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Discontinued drugs in 2012 - 2013: hepatitis C virus infection
Ivan Gentile1, Antonio Riccardo Buonomo, Emanuela Zappulo
1University of Naples 'Federico II', Department of Clinical Medicine and Surgery (Ed. 18) , via S. Pansini 5,I-80131, Naples , Italy +39 81 7463178 ; +39 81 7463190 ; ivan.gentile@unina.it.
Introduction:
Hepatitis C virus (HCV) chronically infects about 150 million people worldwide. Antiviral treatment can stop and even reverse the progression of the disease. Several antivirals have been developed. However, about 10,000 compounds are tested for each drug that eventually reaches the market. It would be useful to learn from these failures, for example, by reporting the candidate drugs that were discontinued and the reason for discontinuation.
Areas Covered:
This article focuses on the anti-HCV drug candidates discontinued between 1 January 2012 and 1 January 2014.
Expert Opinion:
In detail, 17 drugs were discontinued. Of these: 10 were NS5B inhibitors, 3 were NS5A inhibitors, 2 were immunostimulants, 1 was a therapeutic and prophylactic vaccine and 1 an NS3 inhibitor. Only 3 candidates were discontinued in the preclinical phase, and 14 were discontinued during clinical development (8 in Phase II and 6 in Phase I). Most discontinuations were attributed to corporate strategic decisions. The authors believe that learning from HCV drug development failures will help pharmaceutical companies and researchers to develop better strategies for the future. It is therefore important that this information is made available.
Insights
Analyzing Hepatitis C virus (HCV) drug development failures between 2012-2014 reveals 17 discontinued candidates, primarily due to strategic decisions. Learning from these failures is crucial for future antiviral drug discovery.
Area of Science:
- Hepatology and Viral Disease Research
- Pharmaceutical Development and Drug Discovery
Background:
- Hepatitis C virus (HCV) affects 150 million globally, necessitating effective antiviral treatments.
- Drug development for HCV is lengthy, with thousands of compounds tested per successful drug.
- Understanding reasons for drug candidate discontinuation is vital for improving future strategies.
Purpose of the Study:
- To analyze anti-HCV drug candidates discontinued between January 1, 2012, and January 1, 2014.
- To identify the types of drug candidates and the phases at which they were discontinued.
- To highlight the reasons behind these discontinuations to inform future research and development.
Main Methods:
- Focused review of anti-HCV drug candidates that were discontinued during a specific two-year period.
- Categorization of discontinued drugs by their inhibitory targets (e.g., NS5B, NS5A, NS3) and development phase (preclinical, Phase I, Phase II).
Main Results:
- Seventeen anti-HCV drug candidates were discontinued.
- The majority were NS5B inhibitors (10) and NS5A inhibitors (3).
- Most discontinuations (14) occurred during clinical development (8 in Phase II, 6 in Phase I), with corporate strategy cited as the primary reason.
Conclusions:
- Discontinuation of HCV drug candidates, particularly in later development stages, is often driven by strategic business decisions rather than solely efficacy or safety.
- Analyzing these failures provides valuable insights for optimizing future antiviral drug development pipelines.
- Making information on discontinued drug candidates publicly available can accelerate progress in combating HCV.
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