 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
| 
FDA-approved
Combination Therapies for Chronic HCV Infection
