Hepatitis C virus (HCV) chronic infection is a leading cause of advanced liver disease and hepatocellular carcinoma and a common indication for liver transplantation. The FDA’s approval of Gilead’s Sovaldi (sofosbuvir) and Johnson & Johnson/Janssen/Medivir’s Olysio (simeprevir) in 2013 ushered in an era of interferon-free therapy for chronic HCV infection and triggered a major shift in the HCV treatment paradigm. With the availability of these new agents and the anticipated near-term launch of other promising therapies (e.g., Gilead’s Harvoni [sofosbuvir/ledipasvir fixed-dose combination]), the treatment landscape for HCV is expected to rapidly evolve and experience major improvements in drug safety and tolerability, efficacy, compliance, and treatment duration. This report focuses on the current and anticipated use of Sovaldi- and Olysio-containing regimens, interferon-based regimens, and emerging interferon-free regimens—including Gilead’s Harvoni, Bristol-Myers Squibb’s Daklinza (daclatasvir), and AbbVie’s three-direct-acting agent (DAA) combination (ombitasvir/paritaprevir/ritonavir + dasabuvir)—by capturing patient-share data, current prescribing trends, and anticipated changes in prescribing and treatment behavior. We also evaluate physician-perceived strengths and weaknesses, barriers to uptake, and salesforce performance associated with key brands and physician awareness of, interest in, and potential impact of agents in development.

Questions Answered in This Report:

  • New treatment options for HCV are affecting current medical practice and prescribing choices. How have diagnosis rates for HCV changed in the past 12 months? What percentage of patients are undergoing treatment versus being warehoused? For which emerging therapies are physicians warehousing patients? What are the drivers of active treatment? What are the recent changes in physicians’ approach to treatment and management of HCV? What is the impact of treatment guidelines on prescribing? What proportion of HCV patients are currently treated with existing HCV regimens?

  • Reimbursement and payer issues are noted obstacles to treatment with effective but highly priced drugs. Why are some HCV patients currently not undergoing active treatment? What are the reasons for prescribing first-generation protease inhibitors over new DAAs? How often do patients prematurely discontinue treatment with current regimens? What factors contribute to early discontinuation of HCV treatment? Which patient types are more likely to access new treatment options? Considering the managed care approval process, which patient types are more likely to access Olysio and Sovaldi? Will physician treatment choices align with payer preferences if treatment options for HCV are not well differentiated?

  • 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? How aware are specialists of emerging therapies? When do physicians expect to initiate prescribing of emerging therapies (e.g., Gilead’s Harvoni, Bristol-Myers Squibb’s Daklinza)? In the next six months, what percentage of HCV patients by genotype do physicians expect to have on key regimens, including interferon-free regimens?

  • HCV patients are aware of the evolving treatment options and are requesting new treatments. Which current and emerging therapies are patients mostly likely to request? What are the salesforce interactions, promotional detailing efforts, and messaging associated with key brands? What are the key messages that sales representatives deliver for the different brands?

Scope:

Markets covered: United States.

Primary research: 25 infectious disease specialists, 50 gastroenterologists, and 32 hepatologists participated in an online survey.

Emerging therapies: Phase III: 4 drugs; Preregistered: 4 drugs; Registered: 2 drugs.

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