Hepatitis C Virus

Pharmacor -- June 2008

  Introduction:

Hepatitis C virus (HCV) is a leading cause of advanced liver disease in the major pharmaceutical markets, and over the next decade, HCV-related morbidity is projected to increase significantly as the cohort of chronically infected patients ages. Current treatment with a pegylated interferon-alpha and ribavirin is associated with relatively poor efficacy and tolerability, and significant opportunity exists for drug developers. HCV has one of the most active pipelines in infectious diseases, and emerging protease and polymerase inhibitors are among the most promising approaches. Since we last reported on HCV, several major events have resulted in an updated forecast of the HCV market, including the presentation of promising data from Vertex and Schering-Plough; the discontinuation of Novartis/Idenix’s high-profile polymerase inhibitor, valopicitabine; and greater visibility of data from the next generation of protease and polymerase inhibitors.

  Questions Answered in This Report:

Several novel classes are in development for HCV, including protease inhibitors, polymerase inhibitors, and novel long-acting interferons. How do HCV experts believe these agents will be integrated into treatment in the near and long term? Which agents hold the greatest promise, and what is their commercial potential?

Two interferon-alpha products--Roche’s Pegasys and Schering-Plough’s PegIntron--currently dominate the HCV market. How will emerging interferons and novel protease and polymerase inhibitors affect sales of these agents? What is the long-term outlook for interferons in the HCV market?

The HCV market has a complex epidemiology because it includes a large undiagnosed population, a sizeable segment of patients who have not responded to therapy, and an aging cohort of chronically infected patients. How will changes in the underlying epidemiology of the disease affect sales? What will the key market drivers and constrainers over the next decade be?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Primary research: 37 country-specific interviews with HCV thought leaders and experts.

Epidemiology: Prevalence of HCV infection; prevalence of HCV viremia.

Population segments in market forecast: Treatment-naive patients; treatment nonresponders.

Emerging therapies: Phase II: 25 drugs; Phase III: 4 drugs. Coverage of 9 select preclinical and Phase I products.

Market forecast features: Using a patient-flow model incorporating incidence and mortality, we forecast population sizes and drug sales for treatment-naive and nonresponder patient segments through 2017.

Alternative market scenarios: (1) In Phase III trials, protease inhibitors fail to show improved sustained virologic response for nonresponders; (2) All-oral combinations of protease inhibitors and polymerase inhibitors are found to be at least as effective as pegylated interferon-based combinations; (3) Chronic maintenance therapy with oral protease and polymerase combinations in patients who do not respond to an interferon regimen is found to provide significant clinical benefit, such as delayed fibrosis.