile of IDX375, A Novel and Potent Non-Nucleoside HCV Polymerase Inhibitor

4/24/09


Preclinical Profiles of IDX136 and IDX316, Two Novel Macrocyclic HCV Protease Inhibitors
4/24/09


ITMN 191 and ANA598 (HCV Polymerase Inhibitor)

Natural Prevalence of Resistance to HCV Protease Inhibitors
9/25/08


InterMune and Anadys Begin Phase 1 Clinical Trials of Experimental HCV Therapies ITMN-191 and ANA598
6/06/08


InterMune Presents Top-line Results from Phase 1b Trial of HCV Protease Inhibitor ITMN-191 Monotherap

4/04/08


InterMune Announces Progress on HCV Protease Inhibitor ITMN-191
1/11/08


MK-06080 (HCV Nucleoside Inhibitor)

MK-7009 Significantly Improves Rapid Viral Response (RVR) in Combination with Pegylated Interferon Alfa-2a and Ribavirin in Patients with Chronic Hepatitis C (CHC) Genotype 1 Infection
4/24/09


Experimental Nucleoside Inhibitor MK-0608 Suppresses HCV Replication in Chimpanzees  
9/29/06


R-1626, R7128 and PSI-7851 (HCV Polymerase Inhibitor)  

Pharmasset Initiates First Clinical Trial of Second-generation HCV Polymerase Inhibitor PSI-7851 - 4/10/09

New Hepatitis C Treatment Trials: HCV Polymerase Inhibitor R7128, Nucleotide Prodrug IDX184, and Albumin Interferon (Albuferon) - 1/20/2009


HCV Polymerase Inhibitor R7128 Demonstrates Good Antiviral Activity in Genotype 2 or 3 Prior Non-responders and Relapsers - 11/14/2008

R7128 plus ITMN-191 Perform Well in Laboratory Study; STAT-C Combination Clinical Trial Now Underway - 11/14/2008

Combination Therapy with Investigational HCV Polymerase Inhibitor R7128 Produces Rapid Response in Patients with Genotype 2/3 HCV - 9/12/2008

Pharmasset Releases Preliminary Data from Phase 1 Study of Investigational HCV Polymerase Inhibitor R7128 - 8/08/2008


R7128 Demonstrates Potent Anti-HCV Activity in Combination with Pegylated Interferon/Ribavirin; Ongoing Trial to be Expanded - 4/29/08

HCV Polymerase Inhibitor R1626 Produces Good Response with Pegylated Interferon/Ribavirin and Has High Barrier to Resistance
- 4/29/08

Pharmasset Announces Promising 4-Week Data on Combination Therapy with HCV Polymerase Inhibitor R7128 - 1/11/08




STAT-C Agents


Vertex Acquires VCH-222 and VCH-759, Two Experimental Oral HCV Polymerase Inhibitors - 3/09/2009

Companies Announce Phase 1b Study Data for Experimental HCV Polymerase Inhibitor ANA598 and Cyclophilin Inhibitor SCY635 - 1/23/2009


Three New STAT-C Agents Show Promise in Preclinical Studies and Early Clinical Trials: MK-7009, ANA598, and IDX375 - 11/25/2008


R7128 plus ITMN-191 Perform Well in Laboratory Study; STAT-C Combination Clinical Trial Now Underway - 11/14/2008

Several “STAT-C” Agents Discussed at the Liver Meeting - 11/07/2008


Valopicitabine (HCV Polymerase Inhibitor)

Two Studies Yield Mixed Results for HCV Polymerase Inhibitor Valopicitabine - 5/05/07


Viramidine (Taribavirin)

Prodrug Taribavirin Produces Equivalent Response, but Less Anemia than Ribavirin at 48 Weeks - 12/02/2008

Taribavirin Efficacy Similar to Ribavirin in Combination Therapy for Hepatitis C, but with Less Anemia
- 5/09/08

Valeant Reports Promising 12-week Phase IIb Data on Taribavirin - 4/01/08

Virological Response and Safety Outcomes in Chronic Hepatitis C Patients Treated with Pegylated Interferon plus Taribavirin (Viramidine)   - 8/10/07



TMC435350

OPERA-1 trial (Study TMC435-C201): interim analysis of safety and antiviral activity of TMC435 in treatment-naïve genotype-1 HCV patients
5/01/2009

Antiviral activity and safety of TMC435 combined with peginterferon -2a and ribavirin in patients with genotype-1 hepatitis C infection who failed previous IFN-based therapy

5/01/2009

Experimental HCV Protease Inhibitor TMC435350 Demonstrates Favorable Safety and Efficacy in Phase 2a Trial
11/11/2008


Experimental HCV Protease Inhibitor TMC435350 Demonstrates Promising Activity and Tolerability in Early Clinical Trial
5/13/08




Telaprevir (aka VX-950)  monotherapy / combination

Adding Telaprevir Improves Sustained Response to Pegylated Interferon plus Ribavirin in Genotype 1 Chronic Hepatitis C Patients (PROVE3)
5/01/09

HCV Protease Inhibitor Telaprevir (VX-950) Continues to Perform Well in PROVE Trials
11/11/2008


Tibotec Begins Enrolling Phase III Study of HCV Protease Inhibitor Telaprevir for Hepatitis C Patients with Prior Treatment Failure
10/24/2008


Vertex Reports Encouraging Data from PROVE3 Trial of HCV Protease Inhibitor
Telaprevir (VX-950)
6/13/08


Telaprevir plus Pegylated Interferon and Ribavirin Allows Shorter Therapy for Patients with Genotype 1 HCV
4/26/08


Vertex to Start Phase 3 Trials of HCV Protease Inhibitor Telaprevir (VX-950)
2/01/08


Telaprevir
plus Pegylated Interferon Is Effective against Both Wild-type and Drug-resistant HCV Strains
- 8/17/07

Mutations That Confer Resistance to HCV Protease Inhibitors
5/01/07


Telaprevir-based Therapy for HCV May Shorten Treatment Duration from 48 to 24 Weeks for Some Genotype 1 Patients
4/17/07


In Vitro Studies Suggest Promising Outcomes with New HCV Protease Inhibitor ACH 806 in Combination with Interferon, Telaprevir, or NM 107
4/05/07


Telaprevir Demonstrates Safety and Anti-HCV Activity in 12-week Interim Analysis
1/05/07