Hepatitis C virus (HCV) chronic infections are a leading cause of advanced liver disease and hepatocellular carcinoma in the EU5 and a common indication for liver transplantation. The 2013-2015 EMA authorizations of Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir), combined with Bristol-Myers Squibb’s Daklinza (daclatasvir) and AbbVie’s Viekirax +/- Exviera (ombitasvir/paritaprevir/ritonavir +/- dasabuvir), have ushered in the era of IFN-free therapy for chronic HCV and completely reshaped the HCV therapeutic market. Recent EMA approvals of Gilead’s Epclusa (sofosbuvir/velpatasvir) and Merck & Co’s Zepatier (elbasvir/grazoprevir) provide additional IFN-free options for EU5 HCV patients. Taken together, currently approved regimens provide efficacious IFN-free options for most HCV genotypes in the EU5. This research focuses on current and anticipated use of HCV regimens, including IFN-free and remaining IFN-based regimens, by capturing patient-share data, current prescribing trends, and anticipated changes in prescribing and treatment. We also evaluate physician-perceived drivers and obstacles to the uptake of key brands.

Questions Answered in This Report:

What factors influence physicians’ treatment and management of chronic HCV infections?

What are the major drug attributes driving physicians to prescribe certain brands?

What obstacles prevent physician prescribing of key HCV therapies?

How do physicians anticipate their prescribing of different therapies to change in the next six months?

Scope:

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

Methodology: Survey of 89 gastroenterologists and 162 hepatologists; approximately 50 respondents per EU5 country

Key drugs covered: Incivo, Victrelis, Sovaldi, Olysio, Daklinza, Harvoni, Viekirax + Exviera, Zepatier, Epclusa, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir

Key companies mentioned: AbbVie, Bristol-Myers Squibb, Gilead, Merck & Co., Janssen, Johnson & Johnson, Roche

