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. The 2013-2015 FDA approvals of Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) combined with Bristol Myers Sqibb’s Daklinza (daclatasvir) and AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir) has ushered in the era of IFN-free therapy for chronic HCV infections and have completely reshaped the HCV therapeutic market. Recent approval of Merck’s Zepatier (elbasvir/grazoprevir) has provided an additional interferon-free option for genotype 1 and 4 patients. Taken together, currently approved regimens provide efficacious interferon-free options for most HCV genotypes. This research focuses on current and anticipated use of all-oral HCV regimens, including IFN-free and remaining IFN-based regimens, by capturing patient market share data, current prescribing trends and anticipated changes in prescribing and treatment behavior. For key brands, physician perceived drivers and limitations to prescribing behavior, and sales force performance will be evaluated.

Table of contents

  • Hepatitis C Virus - Current Treatment - Detailed, Expanded Analysis (US)
    • Key Updates
      • March 2017
        • May 2017
        • Physician Prescribing Practices
          • Key Findings
          • Patient Characteristics
            • High Rates of DAA Exposure in Treatment-Experienced Population
            • Genotypic Makeup of HCV Patients Managed by Physicians (Survey Data)
            • Subgenotyping of Genotype 1 Patients (Survey Data)
            • Key Patient Attributes and Comorbidities in HCV Patients (Survey Data)
            • Liver Damage in HCV Patients (Survey Data)
            • Treatment-Naive and Treatment-Experienced HCV Patients (Survey Data)
            • Baseline Viral Loads in Non-Cirrhotic Genotype 1 HCV Patients (Survey Data)
            • Percentage of Genotype 1a HCV Patients Screened for Baseline RAVs (Survey Data)
            • Baseline RAVs Detected in Genotype 1a HCV Patients (Survey Data)
            • Treatment Experience by Regimen and Genotype in Treatment-Experienced HCV Patients (Survey Data)
            • Treatment Experience by Regimen and Genotype in Treatment-Experienced HCV Patients, Split by Physician Specialty (Survey Data)
          • Treatment Practices
            • Treatment Rates High in HCV Population, and Harvoni is Preferred Regimen
            • Time to Treatment Start Driven by Payer Dynamics
            • More than Half of HCV Patients are Currently Undergoing Treatment
            • Number of Total Patients and HCV Patients Under Management by Physicians (Survey Data)
            • Percentage of HCV Patients Compared to Total Patients Under Management by Physicians (Survey Data)
            • Number of HCV Patients Under Management by Physicians and Those Being Actively Treated (Survey Data)
            • Percentage of HCV Patients Being Actively Treated (Survey Data)
            • Gilead Regimens Highly Utilized in Every HCV Genotype
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 1 Patients (Survey Data)
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 1 Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 2 Patients (Survey Data)
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 2 Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 3 Patients (Survey Data)
            • Patient Share for Non-Cirrhotic and Cirrhotic Genotype 3 Patients, Split by Physician Specialty (Survey Data)
            • Harvoni Outperforms the Competition on Treatment Duration
            • Nonpharmacological Are Not Typically Prescribed for HCV
            • HCV Patients Are Characterized on the Basis of Prior Treatment and Response
            • High Treatment Rates Are Noted for Treatment-Naive Non-Cirrhotic Patients
            • Treatment Rates of HCV Patients Split by Genotype, Liver Damage, and Treatment Experience (Survey Data)
            • Timing of Retreatment After Failure Varies
            • Harvoni Dominates the HCV Genotype 1 Market
            • Treatment Approach in Non-Cirrhotic and Cirrhotic HCV Patients (Survey Data)
            • Treatment Approach in Non-Cirrhotic and Cirrhotic HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 1 HCV Patients (Survey Data)
            • Patient Share for Selected Regimens in Treatment-Naive Non-Cirrhotic Genotype 1a HCV Patients (Survey Data)
            • Patient Share for Selected Regimens in Treatment-Naive Cirrhotic Genotype 1b HCV Patients (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 1 HCV Patients (Survey Data)
            • Patient Share for Selected Regimens in Treatment-Experienced Non-Cirrhotic Genotype 1a HCV Patients (Survey Data)
            • Patient Share for Selected Regimens in Treatment-Experienced Cirrhotic Genotype 1b HCV Patients (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 2 HCV Patients (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 2 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 2 HCV Patients (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 2 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 3 HCV Patients (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 3 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 3 HCV Patients (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 3 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Selected Regimens in Subpopulations of Genotype 1 HCV Patients (Survey Data)
