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Development and Marketing of INCIVEK (Telaprevir; VX-950): A First-Generation HCV Protease Inhibitor, in Combination with PEGylated Interferon and Ribavirin

  • Ann D. KwongEmail author
  • Robert B. Perni
  • Camilla S. Graham
Chapter
Part of the Topics in Medicinal Chemistry book series

Abstract

In the years before the development of direct-acting antiviral (DAA) drugs, patients were treated with a toxic combination of PEGylated interferon (P) and ribavirin (R) which was associated with a low success rate in patients with the most common genotype 1 hepatitis C virus (HCV) infection (40–50%), significant treatment-limiting side effects, and a long (48-week) duration of treatment. The HCV protease inhibitor telaprevir (VX-950) was discovered as part of a research collaboration between Vertex and Eli Lilly scientists. Clinical development of telaprevir in combination with PEGylated interferon alfa plus ribavirin (PR) was in collaboration with Tibotec (Janssen) and Mitsubishi Tanabe Pharma. INCIVEK (telaprevir) in combination with PR was approved in 2011, 10 days after the approval of Schering-Plough/Merck’s HCV protease inhibitor VICTRELIS (boceprevir), also in combination with PR. Both INCIVEK and VICTRELIS had similar safety and tolerability concerns, similar efficacy, three times daily dosing, and similarly complex treatment plans requiring significant attention by medical personnel. INCIVEK’s list price was higher than VICTRELIS, and INCIVEK was Vertex’s first launch, whereas Schering-Plough had been a HCV market leader with sales of Peg-INTRON/Rebetron. This chapter will briefly review the scientific challenges faced in the development of telaprevir and INCIVEK, as this story has been the subject of numerous review articles and book chapters. More emphasis will be given to the lesser-known story of how Vertex worked to prepare the HCV market, and we will unpack the variables contributing to the conundrum of why, despite being similar drugs, INCIVEK significantly outsold VICTRELIS.

Keywords

Boceprevir HCV HCV protease INCIVEK PI Telaprevir VICTRELIS VX-950 

Notes

Compliance with Ethical Standards

Conflict of Interest Robert B. Perni, Camilla S. Graham, and Ann D. Kwong were employees of Vertex Pharmaceuticals.

Ethical Approval

All applicable international, national, and/or institutional guidelines for the care and use of animals were followed.

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all patients who participated in the studies.

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Copyright information

© Springer Nature Switzerland AG  2019

Authors and Affiliations

  • Ann D. Kwong
    • 1
    Email author
  • Robert B. Perni
    • 2
  • Camilla S. Graham
    • 3
  1. 1.Kwong Pharma Consulting, LLCPepperellUSA
  2. 2.JMD Pharma Creativity LLCMarlboroughUSA
  3. 3.Beth Israel Deaconess Medical CenterBostonUSA

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