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Clinical Trial Risk in Hepatitis C: Endpoint Selection and Drug Action

Nicole A Tillie1, Jayson L Parker1, Jordan J Feld2

  • 1Department of Biology, University of Toronto Mississauga, 3359 Mississauga Road, Mississauga, ON, Canada L5L 1C6.

Canadian Journal of Gastroenterology & Hepatology
|July 23, 2016
PubMed

Insights

The overall success rate for new hepatitis C drugs in clinical trials was 20%, double industry expectations. Viral inhibitor small molecule drugs showed the lowest failure risk, indicating promise for hepatitis C treatment development.

Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Hepatitis C virus (HCV) infection remains a significant global health concern.
  • Effective antiviral therapies are crucial for managing HCV and preventing long-term complications.
  • Assessing the efficacy and risks of novel drug candidates is vital for successful treatment strategies.

Purpose of the Study:

  • To analyze the clinical trial failure risk of new hepatitis C drugs.
  • To compare observed success rates against industry expectations.
  • To identify drug characteristics associated with lower failure rates.

Main Methods:

  • Retrospective analysis of Phase I-III clinical trials for hepatitis C drugs (1998-2015).
  • Data sourced from public clinical trial repositories and databases.
  • Exclusion criteria included pre-1998 initiation, non-industry sponsorship, and treatment of secondary complications.

Main Results:

  • 123 unique drug compounds met inclusion criteria; 8 received FDA approval.
  • The cumulative pass rate for hepatitis C drugs was 20%, twice the industry norm.
  • Viral inhibitor small molecules demonstrated significantly lower failure risks compared to other drug classes.

Conclusions:

  • Approximately 20% of hepatitis C drugs entering clinical trials achieve market approval.
  • Viral inhibitor small molecules represent the most promising therapeutic class with the lowest risk profile.

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