Hepatitis C virus (HCV) chronic infections are a leading cause of advanced liver disease and hepatocellular carcinoma and are a common indication for liver transplantation in Europe. The recent approval of Gilead’s Sovaldi, Janssen/Medivir’s Olysio, and Bristol-Myers Squibb’s Daklinza ushered in the era of interferon-free therapy for chronic HCV infections and has precipitated a shift in the HCV treatment paradigm. With the availability of these new agents and the anticipated market entry of other promising emerging therapies (e.g., Gilead’s Harvoni) in the near term, the treatment landscape for HCV is expected to rapidly evolve and to see major improvements in drug safety and tolerability, efficacy, compliance, and treatment duration. This report focuses on current and anticipated use of Sovaldi-, and Olysio-containing regimens, interferon-based regimens, and emerging interferon-free regimens, including Gilead’s Harvoni and AbbVie’s three-direct-acting agent (DAA) combination by capturing patient market share data, current prescribing trends, and anticipated changes in prescribing and treatment behavior. For key brands, physician perception of these agents’ strengths and weaknesses, barriers to uptake, and sales force performance will be evaluated. Physician awareness, interest, and potential impact of agents in development are also gauged in this study.

Questions Answered in This Report:

  • New treatment options for HCV are impacting current medical practice and prescribing choices, especially in France and Germany. How have the diagnosis rates for HCV changed in the past 12 months? To what extent and which types of patients are undergoing treatment versus being warehoused? Which emerging therapies are physicians warehousing patients for? What are the drivers of active treatment? What are the recent changes in physician approach to treatment and management of HCV? How important are treatment guidelines for prescribing and management of HCV? What proportion of HCV patients are currently treated with existing HCV regimens?

  • HCV specialists expect to shift treatment approaches and prescribing in favor of new emerging interferon-free regimens. What percentage of HCV patients by genotype do physicians anticipate treating in the next six months? Are specialists aware of emerging therapies? When do physician expect to initiate prescribing of emerging therapies (i.e., Gilead’s Harvoni, BMS’ Daklinza, AbbVie’s three DAA combination)? In the next six months, what percentage of HCV patients by genotype do physicians expect to have on key regimens including interferon-free regimens?

  • Despite sporadic availability and limited uptake of new DAAs due to ongoing pricing and reimbursement negotiations in Europe, Sovaldi emerges as the top brand for satisfaction and product performance. How do physicians perceive current and leading HCV brands? How do key brands perform on surveyed prescribing attributes including efficacy in common genotypes and cost/reimbursement? What channels can drug developers employ to disseminate information about their brands? What are the remaining unmet needs for the HCV space? What are additional benefits or areas of improvement for HCV treatment?

  • HCV patients are aware of the evolving treatment options and are requesting new treatment options. Are patients aware of current and emerging therapies? Which current and emerging therapies are patients mostly likely to ask their physician about? What are the salesforce interactions, promotional detailing efforts, and messaging for key brands? What are the key messages delivered by sales representatives of major brands?

Scope:

Markets covered: EU5: France, Germany, Spain, Italy, and United Kingdom.

Primary research: 256 specialists, including 127 gastroenterologists and 129 hepatologists, in the EU5 participated in an online survey (approximately 50 respondents per country).

Emerging therapies: Phase III: 4 drugs; Pre-registered: 4 drugs; Registered: 3 drugs.

Author(s): Brenda Perez-Cheeks, Ph.D.