HCV Discussion
April 2007

Deliverable: Transcripts

Objectives:

n      Assess current practice patterns of chronic and acute hepatitis C (HCV)

n      Examine ITMN-191’s strengths and weaknesses

n      Gauge ITMN-191’s strengths and weaknesses in comparison to other promising agents in development:

·       VX-950

·       SCH 503034

·       R1626

·       HCV-796

n      Explore the implications of drug potency, resistance, and drug toxicity on panelist enthusiasm for ITMN-191

Products Highlighted:

n      VX-950, Vertex

n      SCH 503034, Schering-Plough

n      R1626, Roche

n      HCV-796, ViroPharma/Wyeth

n      Peginterferon, Roche (Pegasys®), Schering (Peg-Intron®)

n      Ribavirin

Topics:

n      Treatment approaches to chronic and acute  HCV

n      Unmet needs and treatments in development

n      Reactions to and comparisons of several product profiles

n      Importance of potency, drug resistance, toxicity, and stage in development

Quotes:

n      “The prime need is for more…”

n      “So far, … has the highest log order reduction. I think this will equate to the best efficacy in the long run. On the other … had at best a 1 log reduction, so I do not think that patients will be cured with this and I think even as add on therapy, it will not add much benefit.”

n      “Combination therapy with … seems to be the most promising as there was undetectable virus in 12/12 patients after just one month of treatment and these low levels would make resistance less likely.”

n      “So far the side effects appear…”

Screening Criteria:

n      US-based practitioners

n      Publication history on treatment of Hepatitis C

·       High volume treaters of Hepatitis C

Representative Institutions:

n      Temple University Hospital, PA

n      California Pacific Medical Center, CA

n      Washington Adventist Hospital, MD

n      University of California San Francisco, CA

n      Cleveland Clinic Foundation, FL

n      North Shore University Hospital, NY

n      Lenox Hill GI Fellows Clinic, NY

n      John Hopkins School of Medicine, MD

n      Long Island Jewish Hospital, NY

n      Partners Hospital Affiliation--North Shore Medical, MA