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Hepatitis C: KOL Insight

Hepatitis C: KOL Insight

Introduction

The Hepatitis C (HCV) market will be driven by meeting the needs of under-served patient populations, reducing treatment duration and pricing regimens competitively. The market has grown 5 fold since the introduction of Gilead’s Solvadi in 2014, and BMS Daklinza (daclatasvir), Abbvie’s Viekira Pak/Viekirax plus Exviera (paritaprevir/ombitasvir/dasabuvir) have extended therapy options. New broader acting dual and triple combinations providing high SVR and shorter duration of treatment are on the horizon – but the price must be affordable. Can Gilead’s current dominance be challenged and how do KOL’s view the next generation of DAA therapies?

This comprehensive report reveals the unique insights of 12 leading US and European KOLs – see who they are. How they view the clinical benefits of current and late-stage products, what influence the patient’s condition has on treatment choice and concerns about spiralling costs that determine therapy choice are fully explored. The report analyses 5 leading launched products and 7 significant late stage therapies – see full list.

Reasons to Purchase

Answering key questions

  • Do KOLs look favourably on the prospect for an 8 week course of Gilead’s Harvoni for GT4 patients and how might that impact Abbvie’s Technivie/Viekirax?
  • Despite price advantages, Abbvie’s Technivie/Viekirax is not finding traction in the market – where do KOLs see its future?
  • Is there a place for Johnson & Johnson’s Olysio in the treatment paradigm, and will ongoing trials change perceptions?
  • Clinical trial results for Bristol Myers Squibb’s Daklinza for GT3 patients looks promising – how does the data stack up against competing therapies and can it differentiate itself in the market?
  • Will Merck & Co.’s Grazoprevir/MK-3682/MK-8408 triple DAA regimen be the next game changer in HCV, and does it have advantages over AbbVie’s promising ABT-493/ABT-530 dual therapy?
  • Who’s leading the drive for shorter treatment durations: payers or clinicians?
  • With the high cost of treatment, compliance is critical: can industry practically respond?
Top Takeaways
  • A diverse patient pool: Estimate how many HCV patients there are by genotype in the US and Europe and examine how this patient pool will change as treatment advances
  • The impact of co morbidities: Assess how co-morbidities such as cirrhosis, fibrosis and renal impairment impact prescribing decisions
  • Getting the price right: Evaluate the contentious issue of pricing and its impact on formulary placement and uptake
  • What are US/EU differences?: Appreciate how differing labels and prices are impacting drug choice in US and Europe
  • Optimal treatment duration: Know the importance of treatment duration and formulate strategies to develop niches and drive differentiation
  • The next generation: Understand how pipeline pangenotypic dual and triple combination therapies may fit into the treatment paradigm, and identify launched products that will be positively or adversely affected
  • Research points the way: Review KOL attitudes to recently completed or ongoing clinical trials such as RUBY, AGATE, IMPACT, COMMIT, ACCORDION, ALLY and SURVEYOR
Key Issues Explored
  • Serious concerns about the cost of HCV drugs have been expressed, leading to payers prioritising patients and limiting access. Clinicians will prescribe the best therapy they can, as long as it’s available and reimbursed, so opportunities exist for new entrants with progressive pricing policies
  • The advent of broad spectrum pangenotypic oral drugs could see treatment move from secondary to primary care – could this open the market to wider prescribing, and what needs to be considered?
  • The drive is to shorten treatment durations – is 4 weeks possible?
  • With such high costs associated with HCV therapies, ensuring patients take the full course of treatment to fully benefit is critical, yet the lifestyle challenges of many HCV patients means they do not always comply. Can industry do anything really practical to help?
  • Product differentiation is critical in getting formulary placement. Knowing what product attributes and patient characteristics KOLs think are the most important in terms of prescribing decisions are must-knows in order to better position a therapy for commercial success
  • What are the unmet needs that KOLs identify as being most important to address?
A report based on expert knowledge

US KOLs
  • Brian Edlin - Weill Cornell Medical Center, New York Center for the Study of Hepatitis C
  • Sammy Saab - Professor and Head, Outcomes Research in Hepatology, Pfleger Liver Institute, David Geffen School of Medicine, UCLA, Los Angeles, USA.
  • Mitchell L Shiffman - Director of the Liver Institute of Virginia at the Bon Secours Virginia Health System and Professor of Medicine at the Eastern Virginia Medical School in Norfolk, Virginia.
  • David Wyles - Associate Professor of Medicine at the University of California San Diego.
  • Vinay Sundaram - Assistant medical director of liver transplantation at Cedars-Sinai Medical Center in Los Angeles, California.
  • Anonymous KOL - Professor of Medicine, US.
KOLs from Europe:
  • Luis Rodrigo - Doctor in Medicine and Specialist in Gastroenterology and Hepatology and Professor of Medicine at the University of Oviedo.
  • Giorgio Barbarini - Infectious Disease and Hepatology Physician in the Clinic of Infectious and Tropical Diseases Foundation IRCCS Polyclinic San Matteo-University of Pavia.
  • Ashley Brown - Consultant Hepatologist at St. Mary’s and Hammersmith Hospitals in London, and an Adjunct Reader at Imperial College.
  • Steve Ryder - Consultant Hepatologist, Nottingham University Hospitals NHS Trust and Biomedical Research Unit.
  • Anonymous German KOL – Professor of Medicine. A renowned expert whose clinical focus is on acute and chronic liver diseases.
  • Anonymous French KOL – Professor of Medicine and Head of Department of Internal Medicine and Infectious Diseases. An expert in HCV therapy with a specialism in HCV/HIV co-infection.
Get detailed KOL views on:

