Hepatitis C virus (HCV) chronic infections are a leading cause of advanced liver disease and hepatocellular carcinoma and are a common reason for liver transplantation in Europe. The recent market entries of Gilead’s Harvoni, Bristol-Myers Squibb’s Daklinza, and Abbvie’s Viekirax +/- Exviera have ushered in the era of interferon-free therapy for chronic HCV infections and have 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., Merck & Co.’s grazoprevir/elbasvir) in the near term, patients will potentially have access to many different IFN-free treatment regimens that are safe, tolerable, and efficacious and address the needs of different genotypes and liver disease stages. This report focuses on current and anticipated use of Harvoni, Sovaldi, Daklinza, Viekirax +/- Exviera-based regimens, first-generation DAA-containing regimens, and interferon-based regimens by capturing patient share data, current prescribing trends, and anticipated changes in prescribing and prescribing behavior. In addition, physician opinion and awareness of emerging therapies is assessed, including regimens such as Merck & Co.’s grazoprevir/elbasvir and Gilead’s Sovaldi/GS-5816. For key brands, physician perception of these agents’ strengths and weaknesses, barriers to uptake, and salesforce performance are evaluated. Physician awareness and interest and the potential impact of agents in development are also gauged in this study.

Questions Answered in This Report:

  • New treatment options for HCV are affecting current medical practice and prescribing choices, especially in Italy, Spain, and the United Kingdom. How have the diagnosis rates for HCV changed in the past 12 months? Which types of patients are undergoing treatment versus being warehoused, and to what extent? 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 have seen a rapid shift in 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 (e.g., Merck & Co.’s grazoprevir/elbasvir or Gilead’s Sovaldi/GS-5816)? In the next six months, what percentage of HCV patients by genotype do physicians expect to have on key regimens, including interferon-free regimens?

  • Physician perception on brand performance and value hinges on the brand’s perceived efficacy in key HCV subpopulations as the efficacy emerges as the important driver of prescribing. 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 are the remaining unmet needs in the HCV space? What are additional benefits or areas of improvement for HCV treatment?

Scope:

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

Physician research: 252 specialists, including 123 gastroenterologists and 129 hepatologists, in the EU5 participated in an online survey (approximately 50 respondents per country).

Emerging therapies: Phase II: 9 drugs; Phase III/preregistered: 3 drugs; Registered: 11 drugs.

Author(s): James T. Heeres, Ph.D.