Table of contents

  • Hepatitis C Virus - Current Treatment - Detailed, Expanded Analysis (EU5)
    • Introduction to Current Treatment for HCV
      • Cost and Efficacy Are the Key Drivers of the EU5 HCV Market
      • Summary Figures
        • Patient Share for Noncirrhotic and Cirrhotic Genotype 1 Patients by Country
        • Drivers of Treatment Initiation and Completion by Country
        • Anticipated Prescribing of Current and Emerging HCV Therapies by Country
      • Introduction to Current Treatment and Medical Practice for HCV
      • Drugs Included in This Study of Current Treatment for HCV
    • Physician Prescribing Practices
      • Cost-Based Competition Has Driven Changes in EU5 HCV Prescribing
      • Patient Characteristics
        • Majority of EU5 HCV Patients Have Genotype 1 Infections
        • Genotypic Makeup of the HCV Patients Managed by EU5 Physicians
        • Subgenotyping of Genotype 1 Patients
      • Physician Treatment Practices
        • Reduced Patient-Level Access Restrictions and Cost-Based Competition Are Driving Improved Patient Care
        • Time to Treatment Initiation is Governed by Payer Policy on Fibrosis Restrictions
        • Time to Treatment Initiation Following HCV Diagnosis by Country
        • Nearly Half of HCV Patients Under Management by EU5 Physicians Were Treated in the Last Six Months
        • Number of HCV Patients Under Management by EU5 Physicians
        • Number of HCV Patients Under Management by EU5 Physicians by Physician Specialty
        • Number of HCV Patients Being Actively Treated by Country
        • Number of HCV Patients Being Actively Treated by Speciality
        • Patient Share for Noncirrhotic and Cirrhotic Genotype 1 Patients by Country
        • Patient Share for Noncirrhotic and Cirrhotic Genotype 2 Patients by Country
        • Patient Share for Noncirrhotic and Cirrhotic Genotype 3 Patients by Country
        • Treatment Duration Linked to Liver Damage, Treatment Experience, and Baseline Polymorphisms
        • Nonpharmacological Therapies Are Not Typically Prescribed for HCV in the EU5 Markets
        • Novel IFN-free HCV Regimens Continue to Streamline the HCV Treatment Algorithm
        • Treatment Rates Are Similar Across Genotypes
        • Treatment Rates of HCV Patients by Country, Genotype, Liver Damage, and Treatment Experience
        • Progression Between Lines of Therapy Is Uncommon and Depends on Payer Restrictions
        • Failure to Achieve SVR by HCV Regimen and by Country
        • Relapse Rate by HCV Regimen and by Country
        • Low-Cost Therapies Threaten Harvoni's Dominance in Genotype 1 Patient Treatment
        • Patient Share of Select Regimens in Genotype 1 HCV Subpopulations by Country
        • Patient Share of Select Regimens in Treatment-Naive Noncirrhotic Genotype 1a HCV by Country
        • Patient Share of Select Regimens in Treatment-Naive Noncirrhotic Genotype 1b HCV by Country
        • High Cost of IFN-Free Therapies Influences Treatment Duration in EU5 Markets
        • Percentage of Treatment-Naive Noncirrhotic Genotype 1 HCV Patients Who Received an 8-Week Harvoni Regimen by Country
        • Percentage of Genotype 1 HCV Patients Who Received a 16-Week Zepatier Regimen by Country
        • Duration of Sovaldi + Daklinza Regimens Prescribed to Genotype 3 HCV Patients by Country
        • All IFN-Free HCV Therapies Are Combination Regimens
      • Physician Insight on Persistency and Compliance
        • Nearly All Drug-Treated HCV Patients in the EU5 Complete Their Course of IFN-Free Regimen
        • Treatment Discontinuation Rate by HCV Regimen and Country
        • Time to Treatment Discontinuation by HCV Regimen and Country
      • Sequencing of Treatment
        • Patients Failing DAA Therapy Are Not Often Retreated, with EU5 Physicians Preferring to Switch Regimens
        • Retreatment Rates After Previous DAA Failure by HCV Regimen and by Country
        • Retreatment Rates After Previous DAA Failure by HCV Regimen and by Physician Specialty
        • Retreatment Approach After Previous DAA Failure by HCV Regimen and by Country
        • Retreatment Approach After Previous DAA Failure by HCV Regimen and by Physician Specialty
        • Reason for Retreatment Deferral After Previous DAA Failure by HCV Regimen and by Country
        • Reason for Retreatment Deferral After Previous DAA Failure by HCV Regimen and by Physician Specialty
        • Preferred Retreatment Approach in Hypothetical DAA Failures by HCV Regimen and by Country
        • Preferred Retreatment Approach in Hypothetical DAA Failures by HCV Regimen and by Physician Specialty
      • Recent and Anticipated Changes in Treatment Practices
        • EU5 Physicians Anticipate a Shift Toward Pangenotypic Regimens
        • Changes in Prescribing of HCV Therapies in the Past Six Months by Country
        • Anticipated Prescribing of Current and Emerging HCV Therapies by Country
    • Physician Insight on Medical Practice
      • Physicians Indicate the Importance of Clinical Efficacy and Improved Access
      • Factors Influencing Treatment Practice