Marketed HCV Drugs
  • Gilead Sciences: Sovaldi (sofosbuvir)
  • Gilead Sciences: Harvoni (sofosbuvir/ledipasvir)
  • AbbVie: Viekira Pak/Viekirax+Exviera (paritaprevir/ombitasvir/dasabuvir)
  • ohnson and Johnson: Olysio (simeprevir)
  • Bristol Myers Squibb: Daklinza (daclatasvir)
HCV Pipeline
  • Bristol Myers Squibb: Daclatasvir/asunaprevir/beclabuvir (DCV Trio)
  • Gilead Sciences: Sofosbuvir/velpatasvir
  • Gilead Sciences: Sofosbuvir/velpatasvir/GS-9857
  • Merck & Co.: Grazoprevir/elbasvir
  • Merck & Co.: Grazoprevir/MK-3682/MK-8408
  • AbbVie: ABT-493/ABT-530
  • Johnson & Johnson: odalasvir/NS34A inhibitor/nucleotide NS5B inhibitor
Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends clients up to date with regular update bulletins offers a real commercial advantage.

Consider the benefits:
  • Regular updates to cover significant market events such as new product approvals or pivotal research results will be covered with primary market research with preeminent KOLs
  • Each update bulletin provides Therapy Trends clients with fresh expert insights on the likely impact of the latest market developments
  • Therapy Trends clients get access to the results of primary research through Research Update Bulletins – brief reports that bring the impact of the latest events into sharp focus
  • All updates are included in the price.
  • Bristol Myers Squibb: Daklinza (daclatasvir)
  • HCV Pipeline


1. Executive summary
2. Research objectives
3. Research focus
4. HCV market overview: patient and treatment dynamics
4.1. 5.7 million persons have chronic HCV infection in the US and Europe
4.2. Harvoni is the dominant therapy but sales growth slows
4.3. Forty percent of patients have severe or very severe fibrosis
4.4. Treatment access restrictions may be eased once additional regimens are approved
4.5. Harvoni favoured by US payers despite approval of a lower priced alternative
5. Current treatments
5.1. Gilead Sciences: Sovaldi (sofosbuvir)
5.2. Key insights summary
5.3. Drug summary
5.4. Sofosbuvir plus PEG-IFN/RBV has impressive efficacy in GT3 patients
5.5. Gilead Sciences: Harvoni (sofosbuvir/ledipasvir)
5.6. Key insights summary
5.7. Drug summary
5.8. Eight week course is widely used to treat GT1 infections
5.9. Harvoni has encouraging efficacy in decompensated cirrhotics
5.10. An eight week course is feasible in GT4 infections
5.11. Harvoni is least effective in GT3 infections
5.12. AbbVie: Viekira Pak/Viekirax+Exviera (paritaprevir/ombitasvir/dasabuvir)
5.13. Key insights summary
5.14. Drug summary
5.15. Excellent efficacy in GT1 patients but Harvoni still preferred
5.16. Grazoprevir/elbasvir more attractive in patients with renal impairment
5.17. AbbVie: Technivie/Viekirax (paritaprevir/ombitasvir)
5.18. Key insights summary
5.19. Drug summary
5.20. A lower-cost alternative to Harvoni in GT4 infections
5.21. Johnson and Johnson (J&J): Olysio (simeprevir)
5.22. Key insights summary
5.23. Drug summary
5.24. Harvoni makes the Olysio plus sofosbuvir regimen redundant
5.25. 6 or 8 weeks of simeprevir/daclatasvir/sofosbuvir may reduce costs
5.27. Bristol Myers Squibb: Daklinza (daclatasvir)
5.28. Key insights summary
5.29. Drug summary
5.30. Little role in treatment of GT1 infections due to high cost
5.31. A promising regimen for GT3 patients
6. Pipeline drugs
6.1. Overview
6.2. Bristol Myers Squibb: Daclatasvir/asunaprevir/beclabuvir
6.3. Gilead Sciences: Sofosbuvir/velpatasvir
6.4. Gilead Sciences: Sofosbuvir/velpatasvir/GS-9857
6.5. Merck & Co.: Grazoprevir/elbasvir
6.6. Merck & Co.: Grazoprevir/MK-3682/MK-8408
6.7. AbbVie: ABT-493/ABT-530
6.8. Johnson & Johnson: odalasvir/NS34A inhibitor/nucleotide NS5B inhibitor
7. KOL biographies
7.1. KOLs from North America
7.2. KOLs from Europe

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