            • Short-Duration Regimen of Harvoni is Underutilized, While Daklinza Regimens Remain Costly
            • Duration of Harvoni Regimens Prescribed to Treatment-Naive Non-Cirrhotic Genotype 1 HCV Patients (Survey Data)
            • Duration of Zepatier Regimens Prescribed to Treatment-Naive Genotype 1 HCV Patients (Survey Data)
            • Duration of Harvoni Regimens Prescribed to Treatment-Experienced Cirrhotic Genotype 1 HCV Patients (Survey Data)
            • Duration of Zepatier Regimens Prescribed to Treatment-Experienced Genotype 1 HCV Patients (Survey Data)
            • Duration of Sovaldi + Daklinza Regimens Prescribed to Treatment-Naive Genotype 3 HCV Patients (Survey Data)
            • Duration of Sovaldi + Daklinza Regimens Prescribed to Treatment-Experienced Genotype 3 HCV Patients (Survey Data)
            • All HCV Regimens Are Combination Therapies
          • Persistency and Compliance
            • At Least 95% of HCV Patients Complete IFN-Free Regimens
            • Treatment Discontinuation Rate by HCV Regimen (Survey Data)
            • Time to Treatment Discontinuation by HCV Regimen (Survey Data)
          • Sequencing of Treatment
            • Harvoni-Treated Patients Unlikely to be Switched After Failure
            • Failure to Achieve SVR by HCV Regimen (Survey Data)
            • Relapse Rate by HCV Regimen (Survey Data)
            • Retreatment Rates After Previous DAA Failure by HCV Regimen (Survey Data)
            • Retreatment Approach After Previous DAA Failure by HCV Regimen (Survey Data)
            • Preferred Retreatment Approach in Hypothetical DAA Failure by HCV Regimen (Survey Data)
            • Preferred Retreatment Approach in Hypothetical DAA Failure by HCV Regimen, Gastroenterologists (Survey Data)
            • Preferred Retreatment Approach in Hypothetical DAA Failure by HCV Regimen, Hepatologists (Survey Data)
            • Preferred Retreatment Approach in Hypothetical DAA Failure by HCV Regimen, Infectious Disease Specialists (Survey Data)
          • Recent/Anticipated Changes in Brand Usage/Treatment Approach
            • Viekira Pak and Technivie Stand to Lose Market Share
            • Changes in Prescribing of HCV Therapies in the Past Six Months (Survey Data)
            • Changes in Prescribing of HCV Therapies in the Past Six Months, Split by Physician Specialty (Survey Data)
            • Changes in Prescribing of HCV Therapies in the Past Six Months and Next Six Months (Survey Data)
            • Anticipated Prescribing of Current and Emerging HCV Therapies (Survey Data)
            • Anticipated Prescribing of Current and Emerging HCV Therapies, Gastroenterologists (Survey Data)
            • Anticipated Prescribing of Current and Emerging HCV Therapies, Hepatologists (Survey Data)
            • Anticipated Prescribing of Current and Emerging HCV Therapies, Infectious Disease Specialists (Survey Data)
        • Physician Insight on Medical Practice
          • Key Findings
          • Drivers of Treatment Selection
            • Efficacy and Safety/Tolerability Reign Supreme
            • Genotype 1 Efficacy and Safety/Tolerability Are Important Attributes
            • Changes in the Number of Patients Initiating or Completing HCV Therapy (Survey Data)
            • Drivers of Treatment Initiation and Completion (Survey Data)
            • Importance of Clinical Efficacy Attributes in Prescribing Practices for HCV (Survey Data)
            • Importance of Nonclinical Attributes in Prescribing Practices for HCV (Survey Data)
            • Awareness of the February 2016 Update to AASLD-IDSA HCV Treatment Guidelines (Survey Data)
            • Impact of the February 2016 Update to AASLD-IDSA HCV Treatment Guidelines (Survey Data)
            • Efficacy and Increased HCV Patient Load Drive Prescribing
            • Major Drivers of Prescribing of Key HCV Regimens (Survey Data)
            • Reasons for Increased Prescribing of Key HCV Brands (Survey Data)
            • Drug Cost and Insurance Coverage Remain Main Obstacles to Prescribing
            • Major Obstacles to Prescribing of Key HCV Regimens (Survey Data)
            • Reasons for Decreased Prescribing of Key HCV Brands (Survey Data)
            • Treatment Switching is Rare, but Result of Failure or Relapse
            • Treatment Discontinuation Most Common for IFN Regimens
            • Treatment Deferral is Likely Driven by Patient Access
          • Face-to-Face Product Detailing Effectiveness
            • Genotype 1 Regimens Dominate the Discussion
            • Sales Representatives for Harvoni and Zepatier Are Actively Engaging Physicians