        • Physicians See More Patients as Access to Therapies Improves
        • Changes in the Total Number of HCV Patients and the Number of Patients Initiating or Completing HCV Therapy by Country
        • Changes in the Total Number of HCV Patients and the Number of Patients Initiating or Completing HCV Therapy by Physician Specialty
        • Drivers of Treatment Initiation and Completion by Country
        • Drivers of Treatment Initiation and Completion by Physician Specialty
        • Factors Leading to a Decrease in Treatment Initiation and Completion
        • Factors Leading to a Decrease in Treatment Initiation and Completion by Physician Specialty
        • Importance of Clinical Efficacy Attributes in Prescribing Practices for HCV by Country
        • Importance of Clinical Efficacy Attributes in Prescribing Practices for HCV by Physician Specialty
        • Importance of Attributes Other Than Efficacy in Prescribing Practices for HCV by Country
        • Importance of Attributes Other Than Efficacy in Prescribing Practices for HCV by Physician Specialty
        • IFN-Free Regimens' Improved Efficacy and Safety/Tolerability Drive Prescribing
        • Major Drivers of Prescribing of Key HCV Regimens
        • Reasons for Increased Prescribing of Key HCV Brands
        • Prescribing Is Constrained by Budgetary Limits and Regimen-Specific Clinical Characteristics
        • Major Obstacles to Prescribing of Key HCV Regimens
        • Reasons for Decreased Prescribing of Key HCV Brands
        • Tolerability Concerns Fuel Treatment Discontinuation of IFN-Based Regimens
        • Reasons for Therapy Discontinuation by HCV Regimen and Country
        • Payer-Imposed Restrictions Most Responsible for Treatment Deferral in the EU5
    • Methodology
      • Primary Market Research Methodology
      • Location of Practice by Country
      • Physician Specialty
      • Years in Practice Post-Residency by Country
      • Years in Practice Post-Residency by Physician Specialty
    • Appendix
      • Primary Market Research
        • Awareness of Current and Emerging HCV Therapies by Country
        • Awareness of Current and Emerging HCV Therapies by Physician Specialty
        • Number of Physicians at Practice Location by Country
        • Number of Physicians at Practice Location by Physician Specialty
        • Practice Type
        • Prescribing of Current HCV Therapies in the Past Six Months by Country
        • Prescribing of Current HCV Therapies in the Past Six Months by Physician Specialty
        • Key Patient Attributes and Comorbidities in HCV Patients by Country
        • Key Patient Attributes and Comorbidities in HCV Patients by Physician Speciality
        • Liver Damage in HCV Patients by Country
        • Liver Damage in HCV Patients by Physician Speciality
        • Obstacles to Treatment Initiation and Completion by Country
        • HCV Patient Treatment-Experience Subpopulations by Country
        • HCV Patient Treatment-Experience Subpopulations by Physician Specialty
        • HCV Patient Treatment-Experience Subpopulations Currently Receiving Treatment by Physician Specialty
        • Proportion of Treatment-Naive Noncirrhotic Genotype 1 Patients by Country
        • Baseline Viral Loads in Treatment-Naive Noncirrhotic Genotype 1 HCV Patients
        • Time to Treatment Initiation Following HCV Diagnosis by Physician Speciality
        • Patient Share of Noncirrhotic and Cirrhotic Genotype 1 Patients by Physician Specialty
        • Patient Share of Noncirrhotic and Cirrhotic Genotype 2 Patients by Physician Specialty
        • Patient Share of Noncirrhotic and Cirrhotic Genotype 3 Patients by Physician Specialty
        • Anticipated Prescribing of Current and Emerging HCV Therapies by Physician Specialty
        • Duration of Sovaldi + Daklinza Regimens Prescribed to Genotype 3 HCV Patients by Physician Specialty
        • Failure to Achieve SVR by HCV Regimen and by Physician Specialty
        • Relapse Rate by HCV Regimen and by Physician Specialty
        • Patient Share of Select Regimens in Genotype 1 HCV Subpopulations by Physician Specialty
        • Treatment Discontinuation Rate by HCV Regimen and Physician Specialty
        • Time to Treatment Discontinuation by HCV Regimen and Physician Specialty
        • Reasons for Therapy Discontinuation by HCV Regimen and Physician Specialty
        • Changes in Prescribing of HCV Therapies in the Past Six Months by Physician Specialty

Author(s): Steven F. Trueman, PhD

Steve is a member of Decision Resources Group’s Infectious, Niche, and Rare Diseases (INRD) team. Currently, he provides analyses and content production on infections caused by the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV).

Steve conducted his postdoctoral research on models of neurodegenerative disease in the Department of Biochemistry at Brandeis University. He earned a doctorate in biochemistry from the University of Massachusetts Medical School, Graduate School of Biomedical Sciences, where he studied protein translocation into the endoplasmic reticulum.