NATAP/EASL: High HCV Cure/SVR Rates/New HCV Drugs

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Subject: NATAP/EASL: High HCV Cure/SVR Rates/New HCV DrugsHIGHLIGHTSfrom Jules: here are highlights from the EASL HCV liver conference in Barcelona last week, there are sooo many highlights: # 1 - interferon-free therapy is here with cure/SVR rates of 88-100% in initial studies using only initial regimens, the regimens can only get better, and so they will as researchers & companies seek to make better drug regimen combinations with more potent combinations; for prior null responders although initial research sees they are harder to treat succussfully with all-oral new HCV drug regimens, future research will explore what potent combinations using more drugs with more potency is successful for this harder to treat group, but several studies here show that QUAD therapy certainly appears to be succesful for them with 2 orals + peg/rbv achieving 100% SVR rates in some studies.EASL 47th Annual Meeting

Barcelona, Spain

April 18th - 22nd 2012EASL: Interferon-Free Regimens at EASL - (04/24/12)EASL: Potent

Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - 100% SVR (04/19/12)EASL: A

12-Week Interferon-Free Regimen of ABT-450/r + ABT-333 + Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders - 92% SVR (04/23/12)EASL: A

12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects - 90% SVR (04/19/12)EASL: Once Daily GS-7977 Plus Ribavirin in HCV Genotypes 1-3: The ELECTRON Trial -88% SVR (04/21/12)EASL: GS-7977 + PEG/RBV in HCV Genotype 1: The ATOMIC Trial An End To Response-Guided Therapy - 97% SVR (04/20/12) EASL: SVR4

and SVR12 with an interferon-free regimen of BI 201335 AND BI 207127, +/- ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Interim results of SOUND-C2 - 70% SVR (04/22/12)EASL: Dual

Oral Therapy with NS5A Inhibitor Daclatasvir (BMS-790052) and NS3 Protease Inhibitor Asunaprevir (BMS-650032) in HCV Genotype 1b-Infected Null Responders or Patients Ineligible/Intolerant to Peginterferon/Ribavirin - 77% SVR (04/19/12)EASL: TMC435

with peginterferon and ribavirin in treatment-experienced HCV genotype 1

patients: the ASPIRE study, a randomised Phase IIb trial - 51% SVR null responders; 75% prior partial responders; 85% prior relapsers (04/19/12) EASL: RAPID

AND SUSTAINED ACHIEVEMENT OF UNDETECTABLE HCV RNA DURING TREATMENT WITH

RITONAVIR-BOOSTED DANOPREVIR/PEG-IFNα-2A/RBV IN HCV GENOTYPE 1 OR 4 PATIENTS: DAUPHINE WEEK 36 INTERIM ANALYSIS - Roche protease 90% SVR (04/22/12)EASL: Confirmation

That Quadruple Therapy With Daclatasvir (NS5A Inhibitor), Asunaprevir (NS3 Inhibitor) and Peginterferon/Ribavirin Results in a High Rate of SVR4 in HCV Genotype 1 Null Responders - (04/19/12)EASL: 100%

SVR in IL28B SNP rs12979860 C/C patients treated with 12 weeks of telaprevir, peginterferon and ribavirin in the PROVE2 trial - (04/23/12)EASL: Triple

Therapy With Daclatasvir (DCV; BMS-790052), Peginterferon Alfa-2a and Ribavirin in HCV-Infected Prior Null and Partial Responders: 12-Week Results of Phase 2b COMMAND-2 Trial - (04/27/12)EASL:

ABT-450/ritonavir (ABT-450/r) Combined With Pegylated Interferon Alpha-2a/Ribavirin (P/R) After 3-Day Monotherapy in HCV Genotype 1 (GT1)-Infected Treatment-Naïve Subjects: 12-Week Sustained Virologic Response (SVR12) and Safety Results - (04/27/12)EASL: Safety

and Antiviral Activity of ABT-267, a Novel NS5A Inhibitor, During 3-Day

Monotherapy: First Study in HCV Genotype-1 (GT1)-Infected Treatment-Naïve Subjects - (04/25/12)EASL: ABT-267

Combined With Pegylated Interferon Alpha-2a/ribavirin in Genotype 1 (GT1) HCV-Infected Treatment-Naïve Subjects: 12-Week Antiviral and Safety Analysis - (04/25/12)EASL:

In Vitro Resistance Analysis of Merck's HCV NS5a Inhibitor MK-8742 Demonstrates Increased Potency AgainstClinical Resistance Variants and Improved Resistance Profile - (04/23/12)EASL: Antiviral Activity and Resistance Profile of the Novel HCV NS5A Inhibitor GS-5885 - (04/25/12)EASL: A

Phase 2a Study of BMS-791325, an NS5B Polymerase Inhibitor, With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Genotype 1 Chronic Hepatitis C Virus Infection - (04/25/12)EASL: Patients

of all IL28B Genotypes have High SVR Rates when Treated with VX-222 in Combination with Telaprevir/Peginterferon/Ribavirin in the ZENITH Study - (04/24/12)EASL: GS-9669,

A Novel NS5B Non-Nucleoside Thumb Site II Inhibitor, Demonstrates Potent Antiviral Activity, Favorable Safety Profile and Potential for Once-Daily - (04/24/12)EASL: Peginterferon

Lambda-1A (Lambda) Compared With Peginterferon Alfa-2A (Alfa) in Treatment- Naive Patients With HCV Genotypes 2 or 3: First SVR24 Results

From EMERGE Phase IIb - (04/20/12)EASL: FINAL

RESULTS: Randomized, Double-blind, Placebo-controlled Safety, Anti-viral, Proof of Concept Study of Miravirsen, an Oligonucleotide Targeting miR-122, in Treatment-Naïve Patients with Genotype 1 Chronic HCV Infection - (04/27/12)EASL: Closing

Summary by Jean-Michel Pawlotsky: New HCV Drug Development, Goodbye Interferon?, Triple, QUAD, IFN-Free, Adherence, New HCV Drugs - (04/26/12)EASL: Resistance: Meeting the Challenge: A- Telaprevir, B- Boceprevir Christophe Sarrazin - (04/26/12)Analysis

of long-term persistence of resistance mutations within the hepatitis C

virus NS3 protease after treatment with telaprevir or boceprevir - (04/27/12)EASL: CUPIC: French Early Access Program - Compassionate Use of Protease Inhibitors in Viral C Cirrhosis - (04/26/12)