            • Pharmaceutical Sales Representative Access Restricted? (Survey Data)
            • Sales Representative Contact by HCV Therapy (Survey Data)
            • Frequency of Sales Representative Detailing by HCV Therapy (Survey Data)
            • Most Recent Sales Representative Contact by HCV Therapy (Survey Data)
            • Sample or Voucher Availability During Most Recent Sales Representative Visit by HCV Therapy (Survey Data)
            • Physicians Note Few Differences in Sales Representative Satisfaction
            • Level of Satisfaction with Pharmaceutical Sales Representative by HCV Therapy (Survey Data)
            • Frequent Discussions Include Indications, Safety, and Prescribing Practices
            • Aided Messages from Recent HCV Detailing (Survey Data)
        • Methodology
          • Primary Market Research Methodology
          • Physician Specialties (Survey Data)
          • Years in Practice Post-Residency (Survey Data)
          • Regional Practice Location (Survey Data)
          • State Practice Location (Survey Data)
        • Appendix
          • Primary Market Research
            • Number of Physicians at Practice Location (Survey Data)
            • Practice Type (Survey Data)
            • Practice Location (Survey Data)
            • Awareness of Current and Emerging HCV Therapies (Survey Data)
            • Prescribing of Current HCV Therapies Within the Past Six Months (Survey Data)
            • Prescribing of Emerging HCV Therapies Within the Past Six Months as Part of a Clinical Trial (Survey Data)
            • Treatment-Naive and Treatment-Experienced HCV Patients, Split by Physician Specialty (Survey Data)
            • Changes in Number of Patients Initiating or Completing HCV Therapy, Split by Physician Specialty (Survey Data)
            • Barriers to Treatment Initiation or Completion (Survey Data)
            • Treatment Rates for HCV Patients Split by Genotype, Liver Damage, and Treatment Experience, Gastroenterologists (Survey Data)
            • Treatment Rates for HCV Patients Split by Genotype, Liver Damage, and Treatment Experience, Hepatologists (Survey Data)
            • Treatment Rates for HCV Patients Split by Genotype, Liver Damage, and Treatment Experience, Infectious Disease Specialists (Survey Data)
            • Patient Share for Treatment-Naive Non-Cirrhotic and Cirrhotic Genotype 1 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Treatment-Experienced Non-Cirrhotic and Cirrhotic Genotype 1 HCV Patients, Split by Physician Specialty (Survey Data)
            • Patient Share for Selected Regimens in Subpopulations of Genotype 1 HCV Patients, Gastroenterologists (Survey Data)
            • Patient Share for Selected Regimens in Subpopulations of Genotype 1 HCV Patients, Hepatologists (Survey Data)
            • Patient Share for Selected Regimens in Subpopulations of Genotype 1 HCV Patients, Infectious Disease Specialists (Survey Data)
            • Retreatment Rates After Previous DAA Failure by HCV Regimen, Split by Physician Specialty (Survey Data)
            • Major Drivers of Prescribing of Key HCV Regimens, Gastroenterologists (Survey Data)
            • Major Drivers of Prescribing of Key HCV Regimens, Hepatologists (Survey Data)
            • Major Drivers of Prescribing of Key HCV Regimens, Infectious Disease Specialists (Survey Data)
            • Major Obstacles to Prescribing of Key HCV Regimens, Gastroenterologists (Survey Data)
            • Major Obstacles to Prescribing of Key HCV Regimens, Hepatologists (Survey Data)
            • Major Obstacles to Prescribing of Key HCV Regimens, Infectious Disease Specialists (Survey Data)
            • Reasons for Increased Prescribing of Key HCV Brands, Gastroenterologists (Survey Data)
            • Reasons for Increased Prescribing of Key HCV Brands, Hepatologists (Survey Data)
            • Reasons for Increased Prescribing of Key HCV Brands, Infectious Disease Specialists (Survey Data)
            • Reasons for Decreased Prescribing of Key HCV Brands, Gastroenterologists (Survey Data)
            • Reasons for Decreased Prescribing of Key HCV Brands, Hepatologists (Survey Data)
            • Reasons for Decreased Prescribing of Key HCV Brands, Infectious Disease Specialists (Survey Data)

      Author(s): James Heeres, PhD; Brenda A. Perez-Cheeks

      James is a part of the infectious, niche markets, and rare diseases team at DRG. His work involves evaluating treatment landscape, unmet needs, emerging therapy positioning, commercial potential, drug development opportunities, and company competitiveness. Currently, his concentration is in hepatitis C virus (HCV) infection in US and EU5 markets.

      James earned his Ph.D. in biochemistry from the University of Illinois at Urbana-Champaign while studying high-throughput screening technologies and small-molecule inhibitors of apoptosis. Prior to joining DRG, his postdoctoral studies involved drug discovery and development in neurodegenerative diseases at both Harvard Medical School and Boston University School of Medicine.